Talk:Breast implant

Archived discussions

• Archive 1
• Archive 2 (to 30 April 2006)

Anonymous Editors Making Major Edits

I would like to make a request that the edits of anonymous editors be deleted and the original material restored. This article has been very contentious, and I see an edit war re-occurring. The edits I had made previously did not delete large amounts of material that was already in the article. The recent editor has made major edits and I have restored most of what was there earlier, although I did include a study he included, with a proper context. I would request also that further edits of any kind be done on the page David provided -- and that any edits not discussed here or changed on that off-line page be deleted.molly bloom 00:41, 29 April 2006 (UTC)

• Thank you Molly - indeed all article editing, for now, should be to the 2 subpages as this article is in process of being SPLIT (see above). Also given prior edit-war, please engage in this talk-page discussion before making any significant additions or deletions to the list of studies included.
• I have therefore reverted the article back to its point prior to splitting the 2 sub pages on 25th April. Sorry Molly, can you transfer any appropriate edits across there too, otherwise dealing with the subpage work-in-progress will be impossible if the main article is also being edited in parrallel (for this reason we will need to knock the subpages into reasonable shape over the next 1-2 weeks so that the split can be made live).
• I intend to work more heavily on the subpages (revising the English as well as posing specific questions on how to expand up some of the risks debate with info Molly & others have previously had common ground over) after this (UK) May Bank-holiday weekend, so I'll be back in a few days.... David Ruben ^Talk 02:49, 29 April 2006 (UTC)

Sure, David, that will be fine. Thank you.molly bloom 03:54, 29 April 2006 (UTC)

David, I am not sure where we are now. Rob Oliver gutted the entire working articles and changed them without comment or discussion. I reverted back to the original, but I think I lost your inclusion of rupture in the local complications. Would you help with that, please? We had agreed to include a limited discussion of rupture in the 'local complications' in the main article, and discuss at length in the 'Risk & Controversy' section. I don't know how we are going to come up with any kind of article, because so far Rob refuses to cooperate not just with me, but with you and other editors as well.molly bloom 00:39, 1 May 2006 (UTC)

NCI update

NCI longitudinal update added in oncolgy section Droliver 16:35, 29 April 2006 (UTC)

Reversion of Oliver's Edit pursuant to requests by Wiki editors

I have reverted this major edit by Oliver, again. Perhaps someone else can discuss this with Oliver, as he has either not read or chooses to ignore the requested format in discussing and editing this article.

I will be happy to suggest edits in the fashion requested by those who have posted above (David, Encephalon etc). Again, in the interest of NPOV and civility, I ask that some others discuss this with Oliver. molly bloom 03:01, 30 April 2006 (UTC)

Molly, what I added was the update on that material put out last week verbatim from the NCI in their press release (which you can look up on the NCI page) on the material in that paragraph. That is about as non-controversial as it gets & if you can think of a compelling reason not to update this, please elaborate.I will respectively submit that anyone can look at the revision history of this article to see who has observed the requested editing/revision break & who has not.

Droliver 13:50, 30 April 2006 (UTC)

Yes, there is a compelling reason. If you read the discussion above, David, Encephalon and others have requested that you use the off-line article to make edits where all can discuss and edit offline. That is the reason for the revert. In fact, if you look at the history in the article, David specifically requested that we do this. David provided the off-line article to do this in.

Also, I don't appreciate your simply deleting all that I wrote. That is not cooperation, Oliver.molly bloom 16:27, 30 April 2006 (UTC)

"cooperation" does not mean that you continue to edit/revise with impunity & then get to blow the whistle when NEW material is added. I took the initiative to sharply reshape the draft when no one was touching the offline edits for days as I understood that's where we were to do it, while leaving subtle changes for the main. Your "deleted" material replaced my work in those areas prior (Which you deleted BTW) & is I feel both inflated & distorted 65.89.98.20 19:28, 1 May 2006 (UTC)rob

Discussion

"All article editing, for now, should be to the 2 subpages as this article is in process of being SPLIT (see above). Also given prior edit-war, please engage in this talk-page discussion before making any significant additions or deletions to the list of studies included."

Rob gutted the working article, without discussion. The idea of that is to DISCUSS changes with other editors, not gut all their work. We will never get a working article with this lack of cooperation. Edits that are not discussed will be reverted. Hopefully, we can get input from other editors as well. I am going to ask Dr. Laub to contribute here. Perhaps he and Dr. Melmed (the other plastic surgeon) can help. Dr. Laub is also a professor of medicine.

I agree with Dr. Laub that the existing majority view (if there is one, since the FDA has not yet approve silicone implants and other countries also do have restrictions) should be included. However, that should be in the context of the whole, and not a sentence that dismisses all controversy. The local complications should not be confined only to contracture, either, since there are other complications unique, or at least of special concern, to breast implants. We already have deleted complications that are risks with any surgery and not important to the BI article. As to the table, other editors have stated they thought it inappropriate.

I have taken Dr. Laub's suggestion and removed a photo that was a complication of both implants and mastopexy. I also am willing to work on the sections to include other findings. I am not willing to have someone unilaterally and without discussion gut the entire article.

"Qualified to chime in" on the BI article

I am not willing to have this article look like an advertisement for breast implants, or link to Rob's blog as he did on another article (which Rob was told is a conflict of interest and not acceptable in Wikopedia.) On this blog, he suggested I was not qualified to "chime in" on the BI article on Wikopedia. This is quite something, coming from a "doctor" who has been licensed less than a year. To other Wiki editors, he (unsuccessfully) attempted to portray the blog as 'independent', just as he has tried to portray his comments on this article as NPOV. His blog is a personal promotion, and has a link to his personal business website. If Rob attempts to link his blog or personal website to any Wiki article, or continues to ignore all pleas for cooperation, I will ask that he be banned and will take whatever steps I need to take to see that this happens.[User:Jgwlaw|molly bloom]] 23:42, 30 April 2006 (UTC)

Molly, apparently you failed to read the entry re. this article in the context I meant. It's a cautionary tale about the quality of internet medical literature (in general) and controversial areas on wikipedia (in particular)when partisans get involved. You're qualifications to "chime-in" aren't in question, your interest in neutral POV is (in my POV;) ) The entry ends with an admonishment to be skeptical about everything on the web and includes my own writing in that respect. (There have now been several recent articles in the mainstream press now about how controversial Wikipedia topics are being manipulated as well.) About the only commercial element to the blog is the websense-click google ads for which I recieved a check for $0.07 for the first quarter of the year! (which I think was 2 clicks) I have really tried to limit self-promotion in the blog as I hate reading all the other blogs by Plastic Surgeons which are extensions of their practice print ads. Trying to come up with new stuff is why entries come out in spurts when I get interested in something. (Please check out the "commercial" post I added yesterday discussing facial nerve palsy in face-transplants). I put the blog link in when first found out about wikipedia months ago thinking people would be interested in what I'd be writing about- I agree now (being more Wiki-familiar) that it's prob. not what should be attached in the links section of entries. BTW, I've been licensed for nearly 8 years, fully trained in two surgical specialties, completed a fellowship in cosmetic/reconstructive breast surgery, do several breast cases a week, have written on breast surgery, and am an investigator for 2 (soon to be 3) of the FDA adjunct silicone gel studies. So I do feel qualified to chime in.

You are an investigator? Then why do so many plastic surgeons who implant women with silicone implants not follow the rules? Why do so many not tell women they are even a part of the study, and do not provide them with information about it? I am collecting data about this myself. One woman today told me that her plastic surgeon dismissed her health complaints saying that implants couldn't possibly cause her problems (which are very similar to those many women experience with implants) and accused her of 'making it up'. It is no wonder the FDA did not want to use the adjunct studies. It's a joke. This is appalling. I wonder if maybe there is yet another conflict with you being an investigator, since you obviously see no reason to even have an adjunct study. That explains a whole lot.molly bloom 22:51, 1 May 2006 (UTC)

Molly, I do encourage you and anyone else to review & participate in Plastic Surgery 101 as I'm proud of it. It's definately Rob-POV & that's what a blog is for

Rob Oliver Jr. 65.89.98.20 19:19, 1 May 2006 (UTC) (sorry this machine won't accept log-on cookies)

I read the entry exactly as you intended it. You are hardly one to question my 'bias'. I did see that you attended the University of South Alabama. (They used to have a good baseball team.) You graduated in 1998, and the website has your license date as 5/25/05. You were born in 1971. That is what I found. And I was responding to your statement - you clearly attempted to discredit me (but that is not surprising, since you also called the FDA decision 'lunacy').. And yes I am suspicious of some doctors ..doctors like you who have a closed mind and ridicule regulation of your profession. A good doctor, especially one without a lot of experience, would keep an open mind. Instead, I see some plastic surgeons simply ridicule women who fear their breast implants are causing health problems that they did not have prior to implantation. That is astounding, especially since the adjunct study was not intended to be a Murphy's law where the participating surgeons decide the outcome, then plot the curve. But it seems to happen all too frequently. But that is not the issue here. You can do whatever you want on your blog. But you cannot link your personal blogs and business website to Wikopedia. Similarly, you can write whatever you want on your blog, but you cannot do so here, without cooperating with other editors. You have consistently refused to do so, instead making major changes (gutting everything I wrote) and refusing to discuss it on this forum. This is not cooperation. How many people have to request that changes are discussed here - instead of making major changes without comment?molly bloom 19:55, 1 May 2006 (UTC)

Molly that date is for one of my multiple state liscences (TN I think)incidentally some 7 or 8 years after my initial one. I agree 100% with not linking commercial sites to these articles (I still don't consider the blog commercial, but I do get the point) and I would not do that again as I've come to understand the wiki-project better. I myself have been pretty aggressive in removing links Droliver 20:11, 1 May 2006 (UTC)

First, that was not TN, because it was an Alabama website, for the Alabama medical board. But that is not relevant here.

Your blog is very self promoting, and links to your commercial site. That you can't see this is only a reflection of your inability to see your POV here. Your blog is not appropriate for Wikopedia. I also find your blog offensive and I have no interest in contributing to it, other than the statements I made in response to your outrageous statements. You can delete my comments to your heart's content there, but not here. I still don't think you 'get' the Wikopedia project, since you want still to whitewash the BI article. molly bloom 22:33, 1 May 2006 (UTC)

Attempt at Editing

Rob, here is the reason I (and others) do not want to include a chart or table of studies -for or against. This is an excerpt of what David wrote, which identifies the purpose of the article, and the split suggested.

The main article listing of risks needs be kept very small (ie list a concern and summary of view on this as already well done), any fuller explanatipon then is in the sparate risks article. Note I chose 'Risks and Debate' as 'controversy' suggests that risks have not been suggested - they cearly have in some of the research, there is a debate though as other studies are done as to the significance of any single report or critical reading of a single report. Dlaub's comments re likely risks, evidence perhaps not conclusively confirming this yet, surgeons aparent lack of concern for issues or uncertainty well voiced. Can we suggest ways to take the parts of this topic (i.e. the editing sub-pages) to reflect this ? Remember whilst currently well written as an essay on the topic, it is perhaps not the best example (yet) of an encyclopaedic entry in wikipedia - hence the creaion of subpages for collaborative work by editors, as per Encephalons comments above. David Ruben Talk 17:42, 25 April 2006 (UTC)

If you remove the "Risks and Controversy" section, you should still leave the 'local complications' with the main article, since it is not controversial. Nobody disputes that these occur. Secondly, upon separation, you should add 'rupture' and the problem with implants & mammography in the 'local compllication' section since the fact that these occur is not controversial. Further discussion about the problems involved could be in the "Risks and Controversy" section.molly bloom 18:16, 25 April 2006 (UTC)

Indeed - I so moved the local complications to remain within the main article. I mention rupture, but not at length - the fact that it occurs is given, but with quite a lot of info on the rates of rupture and with how this is then responsible (via the leaked silicone) for the local/systemic effects given in the risks article, I did not wish to over duplicate - don't think balance is quite right yet though. David Ruben Talk 21:56, 25 April 2006 (UTC)

Your summarizing and 'tidying up' for an intro paragraph is excellent. Very good intro.molly bloom 18:19, 25 April 2006 (UTC) [edit]

David, your mention of rupture was deleted when Rob deleted the whole section on local complications. Is what I wrote on rupture okay now? There is no belaboring of any of the local complications. They are as short as they can be, without eliminating them altogether, which I refuse to do.molly bloom 22:45, 1 May 2006 (UTC)

Sting Implants

Why is there no information on her about String breast implants? I know it was here before, but where did it go? (unsigned)

It was removed, but I restored it. The non-English links were also removed, so I restored those, too. I recommend that editors be more careful to avoid removing valuable text. Al 15:28, 22 May 2006 (UTC)

Alienus, this article has been contentious and other admins and users have requested that additional links be discussed here first.

String implants were banned a long time ago, and are NOT among the primary types of breast implants. They are unlikely to be reintroduced to the market anytime soon. Also banned were hydrogel implants in the UK, and those are not included in the BI article. That is one thing we all had agreed on. The string implants, however, have a certain 'appeal' to some because they are what adult entertainers used and create cartoonishly large breasts. However, they were also dangerous. There is still debate about the safety of silicone gel implants, but at least they are allowed on the market, so should be included..MollyBloom 17:39, 22 May 2006 (UTC)

I added two other implants, if the consensus is to include those. However, I added a reference and put them in context. The string implants are rarely used anywhere, and were banned in the US completely. I also added 'tissue engineered' implants which are in development.MollyBloom 18:45, 22 May 2006 (UTC)

Ok. There's also a procedure in which saline is injected directly to give a temporary boost in size and perhaps firmness. This is probably a type of implant, however temporary, so I think we should briefly mention it here. Al 20:52, 22 May 2006 (UTC)

Are you not talking about injection into an already-implanted double-lumen or saline implant? I can't imagine the value of injecting saline directly into breast tissue.

We can't possibly mention all the implants ever used or banned - there are many. I still dont' think string implants should be included for that reason, but I have no major objection.MollyBloom 00:08, 23 May 2006 (UTC)

No, I'm definitely talking about directly injecting saline into the breasts, as per this link. It's not popular and I couldn't quickly find a more reliable source.

As for how many types to mention, while I certainly don't want rare and unavailable types to dominate the article, a line or two max should be fine. Comprehensiveness is worth the small cost in space, I'd say. Al 02:45, 23 May 2006 (UTC)

Other languages

Sorry I deleted that - that was inadvertant. I meant only to delete the Inamed promotion on Inamed's 'bouncy breast implants' that had initially been added. MollyBloom 17:43, 22 May 2006 (UTC)

Images

I just wandered into this article and noticed something rather surprising: the images of ruptured and damaged implants are duplicated, while there are exactly zero images of female breasts, containing implants, from the outside - as in, the way they are intended to appear with functioning implants.

I don't personally have any way of acquiring copy-free images to upload in order to fix the second problem, but would anyone disagree with my removing the redundant copies of the implant-rupture images? Also, any editor who does have access to copy-free images of breasts containing implants, please upload them! Cheers, Kasreyn 05:19, 25 May 2006 (UTC)

That's a good point. If we could get some decent images that we are free to use, I would support using them. Considering what's on vulva and circumcision, I can't see any objection on the basis of content. Al 05:44, 25 May 2006 (UTC)

What about culling the dupe images? Kasreyn 06:06, 25 May 2006 (UTC)

If we have those, then yes, they should be removed. Al 06:10, 25 May 2006 (UTC)

The article will be split. That is why there is duplication. Please read the history, and also edit on the offline pages, after discussion. MollyBloom 01:09, 31 May 2006 (UTC)

Some additional problems.

Why is information on ruptures and other problems scattered around amongst "Local Complications" and "Risks and Controversies" sections? Aren't "complications" just a kind of "risk"? All these should be relocated under the "Risks and Controversies" section. There also appears to be redundant material in several areas. The article seems to spend a great deal of time focusing on the effects of the failures and complications of these devices, and very little time focusing on the motivations of the women who chose to undergo such a procedure. If a Martian were to read this article, he would be left wondering, "why do Earthling women do this? It never said!" The continued popularity of the procedure surely indicates that there is something motivating women to do this. It would definitely be notable to cover it in this article, whatever it is. Other possible details which are not covered are customer satisfaction rates (can surveys be found?), information on effects on breastfeeding (if any?), and more detail on the history of the procedure (which skips past everything between 1865 and the 1940's!)

I don't really know who did what and I'm going to assume good faith on the part of every individual, but on the whole, the article seems to take a very one-sided approach to the issue. It goes into great detail on every negative aspect of implants, but scarcely breathes a word elsewhere. Kasreyn 06:32, 25 May 2006 (UTC)

If you were reading the discussion above, you would see that we need knowledgeable (and NPOV) editors to help with a balanced view, on the 'offline' pages. Rupture is a local complication; the photos should stay there. Also, if you read the discussion , you will see that the article will be split, after it is worked out. Thus, the 'rupture' in the local section will be short - but with actual photos of rupture, while the 'risks and controversy' section will be more detailed. Please read the discussion and edit on the off-line pages. The adverse effects of implants often do not occur for years - that was my situation, and that of many women like me. The 'main' article should not go into the risks or controversy, but be factual, without discussion on the controversial risks. MollyBloom 14:02, 25 May 2006 (UTC)

As to 'why do earthlings do this' question, my answer would be because many plastic surgeons tell women implants are completely safe, and Dow has spent millions on studies insisting these are safe. Thousands of women who have had to have multiple surgeries, been disfigured and become ill know full well why women do this, and wish they never had.MollyBloom 14:06, 25 May 2006 (UTC)

Well, I can certainly see that a lack of information can make for poor decisions. But underlying all this is still the question of "why do women want these things inside their bodies?" I could trot out several possible answers that come to mind, but being a guy and not personally knowing any women who've had implants, I don't have anything better than guesses based on popular conceptions. Issues such as fashion, social conformity, and possibly even professional careers may be involved (women who work as actresses, or in the "adult" industry, seem to predominantly pursue plastic surgery of all kinds, from what I've seen). These motivations, I'm sure, could be expressed in a neutral manner without being insulting to women who have chosen to have implants.

As to the offline version, sorry! Can you direct me to it so I can have a look at how it's coming along?  :) Kasreyn 21:10, 25 May 2006 (UTC)

Kasreyn, you wrote "but on the whole, the article seems to take a very one-sided approach to the issue. It goes into great detail on every negative aspect of implants, but scarcely breathes a word elsewhere". You are 100% spot on. There is one editor who has taken it upon herself to highjack this topic to the point where it's irrelevent as a source of information. There is a tremendous amount of information about the safety, efficacy, and patient satisfaction available, much of which is politically inconvienent to said editor.Droliver 03:07, 26 May 2006 (UTC)

He's talking about me, of course, Kas. I don't quite care what Rob thinks, because he has shown himself to be every bit as one-sided as he claims me to be. Only in his case, his bias is dangerous for his customers. The article as he had written it looked like an advertisement for breast implants - which, of course, is his business. By the way, I did not 'freeze' the article. Other editors chose to do that, and suggested we discuss any further changes on the off-line pages.

Why on earth would implant safety (if indeed a fact) be 'politically inconvenient' to me, Rob? That is simply ludicrous, or crazy. Unlike Rob, I have no personal financial or political stake in this. I do know what implants can do, because I experienced it, as have hundreds of women I know. Every bit of information that is on the article right now is accurate. I challenge Rob to point to anything that is not. I have referenced every single statement that I added there. That is politically inconvenient for Rob (who does not know how to use legaleze, btw). And, of course, I was not the only editor. You can find the off-line pages at the top of the article. You can't miss them. I hope that some neutral observers and scientists will help edit. I also think it is important to discuss the studies that say there is a lack of evidence to show implants are dangerous (they do NOT say implants are safe, by the way). Also, I suspect that we should discuss the shortcomings of the studies. In fact, another plastic surgeon, and professor of medicine, had written that he also thinks silicone implants are unsafe, and that it will eventually be proven. I don't share his optimism, unless and until the conspiracy theorists are exposed for what they are -- those who claim all the women's problems are merely a platintiff lawyer's greed. Good God. Talk about ludicrous. I didn't file a lawsuit. I didn't even register for the class action settlement. I did, however, become sick from implants, to the point I was disabled. Thank God I had them removed, and my health has improved: not just subjectively but objectively (my lab tests are now normal, where they had been very abnormal for 5 years before explant). This is consistent with peer-reviewed studies that show women do improve after explant. But that is politically inconvenient for Rob, who makes his living putting implants in women. Alleged doctors like this harm women. Had I listened to an ignorant (or blind) plastic surgeon who told me removing my ruptured implants would not improve my health, I believe I would be dead now. Fortunately, I had a friend who is a medical doctor who convinced me to get them removed. Also, my internist and rheumatologist advised that I remove the implants. Just two days ago my internist called me at home, to tell me that a repeat of my blood tests was normal! She still is in awe, because I had been so sick just two years before (when I had surgery to remove ruptured, sticky, yellow-black remains of what used to be implants. She said she has absolutely no doubt that removing my implants made the difference. There is no other explanation. So, going back to political' motive, I suppose I do have a motive. My motive is to warn other women before they become as sick as I, and many many other women, have become from implants. My motive is to see women healthy, and not disabled or dead. As to this article, I hope that someone - NOT Rob here - will start some of the edits. MollyBloom 03:38, 26 May 2006 (UTC)

Molly, you've explained why your POV is so hostile to breast implants. Unfortunately, it is this very bias that is the problem. In reality, the vast majority of breast implant procedures are uneventful, if perhaps a bit tacky. If you want to make sure the article includes reliable sources that recommend removing ruptured implants, that's fine. However, if you want this article to make breast implants sound uniformly deadly, that's simply not acceptable. Al 04:10, 26 May 2006 (UTC)

NO NO NO Alienus. Everyone has a POV. The WRITING is what needs to be NPOV. There is nothing wrong with the information that I and others have added to this article. All work is cited, with accurate references. Do you object to that? The vast majority of implantations are NOT uneventful. Statistics show that. Where do you get this information, anyway? My point was that Oliver has every bit as much bias, if not more so, than I do. I said I would be willing to include other information. But NOT to make it look like an advertisement for breast implants. And I do object to your comment that breast implants are tacky. They are not tacky, as there are many reasons why women want implants - not all are adult entertainers. However, the fact is that the FDA has NOT yet approved silicone breast implants. More than half rupture by 10 years. How on earth do you suggest that the 'vast majority' are uneventful? That simply is untrue. We are splitting this article into the main article and "Risk and Controversy" because there IS controversy as to the safety. And we most certainly will say more than just the advisability of women removing ruptured implants (although I doubt Rob would even agree to that, since he has ridiculed the FDA on other issues, as well. MollyBloom 00:15, 27 May 2006 (UTC)

I see now that you were talking about saline implants. The main issue of contention is silicone, not saline.MollyBloom 02:43, 27 May 2006 (UTC)

Just thought I'd add another voice to the "why do earthlings do that" debate, and I better declare my industry affiliation at the start. I am a plastic surgeon (in Australia, if that becomes important.) It is pretty clear that augmentation is a popular procedure and it is untrue that keeping patients poorly informed is necessary to maintain that demand. Most women requesting implants are really well informed. Most feel much happier about their appearance afterwards, many feel better proportioned and balanced, and often women comment on their confidence improving. The proportion who end up having implants removed and not replaced is very small (like 2%.) Women, in general, like their augmented body better. Will Blake 04:49, 29 May 2006 (UTC)

Welcome aboard. I know this article is controversial, but don't let that scare you away. While you may well have a bias due to your profession, you also have some relevant medical knowledge, so I'm sure you can contribute in a positive way. Al 05:41, 29 May 2006 (UTC)

I think Will does , not mean 'fork' but rather another article. That is the difference. I will not debate his comments here, but to say I doubt that he follows women years down the road. MollyBloom

Fork silicone

There's a tag alterting editors to the fact that the article has gotten a bit large and needs branching. I was thinking that we could separate out the section on silicone implants into a fork. My rationale is that it's well-defined and represents a topic that is considerably more controversial and (due to recent actions to restore the legality of such implants) less stable. What do you think? Al 01:46, 28 May 2006 (UTC)

DO NOT FORK SILICONE - This is what another editor and administrator (Encephalon) explained, and why NOT to fork this section, but make it a separate article:

Now, there is no doubt that the specific subject, silicone breast implant controversy, can be written about at great length: it has a long and involved history, and thousands of pages have been written devoted to it—books, journal reports, court documents, company reports, news reports. It would be inappropriate, however, to reproduce a voluminous account on a general article about breast (including saline) implants, especially at the expense of the other important aspects an article on breast implants should contain as mentioned in 2.

