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Breast implant

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File:BreastImplant(inamed35).jpg
Breast implant diagram

A breast implant is a prosthesis used in cosmetic surgery to enlarge the size of a woman's breasts (known as breast augmentation), or to reconstruct the breast (e.g., to correct genetic deformities or after a mastectomy, or during male-to-female sex reassignment surgery).

According to the American Society of Plastic Surgeons, breast augmentation is the third most commonly performed cosmetic surgical procedure in the United States. In 2005, 291,000 breast augmentation procedures were performed.[1]

Types of implants

There are two contemporary types of breast implant filler materials with many different shapes and textures available:

  • Saline, which have a silicone rubber shell filled with sterile saline liquid. These implants are currently the only type available outside of clinical trials in the United States, but future regulation may make more filler types available.
  • Silicone gel, which have a silicone shell filled with a viscous silicone gel.

History

Implants have been used at least since 1865 to augment the size of women's breasts. The earliest known implant occurred in Germany, in which fat from a lipoma (benign fatty lump) was removed from a woman's back and implanted in her breast. In the following years, the medical community experimented with implants of various materials, most commonly paraffin.

The first use of silicone for breast augmentation was immediately following World War II, when doctors in Japan and Las Vegas began injecting it to enlarge women's breasts. Initially they used the industrial kind of silicone that goes into making furniture polish and transformer fluid. Complications like cysts, sores and painful hardening of the breasts were in some cases so severe that women needed mastectomies. According to the New York Times, at least three women died when silicone obstructed their blood vessels and lungs.[2] Women sometimes sought medical treatment up to 30 years after receiving this type of injection.

Silicone Gel Implants

Houston, Texas plastic surgeons Thomas Cronin and Frank Gerow developed the first silicone breast prosthesis with the Dow Corning Corporation in 1961, and the first woman was implanted in 1962. The implant was made of a silicone rubber envelope (or sac), and was filled with a thick, viscous silicone gel.

When originally introduced by Cronin, medical devices were not regulated in the United States. After the law was changed in 1976 to give the Food and Drug Administration (FDA) the authority to regulate all medical devices, the FDA "grandfathered" many devices that were already on the market, including breast implants. As a result, the long-term safety of the devices had never been documented. In 1992, the FDA restricted the implantation of silicone gel-filled breast implants because of questions about their safety. Silicone implants may be used only under certain controlled conditions. The FDA has not yet lifted the ban for widespread use.[3]

In Canada, silicone gel-filled prostheses were banned by Health Canada on 6th January 1992 in response to concerns raised in the scientific literature regarding possible illnesses associated with the implants. In 1999, Health Canada's Medical Devices Bureau began to make silicone implants available to plastic surgeons again under a Special Access Program. Under the program, surgeons must submit requests to use silicone implants to the Bureau on a case-by-case basis.[4]

First and Second Generation

The first generation Cronin-Gerow implants were redesigned in the 1970's in response to surgeons asking for softer and more life-like devices. The original cohesive gel and thick-shell models were replaced in the 1970’s by implants with thinner gel and thinner shells. These more flexible gels were introduced by various companies from 1972-1975, and thinner elastomer shells were introduced in 1972. These "second generation" implants had a greater tendency to rupture and leak, or "bleed" silicone through the porous shell, and complications such as capsular contracture were also quite common.

Another development in the 1970’s was a polyurethane foam coating on the implant shell. According to a Congressional report an estimated 200,000 women received this type of implant before it was discontinued in the early 1990's because of health concerns.[5] Polyurethane coating was believed to diminish capsular contracture by causing an inflammatory reaction that discouraged formation of fibrous tissue around the capsule. The manufacturer later withdrew the product after FDA scientists determined that the foam broke down to TDA, a known animal carcinogen.[6] FDA scientists advised the low theoretic risk of cancer would not justify removing these implants solely over concerns about TDA.[7] Plastic surgeons have found that removing polyurethane-coated implants "can be disfiguring and lead to chronic infection, drainage from the breast and skin ulceration."[8] While still manufactured in Europe and South America, these implants are not FDA approved for sale in the United States.[9]

Second-generation implants also included various “double lumen” designs. These implants had two cavities and two shells, which were either ”patched” together or had one shell floating freely inside the other. The double lumen was an attempt to provide the cosmetic benefits of gel in the inside cavity, while the outside lumen contained saline and could be used for an expander or even for injection of antibiotics or steroids. The failure rate of these implants is higher than for single lumen implants. The contemporary versions of these devices ("Becker Implants") are used primarily for breast reconstruction. The adjustability of the saline chamber allows tissue expansion and subtle volume corrections to be performed after placement.