On the other hand, the controversy and its history are important, and it is desirable for an encyclopedia to have a good account of it. So what do we do? On Wikipedia this type of problem is resolved by using something known as the Summary style. I urge those of you who haven't read this document to do so. (This should not be confused with a POV fork. A POV fork is a second article on a given subject with an opposing POV; i.e., instead of collaborating to write a single balanced, neutral, article, editors of opposing points-of-view create two biased accounts of the same topic.) The impetus to create silicone breast implant controversy however is that this subtopic is sufficiently noteworthy, important and complex that it requires an individual page, itself conforming to NPOV, which the main article breast implant will summarise in a neutral fashion in the relevant subsection).MollyBloom 03:45, 28 May 2006 (UTC)

I agree but for a different reason: I don't think breast implants are notable enough to merit multiple articles. If this one's getting too long, some of the fat should be trimmed. Kasreyn 16:28, 28 May 2006 (UTC)

I should clarify. On a rereading, my comment was too ambiguous. I am against a fork. Kasreyn 20:43, 28 May 2006 (UTC)

No fork - I agree with Molly - Silicone needs be kept within main topic, but the article is long and so a split half-way down ((a) what they are and (b) the possible risks which has generated noteworthy public controversy for both types) is sensible encyclopedia article writing. Whilst I don't think breast imlants are as important as perhaps heart surgery or hip replacements (by numbers undertaken or significance to myself as a General Practitioner), they are notable and the controversy over whether there is or is not chronic side-effects has been well aired in public. It is one of a number of topics in which general medical consensus, research evidence, vocal patient groups and regulatory authorities are not in accord and the article does need to observe on these issues (although of course WP is not the place to actually argue out debates).David Ruben ^Talk 17:02, 28 May 2006 (UTC)

With as many implantations as there are, I'd say the controversy is a notable subject. The main article should be fairly concise. The 'Risks and Controversy" could and should discuss the issues.MollyBloom 20:26, 28 May 2006 (UTC)

Fork it I reckon the Silicone Implant Controversy forms a very natural self-contained topic which could form a seperate topic refered to in the main breast implant article. There are many people interested in implants but not much in the silicone controversy (because they live in areas where saline is used exclusively) and there are many of us who use silicone who feel the debate has been largely settled in the negative by quality evidence and is essentially ended. Will Blake 04:48, 29 May 2006 (UTC)

I wonder how many plastic surgeons who feel the debate has been 'largely' settled follow women for 5, 10, 15 or 20 years. I doubt many. I use my experience as an example only, because I am only one of many thousands of women who have had problems with implants.... I was very happy with my implants for 15 years, which is approximately when they ruptured. I did not know it at the time, and for the next several years became increasingly ill. This has happened to many many many women.

NOT FORK -- I think you mean a separate article - NOT a fork.MollyBloom 15:09, 29 May 2006 (UTC)

Input on types of Implants

String implants are banned in the US, for anyone. This is not true for silicone implants, for which there is an adjunct study. If string implants are available elsewhere, please post here. Otherwise it does not belong here. And, are string implants very common, if they are available anywhere?MollyBloom 00:46, 31 May 2006 (UTC)

We've been over this before. I'm not sure what's changed or why you decided to revert to the earlier version. Al 00:47, 31 May 2006 (UTC)

If we are going to have implants listed that are not available, then we should have all - including the one you did not add back that was deleted. Since there seems to be some controversy, it is worth discussing here. Let's ask others what they think. Also, let's add such changes to the off-line pages - that is what they are for. I don't have a problem adding other implants that are not in use, but we should be thorough. If one is in development, then it should be added, as in the tissue engineered implant. It is listed on an information webpage as one of the types of implants. I suspect it will become more important in the future, where string implants will become even less likely to ever be used.MollyBloom 00:50, 31 May 2006 (UTC)

Agreed. And it's not unreasonable to put saline implants in a prominent position, since they make up the overwhelming majority, followed by what's legal but less available, what's illegal and what's in development or related. Is that a reasonable order? Al 17:04, 1 June 2006 (UTC)

Actually saline implants are the overwhelming minority in the every market in the rest of the world and likely to be that way here by 2007Droliver 03:02, 2 June 2006 (UTC)

Saline implants should be first to be discussed, as they were in the original article. I agree with Al. Rob, there are numerous implants that have been marketed in Europe. And your perspective is, well, sufffice to say, limited. When I meant that I wanted to hear from MDs, I meant real MDS, who are not as biased as you are. MollyBloom 03:31, 2 June 2006 (UTC)

That's fine with me. That was the order it was in, I think, before someone started deleting.MollyBloom 18:04, 1 June 2006 (UTC)

Ok, so let's plan it out here.

Al, I would add these

Freely available: Saline -- Saline-filled implants are believed to be safer than silicone because rupture or leakage will only release salt water--not silicone gel--into the body. Consequently, FDA has allowed these implants to remain on the market without evidence of safety until 2000. On May 10, 2000, the FDA approved saline implants made by McGhan (now Inamed and soon to be Allerghan) and Mentor for augmentation in women 18 or older. They were approved for reconstructive use for women of all ages.

Limited availability: (This is from a plastic surgeon's website, and it is pretty neutral, which is refreshing)

• Silicone-filled (silicone elastomer shell) --- Very controversial, because of hundreds of thousands of women's complaints and concerns of local complications and systemic illness. Although there is no conclusive evidence that they cause systemic illness, there is still controversy about their safety. Certainly enough to cause alarm in even the most skeptical person. Even the studies which suggest no link advise further study be done to detemine if a subset of women are suseptible to silicone sensitivity. However, there is evidence of granuloma and macrophage accumulation with silicone injections and gel bleed (or rupture) from mammary prostheses. Lower molecular silicones do tend to migrate and cause granulomatous fibroses (nodules of inflamed tissue) as well. Capsular contracture (CC) and thicker capsules have been reported to occur more often with silicone filled implants than in saline-filled implants due to the permeation of lower molecular silicones, called "gel bleed", into the surrounding tissues. The body treats this like an irritant, comparable to a grain of sand in an oyster, and continues to surround it with fibrous collagen.

(We need to discuss availability in NEUTRAL terms. I welcome other's input, but I ask that any editors please identify themselves, and add to, not delete others' suggestions. This is, after all, a discussion page)

• Saline with polysaccharide (Hydrogel) --- Hydrogel mammary prosthesis has a filler which is a silicone elastomer shell filled with either a hyaluronic acid fluid, polysacharide gel or a hydrophilic polycrylamide gel.

• Poly Implant Prosthesis (PIP) Saline: a French-made prefilled saline implant with propietary elastomer coating.

Unavailable:

• Polypropylene (PPP) Strings --- Also known as polypropylene implants, are not currently approved by the US FDA. Intended for individuals wishing to obtain extreme breast sizes, string breast implants continue to grow after they are implanted, and can result in abnormally large breasts; string breast implants have resulted in the largest recorded increases in breast size due to surgical augmentation. The string breast implants were only available for a short time. They are made of a synthetic material called polypropylene, which causes the string breast implants to absorb fluids and expand.

• Poly Implant Prosthesis (PIP) Hydrogel -- Manufactured in France and distributed by Clover Leaf Products Ltd. The PIP is prefilled with a hydroxypropyl cellulose hydrogel (polysaccharide) gel filler. The MDA (The UK Medical Device Agency) requested a recall, for more studies "due to the lack of long-term toxicity data or clinical follow-up, together with methodological flaws in some of the pre-clinical tests." For more information regarding their safety concerns see - Medical Devices Agency - MDA Safety Warnings on PIP Implants. http://www.medical-devices.gov.uk

• Soy or Soya-filled (silicone elastomer shell - Approximately 5,000 women were implanted with the Trilucent™ Soya Implant. This implant was manufactured by Lipomatrix Inc./AEI Inc. (formerly Collagen Aesthetics International, Inc.). The shell is as the above - silicone elastomer - but filled with soya bean oil. Although the manufacturers insist they are safe, concerns about toxicity induced by a possible rupture of rancid soya oil into the body cavity led to them being removed from the market.

Pending: tissue

=

Please do not change what I have written here. This is my suggestion. We can get input from other editors, Rob. Your changing this on the DISCUSSION page is not honest. Write your own suggestion, but do not alter mine. This, by the way, mostly came from the website of BOARD CERTIFIED plastic surgeons. MollyBloom 23:38, 2 June 2006 (UTC)

I don't know about the direct saline injection. Perhaps we can get input from some MDs on this? I think that would be good. The rest sounds fine. I know there were some other implants like Hydrogel in the UK that were banned, but I don't know much about them. Do you think the whole section on silicone implants should be shortened - eg the 'generations'?MollyBloom 21:42, 1 June 2006 (UTC)

string implants, hydrogel, and saline injections are so peripheral as to not worth even being mentioned. Autologous tissue cultures are also more theory then reality at this point as well.Droliver 02:59, 2 June 2006 (UTC)

Al, that sounds fine. Your thoughts on this are very good. It gives a broader perspective on breast implants, that an encyclopedic article should have. WE don't have to write more than a sentence or two on the ones that are not widely used, or are in development. But after thinking about it, I agree that it is important to include.MollyBloom 05:40, 2 June 2006 (UTC)

I don't actually know anything about hydrogel, above what I can infer from the name. Are these currently available? Saline injections are worth linking to, but not worth more than one sentence of coverage. Tissue cultures are, to the best of my knowledge, more an idea than anything available, so I'd also limit it to a sentence. Al 04:32, 2 June 2006 (UTC)

As I said above, I agree with you, Al. This article is too US-centric. It is useful to at least mention the various implants that have been introduced in other countries (not just the US market). The Hydrogel were first introduced into the European market. Also, there is a pattern of putting implants on the market without long term safety studies, which all of these show.

A sentence or two should suffice. There still seems to be controversy on the Hydrogel, too, like silicone. The problem with hydrogel was lack of long term follow up; which ironically, is still the problem with silicone implants - the two US manufacturers only provided the FDA 2 and 3 years of 'core' data. The FDA acknowledged the adjunct studies were fatally flawed. Here are a couple links on Hydrogel. A 2002 plastic surgery article published in PubMed said they were fine (surprise surprise). http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11832859&dopt=Abstract As with silicone implants, women began having serious problems with the Hydrogel, as this article mentions: http://www.timesonline.co.uk/article/0,,25689-2203951,00.html They are no longer available in the UK. http://mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=738 and the UK Times wrote: http://www.timesonline.co.uk/article/0,,25689-2203951,00.html

Uhm, some of these links are NOT about hydrogel implants at all, but rather some crude direct injection that's quite unsafe. Al 23:40, 2 June 2006 (UTC)

Yes, you are right, Al. Sorry about that UK Times article. I missed that. The others are about Hydrogel implants, however, if you read them. One is positive and the other is not. MollyBloom 23:46, 2 June 2006 (UTC)

Hmm, even the negative one wasn't that negative. Mostly, they need better clinical trials, but there don't seem to be any serious problems with them. Al 23:52, 2 June 2006 (UTC)

I also added an external link, that links to a non-profit corp website that focuses on women's health. ON the BI, there are many links to studies, and it presents some of the concerns that still exist about silicone.MollyBloom 21:45, 1 June 2006 (UTC)

Not just no, but hell no on linking to Zuckerman's outfit. It's a political entity led by the person most identified with sensationalizing this issue.Droliver 02:59, 2 June 2006 (UTC)

Yes, and Hell Yes. Rob, you only think it is a political entity because you don't like it. It is a valid non-profit corp, and Dr. Zuckerman is an epidemiologist who just happens to disagree with you. This article should be NPOV, and not just what Rob thinks. That means have pros and cons. PLease see below. MollyBloom 03:30, 2 June 2006 (UTC)

NPOV is the IOM report & the other major studies. That is what is going to lead the summary of this issue. Zuckerman's talking points can be referred to, but they should be clearly identified as the minority viewDroliver 23:10, 2 June 2006 (UTC)

Rob, you are not the final arbiter of this article, although I know you want to think so. There is absolutely no reason that this non-profit needs to be 'clearly identified' as anything, since it is merely an external link. You are out of your mind if you think that is going to happen.MollyBloom 23:27, 2 June 2006 (UTC)

Is there any particular reason for not linking to this place? Keep in mind that if it's known to be biased, all we need to do is label it as such. Consider how abortion links to clearly labeled advocacy groups on both sides of the issue, deftly handling their bias. Al 23:40, 2 June 2006 (UTC)

Al, external links should not be labeled as 'biased'. You will open a can of worms here, because many can say studies funded by Dow Corning were biased. There is no reason to not include this link, along with others that are more favorable towards implants. The reader should be smart enough to see the difference, don't you think?MollyBloom 23:43, 2 June 2006 (UTC)

Even abortion doesn't actually call its links biased. Rather, they're identified as pro or con. This not only defuses bias but can be helpful to readers. For example, if I want to hear the worst case stories about hydrogel implants, I don't want to waste my time on an article that talks only about how nice they feel. Al 23:52, 2 June 2006 (UTC)

AI, you're falling into the trap of confusing politics with science by trying to play nice on this. As much as this is political to Molly, there is no medical "pro" or "con" view of this, there is just the data & the literature. The Institute of Medicine & others are not some "shill" for for Dow Corning, there are the regulatory agencies who have sequentially been commisioned to review this. You don't have to be fluent in reading medical literature to understand the consensus view. In addition, we're nominally charged with reflecting the world-view on this, where there is even less debate on this as reflected by the reviews and policies of other health ministries.Droliver 16:04, 3 June 2006 (UTC)

You insulted Al. He is capable of thinking on his own, and coming to a conclusion, Rob. You are not the end all and be all here. This link is very appropriate as an external link, and it stays.

The IOM simply reviewed the studies that were done that were funded by Dow, Rob. There is a controversy on this issue, which is why the FDA has NOT approved silicone implants yet. There is no harm in adding an external link of a research NON-PROFIT organization. The consensus is to keep it. It stays. MollyBloom 18:09, 3 June 2006 (UTC)

External Links

I would like to ask others (NOT ROB) what they think about the non-profit link that I added. It offers a differing view, but it is academic, and it links to academic articles, as well. Dr. Zuckerman is a Harvard epidemiologist who should be linked to on this issue, as much as the plastic surgeons. I welcome others to view this website, and explain why it is not acceptable as a legitimate link. (I don't think others will.) MollyBloom 03:34, 2 June 2006 (UTC)

It is a vocally political lobbying group. Compare the tone of the articles, press releases, & breathless proclaimations/press releases there to the IOM, FDA, UK-IRG, Canadian health ministry, & other health ministries around the world. It represents a political group with an agenda & dismisses the large body of careful researchDroliver 23:07, 2 June 2006 (UTC)

We all know what you think, Rob. I want to see what others think. As I said before, this is a non-profit group, on women's health. The director is an epidemiologist. The tone is not 'breathless'; it is just not an advertisement for breast implants so it isn't up your alley. Furthermore, this group does not 'dismiss' other studies. They are discussed. This is ONLY an external link, Rob, among many. You can't filter out everything.MollyBloom 23:20, 2 June 2006 (UTC)

I think that this fits within standards for an external link. Al 23:30, 2 June 2006 (UTC)

Thanks, Al.MollyBloom 23:31, 2 June 2006 (UTC)

"Furthermore, this group does not 'dismiss' other studies. They are discussed"...You obviously haven't looked at the site then because that's all it does. It's a discussion that's about as unbiased as the dailykos.com or redstate.org are on politics. If we're to keep links NPOV you cannot put political groups like that in the area segregated for external links. The 'controversy' over silicone should be discussed in context in the article & presented as the alternative view to the mainstream. Linking to the group in that context would be less objectionable if you wanted to briefly point out organizations that object (eg. N.O.W., etc..).Droliver 15:53, 3 June 2006 (UTC)

External Links

We need to discuss external links here.MollyBloom 23:23, 2 June 2006 (UTC)

Since Droliver is insulting the website of the nonprofit organization that I am president of, I will respond. Our organization is not "known" to be biased, except perhaps by individuals who have never read the epidemiological studies that we have reviewed. I would be happy to debate, in civil dialogue and in specific detail, any information on our website. I am trained in epidemiology from Yale Medical School, directed a longitudinal research project at Harvard, and am currently a Fellow at the Center for Bioethics at the University of Pennsylvania. The National Research Center for Women & Families is very concerned about the often-quoted poorly designed implant studies, virtually all of which are funded by implant makers and plastic surgeons. Our detailed criticisms of these biased studies are available on our website, and not a single author of any of those studies has ever complained about our criticisms. We usually rely on data from independent studies, such as those funded by the US government or the Canadian government. Summaries of those government studies are available on our website, as are links to those articles. In addition, we often quote the findings of industry-funded studies that have been analyzed by the FDA, since those findings are more accurate than the analyses conducted by the companies themselves. Unfortunately, those findings have never been published by the companies, apparently because they do not want to publicize their high complication rates. 216.164.59.38 01:59, 3 June 2006 (UTC)Diana Zuckerman, PhD dz@center4research.org

Diana, I'm not insulting your organization but I am calling it for what it is- A political entity determined to keep silicone implants off the market by any means neccessary, despite the general consensus (both here and abroad) of the medical literature to the safety of the devices. It is in no way accurate to describe yourself as just some disinterested "non-profit organization" without a political agenda, and linking to your site would be as inappropriate as putting links to the corporate office of Inamed, Mentor, or other manufacturers. It is a ridiculous position to paint the systemic reviews of every industrialized nation on earth as tainted who have weighed in on this subject.Droliver 15:40, 3 June 2006 (UTC)

ROB, YOU have discussed this. The consensus was to LEAVE this link. Your analogy to Inamed is ludicrous. They are for-profit corporations. This is not. And the consensus was to keep it. This is not YOUR article. It stays.MollyBloom 18:07, 3 June 2006 (UTC)

Okay, Al. I dont have a problem with legitimate links. I do think they should be discussed here. We will leave all three.MollyBloom 18:13, 3 June 2006 (UTC)

Now that there has been a prolonged stagnation

Now that the editorial moratorium seems to have run it's course with this entry, we are left with an article that's still unsatisfactory. At the time it was arrested, it had been freshly edited to aggressively represent a controversial POV on this topic. There is no hint of the mainstream data, reviews, and opinions of the professional bodies who work in the field. We are still left with deliberately pointed sections fiercly guarded from moderation by one said editor who has used this entry as a platform for political crusading on a percieved cover-up of the real-world consequences of these devices by the medical-industrial complex. Even well-documented historical aspects of development which should be pretty non-controversial have been distorted (ie. the bizarre deviation on the history of the saline implant section). It remains clear that when someone who

* regards each piece of the mainstream work on this as tainted - You consider mainstream only the work that supports one view. That is absurd. THere is no mainstream view on the new platinum study for example. But I am sure you dismiss it because a couple of your plastic surgeon friends dismissed it.

* regards each major systemic review as tainted

• • No, the only ones you consider mainstream are all glowing about silicone. You dismiss other equally important works, that are even noted by the FDA.

* highlights controversy over consensus at all times

• • That too is untrue, as can be evidenced in my edits.

* dismisses the expertise of people who work with or on the devices

** No, I only dismiss you, because I do not respect you, based on your actions here.

is not someone who can be collaborated with in a productive way. Outside of the technical aspects of the article, the bulk of this is such a jumble of dis-coherent & inacurate information that it begs to be scrapped.Droliver 22:45, 5 June 2006 (UTC)

Every statement in there that I have added is supported by academic citations. You just have a problem with my raising anything negative about silicone implants. HEavens, you didn't even want to include the LOCAL complications, which are not even controversial.MollyBloom 06:01, 6 June 2006 (UTC)

Droliver, I'm rather new to this article and its behind-the-scenes upheavals. I gather you are referring to Molly Bloom. It seems to me that communications between the two of you have broken down and there may be some difficulty finding a consensus or compromise position between. I'd like to offer to help as a mediator if I can. I am almost entirely ignorant of the subject matter. This is problematic in that I will have to be educated before I can make intelligent decisions, but beneficial in that I am not bringing any previous biases or perceptions to the discussion.

I'd like to see a balanced and stable version of this article arise. As I mentioned before, there are a lot of aspects not being covered which don't seem to be involved in the "are they good or bad" controversy, such as motivation, availability, etc. Images of the "finished product" - completed breast implants in situ photographed from outside the skin - are also conspicuously missing. I feel that these problems at least could have be fixed with little need for mediation, and yet nothing has been done. My guess is that neither camp can make any significant edits without being immediately reverted by the other, and too much attention is being focused on whether breast implants are a "good" or a "bad" thing. As a result, actual progress on uncontroversial aspects has languished.

Would anyone here object to my entering this discussion as a moderator? Kasreyn 02:38, 6 June 2006 (UTC)

Nope. Fine with me.MollyBloom 15:12, 8 June 2006 (UTC)

Would like David to mediate-- As to the 'finished product', a number of people voiced objections about that as being unnecessary, since most people know what breasts look like - large and small. I think you were aware of that, Kas. I don't really care, but I also think it unnecessary.MollyBloom 05:54, 6 June 2006 (UTC)

Yes, above on this page I replied to one such comment. As I said before, there is a very clear visible difference between large real breasts and large false breasts (though some of the more expensive varieties are becoming harder to detect). This is notable as it speaks to the successfulness (or lack thereof) of the intended effect. Kasreyn 22:11, 6 June 2006 (UTC)

In fact, given your stance against implants, I find it very surprising that you don't want the page to include a photograph of breasts which fail to pass as real. I would think you would be in favor of any information that might dissuade women from going through with the procedure. Surely a photograph of obviously false breasts would indicate that, at least in some cases, the illusion is not complete. Almost no women get implants because they want to look like a woman with false breasts. The great majority of women get implants because they want to foster an illusion that they have large natural breasts. Breast implants which "give away" the secret are clearly failures in this light. Kasreyn 22:16, 6 June 2006 (UTC)

No objection - I had mediated previously - see above discussions. Also the purely descriptive info of what they are & how they are inseretd should be split from the description of concerns raised for longterm risks, research into this, regulation issues (see Talk:Breast_implant#Sub-pages_for_article_split). I had created 2 sub-pages for the split article to be worked on in a constructive matter.

I had intended to return to this article, with perhaps an attempt at a rewrite, but the 2 main editors seemed to be engaging more constructively for a time and so I let things run on for a while. Please do help moderate/comment on the editing required... David Ruben ^Talk 02:58, 6 June 2006 (UTC)

Personal Attacks

I am not going to dignify DrOliver's list of complaints against me, with my own list against him. It is unproductive. I have repeatedly ask that DrOliver be civil. I would like to see the focus on the article, and not on the person. I edit on a number of articles, apart from breast implants. I have not had such problem on any other articles I have edited. But on this, there have been all out wars. I would appreciate help with coming to a reasonable resolution. MollyBloom 05:54, 6 June 2006 (UTC)

Offers to Mediate

I appreciate offers to mediate. Please, someone, help. I also would so appreciate it if Dr. Laub or would come help with this. He said he would but has been absent.. I am not a medical doctor, but I do have a background in science and engineering, and law. I have researched this area extensively. I also know that one cannot cherry pick and choose only the positive or only the negative in an article..

The "mainstream" assessment should be included - it has to be. But when DrOliver did that he made it an advertisement. Then he became hostile. The encyclopedic article is not an advertisement. I would like to see a very factual main article, and then a split (soon) for the controversial areas. NOT a fork, but a split into a separate article, as David suggested,. He too pointed out there was genuine controversy, within the medical profession and scientific community. There are still many women becoming ill from local complications or what they perceive to be systemic complications. In short, this is not a situation like, for example, evolution. Science has definitively weighed in on evolution. (I hope I am not going to inflame here) But the anti-evolutionists argue for a biblical interpretation which is simply not scientific. Science has not definitely weighted in on breast implants, regardless of what Rob insists. As a plastic surgeon who performs breast implants, Rob is understandably enthusiastic about them. But a more tempered approach would be a wiser approach, as some other plastic surgeons have pointed out to me. Anyway, I would be happy to have someone act as mediator.MollyBloom 05:52, 6 June 2006 (UTC)

The same could be said that as the president of an organization that is openly biased against breast implants, you're understandably against them. I am all for voicing your opinion about what you believe in, but it doesn't belong in an encyclopedia entry. As an objective third party, I can most definitely say that the current iteration of the article is quite biased towards the associated risks and not the device/procedure itself. As a relatively new Wikipedian I came upon this article to see what all has been written about a subject I've been curious about for some time now, what I found was an article that has been butchered by people with agendas. Why is it that an overwhelmingly large portion of the article is about the risks of Silicone breast implants when most implants used today are saline? Why is there absolutely no information about why women get implants? I would be more than happy to help expand these subjects but I believe it will be quite pointless until those with agendas have moved on, or take their discussion on the controversy of breast implants to the proper page.Aktornado 20:32, 7 June 2006 (UTC)aktornado

This entry has become bogged down because of one person's hostility towards the consensus data on the subject. As I've said several times, the whole section on risks/controversy can be summed up in one paragraph briefly. It has sprawled to pages long as individual studies are plucked out of context of the body of work to endorse the political view that the devices are dangerous and then elaborated on at great length in the most grotesque of ways. Go to medline, the FDA, the UK-IRG, the IOM, whathaveyou and see where the evidence is for yourself. Also look to the positions and policies of other countries (as this is nominally a world-view entry and silicone is used in 90-95% of all cases world-wide) we're alone in the US for having signifigant regulation or restrictions on the device and even that is likely to change any month.Droliver 04:32, 8 June 2006 (UTC)

My response is below. I agree with you ak. That is why the article will split into two articles, one exactly as you describe. And there is need no prolonged discussion of silicone there - it does outbalance the saline to an absurd degree. The second article will be about silicone only, the risk and controversy. Scientists are still in debate about that, regardless of what Oliver wants us to believe. This is well evidenced by the fact the FDA has NOT yet approved siicone implants.

As to Rob's stance. It was bogged down because of an edit war. As you know, there are always two sides to everything.  ;-) I will not wade in muck, to join Rob in insults. His own venom illustrates my point well. MollyBloom 15:24, 8 June 2006 (UTC)

I will help if I can, Molly. I think input from both sides should be synthesized in the article. I don't feel that either you or Droliver should be prevented from contributing simply because of your viewpoints, merely that a reasonable balance must be struck. One issue is the article's giving a great deal of time to the side effects and harmful effects of implants, and very little time to the motivations of the women who get them and the results when they do work as advertised. As Droliver pointed out, there is also the fact that Wikipedia is an encyclopedia for the whole world, and silicone implants are still very common worldwide. I have no interest in getting into a debate over the benefits and risks of implants. All I'm saying is too much space is being devoted

to benefits-vs.-risks, and not enough space to other aspects important to a reader who wants to learn about the subject matter. Kasreyn 22:27, 8 June 2006 (UTC)

I still dont' think you understand what has been going on, Kasreyn. I have no problem with a balance - however, the article had been 'frozen' until further discussions, and adding a little at a time. Oliver is making wholesale changes to the main article, without discussion. Again. I would like some others to help here.

Also, the article needs to be split, with risk and controversy a separate article, as suggested by David. The history and controversy has been huge in this area. To ignore it is deceitful. There are still settlements going on, still women getting sick and still studies going on - some of the very article Rob cited recommended further study, but he stated there was no need for further study and nobody was recommending it!MollyBloom 16:36, 17 June 2006 (UTC)

Need for article improvement

It seems that Oliver and I tried to edit initially at the same time. So I am going to repost the comment/question, and discuss the article improvement. We all need to be civil, and not disparage other users.

The same could be said that as the president of an organization that is openly biased against breast implants, you're understandably against them. I am all for voicing your opinion about what you believe in, but it doesn't belong in an encyclopedia entry. As an objective third party, I can most definitely say that the current iteration of the article is quite biased towards the associated risks and not the device/procedure itself. As a relatively new Wikipedian I came upon this article to see what all has been written about a subject I've been curious about for some time now, what I found was an article that has been butchered by people with agendas. Why is it that an overwhelmingly large portion of the article is about the risks of Silicone breast implants when most implants used today are saline? Why is there absolutely no information about why women get implants? I would be more than happy to help expand these subjects but I believe it will be quite pointless until those with agendas have moved on, or take their discussion on the controversy of breast implants to the proper page.Aktornado 20:32, 7 June 2006 (UTC)aktornado

Aktornado, I agree with you on all counts. The article needs work, and it will be split into two articles. That was the consensus of all the editors who weighed in.

The main article should be very factual in the main section, including local complications, and maybe some of the things you mention. The Risk and Controversy section is predominantly about silicone implants, because the manufacturers have fought long and hard to get the FDA to approve silicone implants. As yet, the FDA has not, but is expected to rule one way or the other, probably this year.

I am not going to attack any editor. There has been far too much of that. The "Risks and Controversy" section is predominantly about silicone, and will be a separate article. I and others have hoped we could get new blood, so to speak, to help with the article. There has been bias both ways. You can judge the comment below and its tone, for yourself.

My hope is that we can obtain a good, solid factual article for breast implants. The other discussion will be a separate article. By the way, I am a scientist as well as a lawyer, and certainly am not anti-science. I am however well aware of the existing controversy that still exists within the medical community. I have a few letters or emails I from neurologists, rheumatologists and plastic surgeon , and certainly could scan and enter them, if there is serious question that there is still a debate. Moreover, the editor below blasted a Harvard and Yale epidemiologist and expert in this area who disagreed with him. Now. Let's not start another war. let's get new blood to help rewrite!

Why don't you help us rewrite the article? We need some 'new' perspective, from someone who is not overtly biased, one way or the other. Thanks!!  ;-) 04:43, 8 June 2006 (UTC)

Also, the consensus in a long debate on this subject (including other doctors weighing in) was to create a second article, because of the importance of the subject. Certainly not to sum up in a sentence. Please look at the tags and discussion for explanation of this. ThanksMollyBloom 04:50, 8 June 2006 (UTC)[User:Jgwlaw|MollyBloom]] 04:43, 8 June 2006 (UTC)

Actually, "to disparage" is to slight, to reduce esteem, to insult. Did you meant "not to disparage"? Kasreyn 00:30, 9 June 2006 (UTC)

Yes, thank you.

I wasn't ware of the consensus to split this article. I believe above I argued against making a second article. I don't feel the risks & controversies are notable enough to merit their own article. Kasreyn 00:32, 9 June 2006 (UTC)

The majority of those weighing in thought a split important. I had initially disagreed, but conceded with the others. I am aware that you did not, but I do not think that was the consensus. If not split, then a new article can (and will) be written. The issue was not whether to have some information on the controversy, but what, where and how to place it. To say that the controversy is not notable is to either not understand or want to ignore the long history of this issue. In fact, whether you think silicone implant controversy is 'settled' or 'not settled' does not mean there has been no controversy. In fact, there is still controversy as there are very new peer-reviewed studies discussing it. Again, whether one believes the peer-reviewed studies or not is not the issue. Please see David's comments on this, for example:

No fork - I agree with Molly - Silicone needs be kept within main topic, but the article is long and so a split half-way down ((a) what they are and (b) the possible risks which has generated noteworthy public controversy for both types) is sensible encyclopedia article writing. Whilst I don't think breast imlants are as important as perhaps heart surgery or hip replacements (by numbers undertaken or significance to myself as a General Practitioner), they are notable and the controversy over whether there is or is not chronic side-effects has been well aired in public. It is one of a number of topics in which general medical consensus, research evidence, vocal patient groups and regulatory authorities are not in accord and the article does need to observe on these issues (although of course WP is not the place to actually argue out debates).David Ruben Talk 17:02, 28 May 2006 (UTC).MollyBloom 07:39, 11 June 2006 (UTC)

No fork. Splitting it elevates an imagined controversy in the medical literature. There is in fact little medical controversy ongoing, with most involved feeling the issue has largely been settled some years ago. Droliver 22:42, 14 June 2006 (UTC)

Oliver does not know the difference between fork and another article. The controversy is not imagined. The FDA has still not approved silicone implants. Please see what David stated about the history of the controversy and what is ongoing. MollyBloom 16:31, 17 June 2006 (UTC)

Discussion on Main Article

Per what Aktornado and others have said, there is a great deal on silicone implants, which considerably outweighs saline. The percentage of which is used more than the other doesn't make a whole lot of sense, since both are used. In fact, there are more restrictions on silicone than saline. Either way, it makes sense to not go into prolonged detail about the history of silicone implants. A short history should suffice, with the descriptioin of what they used to be (thin shell, liquid gel) and the efforts to make them less prone to rupture (different gel). Then one might mention in a sentence about the gummy bear. That is sufficient. The long dissertation on how each one differs is way beyond the scope of a WIki or encyclopoedia article.

I suggest continuing on the main article, recognizing Wikopedia is not a medical text. As several have said, the main article should be factual and relatively short. Ak made an excellent suggestion in a section on why get implants. Again, this need not be long, but a bullet point or paragraph would do. This is mentioned in passing, but not in a context by itself. Perhaps it should be, since Ak didn't see the sentence about it - and maybe others won't either. It could be unclear.MollyBloom 23:55, 8 June 2006 (UTC)

No discussion on changes & replacing 2006 research with 1999 review

I think that says it all. Rob continues to refuse to discuss changes. He reverts without comment. Moreover, he replaced 2006 research with a 1999 review. This is scandalous.MollyBloom 04:53, 20 June 2006 (UTC)

I reverted back to the original, since Rob seems unwilling to discuss changes here, and simply deletes large portions of text.MollyBloom 16:12, 20 June 2006 (UTC)

With people interested in making this entry better, I will talk. With people that aren't interested in making it better I don't. Please refer to the 2004 FDA breast implant guide & recent Canadian toxicology review for their take on platinum. This is not a subject that's been controversial.

This is flatly untrue, Oliver. The 2006 study could not possibly be included in the 2004 FDA guide, could it? Furthermore, the 2004 guides states the need for further research. (I quoted it below)One reason the FDA has not yet approved the implants is because of recent research.

Secondly, you need to discuss changes here, before making major edits and major section deletions. It is not for you to decide who is 'interested' in making the article better. Several edtiors have requested that major changes be discussed first here. That means not deleting whole sections of work, because they do not comport with your opinion on the subject.

This is an area with a good bit of work done which has all been reviewed before several times. You are trying to highlight a single,uncontrolled study which is both not congruent with the existing body of research & viewed with skepticism by others who work in silicone chemistry. It does deserve mention for raising the question of whether highly reactive oxidation states of Platinum can exist in vivo but it should be viewed in context for what it is. Devoting several paragraphs to it (at the expense of context) in an article we're shortening is not warrantedDroliver 16:18, 20 June 2006 (UTC)

The 2006 study is the most current research. The two people in the 'silicone chemistry' business are or were employed by implant manufacturers, which the article points out. The FDA is currently reviewing the study, which was peer-reviewed and published in a scientific (chemistry) journal.MollyBloom 01:09, 21 June 2006 (UTC)

As you can see below, there is not just one study, but several, that have questioned implant safety. The FDA's 2004 guidebook that you reference speaks for the need for further research. Baylor Plastic Surgery dept (quoted below) states that there is still controversy.

Dr. Zuckerman, who is a Yale trained epidemiologist and expert in this area, says there is still controversy. I know you don't like her views, but that does not negate her qualifications and knowledge in this area.

MollyBloom 14:44, 21 June 2006 (UTC)

I noticed that Droliver's edits seemed to include a lot more concrete data, while the one you replaced his with seemed to have nothing but vague statements with few figures. Is there a reason for this? Kasreyn 18:47, 20 June 2006 (UTC)

I think you need to re-read this, Kas. I looked back at the references, and they are absolutely concrete and specific and every bit as much or more so than Oliver's. There is no vague statement with few figures. Every statement made is clear, not vague, and has a reference (except the 'thousands of women' but that is clear from the class action lawsuits, but if you want me to add it I will). You do, of course, need to read the references. This is not a medical journal, and there is no reason to have a litany of numbers in the text. And, Oliver's edits don't do that either. Dr. Zuckerman looked at the references, as well. While the formatting needs correcting, the references are there. They are every bit as specific and concrete as anything Oliver added. IN fact, I left some of what Oliver added, as far as studies, although they need citations. I also added a reference to the statement about the need for further study - this was from the 2004 FDA booklet. EVERY section discussion has CONCRETE references to studies (not reviews, which are different).MollyBloom 20:44, 20 June 2006 (UTC)

Some of the reference formatting seems to have been lost in the deletions, but I have added the FDA citation back, since it appeared to be the most vague (without reference). The information about the need for further research was, in fact, a direct quote from the FDA. As to 'thousands of women' comment, that hardly needs referencing, since thousands of women are involved now in class action settlements. One law firm alone near me has over 1000 implant clients.MollyBloom 14:44, 21 June 2006 (UTC)

Controversy over BI and CONCRETE references

Kas, Oliver had deleted much of what Dr. Zuckerman and I had written, which is why many of the references are messed up. I also hope for other mediators, since you have made clear your opinion on this. If you look at the references, there are specific and concrete citations for each statement made. The 2006 study on platinum is not in the 2004 FDA booklet, for obvious reasons.

Please see the comments of other doctors here who DO believe that silicone is still controversial (Dr. Laub and Ruben). There are many many doctors who understand and talk about the controversy. See below for further quotes. Also the FDA has not yet approved silicone implants, although the panel met a year ago. Had there been no controversy, they would be approved by now. It is very unusual to wait this long.

I reported a 2006 study on platinum. This is the most recent study. Is this not specific enough for you? I have very specific reports, which I had listed previously.. Most of it was deleted by Oliver. I can go back and find it, if necessary. The 2006 study on platinum is one reason the FdA has not yet approved implants. If that is not specific enough, I don't know what is.MollyBloom 19:49, 20 June 2006 (UTC)

Here are some very specific studies that Oliver just deleted. I and an epidemiologist had made a number of changes, all of which he removed from the rheumatology section: "In 2003, The Journal of Rheumatology, reported that women with silicone breast implants report more severe pain and chronic fatigue. Notably, more women with ruptured implants than those with intact implants had debilitating chronic fatigue (75% vs 51%), postexertional malaise > 24 h (77% vs 51%), impaired short term memory (58% vs 38%), and multi-joint pain (77% vs 60%). This supports a 2001 FDA study showing a correlation between fibromyalgia and ruptured silicone breast implants. Earlier, in 1998, the UK Independent Review Group, a blue-ribbon panel of scientists and physicians concluded that an "interesting study reviewing the possible association between extra-capsular silicone -gel breast implant rupture and fibromyalgia" is of "potential clinical significance.""

Here is an example of where studies Rob linked to called for further study:

In a 1999 review of previous studies, the US Institute of Medicine concluded that "... a very substantial body of evidence, consisting of a number of independent investigations and other analyses, does not provide sufficient evidence for an association of silicone gel- or saline-filled breast implants with defined connective tissue disease".[5] The FDA concludes that these studies suggest that the risk of developing a typical or defined CTD or related disorder due to having a breast implant is low. However, the FDA also points out that the studies have not been large enough to resolve the question of whether or not breast implants increase the risk of CTDs or related disorders. Researchers must study a large group of women without breast implants who are of similar age, health, and social status and who are followed for a long time (such as 10-20 years) before a relationship between breast implants and these diseases can conclusively be made.

The UK report concluded that while there was no evidence to support a link between silicone gel breast implants and specific connective tissue diseases, there was a lack of information on the "incidence, amount, and rate at which silicones escape from different types of implants, particularly in the case of implants inserted more than 7 years previously."

The UK report also stated that the question of whether siloxane polymers cause inflammatory reactions that directly provoke immune responses to the recipient's own tissues is unresolved. The possibility that a sub-group of recipients who develop immune response has not been formally disproved.
Further studies would be necessary to identify:

a) any sub-group of recipients at risk;

b) the auto-antibodies provoked and their target antigen.

Studies have shown that some women with silicone gel-filled breast implants produced antibodies to their own collagen (a connective tissue protein), but we do not know how often these antibodies occur in the general population, and there are no data that show these antibodies cause CTDs and related disorders. In contrast,a recent Danish study reported no evidence of increased autoantibodies.

Dr. Zuckerman added "Researchers must study a large group of women without breast implants who are of similar age, health, and social status and who are followed for a long time (such as 10-20 years) before a relationship between breast implants and these diseases can conclusively be made. ". I have added in a reference to the FDA booklet that addresses this.

The above examples should show you that there IS controversy and there still IS a call for more research. MollyBloom 20:00, 20 June 2006 (UTC)

Dr. Zuckerman's Comments

Last week, I testified on breast implants for the Health Committee of the Canadian Parliament. I was invited because I am an epidemiologist (post doctoral training at Yale Medical School) and internationally recognized expert on this topic. There are still many unanswered questions about the risks and benefits of breast implants, and much controversy. That's why the FDA and Health Canada are both unsure whether to approve silicone gel breast implants.

Last week I also spoke at a Women's Health conference in Virginia, on a panel with a plastic surgeon. We talked about the risks and benefits and agreed on almost everything regarding breast implants.

I have repeatedly added research data to this article, and Dr Oliver keeps removing it. I want this article to be accurate, but I have a fulltime job as the director of a research center and I don't think it is fair for me to have to keep putting back information that he removes for no scientific reason. He is entitled to his own opinion, but not his own facts.

I have taught at Yale and Vassar, and was the director of a major research project at Harvard. What research credentials does Dr Oliver have that entitles him to keep deleting my scientific additions to this article? (Dr. Zuckerman wrote this as can be seen from the history.)

From WebMD & Reviewed By Cleveland Clinic Dept of Plastic Surgery: Shows the Controversy and need for further research

"Since the 1999 IOM report, there have been other studies published with conflicting results. A 2001 NCI study reported that women who had breast implants (both saline- and silicone-filled) were two to three times as likely to die of brain cancer and three times as likely to die of lung cancer, compared to other plastic surgery patients.

And that same year, FDA scientists published a study with findings of more autoimmune disease among women with leaking breast implants compared to women with intact breast implants.

More recently reported, in 2004, scientists at the National Cancer Institute (NCI) found an increase in reported connective-tissue diseases among those with breast implants, but also found that many of the women made errors in their self-reported diagnoses. They concluded that this area needed further study."

Reviewed by the doctors at The Cleveland Clinic, Department of Plastic Surgery. Edited by Cynthia Haines, MD, April. 2005. http://www.webmd.com/content/article/76/90243.htm

Rob may believe there is no controversy but as Dr. Zuckerman said, while he is entitled to his opinion, he is not entitled to his "facts". Whether he (or anyone else) likes it or not, there is still controversy over the safety of breast implants. I also want this article to be accurate. Everything in there now is accurate, and supported with studies and academic research. To say there is no controversay is either to not understand the issues, or is deceitful. MollyBloom 04:00, 21 June 2006 (UTC)

I also deleted the recent addition of a "review" on the platinum study that was not discussed on this page. I missed it before. This "review" was written immediately after the 2006 peer-reviewed study. The review was written by a former Inamed consultant, as numerous newspaper articles mention. This is not a conflicting study. It is the opinion of a man with strong manufacturer ties. In fact, there are numerous articles about how he was "paid by Inamed to provide information to FDA advisory panel members" supporting the approval of silicone implants. This is hardly a peer-reviewed study of the same weight as the 2006 study discussed. The inclusion of this is patently dishonest. Now, to repeat and emphasize, this non-peer reviewed opinion is not of equal weight to a peer-reviewed study. It does not merit inclusion here, except as a comment, maybe, and only then disclosing this man's bias (which ALL the newspaper articles mention but Oliver conveniently omits) and the fact that this 'review' is an opinion of its author.MollyBloom 22:59, 21 June 2006 (UTC)

I reverted back properly referenced article. One editor cannot unilaterally decide what is going to be in this article. It is not proper and it will not be tolerated. This article is a collaboration. Further attempts to unilaterally delete large sections, after all this effort by David, me, Dr. Zuckerman and others will not be tolerated. Rob simply ignored all of the discussion here and reverted. MollyBloom 03:37, 22 June 2006 (UTC)

I agree with Rob's change from "extracapsular silicone" to the proper term "extracapsular rupture." He cannot, however, detele the entire properly referenced section on the controversy. Please read Dr. Zuckerman's comments. Rob is not in a position to simply delete work because he does not like it. Dr. Zuckerman is an expert in this area. Similarly, read the comments on the recent 2006 study.

signifigant tightening of segments

As has been the charge both to reflect the international and mainstream views of this topic, a number of the tangents introduced into segments on mammography, rupture, and systemic illness which bloated this article have been reduced. The treatment of this now more closely resembles the FDA , UK-MHRA [[ http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=736]], Australian [[1]], and Canadian health ministries' treatments of this and reflects the general consensus data. Editors interested in putting this into a consise, readable, and consensus form please jump in. It is beyond clear that some are not going to be willing to work in a productive wayDroliver 03:43, 22 June 2006 (UTC)

Productive is not defined by Oliver. The suggestion has been to reflect both the mainstream and the controversy, and recent research. The 'charge' as Oliver calls it, was also to discuss all changes HERE before putting in the article. Oliver ignores this. He also ignored the discussion on splitting the article that Dr. Ruben recommended, ignored Dr. Zuckerman's comments, and ignored mine. I guess he presumes that all of these people are not 'productive'. Further, he ignores the Baylor article here that specifically pointed out that there IS controversy, and recent research AFTER the 1999 IOM raised concerns. Once again, Oliver has an extreme POV and is not content on having anything but a POV article, that is pro-implant. MollyBloom 15:28, 22 June 2006 (UTC)

Deleted major sections

Well, it seems that there are two different editors that Oliver has insulted now. Dr. Ruben suggested that the article be separated into two articles. I may do that myself, and take the Risks and Controversies to a separate article. The consensus seems to be to do so. That said, Oliver has misquoted the FDA and deleted sections of the FDA's quote that he doesn't like. Please see all the discussion above, including Baylor Plastic Surgery Dept article that specifically addresses the controversy. Yes, we can include what Oliver calls the "mainstream". No, we cannot include it at the expense of the controversy. The section under "Risks and Controversy" will specifically be about this. Oliver does not want this concise or readable. He wants it a POV on breast implants, as it was before.

He has ignored the article I included here from Baylor, ignored Dr. Zuckerman, ignored Dr. Ruben, and ignored my comments. This is not collaboration.MollyBloom 15:23, 22 June 2006 (UTC)

An example of Oliver's "tightening up"and misrepresentation

This is what the article I (and Oliver) referenced, specifically said about mammography and rupture:

In addition, women should be aware that hard pressure on the breast (compression) during mammography may cause implant rupture.

This is what was there (and is now) about the same issue:

However, pressure on the breast (compression) during mammography can cause implant rupture.

This is what Oliver had changed it to:

However, pressure on the breast (compression) during mammography has caused a small number of documented implant ruptures.

Not only did Oliver NOT correctly represent what the article said, but what he wrote was longer than what was there before. Hardly tightening up.

The problem is 'silent rupture' where the woman does not know her implant is ruptured. This happened with me - and my doctors now believe it was a result of the mammogram. MOST doctors will acknowledge that mammograms can and do rupture implants, especially as they age. And in fact, the article cited for this sentence does NOT say 'a small number of documented implant ruptures', nor does it provide numbers from which one could draw a context of 'small number'.

Furthermore, the conclusion of another 2000 study cited in the article states:

The prevalence of silent or occult silicone gel breast implant rupture is higher than was previously suspected. Most women in this study had MR imaging evidence of at least one ruptured silicone gel breast implant. While this does not state specifically that mammograms caused rupture (which the other article did state), this does document the prevalence of 'silent rupture', as does this, in the same FDAarticle Oliver cited:

In addition, a rupture can occur at any time. While saline-filled breast implants leak only salt water when they rupture, the health effects of leaking silicone gel-filled implants remain controversial. Women sense a change more easily when saline-filled breast implants rupture. But the silicone gel-filled implants are more likely to maintain their shape after they rupture, which can make it more difficult to detect a break. Called "silent ruptures," these breaks involving silicone gel implants may occur without a visible change. And a woman may not feel any sensation, says Sahar M. Dawisha, M.D., a medical officer in CDRH who has reviewed data submitted by implant manufacturers. Magnetic resonance imaging (MRI) with equipment specifically designed for imaging the breast may be used for evaluating women with suspected rupture of their silicone gel-filled implant. The FDA considers MRI to be the best method at this time. There are no standards on how often to screen for silent rupture with MRI, and the costs of this procedure must be considered when choosing a silicone gel-filled breast implant.

This is only one example of Oliver's misrepresentation of the articles and studies. I welcome someone who is less biased and more intellectually honest to help edit this article. I am sorry to have to impugn Oliver's good faith here, but I know of no other way to say this. I can't be any blunter than this.MollyBloom 15:56, 22 June 2006 (UTC)

This misrepresentation of the content of the articles is very foolish of Dr.Oliver. It was very easy to track him to his plastic surgery web site, his blog and his various medical licenses. It could be just as easily done in reverse by an enterprising medical malpractice lawyer, if they were pursuing a case on failure to give informed consent. This sort of misrepresentation and shading could become relevant and would provide ammunition. As a practical matter, intellectual honsety issues aside, it would be wise to avoid this sort of misrepresentation. Gfwesq 23:40, 22 June 2006 (UTC)

Two sections on rupture for purpose of splitting article

The section on rupture in the main article is very short. The section in the "Risks and Controversy" article is expanded, to discuss the risks, and the controversy. Dr. Ruben had, in fact, suggested this himself. Oliver wants to simply delete the 'Risks and Controversy' section because he does not want any discussion on contorversy. That is not going to happen. There are a number of people who will not allow this.MollyBloom 16:01, 22 June 2006 (UTC)

Another example of misrepresentation

This is what Oliver wrote:

"...reviewed the available studies from the medical literature on platinum and breast implants in 2002 and did not find evidence that leached platinum causes illness in women with breast implants"

This is what the report actually said, "We found no published report with convincing evidence that platinum causes allergic reactions in women with breast implants or that women with breast implants are any more likely to have allergic reactions than women without breast implants." An allergic reaction is not equivalent to illness,. This review was specifically looking for allergic reactions, The study in 2006 (several years later) was, first, a study and not a review, and secondly, looked for something different than the 2002 review. It is misleading to make this statement in the way it was made.MollyBloom 05:09, 23 June 2006 (UTC)

And this is what Oliver simply deleted - absoulutely proper, referenced text, from the FDA's own website. However, this does not comport with Oliver's veiw of the world, or at least implants, so he simply deleted it, with no scientific basis for doing so. This is not 'tightening up', This is blatant deletion of NPOV text, as reoported by the FDA. This is not appropriate, and if it continues, there are a few of us who will lodge a more formal complaint. To simply delete this shows clear POV and intellectual dishonesty.

However, many of these studies have addressed the need for further study, and some have been criticized for the length of the studies or the method of selection. The FDA points out that previous studies have not been large enough to answer the question of whether or not breast implants increase the risk of connective tissue disease or related disorders. [2] Several autoimmune conditions, such as scleroderma and Sjogren's, are rare and require large numbers of study participants in order to ensure that increases risks can be detected. [3] Researchers must study a large group of women without breast implants who are of similar age, health, and social status and who are followed for a long time (such as 10-20 years) before a relationship between breast implants and these diseases can conclusively be made.

== POINT BY POINT REPLY TO MOLLY and MOLLY'S RESPONSE: STILL MISREPRESENTING ==

Brook is a former Inamed Consulant

[4] The 2004 FDA statement verbatim is " FDA scientists reviewed the currently available studies from the medical literature on platinum and breast implants and did not find evidence that leached platinum causes illness in women with breast implants."

A recent update was added addressing Molly's percived explosive charge of platinum toxicity and address the post IOM including Lykissa's and Brook's recent articles:

Trying to read the nonsensical sentence above, I can only point out that this is not my "explosive charge", Oliver. You need to stop being so personal about this. I did not do the study, nor did I publish the results. It seems that anything that raises any danger about implants is to you "explosive". With that kind of objectivity, this article would again look like an advrtisement as it did before.

Here is the Washington Post article about the platinum also. I suppose that is "explosive" also?MollyBloom 23:20, 23 June 2006 (UTC)

"Brook has recently published a review of platinum in breast implants, including the chemistry of platinum, the catalysts used in the manufacturing process, migration of platinum from breast implants, and its biological effects. The author provides his assessment of four of the studies discussed in this Backgrounder. In his review article, Brook concluded that platinum is found in its zero oxidation state at parts-per-million levels in silicone breast implants. He stated, “The experimental evidence supports the conclusion that there are no clinical consequences of the platinum in silicone breast implants.” FDA concurs with Brook’s conclusions."

Brook is a former Inamed consultant and every newspaper that discussed this has mentioned his bias. I do see that the FDA seems to agree with Brock. I suspect the FDA will be strongly criticized for this, and for the fact that they did not point out his affiliation with Inamed. But okay, the FDA has stated this.MollyBloom 02:27, 24 June 2006 (UTC)

"Based on the existing literature, FDA believes that the platinum contained in breast implants is in the zero oxidation state, which would pose the lowest risk, and thus that the small amounts of platinum that leak through the shell do not represent a significant risk to women with silicone breast implants" Droliver 22:43, 23 June 2006 (UTC)

Again, this is from Brook. If you have an FDA quote published after the April 2006 publication of the study, then please present it. If there is, then I will agree wtih you.MollyBloom 23:01, 23 June 2006 (UTC)

Here is a copy of the WAPO article. http://www.washingtonpost.com/wp-dyn/content/article/2006/04/06/AR2006040601917.html MollyBloom 23:31, 23 June 2006 (UTC)

Molly, before you make an even uglier scene of yourself, please follow the link to the FDA I provided above updated this week on platinum which is what I was quoting from. It is pretty dismissive of the charges & would indicate that this particular claim silicone has once again been reviewed and found lacking. I used the word explosive to characterize your enthusiasm over the research which I've been trying to explain to you is not really the consensus on the issue. The FDA update shows the peril of grasping at these straws while dismissing the large reviewsDroliver 01:46, 24 June 2006 (UTC)

before you make an even uglier scene of yourself is an uncalled for personal attack. Try to behave civilly. You were already admonished once on your talk page not to engage directly. Gfwesq 02:49, 24 June 2006 (UTC)

Oliver, you used the word 'explosive' in reference to the study. I have included the FDA comments in the text of the article. If I am wrong, I admit it, unlike you. Also, I notice that you simply ignore the other editors here. Is there a reason for that? I have also pointed out how you have misrepresented other issues, which you refuse to address.MollyBloom 02:36, 24 June 2006 (UTC)

FDA & UK-IRG mammography statements

According to the FDA adverse event database, there were 41 reported cases of breast implant rupture during mammography reported between 1992 and 2002.46 An additional 17 cases of rupture during mammography were reported in the medical literature.

From the UK-IRG There is only anecdotal information in the literature regarding the breast implant rupture during mammography

Out of hundreds of thousands of patients 60 some odd case reports make this safe to call rareDroliver 22:57, 23 June 2006 (UTC)

The problem is the many silent ruptures. I was quoting the FDA. And of course, there is only 'anecdotal' information because so many ruptures are silent. That is why it is better to say what the FDA stated, that mammograms can (or may) cause rupture. There has not been a significant study on rupture from mammograms. The only reason to report it is 'rare' is to push a POV. Saying what the FDA said in its booklet (intended for the public) is MUCH more NPOV, and does not mislead women. Your statements do.

Also, my point was the way you misrepresented the reference you cited. You did misrepresent it.

Going back to my original point, it is more NPOV to simply say what the FDA does in its booklet intended for the public.MollyBloom 23:05, 23 June 2006 (UTC)

Once again, here is what the FDA said, I said, and what Oliver wrote:

This is what the article I (and Oliver) referenced, specifically said about mammography and rupture:
In addition, women should be aware that hard pressure on the breast (compression) during mammography may cause implant rupture.

This is what was there (and is now) about the same issue:
However, pressure on the breast (compression) during mammography can cause implant rupture.

This is what Oliver had changed it to:
However, pressure on the breast (compression) during mammography has caused a small number of documented implant ruptures.

Not only did Oliver NOT correctly represent what the article said, but what he wrote was longer than what was there before. Hardly tightening up. As Oliver is well aware, and the reason the FDA says what it says, is that the problem is 'silent rupture' where the woman does not know her implant is ruptured. In fact, the article cited for this sentence does NOT say 'a small number of documented implant ruptures', nor does it provide numbers from which one could draw a context of 'small number'.

Furthermore, the conclusion of another 2000 study cited in the article states: The prevalence of silent or occult silicone gel breast implant rupture is higher than was previously suspected. Most women in this study had MR imaging evidence of at least one ruptured silicone gel breast implant. While this does not state specifically that mammograms caused rupture (which the other article did state), this does document the prevalence of 'silent rupture', as does this, in the same FDA article Oliver cited:

In addition, a rupture can occur at any time. While saline-filled breast implants leak only salt water when they rupture, the health effects of leaking silicone gel-filled implants remain controversial. Women sense a change more easily when saline-filled breast implants rupture. But the silicone gel-filled implants are more likely to maintain their shape after they rupture, which can make it more difficult to detect a break. Called "silent ruptures," these breaks involving silicone gel implants may occur without a visible change. And a woman may not feel any sensation, says Sahar M. Dawisha, M.D., a medical officer in CDRH who has reviewed data submitted by implant manufacturers. Magnetic resonance imaging (MRI) with equipment specifically designed for imaging the breast may be used for evaluating women with suspected rupture of their silicone gel-filled implant. The FDA considers MRI to be the best method at this time. There are no standards on how often to screen for silent rupture with MRI, and the costs of this procedure must be considered when choosing a silicone gel-filled breast implant.67.35.126.14 02:47, 24 June 2006 (UTC)

FDA & UK neurologic assessments

Several studies have indicated that women with implants are not at an increased risk of being hospitalized with neurological disease compared to other women. The IOM report found no basis for thinking that women with implants were more likely to have neurological diseases or symptoms. Since the IOM report, Winther, et al. published additional follow-up of the Danish group of 1,653 women with cosmetic breast implant surgery at private clinics in Denmark compared to a comparison group of 1,736 women who underwent other types of cosmetic procedures. No increased risks for neurological disorders were found in the breast implant patients. However, it should be noted that these studies are limited in that rare disorders cannot be addressed.

From the UK-IRG There does not appear to be any evidence of a conventional or validated type of systemic reaction, or of abnormalities of the immune system in subjects who have received implantsDroliver 22:58, 23 June 2006 (UTC)

This is a link, and is also discussed in the text. The IRG was also Dow funded.MollyBloom 23:06, 23 June 2006 (UTC)

However, it should be noted that these studies are limited in that rare disorders cannot be addressed. Systemic illnesses that have been found in women with implants, like scleroderma, are rare. This is discussed in the text of the article.MollyBloom 23:55, 23 June 2006 (UTC)

Thanks to the Anti-Vandal Bot

Thanks to the anti-vandal bot for changing back! Wholesale unilateral changes on this article are not permitted. jgwlaw 23:59, 7 July 2006 (UTC)

neutral point of view is appreciated

I just wanted to say that I am pleased that this article doesn't read like an advertisement for breast implants. It's neutral and educational, which is something that I appreciate, as a graduate student and employee at a women's health organization.

Jrlazar 15:44, 23 June 2006 (UTC)

Thanks, Jrlazar! The problem we are having is that there are those (well, one anyway) who DO want it to look like an advertisement, completely ignoring the controversy - which is not just a few remote 'quacks' but even Baylor Dept of Plastic Surgery acknowledged. MollyBloom 23:07, 23 June 2006 (UTC)

Baylor Agrees there is a Controversy

From WebMD & Reviewed By Cleveland Clinic Dept of Plastic Surgery: Shows the Controversy and need for further research

"Since the 1999 IOM report, there have been other studies published with conflicting results. A 2001 NCI study reported that women who had breast implants (both saline- and silicone-filled) were two to three times as likely to die of brain cancer and three times as likely to die of lung cancer, compared to other plastic surgery patients. And that same year, FDA scientists published a study with findings of more autoimmune disease among women with leaking breast implants compared to women with intact breast implants. More recently reported, in 2004, scientists at the National Cancer Institute (NCI) found an increase in reported connective-tissue diseases among those with breast implants, but also found that many of the women made errors in their self-reported diagnoses. They concluded that this area needed further study." Reviewed by the doctors at The Cleveland Clinic, Department of Plastic Surgery. Edited by Cynthia Haines, MD, April. 2005. http://www.webmd.com/content/article/76/90243.htmMollyBloom 23:13, 23 June 2006 (UTC)

Dr. Zuckerman's Comments

Last week, I testified on breast implants for the Health Committee of the Canadian Parliament. I was invited because I am an epidemiologist (post doctoral training at Yale Medical School) and internationally recognized expert on this topic. There are still many unanswered questions about the risks and benefits of breast implants, and much controversy. That's why the FDA and Health Canada are both unsure whether to approve silicone gel breast implants.

Last week I also spoke at a Women's Health conference in Virginia, on a panel with a plastic surgeon. We talked about the risks and benefits and agreed on almost everything regarding breast implants.

I have repeatedly added research data to this article, and Dr Oliver keeps removing it. I want this article to be accurate, but I have a fulltime job as the director of a research center and I don't think it is fair for me to have to keep putting back information that he removes for no scientific reason. He is entitled to his own opinion, but not his own facts.

I have taught at Yale and Vassar, and was the director of a major research project at Harvard. What research credentials does Dr Oliver have that entitles him to keep deleting my scientific additions to this article? (Dr. Zuckerman wrote this as can be seen from the history.)

I re-added these two comments since they have been ignored. MollyBloom 02:44, 24 June 2006 (UTC)

neutral point of view is appreciated

I just wanted to say that I am pleased that this article doesn't read like an advertisement for breast implants. It's neutral and educational, which is something that I appreciate, as a graduate student and employee at a women's health organization.

Jrlazar 15:44, 23 June 2006 (UTC)

Thanks, Jrlazar! The problem we are having is that there are those (well, one anyway) who DO want it to look like an advertisement, completely ignoring the controversy - which is not just a few remote 'quacks' but a number of US Senators, the Baylor Dept of Plastic Surgery, and others, have acknowledged. MollyBloom 23:07, 23 June 2006 (UTC)

Someone is deleting my research citations

Someone who seems to have a strongly pro-implant POV has edited the information about the new platinum study, despite the fact that I included quotes and citations. He or she replaced my paragraph with one based on an analysis by Dr Brook, a paid consultant to one of the implant makers. I was wondering if this addition was in fact inserted by a paid consultant to an implant company.

I have rewritten my brief summary, which is based on conversations I recently had with the study authors, FDA officials, and several experts on platinum exposure who do not have any financial ties to plastic surgery or implant makers. I have also met with the FDA Commissioner to discuss the platinum study. The Lykissa and Maharaj study can't be considered conclusive, but it is the only article using a new technology to measure ionized platinum in the body, and it is published in a peer-reviewed chemistry journal. If someone has more expertise than those authors or than me and if he or she does not have financial ties to implants, they are welcome to change my contribution to this article. Otherwise, I would hope they wouldn't.

Are there any Wikipedia rules about changes made by people with a financial interest in what an article says? Drzuckerman 01:22, 25 June 2006 (UTC)DrZuckerman

I have reviewed the Lykissa and Maharaj study in detail, the position of the FDA citing the Brook Review article, the abstract of the Brook article along with the editorial comments. I have also reviewed additional literature regarding the platinum controversy. "Results" from the ground breaking clinical study of Lykissa and Maharaj are valid for inclusion in this section. While the FDA cited the Brooks article as justification for it's current position, I do not agree 100% that a peer-review article should have taken precedence over a clinical study. Be that as it may, it is the current position of the FDA.

Additionally, due to the nature of the platinum controversy, both the funding sources as well as the alliances of the authors for these studies should be disclosed in the main text or perhaps noted at the end of the section.

In other words, User: Drzuckermans comments should remain intact. User:Sheehs1 23:56,25 June 2006 {UTC} Sheehs1

The FDA update speaks for itself. The notability of the Lykissa study is for reporting to find new Platinum radical species. This was discussed in the FDA review & it was taken in context of previous work & a number of post IOM reports on this area. This is no ambiguiity in the language on how skeptical the FDA is of this finding. You are trying to frame this in a political advantageous way which is not appropriate.Droliver 16:09, 26 June 2006 (UTC)

Dr. Z's paragraph told both the FDA finding as well as the controversy about it. Therefore, it is the better paragraph.MollyBloom 01:30, 27 June 2006 (UTC)

I am not trying to frame anything in a politically advantageous way. Additional research is often required when there are 2 opposing and "recent' papers such as this. Perhaps a better point is that both papers, the Lykissa and the Brooks article should be treated skeptically until more research is conducted and published using sujects implanted for more than 10 years by unbiased researchers who have no interest what so ever. {{User:Sheehs1]] 11:15 29 June 2006 [UTC}

Furthermore, personal attacks regarding my motivation for posting do not seem appropriate nor are they appreciated. As a "consumer", I have read the recent literature. As a previous researcher in a different medical field, I am quite able to interpret the scientific literature and form my own conclusions. I am not connected with any political party. What I am is a person with 12 year old saline implants and am having many medical issues. These implants are being taken out soon. Thus, I have become very interested in this topic. Consumers need all the information which includes both sides of any issue so they can make an "informed" decision. The powers that be will make their determination known to the public. This does not mean those of us that take the time to delve into this further and are able to form our own conclusions have to agree with them. User: Sheehs1 10:07 1 July 2006

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External Links

This is a controversial and highly political subject. There is nothing improper having links that address the controversy - that have been deleted as 'political'. It is instructional that women's groups such as NOW and 5 other women's health gropus have taken this up as an issue. These links must stay.MollyBloom 03:11, 25 June 2006 (UTC)

Molly, if you are going to add political links to this you've introduced a pandora's box of what is & is not appropriate. Is Inamed's breast implant page appropriate? Are we to catalog the various internet bulletin boards about women discussing their upcoming augmentation surgeries? You can go on and on with this into until that section is so diluted from the major ones as to be non-useful. It would seem more useful to keep some of the weblinks (re. N.O.W. and the like) you wish to include in what becomes the eventual paragraph on opposition to reintroduction. I'd have no problem with it in that contextDroliver 16:20, 26 June 2006 (UTC)

Inamed's links are commercial websites. The links I added are not. I don't know what you mean by the "paragraph on opposition to reintroduction." I'/m not sure ....let's discuss...

getting all the facts

I just wanted to say that as a young woman who has had to watch a very close family member attempt to make a tough but thoroughly informed decision on breast reconstruction after a mastectomy, it is refreshing to find the info we have in this article on Wikipedia. It has been very useful to read about all of the controversy surrounding silicone breast implants. While I assure you that this article is not the only source of information we have turned to, it is very much appreciated. Maxsanders 20:08, 26 June 2006 (UTC)

I think this user's comments are a huge testament to why complete and thorough risk information on breast implants should be included in this article. Dr. Oliver, as a doctor yourself, you should understand the importance of patients having enough information to make an informed decision. To decide what information patients should and should not know is not only paternalistic; it is bad medicine. --Grace Zander 16:00, 29 June 2006 (UTC)Grace Zander

Oliver doesn't want any 'negative' information out there about breast implants. That much is clear. Unfortunately, not all doctors present their patients with unbiased information. That is why there are 'informed consent' laws. See G. Patrick Maxwell

a proposal for a subheading supporting systemic illness

Molly & Diana, I would propose inclusion of a succinct description of the case supporting links to systemic disease. Even though I would argue this has been addressed fairly comprehensively by the body of work, I wish to break the logjam of our competing views. As I see the arguments for such a link they would include: the relationship of industry to research, the observational reports of some rheumatologists treating these patients, the induction of an anti-body response, and a number of individual studies reporting an incr. in fibromyalgia,etc.... As with the case non-supporting this association, it would seem this can be summarized briefly with an attached hyperlink to the study or finding referred within the body of the text. I also support including or linking to reports of organized political opposition such as Molly's N.O.W. press release or Dr. Zuckerman's organization within the context of this segment. I do not think we need a lot of expansion (as has existed) on individual studies that are not really representative of the body of work or general consenus. 64.79.232.50 18:53, 28 June 2006 (UTC)

Several others have added comments here, Oliver, about the article, which you seemed to have ignored. Some would argue that there is NOT a 'clear' consensus. The FDA states that more studies are needed, for a number of reasons. If you really wish to break the logjam, you will not use such categorical language. There is no consensus, for example, about antibody response. You cannot summarize all that you want in one paragraph, while consigning all else to a secondary paragraph.

Secondly, you cannot call Dr. Zuckerman's group a political group. It is not the same as NOW. For that reason, and since we disagree, I do not see how we can break this up. All the external links should be one grouping.

Since many editors have requested that we discuss major changes here and get input BEFORE editing, I reverted back to what the last editor had.MollyBloom 22:51, 28 June 2006 (UTC)

Molly, you can argue all you want about what you consider clear consensus. The facts on the ground are the cthat every authorized panel to ever have considered this are in agreement, both in the USA and the world. That is where the discussion starts. Dr. Zuckerman's group is most certainly politically involved. She herself is the single most well-known activist in this issue.Droliver 16:57, 29 June 2006 (UTC)

--Dr Oliver seems to not understand the difference between political involvement and policy expertise. Political involvement means working for a political candidate or party. No efforts are being made to change any laws regarding breast implants, although that would not be political anyway, it would be policy. What our Center is doing is providing scientific information to health policy experts. That's not political using any reasonable definition of the word. Drzuckerman 02:27, 30 June 2006 (UTC)

Anything Robbie doesn't like he calls political. 172.147.25.119 23:20, 3 July 2006 (UTC)

"Political" links as determined by whom?

As the president of a nationally-respected independent think tank that has been quoted in every national newspaper, magazine, and TV network (and has over 40,000 entries in google), I am tired of Dr. Oliver's bullying comments and repeated deletions of scientific facts and analyses that I have contributed to this article. And, I am offended by Dr Oliver's repeated slurs against the National Research Center for Women & Families, an organization that he apparently knows nothing about. Dr. Oliver, you are entitled to your opinion but you should not be making up facts in Wikipedia. I don't want to be rude, but the truth is I have never seen you interviewed as an expert on this topic by the major media, nor have I seen even one article by you on breast implants in the peer-reviewed medical literature. I understand that you have strongly-held views on the topic but you don't seem to have an objective grasp of the research. I have published dozens of articles on health topics, including breast implants, in peer-reviewed medical journals, and I am happy to defend anything I have written. Feel free to debate me in this discussion area, but please stop deleting my additions to this article. Drzuckerman 04:23, 29 June 2006 (UTC)Dr Zuckerman

I beg your pardon but if I don't seem to have an objective grasp of the research then neither do the IOM, the FDA, and about a dozen other world-wide expert reviews. That is the body of work that your political argument is working against. Time and time again this has been looked at, and the evidence has consistantly been found to be lacking to make the conclusion that you are promoting (a distinct minority viewpoint). There is no other way to accurately describe the research in this field to date. Playing up a controversial & poorly desighned/executed on platinum at the expense of the work done already on this & the smack down it recived last week in print by the FDA does not accurately portray where we are in research on thisDroliver 17:10, 29 June 2006 (UTC)

Discussion on the controversy is warranted, and will be included in the article. Other editors have agreed that this is important and needed. And I can't speak for Dr. Z, but I do not think you have any objectivity on this at all. You have attempted to spread your love of silicone implants and your belief of how safe they are all over Wikipedia. You are clearly a single-issue editor, and you clearly have an extreme bias.

I would say you (Rob) is the political one here, since this seems to be an obsession for you.jgwlaw 20:35, 29 June 2006 (UTC)

The Nature of Science

--As is frequently true of research in a new scientific area, reports that summarize research become outdated as new research is conducted. That is true of the Institute of Medicine report and the other reports you have previously mentioned.

If you look on the IOM website, reading their reports over the years on once controversial issues such as Agent Orange(dioxin), you will see that the first reports done by IOM or the National Academy of Sciences concluded that there was no evidence that dioxin caused cancer or other serious health effects. They concluded that therefore Vietnam vets were not in apparent danger. Years later, based on subsequently conducted research, NAS and IOM concluded that dioxin did cause cancer. But before that happened, Vietnam vets were criticized for claiming illnesses related to dioxin exposure, much as women with implants are today.

Sometimes these changes in conclusions happens because it takes many years of epidemiological research to determine that certain exposures cause illness. In other cases it happens because all the initial research is conducted or funded by the company that makes the product whose safety is being evaluated (in the case of Agent Orange and of silicone implants, the company was Dow).

The IOM report was a summary of many studies, but only 17 were studies evaluating connective tissue diseases of women with breast implants, and a handful of others were of breast cancer. There were no mortality studies at all. The one largest study of connective tissue diseases, conducted by Harvard researchers, found a significant association between symptoms and breast implants. The other studies, all smaller and based on either hospitalization records or classically defined connective tissue disease, were all funded by Dow and none found a significant risk associated with implants.

The IOM report was completed in 1999 and based on research published in 1998 and earlier. Better designed studies conducted by the National Cancer Institute and the FDA were published after the IOM report was completed. And, the only longitudinal clinical trials of silicone implants were also completed years later, and although they were conducted by Inamed and Mentor, both reported extremely high complication rates and significant increases in autoimmmune symptoms. Those studies are available on the FDA website, www.fda.gov, but the companies have never published them. Why? Perhaps because the results are not favorable to the companies bottom line.

This reminds me of another recently published study, which found that research on antidepressants always shows the superiority of the antidepressant made by the company that funded the study. In other words, if company A compares its anti-depressant to one by company B, the article based on the study funded by company A concludes their product is superior to company B's product. But when company B conducts its comparison study, it concludes that company B's product is superior. Are they lying? Nobody knows, because we don't have access to the raw data. All we know is that companies have a tendency to not publish findings if they don't like them, and they tend to publish findings that they do like. They have a right to do that, but it sure makes it difficult to trust research funded by those companies because you don't have all the information you need to make a judgment.

A careful look at the FDA's scientific review of silicone gel breast implant research, completed in 2005, shows their very great concerns about the safety of silicone gel implants and their lack of enthusiasm for the safety data available. I agree with almost everything in the summaries that the FDA scientists wrote, which are available for anyone who takes the time to read them: [5] and [6]

I agree that there is not conclusive evidence that silicone breast implants cause disease in large numbers of women. There is, however, research evidence of statistically significant increased risks of autoimmune symptoms such as joint pain in several studies, increases in some cancers in a few studies, and suicides in numerous studies. More research is needed. Meanwhile, there is a world of difference between "no conclusive evidence" and "no evidence" and there is a world of difference between "no conclusive evidence" and "this product is proven safe."

The release this week of the Surgeon General's report on second-hand smoke is another good example of this phenomenon. For many years the tobacco companies claimed that there was "no conclusive evidence" that second-hand smoke caused cancer or other illnesses. The Tobacco Institute, a research institute funded by tobacco companies, published research denying such a link. It is now absolutely clear that second-hand smoke can be lethal, but it has taken years of expensive research to draw that conclusion.

One of the previous commenters asked for more information in this article about why women get breast implants. Unfortunately, there is very little research to answer that question, other than the obvious answer: they want larger breasts (85%) or to replace breasts lost to cancer (15% at the most). A very small percentage of women had deformities or abnormalities such as one or both breasts that never developed normally. There is one interesting study showing that women who want breast augmentation often have the same size breasts as women who don't, but the women who want augmentation think that the ideal breast size is a C or D cup, and women who don't think the ideal bresat size is a B or C cup. If you'd like me to add that info into the article with a reference, I will. Drzuckerman 01:54, 30 June 2006 (UTC)

The conclusion statements of multiple world-wide reviews of this do not mince words on the evidence of this connection you take for granted. That is the body of work from where you have to lead this discussion with. The defacto position of the FDA is that these devices are pending approval. The position of other countries health ministries is there is no evidence that supports this. How hard is it to distinguish between the mainstream NPOV and the minority alternative? Not very.

Dr. Zuckerman, Oliver would only provide 'positive' information to the world, about breast implants. He selectively picks study results, ignoring all that suggests further research is needed. It is unfortunate, but that is why there are 'informed consent' laws, thank God. And, Wikipedia is an encyclopedia, not Oliver's business website or breast implant advertisement.172.147.25.119 23:17, 3 July 2006 (UTC)

Problems and solutions

I have been asked by Dr Oliver to comment on the present state of things. Firstly, let me declare my bias: I have previously been unimpressed with Molly's approach, and I am a practicising doctor. On the mitigating side: I am not a surgeon and have no extraneous interests in breast implants. My main interest is that scientific findings are not misrepresented to suit either side's agenda. Examples of my previous work on scientific NPOV includes aprotinin, which changed from a compensation lawyer's advert to a historically and scientifically sound article under my hand.

I'd like to make the following points about the article:

• Clinical indications are completely snowed under. Are there clinical studies measuring satisfaction with breast implants, e.g. after radical mastectomy? What tools are used to gauge patient satisfaction, and how have they been validated (compare SF-36).
• A short word should be devoted to the surgical technique, e.g. how is the skin closed to minimise cosmetic problems (e.g. intracutaneous suturing, tissue glue, using skin folds). This may improve the worrisome phenomenon that >50% of the article presently focuses on "negative effects", while there are millions of women quite happy with their implants.
• When it comes to negative effects, we need to agree in principle that large, well-designed and neutral clinical studies are inherently better sources than individual observations about individual patients. Can we settle some specific arguments on what constitutes a reliable source in this context?
• If anti-silicone antibodies have been demonstrated, do the titers of these antibodies correlate with the severity of the symptoms? Or is it possible it's an epiphenomenon ("bystander effect")?
• The article is presently heavily Americocentric. One forgets that plastic surgery is highly popular in countries such as Brazil. Do side-effects as listed also occur in that population? Or is this locally determined? (I can cite some similar instances in medicine, such as the oddly low incidence of whiplash in Lithuania.)

I'm interested to hear the views of fellow editors. There are only two sorts of conflicts: those that propel articles to ever-higher levels of quality and those that lead to chaos and burnout. With a bit of luck we can focus on the issues, stop emphasising each other's bias, and make this article truly NPOV and a truly useful resource on the topic. JFW | T@lk 20:47, 4 July 2006 (UTC)

What's a compensation lawyer? And 2ndly who says its now historically and scientifically sound?Gfwesq 19:08, 5 July 2006 (UTC)

Dr. Oliver seems to feel Wikipedia is an appropriate place for advertsing. It is not. He was caught linking Wikipedia's breast implant article to his blog which links to his business page. On his blog and business page he presented his POV and helpfully linked to the "NPOV" Wikipedia article which he had edited to the same POV. His agenda was and is clear.

This is issue is not as clear cut as Dr. Oliver would make it out to be. Others have weighed in here with better credentials than Oliver- professors of plastic surgery from Vermont as well as Yale trained epidemologists specializing in this subject. Articles cited from Baylor show this issue is not cut and dried. Yet Dr. Oliver demands that the issue be presented as black and white. One can only wonder about this. One wonders how much information Dr. Oliver gives his patients and does it satisfy the requirements of informed consent?

JFW, you may be a doctor as you claim, however, I note you don't claim to be an epidemologist. I am not sure why you think your credentials are any better than Dr. Zuckerman's, who is an epidemologist and has weighed in here. All things considered, I am not sure your services are needed here at this point, as Dr. Oliver seems to be quite capable of representing Inamed's POV without you.

Finally, if you want to make a positive contribution lose the insulting tone and be respectfull of others including Molly's. Gfwesq 19:08, 5 July 2006 (UTC)

I personally feel aprotinin is more historically and scientifically sound than before . If you dispute that, please comment on Talk:Aprotinin. A compensation lawyer is a lawyer that works mainly on compensation cases. They're not well liked by the medical profession, you will gather.

And that seems to be coloring your perception of me, and others who are lawyers, as noted on your MD project page. In fact, there are many doctors who do not share your venom.jgwlaw 19:36, 5 July 2006 (UTC)

What kind of advertising does Dr Oliver engage in? And why does that answer my points above? I don't dispute Dr Zuckerman's credentials, but on Wikipedia credentials are not automatically equal to editorial quality.

I did not insult Molly. If she's insulted I apologise. I declared that we've had previous skirmishes, but it was not my intention to hurt her feelings. Can we go back to the article now? JFW | T@lk 19:23, 5 July 2006 (UTC)

You most certainly did insult me, and stated categorically that 'doctors' (generalizing to an extreme degree) dislike 'compensation lawyers'. I suspect we need a more neutral person to help with this article.jgwlaw 19:36, 5 July 2006 (UTC)

Ok, its your personal opinion as to whether aprotinin is more historically and scientifically sound than before. So it isn't much of recommendation of your services.

I merely pointed out that what Rob Oliver wants is someone to shill his POV. As for his use of Wikipedia as an adverstisement, surely you are not so obtuse as not to be able to figure out the connections as I gave you a road map.

Not familiar with the term compensation lawyer. I think you are trying to say personal injury lawyer. I am well aware that doctors' don't believe they make mistakes; and if they did make a mistake the injured party shouldn't be compensated; and if the injured party is compensated, whatever they got was too much compensation, particuarly if the doctor had to pay it. Fortunately, that is not how the world works. Doctors are not gods.

 :::Interesting you don't think credentials automatically equal to editorial quality, as you and Dr. Oliver appear to be setting this up to be: we are the doctors, we know best and we are best suited to determine sound science. What is this claim based upon, if not credentials?.... Oh I get it, credentials of those who agree with my POV are the sound credentials.Gfwesq 19:59, 5 July 2006 (UTC)

Do you think my version of aprotinin is inferior? JFW | T@lk 14:26, 6 July 2006 (UTC)

--I disagree that the article is too focused on the US point of view; in fact, most of the studies conducted on women with implants were conducted in Europe. It is unfortunate that they were funded by Dow Corning, however.

Why do so many other countries allow the sale of silicone gel implants but the US and Canada do not? It's because other countries DO NOT REQUIRE clinical trials to prove that medical devices are safe. That may seem strange, especially for implanted medical devices, but it is true. I just wrote a book chapter on that topic.

There are no studies in the research literature in South America, even though plastic surgery is popular there. The most likely reason is that since implants are widely available, who would pay for research? Implant research tends to be paid for by companies when they need to prove their products are safe, and not if the products are widely available.

Clinical experience is useful, but it there are major problems with it when the treatment involved is plastic surgery. When patients have problems they often go back to their original plastic surgeon. However, if he or she is unwilling to fix the problem for free, the patients often seek help from other plastic surgeons.

The plastic surgery journals include clinical observations, however, they are primarily based on case studies of unusual disasters (one study was of a woman who lost 3 limbs to gangrene due to toxic shock syndrome immediately after breast implant surgery) or happy customers (articles written by plastic surgeons describing how happy their patients are). Neither of these present an objective view.

It is absolutely clear that some women are very happy with their breast implants and some women have terrible experiences. Research is the best way to quantify that information.

I think there is a great deal of NPOV and balanced POV in this article. The reason there is so much risk information is that breast implants have much higher complication rates than most cosmetic surgery. And, that is the reason why silicone gel implants have never been approved by the FDA, despite repeated efforts by numerous companies since 1991. Saline breast implants are FDA approved, and that is why the information in this article is less negative about saline. In fact, the cosmetic problems related to saline implants were all included by Dr. Oliver, not by other editors, because he apparently prefers silicone gel implants.72.75.0.18 19:43, 5 July 2006 (UTC)Dr Zuckerman

BIas and Personal attacks

I am unimpressed with Jfw's need to single out and criticize one editor. Please note that a number of others have also made changes to this article, all of which Oliver has summarily dismissed. Until we are able to obtain consensus, the article won't change. Dr. Zuckerman is an epidemiologist who specializes in this, so she should be given credit. Instead, she is dismissed as 'political', and JFW completely ignores her. So JFW, until you can curb your tongue and stop criticizing those whom your buddy oliver doesn't like, please take your comments elsewhere. Your 'doctors' page' seems to be pretty good at gossiping.jgwlaw 18:37, 5 July 2006 (UTC)

What I actually intended was: "I've clashed with Molly before". If it came accross the wrong way I certainly apologise. It was not my intention to single you out, but as I haven't had similar run-ins with others you were the only one I needed to mention by name.

Dr Zuckerman's expertise is welcomed, but no editor has the final word in case of NPOV issues. Can we talk about the article now? JFW | T@lk 19:26, 5 July 2006 (UTC)

"::Indeed, and that includes Oliver and you. jgwlaw 01:25, 6 July 2006 (UTC)

Well, JFW, it seems your way of disagreeing is to lash out, and make innuendos. That is unfortunate. Even your apology is an insult. I suspect we would be better off if we had a less snide editor help us with the edits here.

Please note that a number of others have also made changes to this article, all of which Oliver has summarily dismissed. Until we are able to obtain consensus, the article won't change. Another plastic surgeon had weighed in and agreed that there was a controversy about breast implants. I copied a quote from Cleveland Clinic, which mentions a controversy about the health issues, and another doctor came in, also agreeing that there was a controversy. Yet Oliver ignores all and insists on saying that there is a 'clear consensus'. That simply is factually untrue.

My suggestion is that we wait for a day or two, since many are still on vacation. There are a number of people who have weighed in here, jgwlaw 18:37, 5 July 2006 (UTC)

--Let's skip the personal attacks. But I would appreciate it if Dr Oliver would stop deleting my scientific entries.

In response to JFW, I agree that the platinum issue is not resolved. I believe that is what my entry says. The FDA has thus far quoted implant company reviews on platinum, a new peer-reviewed study shows toxic platinum salts in breast milk, urine, and blood of women with implants, and a larger study, conducted by independent researchers, is needed to determine the truth of the matter.72.75.0.18 19:49, 5 July 2006 (UTC)Dr Zuckerman

Excellent. I agree. Personal insults are never productive. Nor are generalizations, such as 'doctors hate lawyers' and the like. Wikipedia is an open source encyclopedia - there are many varieties of experts, and lay people who can contribute valuable information to an article. The platinum section is good, Dr. Zuckerman, as are the other edits you added. A number of people have commented on the edits, and the article. This is a general article on breast implants and as such, should not read like a medical journal on techniques, for example. It would be too unwieldy, as it was earlier. A balanced article would describe (briefly) studies that suggest there are not proven health concerns, as well as those that have found health concerns. There is most certainly not a consensus about safety, as a number of major universities and health clinics point out (like the Cleveland Clinic). Plastic surgeons even have mixed views on this issue, and most certainly other physicians do. The FDA hearings illustrate the controversy. There are valid concerns. To ignore them is most certainly not NPOV.jgwlaw 21:23, 5 July 2006 (UTC)

JFW, you stated that you were unimpressed with Molly's approach. Aside from the fact that it is a personal attack on an editor, you failed to be specific or to clarify the reasons you are unimpressed. Generalizations such as this do not work well here....as it detracts from the focus, which is the article itself. What has transpired since speaks to this directly.

After having re-read the article, I find it an excellent resource. In response to some of the discussion, some additional verbiage regarding the use of implants in other countries in the first paragraph might address the Americocentric complaint. However it should also include the fact that those countries do not perform the research or clinical trials that have been performed in the US as pointed out by Dr Zuckerman.

On the surface, an actual subheading titled "Benefits" could make this article appear more editorically balanced. I say "appear" because the benefits are discussed within the context of the other paragraphs. Since the risks and controversies have their own sub-headings....I suggest one for "Benefits" (since it is the opposite of negative risks).

So.... rather than continue to argue over the Risks and Controversies and editorial comments in those sections, which by the way are valid and well written,....providing some exclusive weight to "benefits" should "editorially" satisfy you and Oliver. I would expect to see cited references for this as well.

Lastly, this article is a reference article and as such any and all risks and complications and or controversies need to stay. All facets of the topic are by nature controversial.

User:SHEEHS1 7:53 5 Jul 2006 {UTC}

This is really not a controversial area to the rest of the world, as the conclusions of the studies from the early 1990's have been accepted by every other nation at this point. Pointed poltical editing through-out the entry has made this a difficult read. This discussion on sysetimc illness is largely no longer is even taking place worldwide among researchers & physicians. As to 'where' these studies have been done, in point of fact, a great deal of the body of research has come from the databases of western european nations (particularly Scandanavia) and Australia, as have more then half a dozen of the systemic reviews on this issue. It is certainly fair and needed to mention the contrarian viewpoint in this (with references to some relevant work) , but an extensive outlining of that debate ad nauseum isn't reflective of the consensus.

As to risk & complications aside from systemic dz, the ones that deserve specific attention are rupture, capsules, imaging difficulty, and what drives reoperation rates. These are the areas that both Physicians & the FDA are most interested in for improvement. Most of the rest are so non-specific to breast surgery & don't need a paragraph to explain.Droliver 04:53, 6 July 2006 (UTC)

Again, Oliver is proving my point. The studies have not been accepted by 'every other nation'. That is a flatly untrue statement. It seems, Oliver, that you are the only editor here insisting on your facts - that there is no controversy. Since there is a consensus that there is a controversy, and since there are references and facts to back it up, that is the way the article will present it. Oh, an d it seems the Cleveland Clinic, the FDA, and about every other resource DO discuss these issues with more than a paragraph. The FDA points out that further research is needed, which I have quoted in the text.172.131.31.25 13:05, 6 July 2006 (UTC)

Also, to correct Oliver -- this an article about breast implants, not breast surgery. Again, the subject is breast implants, so techniques etc for breast surgery are not germane to this article, but discussion on the controversy of breast implants that has been well publicized and is still controversial most certainly IS pertinent.jgwlaw 13:15, 6 July 2006 (UTC)

Some issues

I'd like to make the following points about the article:

• Clinical indications are completely snowed under. Are there clinical studies measuring satisfaction with breast implants, e.g. after radical mastectomy? What tools are used to gauge patient satisfaction, and how have they been validated (compare SF-36).

There has not been adequate follow up, which is one thing the FDA is aware of regarding the adjunct studies.

• A short word should be devoted to the surgical technique, e.g. how is the skin closed to minimise cosmetic problems (e.g. intracutaneous suturing, tissue glue, using skin folds). This may improve the worrisome phenomenon that >50% of the article presently focuses on "negative effects", while there are millions of women quite happy with their implants.

The problem with including technique is that an entire article was nearly devoted to this. Perhaps we can discusss on the talk page what would be reasonable - but there should not be the long list that there was initially - this is not a medical journal. This too was discussed already, but I guess you did not see that. Also, I would like to see where your information of 'millions of women quite happy' comes from.... Perhaps I hear only of those women who are not happy, but I can tell you it is alarming how many are not.

• When it comes to negative effects, we need to agree in principle that large, well-designed and neutral clinical studies are inherently better sources than individual observations about individual patients. Can we settle some specific arguments on what constitutes a reliable source in this context?

All of the sources cited are "reliable" - except that comes with a huge caveat. There is a dearth of long term and large studies, which is one thing the FDA points out. That is also stated (directly from the FDA) in the article. That said, all of the references in the article are citations from academic sources, journals, regulatory bodies and the like. External links are quite different, of course. I do not believe that there has been ANY reference of an individual observation, so I am not quite sure why you even raise this point. Nobody editing this has relied on individual observations.jgwlaw 00:41, 7 July 2006 (UTC)

• If anti-silicone antibodies have been demonstrated, do the titers of these antibodies correlate with the severity of the symptoms? Or is it possible it's an epiphenomenon ("bystander effect")?

I would like Dr. Zuckerman to address this more fully. However, the FDA has stated that more studies are needed to answer this question. (I know in my own case the antibodies most definitely correlated with my symptoms. jgwlaw 00:41, 7 July 2006 (UTC)

• The article is presently heavily Americocentric. One forgets that plastic surgery is highly popular in countries such as Brazil. Do side-effects as listed also occur in that population? Or is this locally determined? (I can cite some similar instances in medicine, such as the oddly low incidence of whiplash in Lithuania.)

Dr. Zuckerman addressed this already. If anyone has information about Lithuania or Brazil please feel free to share. I don't, except that I have received a call from a woman from Brazil who was having problems with her implants and wanted them removed. One of the most serious problems with implants is a lack of follow up. I suspect that is even more true in countries where they are more widely available - as Dr. Zuckerman suggested.jgwlaw 00:41, 7 July 2006 (UTC)

In case anyone wonders, I'd like to actually discuss these issues. Therefore, I'm restarting the thread. Your views are actually welcomed. JFW | T@lk 14:26, 6 July 2006 (UTC)

Well you can see the issue. Molly does not recognize the conclusions of multiple expert panels convened to review this while the world does. (This is effectively summed up in one paragraph as written.) This is her right as an individual and it deserves mention in the body of the entry. This can be done in short-order with hot-linked refs. The qualifier re. conclusively saying anything on this (as in the FDA consumer info) is preserved. It's that easy to settle. Making an aggressively edited treatise to drive a political view is not productive.Droliver 00:01, 8 July 2006 (UTC)

The article presents a balanced view, of the history and risks. It is not political.

Molly, the FDA rejoinder re. making conclusive statements is indeed preserved. I'm not sure what a "positive only" edit is. What's in the article is a dry description of this topic. You insist on pointedly editing aspects of this that really aren't controversial. What are you going to do when the restrictions are likely relaxed in the US this year? Will you still maintain there's not a general consensus on safety? Droliver 15:16, 8 July 2006 (UTC)

Let's let some other editors weigh in on this. I think you know full well what a 'positive only' edit is - you would consign to a 'hot link' (if that) for anything concern related to breast implants. I really don't th ink it is productive to discuss this with you, since you are incapable of doing so. Therefore, I hope to get some other editors engaging in the discussion - Dr. Zuckerman, Dr. Laub, and a couple of the editors I don't know who signed in above. jgwlaw 17:21, 8 July 2006 (UTC)

Dr. Zuckerman

The comment from Dr. Zuckerman bears reposting:

Last week, I testified on breast implants for the Health Committee of the Canadian Parliament. I was invited because I am an epidemiologist (post doctoral training at Yale Medical School) and internationally recognized expert on this topic. There are still many unanswered questions about the risks and benefits of breast implants, and much controversy. That's why the FDA and Health Canada are both unsure whether to approve silicone gel breast implants. Last week I also spoke at a Women's Health conference in Virginia, on a panel with a plastic surgeon. We talked about the risks and benefits and agreed on almost everything regarding breast implants. I have repeatedly added research data to this article, and Dr Oliver keeps removing it. I want this article to be accurate, but I have a fulltime job as the director of a research center and I don't think it is fair for me to have to keep putting back information that he removes for no scientific reason. He is entitled to his own opinion, but not his own facts. I have taught at Yale and Vassar, and was the director of a major research project at Harvard. What research credentials does Dr Oliver have that entitles him to keep deleting my scientific additions to this article? (Dr. Zuckerman wrote this as can be seen from the history.)

Now if anyone wants to discuss the content of this, feel free to do so. I started by answering JFW's questions as I could. ALso, Dr. ZUckerman also answered some of his questions. THere are also comments by other editors (scroll back) who make suggestions that should be discussed. However, what will not happen is for one editor to unilaterally make this article to his liking, while selectively cherry-picking from the articles he cites.jgwlaw 00:23, 8 July 2006 (UTC)

Some questions

Someone on the silicone article said he had googled and found interesting that the controversy over silicone implants was so heated, among scientists. He also seemed to reject Oliver's position that there is no controversy. The editor astutely suggested that scientists should consider whether a subset of women might be more susceptible to reaction to silicone implants. That is the real key, here, that has scientists recommending further study, with larger samples and longer period of time. At the least, research into this could provide information for women considering implants.

Individual suspectibility combined with silicone (from breast implants, especially when ruptured or leaking) is exactly the issue that is not resolved. The size & length of the studies that exist have been called into question, and even those have commentary that further research is needed in this area. I don't assume all women become ill from implants. But clearly there are a percentage that do. THe question is why. This is why there is still controversy over silicone implants. THe UK has no restrictions on them, but Canada and the US still do. France had restrictions as well, but has recently relaxed them amid much controversy. Evidently, the issue is not as 'settled' as Oliver would like to think it is. Women are rarely told that they may face reoperations from rupture or other problems, nor do many plastic surgeons recommend removal even when the implants are ruptured (contrary to the FDA guidelines). Many women do not have the resources to pay for explant, and further surgeries and had not counted on the need for this.

The issues are these:

1. Not every woman gets sick from implants.

Of course they don't. This has been addressed in multiple studies not identifying any clear patterns of symptoms or diseaseDroliver 15:48, 8 July 2006 (UTC)

And not every smoker gets sick from cigarettes, either. That doesn't mean cigarettes are safe, but perhaps that logic escaped your attention .jgwlaw 23:27, 8 July 2006 (UTC)

2. The time it takes for those women who do become ill can be anywhere from a few years to 20 or more years.

Same thing. There's repeated studies not demonstrating illness at all even @ two decadesDroliver 15:48, 8 July 2006 (UTC)

That isn't what the FDA has stated:

However, these studies have not been large enough to resolve the question of whether or not breast implants slightly increase the risk of CTDs or related disorders. Researchers must study a large group of women without breast implants who are of similar age, health, and social status and who are followed for a long time (such as 10-20 years) before a relationship between breast implants and these diseases can conclusively be made.

jgwlaw 23:10, 8 July 2006 (UTC)

3. Rupture rate -- Breast implants have an extremely high rupture rate. Manufacturers told women that implants would last a lifetime and that ruptures occurred less than 1 percent of the time. But studies published in the American Journal of Radiology in 1992 and the Annals of Plastic Surgery in 1995 reveal a rupture rate of 5 to 51 percent. A third study, published in Plastic and Reconstructive Surgery in 1993, ties rupture to the age of the implant. Of implants aged one to nine years, 35.7 percent had ruptured. Of those aged 10 to 17 years, 95.7 percent had ruptured. A US study showed that 69% of silicone implants rupture within 10 years. This is significant. We know that silicone migrates outside of the capsule and is found in lymph nodes.jgwlaw 20:21, 9 July 2006 (UTC)

This is addressed. Comparing first/second generation devices to contemporary devices isn't accurate. A study is cited estimating ~15% rate at a decade with 3rd generation devices. the relationship to rupture rate and age is pretty clearDroliver 15:48, 8 July 2006 (UTC)

Unfortunately, neither Inamed nor Mentor provided the FDA with more than 2 or 3 years of data on rupture rates, which was not enough to answer the FDA's question about a pattern of rupture, or the consequences of rupture.jgwlaw 20:21, 9 July 2006 (UTC)

4. There are no long term studies that follow women for 15 20 25 years, with rupture. Also some diseases like Sjogrens and Scleroderma are very rare in the general population and large groups of women would have to be studied. This has not happened either.

There are good studies from Scandanavia on this with untreated rupture that are mentioned that are continuing longitudinally. Droliver 15:48, 8 July 2006 (UTC)

Really, how many?

5. There has been no study to try to determine if there is a subset of women who are more susceptible to autoimmune disease resulting from a reaction to migrated silicone. THe FDA has recommended this, as has the IRG (that Oliver cites). The problem is finding an independent study that is large and follows women for a period of 10 years and longer. Many studies only considered up to 8 years. At 8, 10, even 15 years, I was thrilled with my implants. I surely wouldn't have dreamed I'd ever have a problem. I am not irrationally blaming my implants for my health problems. I know without a doubt that my body reacted to the extracapsular rupture.

Your posing a theoretical question that is never going to be able to be studied well. There is nothing that strongly suggests this occurs, but this is one of the things that has been considered before the conclusions of all of these review panels. It echoes the FDA position in the article cited about making conclusive statementsDroliver

This 'theoretical question' was posed by the IRG as a need for further research.:

Further studies would be necessary to identify:- a) any sub-group of recipients at risk; b) the auto-antibodies provoked and their target antigen. jgwlaw 23:10, 8 July 2006 (UTC) Twenty years ago a friend was researching (at a university) as to why some people are more likely to develop lung cancer from smoking, than others. What genetic predisposition might there be? THe fact is that not all people who smoke develop lung cancer or emphezema.

This is not all that different,.

You're substituiting speculation for scienceDroliver 15:48, 8 July 2006 (UTC)

The IRG notes that science has not answered this question and there is a need for further research on what subgroup of women might be more susceptible. jgwlaw 22:16, 8 July 2006 (UTC)

• Why aren't women warned about the increasing danger of rupture as implants age?
  

Mammogram facilities take more images to detect cancer in women with implants, but do not factor in (or even ask about) the age of the implants. (The FDA does, but most labs don't bother). ANd predictably, Oliver wanted to delete the section on rupture and reoperation. This is the very information that a BI article SHOULD have.
This should be common sense, but it is not.

It's discussed that implants can rupture with mammograms & that special views are require (which can obscure parts of the mammogram). It's all thereDroliver 15:48, 8 July 2006 (UTC)

You implied there were only a few documented ruptures. In fact, this is not what the FDA states. My version correctly states the FDA statement.jgwlaw 23:10, 8 July 2006 (UTC)

• Why don't doctors study this? Why don't they warn women not to take mammograms if their implants are over, say, 10 years old? AN MRI can identify both cancer and rupture. Yes it is more expensive, but the benefits outweigh the costs. Mammograms do not adequately identify rupture, and they can actually cause rupture. But too many doctors have a mindset about BI and don't think about it. Until, of course, they have a patient of their own that has this happen. My internist now will not write a script for a mammogram for women with aging implants. Again, it is only common sense. ONe does not need to be an engineer or chemist to figure out that implants degrade with time, compromising their integrity.

Again, you're proposing an expensive mandate without much data to support it. It is intuitive that an older implant is more likely to rupture from a mammogram, but it isn't cost-effective on a systems basis (as both the US and Canada have concluded) to implement MR screening. Regardless, it's clear from the section as is that both age and mammograms can rupture implantsDroliver 15:48, 8 July 2006 (UTC)

Yes, it is. Finally, we agree on something. And this is something that women need to be told..jgwlaw 23:10, 8 July 2006 (UTC)

• Why are women still told that they are better off to keep implants, even if they are ruptured? That is in direct contradiction to the FDA recommendations. Had I listened to the plastic surgeon who told me that, I believe I would be dead now.

There is in fact a study on this who's conclusions you dismissDroliver 15:48, 8 July 2006 (UTC)

WHere?.jgwlaw 23:10, 8 July 2006 (UTC)

• Why aren't women who are needing reconstructive surgery (as I did) given options for reconstruction without implants?

That's a discussion for the breast reconstruction entryDroliver 15:48, 8 July 2006 (UTC)

I hope the newer implants are safer. But even the more form solid implants leach silicone oil. Neither Mentor nor Inamed could answer the 3 questions presented to them by the FDA about rupture: (1) What causes rupture); (2) What is a pattern of rupture as implants age and (3) What are the physical consequences of rupture? THat was from an epidemiologist looking at these issues in Senator SNowe's office. The reason the manufactuerers could not do this is because netiher Inamed nor Mentor provided more than 2 and 3 years of rupture data - insufficient to even identify a pattern. THis was why there was shock that the panel recommneded apoproval of Mentor PMA (although the panel did not make the same recommendation for Inamed).

The shock was after a suprising 'no' decision the day before on Inamed's PMA which had been endorsed several times prior. Removing one device from their PMA (style 153 which had a higher failure rate) secured Inamed's approvable letterDroliver 15:48, 8 July 2006 (UTC)

The shock on the part of the epidemiologist I spoke with is that there was any approval letter, given the fact that these two companies could not answer ANY of the three questions. Oh, and the Republican Senator who advocated an investigation..jgwlaw 23:10, 8 July 2006 (UTC)

WHat is astounding is the dearth of long term studies, when implants have been on the market for 40 years. Certainly, no studies were done on safety for years, and those that were were covered up - this came out in discovery in the lawsuits. Women who removed their implants because of health concerns were dropped from some studies. Animal studies were cut short, when animals died. The list goes on and on and on. That was what so angered Dr. Kessler, and was one of the reasons he demanded silicone implants be removed from the market. It is no 'conspiracy theory' to realize that the manufacturers hid informatiopn they did not want public. Asbestos manufacturers did the same, and the documents are now very public. See Asbestos and the law My own neurologist, who did his residency at Mayo clinic (and MD at Northwestern University) told me that Mayo was a defendant in a lawsuit when it conducted studies with Dow funding. Mayo later sued its insurance company for not paying for what it called 'defense expenses' of the study. No conflict of interest there. THese were among the studies on which the 1999 IOM review based its conclusions. THe whole thing reeks of the "Tobacco Research Institute" that claimed to be independent research but was in reality a front for creating propaganda that smoking was not dangerous. We all know that now, and nobody disputes that. But this is not much different. Perhaps that is why Dr. Laub (a plastic surgeon who popped into the discussion here) said that he believes that the dangers of systemic illness and silicone implants will one day be proven. But it may take time, and some redirection. An d this plastic surgeon is no fly-by-night surgeon. HIs credentials both in clinical practice and teaching are impeccable. Dr. Zuckerman's wealth of background in epidemiology gives her a unique ability to understand the validity of the studies.

right.... The Mayo clinic is biased because you say it is.

I suggest you re-read what I wrote. jgwlaw 23:10, 8 July 2006 (UTC) Molly, editorial review boards of the journals go over these in detail. This is one of the most scrutinized studies done. Dr. Zuckerman's lobbying activities on this are not reflective of mainstream view. Dr. Laub may ultimately be proved right, but that is speculative and not the issue. There is a tremendous amount of work in print already done suggesting otherwiseDroliver 15:48, 8 July 2006 (UTC) My biggest regret is that the health issue of implants arose in the courts first. I believe that had an adverse effect on the medical community's objectivity. It also prompted a flurry of 'research' by manufacturers designed to relieve them of liability. I don't altogether blame them. But it would be a travesty to allow these biases to supercede common sense and medical integrity.

I know that there are an increasing number of physicians who treat women with implants and who do believe that some women suffer from implant related illnesses. I have seen my share of doctors over the last two years, and I would say that 80% of them (non-plastic surgeons) believe implants can be harmful. Even more plastic surgeons are coming to this conclusion. BUt there are others, like Oliver, who steadfastly maintain a black and white dogmatism and will not allow facts to dissuade him.

There is no groundswell of Plastic Surgeons and other doctors coming to any such conclusion. Again, look at the reviews from multiple disciplines from around the world. What you consider "dogma", the rest of the world considers evidence-based medicineDroliver 15:48, 8 July 2006 (UTC)

You are putting words into my mouth, as usual.jgwlaw 20:21, 9 July 2006 (UTC)

A complete article on breast implants needs to address these concerns. It is irresponsible not to do so. In previous versions, I had included articles Oliver cited, as well as the comments about the need for further research and why. [User:Jgwlaw|jgwlaw]] 06:43, 8 July 2006 (UTC)

Again, molly this isn't about your personal view and your percieved conspiracy theories on hundreds of papers on this. There is no mainstream medical group suggesting that. Look for on the record positions by professional and governmental bodies. The conclusions of the independent review groups are clear on the science. The FDA advisory panels have looked at this a number of times. The American courts have also ruled on this in many cases excluding testimony on claims of systemic disease. No other country is persuaded there's a causal link. The U.S. is poised to relax restrictions. Carrying the banner for your political view is not the context of the discussion the world is having on this. Again, I ask you to try and briefly summarize the case for causation in the section on this and link to refs.Droliver 14:38, 8 July 2006 (UTC)

Fortunately, therer are other editors who can speak civilly about this article, without insults and innuendos.

Collaboration?

This is quickly deteriorating into a personal war, once again.

JFW has asked questions, which I tried to answer, and I also hope others weigh in on. I suggest that someone help out here, who is willing to collaborate. I don't have a problem introducing a more 'mainstream' view, but not at the expense of denying any controversy exists. The fact is that the FDA still has not lifted the ban. It may well do so this year, but it hasn't yet. Canada still has restrictions. There are still studies which ARE cited that show an increase in lung cancer, fibromyalgia, autoimmune symptoms and the like. There is also a paragraph on the FDA website that I quoted directly in the article, stating that longer and larger studies are needed. Some editor on the Silicone article (where Oliver has also attempted to spread a POV about breast implants) had this to say:

Some added references on toxicity (both acute and chronic) and links to proponents and opponents of the suitability of silicone compounds as food additives, breast implants and shampoo ingredients would be nice to allow readers to more easily make a decision for themselves....An individual's decision is based not just on what is specifically known about a particular chemical or class of chemicals, but also on the reader's personal tolerance for chemical risk and confidence in the regulatory system to act with precaution and move quickly when initial toxicological estimates need to be revisited. Some quick Googling on the subject yielded this interesting controvery in Environmental Health Perspectives.--Brian Hill 07:25, 26 February 2006 (UTC)

David Reuben, Dr. Laub, and others have requested that major changes be addressed here first, before making changes on the article. That means one step at a time. jgwlaw 17:33, 8 July 2006 (UTC)

The IRG report, which was funded by Dow, even points out the need for further study:

"There are rather few studies in the literature designed to investigate directly whether siloxanes can induce the production of anti-siloxane antibodies in experimental animals."

The important question of whether the patients sera contained antibodies specific for silicone elastomer cannot be clearly answered from the data reported. Taken at face value, the ELISA appears to demonstrate that IgG binds to the silastic tubing, but the evidence that this is specific binding through its antigen-binding sites is inadequate. It remains possible that the binding is non-specific (in the immunological sense) and is due to the physico-chemical properties of the polysiloxane material. More rigorously controlled absorption and elution experiments would be needed to resolve this question. An additional confounding feature was that one of the patients with inflammatory reactions around the shunt was demonstrated to have raised IgG serum levels; hypergammaglobulinaemia is one possible explanation for an increase in non-specific binding of IgG to the silastic tubing.

And this is the issue that is of most concern, that Brian Hill (above) touched on, and which most (legitimate) scientists wonder still, especially given the thousands of 'anecdotes' like my own experience:

The question Do siloxane polymers cause inflammatory reactions that indirectly provoke immune responses to the recipient's own tissues? remains to some extent incompletely resolved. While there is no unambiguous, published evidence showing that the majority of recipients of silicone gel breast implants do develop immune responses to their own tissues as a consequence of the implant rather than through other factors, the possibility that there is a sub-group of the recipients who do so has not been formally disproved. None of the studies claiming an increased frequency of auto-antibodies in women with silicone gel breast implants has been adequate to permit this conclusion. Further studies would be necessary to identify:-

a) any sub-group of recipients at risk;

b) the auto-antibodies provoked and their target antigen.

One suggestion that has been made is that the age of the implant is a relevant factor, and that aged implants are more liable to leak or rupture. Thus women with aged implants may be a sub-group at risk.

A real difficulty in addressing this problem is the lack of quantitative information about the incidence, amount, and rate at which silicone polymers escape from the different types of implants, particularly in the case of implants inserted more than 7 - 10 years previously. This information has potential importance because siloxane polymers injected directly into tissue can produce an inflammatory reaction. This point will be taken up again elsewhere in this report.

The IRG has been cited as concluding that there is no evidence of CTD in women with siicone implants. Yet this report, which has itself been criticized, even points out the problems that still exist. This has been a great concern of the FDA, as well, given the questions they had asked the panel last year, about rupture, rates of rupture and consequences. A good article on breast implants needs to address these issues. Again, Brian suggested:

An individual's decision is based not just on what is specifically known about a particular chemical or class of chemicals, but also on the reader's personal tolerance for chemical risk and confidence in the regulatory system to act with precaution and move quickly when initial toxicological estimates need to be revisited. Some quick Googling on the subject yielded this interesting controvery in Environmental Health Perspectives.

This would also apply to women who read an article for information, such as one would do with WIkipedia. This is why the issues of aging implants, rupture, possible immune repsonses (with a subgroup of women, which would be logical), as well as reoperation are all important topics to touch upon here.

Not everyone who smokes develops lung cancer. Some people are more susceptible than others to developing it. This is likely to be even more true with a woman's response to silicone implants. While some women may not tolerate the implants at all (which has happened), the more likely scenario is that a group of individuals carry a susceptibility to developing a response to silicone implants as the implants age, leak, rupture, etc. This is why long term studies are critical, and still largely absent.

.jgwlaw 19:42, 8 July 2006 (UTC)

The words of another editor

After having re-read the article, I find it an excellent resource. In response to some of the discussion, some additional verbiage regarding the use of implants in other countries in the first paragraph might address the Americocentric complaint. However it should also include the fact that those countries do not perform the research or clinical trials that have been performed in the US as pointed out by Dr Zuckerman. On the surface, an actual subheading titled "Benefits" could make this article appear more editorically balanced. I say "appear" because the benefits are discussed within the context of the other paragraphs. Since the risks and controversies have their own sub-headings....I suggest one for "Benefits" (since it is the opposite of negative risks). So.... rather than continue to argue over the Risks and Controversies and editorial comments in those sections, which by the way are valid and well written,....providing some exclusive weight to "benefits" should "editorially" satisfy you and Oliver. I would expect to see cited references for this as well. Lastly, this article is a reference article and as such any and all risks and complications and or controversies need to stay. All facets of the topic are by nature controversial.

User:SHEEHS1 7:53 5 Jul 2006 {UTC}

It is an excellent resource. However, it can always do with improvement. Yet even when Oliver asks his friend to come help, he can't maintain a civil tone long enough to discuss the questions his friend asked. It says a lot. Unfortunately, I don't know how one can collaborate with such a rabid and dogmatic person. If you have any suggestions, I am all ears. jgwlaw 23:30, 8 July 2006 (UTC)

I think we should back up and remember that this is a reference article and as such should touch on the things I mentioned earlier. Those things being the risks, controversies and the benefits. Oliver, your continual incessant arguing with generalized statements of world views is not accurate. Can you honestly tell me that you have had no woman come into your office wondering if her symptons were her implants? Can you honestly tell me that none of your peers have had a woman come into their office with same? I can tell you of not just one but many plastic surgeons that walk the line on that tact because they know how research is performed, because they know more answers are forth coming with additional research and better designed studies. Anyone in medicine knows that new conclusions are drawn from new research and to treat your view as if it is consensus or a final view is in my opinion to do great harm.

The FDA in the U.S. has not lifted the ban and to try to sway this as if they will is very premature. Neither has Canada. The FDA has received many responses from its' request for public comment. Even Mentor on there disclosure inserts admits they have not studied the long term affects (i.e. for over 10 years.) Even Mentor warns against its use with certain contraindications.....of course releasing themselves of some liability should the recipient be diagnosed after implant with such. Then the battle becomes which came first.

The truth of the matter is that hundreds of woman are getting their implants taken out because they are starting to connect the dots. I have spoken with three such woman in the last two weeks. These woman don't make a big deal about it. They simply have connected the dots, had their implants removed and moved on as they are feeling great. They don't write the FDA or their congressman...etc. These are the woman that are under the radar ...so to speak.

Informed consent means infomed consent. Without the risks, controversies and such in this article....this article would not be in keeping with minimal informed consent. Period.

Further, I believe the Hippocratic oath states something to the affect of "First, do no harm". This goes along with informed consent.

Lastly, I am having a difficult time figuring out just what your point is other than to take pot shots in a personal manner against other editors. Your point does not seem to be one that enlighten the reader of this article on the entire scope of "breast implants" and I find that more than disturbing.User: SHEEHS1 7:50 July 8,2006

-- Thanks to SHEEHS1 for her important comments about informed consent, etc.

It certainly would be fine with me if we had a section called Benefits, but it would be short: larger breasts and for women with mastectomies replacement breasts. The research does not indicate any increase in self-esteem or mental health from breast implants, which is a probably surprising to everyone, even those who are worried about the long-term safety. When implant companies were required to do before and after comparisons of women who had their implants for 2 years, most augmentation patients felt worse on most measures, rather than better. You can read an article by Marcy Oppenheimer, MD based on these studies by Inamed: http://www.breastimplantinfo.org/news/inamed-pma.html and Mentor: http://www.breastimplantinfo.org/news/mentor-pma.html

Even the women with reconstruction after a mastectomy didn't seem to have benefitted as much as expected, and remember there are other options (such as TRAM Flap surgery, which moves fat from the abdomen area or back to make new breasts.) So, unfortunately, I think that addition would not make the article seem more balanced. I haven't added this information into the article itself because the article is already long and I assumed droliver would just delete it with more vitriolic comments. 216.164.59.38 17:55, 9 July 2006 (UTC)Dr. Zuckerman

Collaboration and Comments on this Article

Dr. Zuckerman, I thought you should see what JFW thinks of this article, your work and mine, and the other editors who have contributed, and made comments on the discussion page:

Removed material from personal email not released under the GFDL, as indicated below. Details available upon request JFW | T@lk 20:25, 10 July 2006 (UTC)

I think it might be instructive to look at the other medical articles (such that those he wrote, and mentioned here) to see how much there is on 'patient satisfaction' there. If there are studies on patient satisfaction, though, they might be useful. I haven't seen any, other than what plastic surgeons or manufacturers claim. Of course, in any controversial article, it will never be possible for all editors to agree. Further, the studies that are cited are in peer-reviewed journals, but I guess he wants only those that are consistent with his perception of the situation.

I reread the WP:NPOV and the article as it stands now meets all the criteria -- ALL.jgwlaw 18:29, 9 July 2006 (UTC)

I find it objectionable that Molly uses material from a personal email. This is uncalled for. I stand by my views that the article is in bad state. I also stand by my insistence that as long as we can agree on WP:RS then NPOV should be no big deal. JFW | T@lk 19:41, 9 July 2006 (UTC)

Yes, ordinarily I would not use material from an email, but this was appropriate, since it shows a clar bias, and attitude toward this article. And I have no problem with the WP:RS either, since there is nothing in the article that would violate that.jgwlaw 20:14, 9 July 2006 (UTC)

--Since the comments on the article are relevant to my editing, I will respond.

I'm not sure what JFW's concerns are about the references for this article. The best research that has been conducted in this field are the largest samples of women with implants for the longest period of time, such as the published studies by the National Cancer Institute and the FDA. I have repeatedly included those references, but droliver keeps taking them out, replacing them with articles of studies funded by Dow Corning, that often include women who had implants for as little as one month.

JFW, you mentioned that this is not your area of expertise, so I respectfully suggest that you read the published literature on breast implants. When you review the actual studies themselves, I'm sure you will see a clear pattern: if the study is funded by the government, it almost always reports some significant problems with breast implants related to pain, suicide, or other serious problems. If the study is funded by Dow Corning (which is the bulk of the published literature) it always concludes that breast implants are safe, even if the results section includes data indicating serious problems (see the Breiting et al published study for an excellent example of that).

Reports, such as the IOM study, are based on reviews of all the published literature, and since most of the published literature is funded by Dow Corning, the reports are likely to conclude that "there is no clear evidence that implants cause disease." It would be impossible to conclude anything else, given the dozens of published articles based on industry-funded research. That statement is often misinterpreted, however; it does not mean that the studies prove that implants are safe. It means that we still don't know.

There's another big problem: some of the best clinical trials have never been published. They were conducted by Inamed and Mentor as a requirement for the companies' trying to get approval of their implants. The FDA re-analyzed the data and found very high complication rates and significant increases in auto-immune symptoms. They also found no clear mental health benefits of implants. However, the implant companies never published these results, presumably because they showed serious risks from implants. The FDA scientists who analyzed the data didn't publish the results because that is not something they are allowed to do. So, unfortunately that means that neither the plastic surgeons nor their patients are likely to know about the results of these very important studies. I have referred to these studies in my edits on this article in Wikipedia, either referencing the FDA website directly or referencing an article on breastimplantinfo.org that references the FDA website.

In response to JWF's comments about including patient satisfaction, that is a very subjective measure and does not reflect a NPOV. On the other hand, objective research in this area clearly indicates that augmentation patients are less happy with their lives two years after getting implants than they were before implants. Research also indicates that although reconstruction patients seem to be satisfied with their implants for a year or two, by 5 years after getting their implants, they are not satisfied. Drzuckerman 20:41, 9 July 2006 (UTC)Dr Zuckerman

Dr. Zuckerman, can you provide a reference for the studies that show after 5 years women are not satisfied? That seems to conflict with the plastic surgery journal that JFW mentions below. It might be good to have both references.jgwlaw 20:47, 9 July 2006 (UTC)

JWF, you state the "article is junk" and that "It is one long diatribe of risks and side-effects, completely ignoring the format of any comparable medical article. It lacks perspective,..." Your statement is not accurate and unfortunately shows your bias. There is more information in the article than just risks and side-effects. Exactly which perspective is lacking??? Perhaps a better question is which perspective do you want added? This is an article on Breast Implants....the good , the bad and the ugly. Why should an article on breast implants not include data that should be given to the consumer under informed consent? User:SHEEHS1 6:05 , 9 July 2006

I will not respond to a comment from a private email that Molly placed here without my consent. "Mummy Dianne, look what naughty Dr Jfdwolf has written about something you wrote!" JFW | T@lk 07:44, 10 July 2006 (UTC)

Speaking of personal attacks Doctor... don't you think this comment is beneath you? Gfwesq 11:16, 10 July 2006 (UTC)

I think it's not a personal attack. It's mild ridicule for the purpose of the discussion and my reaction on the content of a personal email suddenly appearing in an open forum. If Molly is offended she is free to tell me. JFW | T@lk 12:08, 10 July 2006 (UTC)

"Mild ridicule" is an attack. As I have said before, JFW, you need to learn to curb your tongue and not engage in personal attacks. It appears you have been on WIkipedia long enough to know your violates WP:NPA. Your 'personal email' has everything to do with your attitude towards the editors of this article and the article. If you cannot engage in a constructive collaboration, it is unlikely that you will make a "positive contribution" to "make a truly useful resource on the topic". I suggest that you stop insulting editors and try to discuss your desired contributions instead. By the way, an encyclopedia is not a medical journal, and some of the format you are trying to force this into will not work well with this article. jgwlaw 16:15, 10 July 2006 (UTC)

My personal email was not released under the GFDL, so you have acted wrongly. I've been making constructive contributions, such as providing historical references, structuring the article, and offering resources on the talk page. Your ongoing criticism is noted; I will make sure this article reads like an encyclopedia article. You are free to make improvements. JFW | T@lk 16:40, 10 July 2006 (UTC)

Information.

This article describes what a breast implant is, two types of implant, and the history of breast implants. It then describes what are the possible complications, beginning with rupture. The complications are sourced from mainstream sources, including the FDA. It presents the issues in a balanced manner. It is not one long diatribe. Since the purpose of an encyclopedia is to inform this article, as structured, fits the bill.

What exactly is objectionable about this information? What parts would a physician tell their patients, so that the patient could make an informed decision? What parts would a physician not want to tell their patients and why would you not tell the patient that information? Before answering please review this page.

Since implants are an elective procedure, the decision is ultimately the patient's, not the physician's. Its the patient's body and the patient has to live with the consequences, not the doctor. Therefore a patient, IMHO, should be informed of the risks and complications regardless of how slight as well as what is known, unknown and areas where responsible organizations, such as the FDA, believe more research is needed. All of the information strikes me as germane. Gfwesq 19:17, 9 July 2006 (UTC)

If large systematic reviews reveal no link between silicone implants and esoteric autoimmune diseases then a health care professional is not duty bound to scare his patients. JFW | T@lk 19:42, 9 July 2006 (UTC)

The problem is as the FDA stated - larger studies are needed, for a longer period of time. That is what has been discussed here at length, so perhaps you need to read the discussion. Also, the manufacturers and the FDA do discuss these issues in their information sections. It is not the doctor's right to selectively choose what he thinks would 'scare' a patient. That kind of paternalism has been criticized at length.jgwlaw 20:37, 9 July 2006 (UTC)

JFW, as I am sure you are aware, a study such as this would be difficult to construct with 100% certainty considering the variables. Otherwise it would have been done by now. This doesn't mean there is not continued suspicion that there is a link between implants and auto immune diseases in subsets of women. The implant manufacturers list as a contraindication on their inserts that woman with auto immune diseases should not be implanted. I suppose this means the manufacturers have reason to believe implants can exacerbate their condition. My point then is... if it can exacerbate it, it can potentially initiate it. [Sheehs1]] 6:10 9 July 2006 {UTC}

Let's phrase it differently then: given that there are no useful long-term studies that explain the risk, a health professional is not bound to scare his patients on the basis of only anecdotal evidence. This is true of any idiosyncratic reaction to any medical treatment as long as it is sufficiently rare. I do agree that informed consent needs to be much stricter in elective/cosmetic operations because the benefits are psychological by definition and there is no risk of harm if the patient elects to avoid the procedure because of a 0.01% risk of a bizarre side-effect. JFW | T@lk 20:44, 9 July 2006 (UTC)

I am not going to belabor this. Your exaggeration and description of the risk again reflects your attitude on this. However, as Dr. Reuben pointed out, there is a long history of concerns about breast implants and they should be discussed in the article. Similarly, a physician would have a duty to mention this. ALso, studies are conflicting and some do show statistical increases in autoimmune symptoms and other problems. If there were no concern, the US and Canada would have already approved silicone implants by now. And even if they are eventually approved, to deny the long history of medical issues (not just legal, but also raised in the medical community) is dishonest and dangerous.jgwlaw 22:30, 9 July 2006 (UTC)

You really didn't address the questions. Somehow I am not surprised. At least you reviewed informed consent. Lets try again. What information is objectionable? What information would you tell a patient and what would you not tell a patient and why? Could the fact that there are "no useful long-term studies" be the reason the FDA has stated that larger studies are needed for a longer period of time? Also isn't lack of "useful long-term studies" an absence of evidence? Absence of evidence is not itself evidence. It just brings us back to the FDA's "larger studies are needed for a longer period of time". Sounds like the problem is lack of studies, not conclusive evidence.

As it is, your answer is very paternalistic. You are very presumptious to assume a patient, if given a proper explanation, would not understand the risks involved and therefore you decide for the patient, that there is no need to explain, because it "might scare" the patient. As a patient, I abhor that sort of paternalism. Fortunately, my doctor treats me seriously and takes time to explain things to me.Gfwesq 21:12, 9 July 2006 (UTC)

I am not going to respond to comments where I'm labeled dishonest, paternalistic and presumptious. I did not label you. There's a big difference between my deliberate hyperbole and your personal attacks. JFW | T@lk 07:44, 10 July 2006 (UTC)

It is not a personal attack, it is descriptive. I can't help it, if you are being paternalistic and presumptious. Perhaps you should examine your response to see why it is paternalistic and presumptious. I didn't accuse you of being dishonest and I don't think anyone else did either (unless, of course, you DO deny long history of medical issues rasied in the medical community).

In any event you have managed once again to not answer the questions posed. Gfwesq 11:13, 10 July 2006 (UTC)

I'll tell you what's objectionable: more than 70% of the material on this page is about complications. That is undesirable; it indicates a lack of balance. Some of it is also phrased in a deliberately alarmist way ("initially they used the industrial kind of silicone that goes into making furniture polish and transformer fluid" - that's not encyclopedic language).

You characterised my (hypothetical) reaction as "very paternalistic". Descriptive or not, it doesn't improve the general tone of these discussions. JFW | T@lk 12:15, 10 July 2006 (UTC)

"Physician, heal thyself". If you expect a better tone in this discussion, you need to stop insulting the editors who have been working on this article. And there is nothing about the language you quote above that is not 'encyclopedic'. If you would prefer, we can use the term 'industrial grade'. jgwlaw 16:20, 10 July 2006 (UTC)

"initially they used the industrial kind of silicone that goes into making furniture polish and transformer fluid" is accurate as to the type of silicone used. How would you phrase that to make it "more encyclopedic"? I suspect you want to use Jargon that is inappropriate for lay persons and their understanding.

I would like to see your methodology in determining 70% of this article is about complications. It was hyperbole, of course, on your part. Do you believe patients have no right to know about complications? If these complications are accurate, what is the objection? To delete them, would make the article less than encyclopedic in its scope and would be a disservice to the topic. The objective is to be comprehensive. It is not the objective to write an advertisment for the breast implant industry, with all caveats in very fine, almost illegible, print.

Finally, your reaction, hypothetical or not, was paternalistic. As such, my characterization was accurate. Where I come from, its offensive. Gfwesq 16:32, 10 July 2006 (UTC)

Of course the complications should be mentioned, as well as studies that seem to contradict them. But the results of either should not be misrepresented. JFW | T@lk 17:35, 10 July 2006 (UTC)

Agreed. And they are not.jgwlaw 00:22, 11 July 2006 (UTC)

Response

I'm tired of droliver's continued reference to my "lobbying activities." He doesn't know what he is talking about since I have engaged in no lobbying activities on the issues he mentions.

--The authors of the Mayo Clinic study themselves admit: "...our study has several limitations...Our results, therefore, cannot be considered definitive proof of the absence of an association between breast implants and connective-tissue disease." (New England Journal of Medicine, 6/16/94)

Here is some detailed info on the study, which droliver does not seem to have read:

Gabriel, S.E., O’Fallon, W.M., Kurland, L.T., et al. Risks of Connective-Tissue Diseases and Other Disorders after Breast Implantation. New England Journal of Medicine 1994; 330: 1697-1702.

Number of implant recipients: 749 Number of controls: 1498

Diseases studied: Any classic connective-tissue disease, including lupus, Sjogren’s syndrome, rheumatoid arthritis, and scleroderma. Also looked at other disorders such as Hashimoto’s thyroiditis, cirrhosis, sarcoidosis, and cancer.

Minimum length of time with implants included in study: This study included women who had implants for less than one year.

Additional notes: Women with breast implants had a 35% higher rate of arthritis, which was not statistically significant (relative risk: 1.35). Morning stiffness was 81% higher for implant patients, which was significantly higher than for women without implants (relative risk: 1.81). The authors estimated that they would need to have studied 62,000 women with implants for an average of 10 years to detect a 100% increase (or less) in rare diseases such as scleroderma. This study relied on medical records. The authors did not question or examine patients directly.

---

Another frequently cited study in the IOM report and international reports was conducted at Harvard. Apparently the hospital where the doctors were located received $5 million from Dow Corning at the time the study was requested:

Sanchez-Guerrero, J., Colditz, G.A., Karlson E.W., et al. Silicone Breast Implants and the Risk of Connective-Tissue Diseases and Symptoms. New England Journal of Medicine 1995; 332: 1666-1670.

Number of implant recipients: 1,183 Number of controls: 86,318

Diseases studied: Any classic connective-tissue disease, including lupus, Sjogren’s syndrome, rheumatoid arthritis, and scleroderma. Excluded women with milder or atypical cases of connective-tissue disease.

Minimum length of time with implants included in study: One month

Additional notes: According to the authors, the study does not exclude small health risks of implants that would be of public health importance. The study was designed to minimize "reporting bias" of health problems by implant patients by excluding any health problems diagnosed after May 1990, which was six months before the major media coverage of implant problems. They did not minimize bias in the opposite direction; for example, they included women who only had implants for one month. Also, they should have excluded women who reported receiving breast implants from 1952 to 1961, since breast implants had not yet been invented. Including these women and their inaccurate statements increased the average years of implantation. The study relied on questionnaires completed by the subjects, who were health professionals. The authors did not question or examine the women directly.

---

A much larger study conducted at Harvard has not been mentioned by Droliver. Although this study may have also received Dow funding, the published results showed an increase in disease among women with implants. Perhaps that is why it is rarely mentioned, even though the results were described in the IOM report.

Hennekens, C.H., Lee, I.M., Cook, N.R., et al. Self-Reported Breast Implants and Connective-Tissue Diseases in Female Health Professionals. Journal of the American Medical Association 1996; 275: 616-621.

Number of implant recipients: 10,830 Number of controls: 384,713

Diseases studied: Any classic connective-tissue disease including lupus, Sjogren’s syndrome, rheumatoid arthritis, and scleroderma. Also included mixed connective-tissue disease.

Minimum length of time with implants included in study: All the women in the study had implants for at least one year.

Average length of time with implants: Not stated, but the authors analyzed the women in three groups: up to four years, five to nine years, and 10 or more years after receiving implants and showed no increased risk with increased duration of exposure.

Additional notes: Implant patients had a 25% higher rate of connective-tissue disease, whether they were reconstruction or augmentation patients (relative risk: 1.25). This was statistically significant and the researchers concluded that there is a small increased risk of connective-tissue disease among women with implants. Although it is a cohort study, this study was analyzed with case-control and cross-sectional studies in the meta analysis because information about the disease and the patient’s exposure to silicone breast implants was gathered at the same time. The study relied on questionnaires completed by the subjects, who were health professionals. The authors did not question or examine the women directly.

---

In summary, the shortcomings of the Mayo Clinic and the "Harvard study" are obvious to anyone who understands research. Most important: nobody would expect a statistically significant increase in illness among women with implants for 3 months or even one year, and including them in the study makes no sense in the study of a product that had been available for 30 years at the time the studies were published. The authors of the studies were quite clear about some of the shortcomings of the study, so I use their own words -- which droliver then refers to as my "lobbying!"

Again, I ask, where is a wikipedia monitor who can stop droliver's ad hominem attacks?

And thanks to the other editors, jglaw and others, who seem more knowledgeable than droliver. And especially to those who have helped by restoring my edits when droliver repeatedly deletes them.

All I ask, droliver, is that you read the studies you're talking about. Not the reports -- the actually studies, published in medical journals. Don't take my word for it -- just read the studies and sit down with any epidemiologist to discuss the research before you edit my entries again.

216.164.59.38 17:40, 9 July 2006 (UTC)Dr Zuckerman

I'm not sure if you can force any editor to sit down with an epidemiologist, but I suggest strongly that any move to delete material presently contained in the article is discussed on the talk page, particularly when it concerns material that is strongly referenced to a reliable source.

If you are concerned about personal attacks, please approach any administrator, who will examine your case and may approach other editors. When making a complaint, please cite relevant diffs and policies concerned.

This article needs a dose of NPOV. It is entirely appropriate to list all the above (or certainly the most relevant) studies, along with methodological criticisms as long as these themselves have been made in a reliable source. But to personally find fault with studies (to give an imaginary example: "this study, though, was insufficiently powered") is original research. If a study itself states its limitations, then of course these may be cited at will.

If you would like to discuss individual studies, please be so kind as to provide a PMID code. This makes it immeasurably easier to find them. In Wikipedia, typing PMID with the code will generate an automatic link. JFW | T@lk 21:01, 9 July 2006 (UTC)

JFW, I have to disagree somewhat. Refighting the issue of individual studies will end up with dozens of references which is not the point of an overview article. If we're to do that, the POV Molly & Dianne would promote will be buried more 10:1 on articles & reviews finding no evidence of systemic disease. As I've made it clear, the pro/con of this can be succinctly done in less then a paragraph. While some here are dying to make this a dramatic debate on this, it's pretty clear to people that this has already been debated & reviewed at length in many countries. While it is frustrating to the activists involved in this issue, EVERY systemic review to date is consistant in their conclusion on this. It is the mainstream view as arrived at thru the works of hundreds of researchers, hundreds of studies, and tens of thousands of patients. While you can take pot-shots at aspects of any number of the studies that went into reviews, the short-comings of these were in fact considered in the summary conclusions of each of themDroliver 23:42, 10 July 2006 (UTC)

Case series

Here is a long-term study that we know would be necessary. It doesn't whitewash anything. I have no access to the fulltext, but it looks useful. PMID 16525261. JFW | T@lk 20:40, 9 July 2006 (UTC)

It would be good to find the full text before inclusion. While the full text is not required as a reference, it would be helpful for the editor including it to read it before adding it to the article. Dr. Zuckerman makes some interesting points on this (see her discussion above.) She also mentioned research on this, and I would like to see what articles she refers to.jgwlaw 20:50, 9 July 2006 (UTC)

--It is an interesting article, although Plastic and Reconstructive Surgery has published many case reports that are not scientific research. We would need a copy of the article to determine its appropriateness, but a few shortcomings are obvious. For example, since it is a series of case reports, from one medical practice, it is not representative of women with implants across the country. These plastic surgeons may be the best or worst in the country -- we have no way of knowing. In addition, since the women did not undergo MRIs, it can't accurately determine rupture or leakage. For example, the authors state that women with polyurethane-covered implants are less likely to have capsular contracture. I have no doubt that is true. However, numerous plastic surgeons and women testifying before the FDA have reported that the shells of polyurethane-covered implants often completely disintegrate. There is no contracture when there is no shell. But, that means the silicone can leak throughout the breast and into the lymph nodes, and from there migrate to other organs.

How often does that happen? Nobody knows, because in the absence of contracture or obvious leaks (which usually take many years to be noticed), the women are not getting surgery or MRIs where these problems could be determined.

So, let's read the procedures and results section of the article before deciding what it contributes to this article.

Please sign your posts. The fact that PRS publishes case reports does not diminish from the value of this article. You might as well ignore The Lancet and NEJM. JFW | T@lk 07:44, 10 July 2006 (UTC)

As you're a little late to this debate, Molly has already dismissed any study published in the Plastic Surgery literature as flawed a priori. The study referred to relates exactly what we have already established, reoperation rates have been too high & patients have been happy with their implants. As I've mentioned, reoperation & rupture rates are really where the interest of the FDA is. Systemic disease concerns have largely been studied & accepted.Droliver 23:48, 10 July 2006 (UTC)

Reliable Resources

I suggest that JFW read Dr. Zuckerman's comments above and respond, since he was the one who brought up reliable resources.jgwlaw 20:58, 9 July 2006 (UTC)

I have responded. Favourably, at that. JFW | T@lk 22:01, 9 July 2006 (UTC)

References

There are presently 19 references at the bottom of the article. None are referenced directly from the article body using Harvard-style references. I think they should be moved to the talkpage if they cannot be linked to specific citable statements in the article. Anyone disagrees? JFW | T@lk 20:51, 9 July 2006 (UTC)

That's fine, as they are on an off-line page if needed for citation. I have thought the same myself, but didn't want to create more waves. jgwlaw 21:00, 9 July 2006 (UTC)

They are already on an off-line page, so I removed them from here - I appreciate your cooperation on this, but it clutters the talk page. Perhaps we should link to the offline article.

This does not in any way affect the relevance of these studies, and if any editor wants to attribute a statement in the article to one of these references then reinsertion is encouraged, using the cite.php syntaxis. JFW | T@lk 21:08, 9 July 2006 (UTC)

All references do not need a PMID code. That would exclude valid references, like the FDA website and articles that are referenced for history. I would like to hear from other editors on this. NO references should be deleted in the article as it currently is written, without discussion here. I noted on another page, a doctor said he had never seen the PMID code, after 40 years of medical practice.jgwlaw 21:15, 9 July 2006 (UTC)

I agree that all references do not need a PMID code as it excludes the references cited by Jgwlaw. Where applicable, a link to the full article is more beneficial that an abstract. Abstracts often are of minimal use regarding "content" as one can not assess methodology or the manner in which conclusions were drawn. User:Sheehs1 5:41 July 2006 {UTC}

I never insisted on a PMID code, but it makes it much easier to find the resources that have one online. I agree one cannot comment on the methodology in the absence of fulltext. JFW | T@lk 22:01, 9 July 2006 (UTC)

Reliable sources - examples from Wikipedia guidelines

• Publications with teams of fact-checkers, reporters, editors, lawyers, and managers — like the New York Times or The Times of London — are likely to be reliable, and are regarded as reputable sources for the purposes of Wikipedia. NOTE: Wikipedia points out that these are not usually good sources for medical references. And this article does not do this - a NY Times article is included in the history section, which is entirely appropriate.
• Use sources who have postgraduate degrees or demonstrable published expertise in the field they are discussing. That would include Dr. Zuckerman's citations which themselves cite peer-reviewed studies.
• Exceptions may be when a well-known, professional researcher writing within his field of expertise
• Full-text online sources are as acceptable as offline sources if they are of similar quality and reliability. (this means that abstracts would actually not be permitted, eg those requiring a subscription?)
• Any scientific journal that insists on being taken seriously is peer-reviewed (does not require PMID, from what I can see, although I agree it would be useful if available)

Finally, the RS points out that it is a guideline, and common sense should be used. Thanks! jgwlaw 21:27, 9 July 2006 (UTC)

Thanks Jgwlaw....that clears that one up!! User: Sheehs1 5:59 9 July 2006

This is only a few points. It is well worth the time to read the Wikipedia guidelines for reliable source. Nothing in the article as it stands now violates any of these guidelines.jgwlaw 21:56, 9 July 2006 (UTC)

I think that there is somewhat of a hierarchy here. If there is a choice between a peer-reviewed medical journal article and coverage of the same material in the popular press, then we should be linking to the primary source. A PMID is not essential, just desirable, as I have explained above. I, too, am warmly in favour of common sense. JFW | T@lk 22:01, 9 July 2006 (UTC)

Without question. I did not put the list in any order, and that is why I backtracked and added the note in the first item. A decent writer would never use a New York Times article for a medical statement - but for a history section, yes, it makes sense, to use a newspaper article. I notice that the Wikipedia reference guidelines have sections for law and other sciences, which have useful information, as well.jgwlaw 22:23, 9 July 2006 (UTC)

I do think some sources could be sharpened up. A New York Times article is not very good at identifying mortality from silicone embolism, and we should be replacing that reference with Dr Rapoport's 80 patient case series (should he ever decide to pursue its publication). JFW | T@lk 22:05, 9 July 2006 (UTC)

I don't believe a New York Times article was in the article to describe anything but a minor historical point.jgwlaw 22:23, 9 July 2006 (UTC)

I agree that the NYT is OK for historical reference, but if you prefer we can use the Congressional report instead. It has all the same information from that paragraph except the number of deaths. In fact, the Congressional report is the source that reporters often use for the history. The reference for the report should be some version of: A Staff Report Prepared by the Human Resources and Intergovernmental Relations Subcommittee of the House Government Operations Committee (1992-12). The FDA's Regulation of Silicone Breast Implants. It is reference #4 in the article, but it may not listed correctly there.

JWF asked for a published criticism of the Mayo Clnic study, etc. I published that information in an article entitled "Are Breast Implants Safe?" published in Medscape General Medicine, October, 2001 and reprinted by their request in Plastic Surgery Nursing, Summer 2002 Vol 22, No. 2, pages 66-71. We can certainly use that reference as needed.

History of BI

This is already a long article. Why make it longer, by duplicating the history in its own section then in each individual type of implant's section? jgwlaw 15:18, 10 July 2006 (UTC)

--I agree. Also, the first reference to the "implantation" of adipose tissue is not really an implant, its a transplant or a tissue transfer. We don't discuss TRAM flaps, which is a much more relevant topic, so why discuss this one procedure, probably done once? That's why I removed it, and I'm sorry to see it back. It doesn't belong in this article. Drzuckerman 15:39, 10 July 2006 (UTC)Dr Zuckerman

Before I started editing, the use of lipoma fat as an implant was mentioned in the intro, minus the Czerny reference! Every historical paper mentions Czerny (e.g. emedicine), and it would be a great loss to the article if we were to remove this fact. I'm sorry you don't like it. Improve it at will; add TRAM flaps as you want - it's about implanting something into a breast. That's why this article is called breast implant. I'm personally much more in favour of condensing the history in one section, rather than mention the history of every type of implant on its own. It would add perspective.

Agreed. I am glad the name of Czerny and his mentor are not in the article, because while this may be of interest to medical doctors, it is not to the general population. I look at other (non-medical articles) here and in a *real* encyclopedia and this much detail as to names from the 19th century would not be included, unless extraordinary & famous. The use of a lipoma is an interesting point in the development of breast implants, however.jgwlaw 21:56, 10 July 2006 (UTC)

Many medical articles now have well-referenced history sections, and they provide a significant difference between a boring clinical review in a boring medical journal and an encyclopedia article. JFW | T@lk 17:35, 10 July 2006 (UTC)

I welcome Molly's moves of old-fashioned and outdated treatments to the "history" section. This is exactly what I mean. I ask Dianne kindly not to remove the Czerny reference again until we have reached consensus whether it is appropriate. JFW | T@lk 17:44, 10 July 2006 (UTC)

Silicone injections belong in the history, unless there are other countries still using them, of which I am unaware. The only thing I have found recently are illegal injections, which have caused a number of deaths. As to the use of 'malginancies', that is in the first sentence of the artilce I referenced, "Silicone injection for breast augmentation is still common in Asia, even though silicone injection induced granulomas and associated malignancy have been reported." This is well referenced, as you point out, and I would appreciate your not deleting it, without a better reason than it is not 'prominent'. IT was in one of the first sentences in the article. jgwlaw 21:51, 10 July 2006 (UTC)

Given that I have no access to the journal, could you summarise how that article arrives at the conclusion that silicone injections caused malignancies? JFW | T@lk 22:19, 10 July 2006 (UTC)

In point of fact, there has been new literature re-examining fat grafting for augmentation. It's briefly seen some mention on the newswire. [7] There is little future in this most would agree due to the time & expense of it & because the saline and silicone implants currently used & in development are good productsDroliver 23:59, 10 July 2006 (UTC)

I don't have access to the full article either, JFW. According to WIki guidelines, we should only include full text. If that is the case, however, most of the references in the medical articles would be deleted. I'm not sure what to do about that, since I agree that it is not a good idea to have a mere abstract.jgwlaw 00:25, 11 July 2006 (UTC)

Wholesale changes and deleting well referenced sections

This needs to stop. We have gone over this, as have other editors, for months now. Also, using PMA as a reference for 'satisfaction' is absurd. Satisfaction studies by an independent source, not intended to gain a PMA, would be useful. But even that would not be appropriate at the expense of deleting the entire section on local complications. Other editors (medical doctors) have told Oliver this, and agreed such a reduction is not appropriate or worthy of Wikipedia. jgwlaw 01:47, 11 July 2006 (UTC)

This article has reached the stage where every significant edit (apart from small corrections) needs to be discussed. I agree with some of Droliver's deletions, but not without some form of consensus over here. JFW | T@lk 07:23, 11 July 2006 (UTC)

Breiting article

The following paragraph from "systemic illness" is confusing:

As studies have followed women with implants for a longer period of time, evidence has grown regarding serious systemic symptoms. A Danish study, funded by Dow Corning and the Danish Cancer Society, reported that women who had breast implants for an average of 19 years were significantly more likely to report fatigue, Raynaud-like symptoms (white fingers and toes when exposed to cold), and memory loss and other cognitive symptoms, compared to women of the same age in the general population. Despite reporting that women with implants were between two and three times as likely to report those symptoms, the researchers concluded that long-term exposure to breast implants "does not appear to be associated with autoimmune symptoms or diseases".

Just looking at the abstract there is no mention at all of significantly increased fatigue, Raynaud's and memory/cognitive problems. In fact, the only significant finding was breast pain. The abstract even concludes that there was no difference in other symptoms and/or diseases. What was the source of this statement? Could whoever inserted this tell us the 95% confidence interval and/or p value? If the 95% CI crosses the 1.0 then we should delete this. JFW | T@lk 07:38, 11 July 2006 (UTC)

I did not include this. I'll let Dr. Zuckerman respond. We can't make such a black and white threshold JFW. Do you propose then to ignore the FDA statement that more research is needed in a certain area? That is a valid source. And do you look up the entire article of each you use? If so, and if that is the standard then we need to delete a good portion of the references Rob cited here.

You can't begin using statistics to shade the article, either, or we then begin looking further at methodology and funding, as well. Let's see what the article says, and what Dr. Zuckerman says..

-- JFW, thank you for making my point better than I did: there is no mention of the significant problems women had with implants in the abstract of the article. It's all in the article itself, which most doctors don't read. If we base our knowledge of implant safety on journal abstracts, we miss some of the most important findings. This is especially a problem for articles funded by Dow Corning, where the abstracts and conclusions have a rosy spin, but the results section have findings that are absolutely consistent with the reports of pain and illness made by women with implants, their testimony at FDA meetings, the unpublished research findings of Inamed and Mentor, and the findings of independently funded (and government-funded) research. Drzuckerman 12:37, 11 July 2006 (UTC)Dr Zuckerman

Exactly and the point made by Dr Zuckerman regarding "abstracts" has been made more than once. One has to read the entire article(s). It appears one limitation of the research to date is results, when one reads the entire article, could also be interpreted as inconclusive rather than conclusive regarding "no association with illness". Why? Because in a lot of cases the results actually "hint" at an association. This simply provides more "evidence" for longer termed, better controlled studies funded and peformed by organizations and researchers that have no ties to the manufacturers. User:Sheehs1 12:53, 11 July 2006 {UTC}

Dr Zuckerman, how do you explain the discrepancy between the article and the abstract? And given that you seem to have access to the fulltext, could you share with us the statistical parameters that I requested?

Sheehs1, we are talking hard data here. There is an association or there is not. Casting aspersions on the trialists' integrity is a rather easy way out compared to dealing with the methodology and the findings. JFW | T@lk 19:42, 11 July 2006 (UTC)

I have to jump in here, JFW. I suspect you don't mean this as black and white as you just suggested. "Hard data" can be conflicting, or the data can be from studies not large enough, etc. which would affect the confidence level one would want to consider as appropriate --and one must not forget the margin of error along with the confidence level - but I don't know how this is factored (or not) in medical journals. In fact, these are some of the issues the FDA has addressed, and is one of the reasons siicone implants had not been approved in the last several years the manufacturers have submitted requests for PMAs. That may change this year, but it is premature to assume it will.

My suggestion is that Dr. Zuckerman give us a quote from the article she discusses (above) or more information so your question can better be answered. While I understand her response, I do hope she will provide the example of the journal text that she refers to. (I personally don't want to buy the article, as I doubt many of us do. It sounds like Dr. Z has read the entire text or has a copy of it.)jgwlaw 22:50, 11 July 2006 (UTC)

This is an example of something being true but not accurate. The article by Breitling indexed 12 catagories of symptoms associated with rheumatologic disease & Dr. Zimmerman highlights those individual symptoms out of context, especially when it's being asserted connective tissue disease (who's diagnosis involves meeting #'s of symptoms) are somehow increased . As compared to the control group of breast reduction patients, patients with implants on average reported 3.2 vs 2.9 of the indexed symptoms. In addition Fewer women with breast implants than controls reported criteria for classic or undefined connective tissue disease or signs indicating other inflammatory conditions.

Again, this is non-productive to have trench warfare over hundreds of individual studies. This body of work has been poured over multiple times with the same conclusion. This study and others since the IOM report have been discussed by the FDA, IRG (Britain), & Health Canada since 2004 & they still do not conclude there's evidence supporting links to systemic illness. Dr. Zuckerman's and others reservations about the research has been well laid out at each of these panels and not been found compelling cause to change their conclusions71.8.78.88 02:02, 12 July 2006 (UTC)

JFW, I agree that there is either an association with data or there is not. What continues to disturb me about some of the research conducted on implants is some of the studies present data and conclusions and are seemingly ignored by the FDA, such as the data from the Lykissa research that supports platinum ionization in woman implanted with silicone gel implants. That too is hard data. The statement in the Breitling abstract that says, "Despite reporting that women with implants were between two and three times as likely to report those symptoms, the researchers concluded that long-term exposure to breast implants "does not appear to be associated with autoimmune symptoms or diseases"." .......does not necessarily tell me their result was conclusive. It says that it "does not appear" to be associated.....thus leaving the door open. I would like to read the entire Breiting article to take a look at their methodology but do not have it. User:SHEEHS! 11:45 11 July 2006 {UTC}

Sheesh, I believe that what you quoted was what Dr. Zuckerman wrote in this article, and not a quote from the study. I think we do all need to read the article, if we are going to debate inclusion of what she wrote here. I believe JFW has a copy of the article, so perhaps he could email it to us through our talkpage email. Or Oliver, or Dr. Zuckman, perhaps either of you could do the same? I would like to read it, as well. And, I would say to all that we should limit our discussion for right now to this one article, since that is what is being challenged for inclusion in the article. Oliver, we are not discussing 'hundreds of studies', and the IOM report was in 1999 (and referenced earlier studies), so your comment above is untrue as well as inaccurate. Moreover, neither Canada nor the US have approved the unrestricted use of silicone implants. Now, let's discuss THIS study, all of us, since reference to it has been questioned, for inclusion in this article.jgwlaw 04:36, 12 July 2006 (UTC)

Breast augmentation

I notice that breast augmentation redirects to this article. Breast reconstruction does not. Perhaps we should make slightly more mention of actual surgical technique, as well as adding other forms of non-implant breast augmentation (e.g. Dianne's TRAM flaps). Alternatively, this can be split off to its own article. JFW | T@lk 08:01, 11 July 2006 (UTC)

Dr. Zuckerman does not suggest we include tram flaps. This is an article about breast implants, not breast reconstruction. They belong to two separate articles. Breast reconstruction should not redirect here. They are two separate articles.jgwlaw 11:56, 11 July 2006 (UTC)

Seeing as this article is now soley about the implants themselves and not about the surgery, I think the breast augmentation page should be developed in its own right. Aktornado 15:45, 11 July 2006 (UTC)

Breast reconstruction does not always required implantation(breast implants). Therefore, breast reconstruction techniques should be handled in an independent article. However if the breast reconstruction article discusses implants at great length, a link to this site from that point could be useful to the reader. User:Sheehs1 12:41 22 July 2006

I never suggested this article should be about breast reconstruction. I was suggesting we either include material on breast augmentation here or split it off to a seperate page. JFW | T@lk 19:42, 11 July 2006 (UTC)

Now I am confused. There is a separate article on 'breast reconstruction' but 'breast augmentation' redirects to 'breast implants'. I don't think we want too much redundant information across articles (as I have seen on some other topics). On the other hand, 'breast augmentation' could be a combination of implants and/or other types of reconstruction. I wonder if 'breast augmentation' should just redirect to both 'breast reconstruction' and 'breast implants'? Or rename the breast implant article to 'breast augmentation' and have it mostly about implants, with a brief comment about other reconstruction with a link to that article? I'm open to suggestions.jgwlaw 22:37, 11 July 2006 (UTC)

--I didn't realize (until now) that if someone was looking for "breast augmentation" using the search engine on Wikipedia they were automatically sent to breast implants. But, that makes sense because breast implants are the only kind of breast augmentation procedure. However, there are several kinds of breast recontruction (TRAM flaps, implants, DIEP, etc) and that should be in an article on breast reconstruction, not here in the implant article (which is already too long).

I don't see the point of having highly technical medical information on techniques and procedures in any article in Wikipedia. Nobody should be learning how to do surgical procedures on Wikipedia, whether it is implants, liposuction, or open heart surgery! Any doctor interested in learning more can find that information on the ASPS or ASAPS websites, and I have to assume that 99.9999% of readers would not understand and would not want that level of information. So, let's try to keep the jargon to a minimum in this article, and stick with a reading level that most high school students (or above) could understand). Otherwise, we can start adding details about the research findings (which is much harder to find elsewhere), and this article will just get longer and longer and harder for most readers to understand. Drzuckerman 01:51, 12 July 2006 (UTC)Dr Zuckerman

On the breast reconstruction page, there actually is a link at the bottom of the page to the "breast implant" article. On the breast implant article there is a link back to "breast reconstruction". Unless I am now really confused, I think this is sufficient cross refererence. [[User: SHEEHS1] 12:15 12 July 2006

Sheesh, thanks for pointing out what I should have seen. That should indeed be sufficient. jgwlaw 04:38, 12 July 2006 (UTC)