Around 1985, gel implants were introduced that used thicker shells, a barrier-coat elastomer to decrease gel-bleed, and a more cohesive gel filler.

Third Generation
Silicone gel-filled breast implants (3rd generation)

Third-generation implants, developed in the 1990s, are made of cohesive gel that better maintains its form. These implants are used in other countries, and are the implants currently being considered for FDA approval. However, these implants can rupture, and the rate of rupture of contemporary devices is still being determined. Data presented to the FDA from the core and adjunct studies is limited to 3 and 4 year data. The increased cohesion of the gel filler has decreased silicone bleed and is believed to reduce leakage of the gel as compared to earlier devices, although leakage of silicone oil has still been reported in these newer implants. FDA studies indicate that most women with these implants will have at least one ruptured implant within 11-15 years. Research by Holmich and his colleagues, estimated rupture rates of "at least 15%" of implants within the first 10 years.[10] Two companies, Inamed Corp and Mentor Corp, provided two to three year rupture data based on Magnetic Resonance Imaging (MRI), which indicated low rupture rates during those first few years, but projecting an accurate device failure rate is not possible based on those data.

File:Cohesive gel.gif
Cohesive Gel Implant
Fourth Generation

Evaluation of "gummy bear" or high-cohesive, form-stable implants is in preliminary stages in the United States. Although these implants are used more widely in other countries, their long-term safety record is still being evaluated. It is speculated that the high degree of gel cohesion in these implants is likely to eliminate or significantly reduce potential silicone migration. Short-term safety and efficacy reports have been favorable, but 10 to 20 year rupture and leakage data are needed to determine whether the silicone leakage problem has been solved.[11][12][13]

Saline-filled breast implants

Saline Implants

There is some dispute as to who originally invented saline implants. Early saline implants were reported in France in 1965 and in the United States that same year, in New York City. [1]. The early models frequently deflated. [2]. In 1967, Dr. Henry Jenny, a California plastic surgeon, found that gel implants leaked so much silicone that they were covered with a greasy film and left large spots of grease when laid down. [3]. Moreover, he found, the implants ruptured in about 16 percent of cases. Dr. Jenny and Dr. Jeri Smahel of Switzerland followed up their observations with experiments on tissue taken from a woman who had gel implants removed. They found that the silicone leaking from her intact implants had gotten into not only body tissues, but into the bloodstream and, as Dr. Jenny put it, "once in the blood, silicone would undoubtedly be distributed throughout the body." It was later proved that even implants that had not ruptured 'bled' silicone into many organs, including the spleen, liver and bone marrow. [4]. As a result of these concerns, Dr. Jenny designed a saline implant that was sturdier than the earliest models and had a diaphragm valve, known as the "Jenny valve." [5].

Original saline implants had a high failure rate and were discontinued in the early 1970s. The current design has thicker, room temperature vulcanized (RTV) shells. After the FDA silicone gel moratorium in the early 1990's, saline implants became the dominant type placed in the United States. Saline implants lacked the problems of gel fluid diffusion through the shell into the tissues; axillary adenopathy secondary to silicone; release of gel on implant rupture, which can be removed only incompletely by surgery and includes the possibility of gel migration and granuloma formation; higher incidences of contracture; and greater radiopacity of gel. [6]

Local complications for saline breast implants are similar to those for silicone gel implants. Case reports of bacteria and fungal contamination have been reported. Advantages of saline implants include intraoperative adjustability, ease of removal, decreased capsular contracture rates, and cost (several hundred dollars less per implant than silicone). As compared to silicone gel however, saline implants are more likely to cause rippling, wrinkling, and be noticeably palpable. Many surgeons also feel that they are more likely to cause an attenuated "bottoming out" appearance of the lower breast pole tissue from the dependent weight of the saline filler. Some of these characteristics can be improved with newer designs, submuscular or partial submuscular placement (the "dual-plane" technique) of the implant and proper implant sizing. CITATION In patients with more breast tissue, it can be difficult to discern an advantage in feel or appearance to silicone. However, with thin breast tissue coverage, and particularly in the setting of post-mastectomy reconstruction, silicone is felt to be the superior device by most plastic surgeons.

Techniques

File:MentorBISM.jpg
A sub-muscular implant
File:MentorBISG.jpg
A sub-glandular implant

There are several techniques employed in the insertion of breast implants. The choice of technique may depend on the surgeon's personal preferences as much as the patient's relevant anatomy, but there are certain considerations that the surgeon can use to help select the implant and method appropriate to the patient.[14]

  • Sub-Glandular - sub-glandular implants are placed in a pocket between the pectoralis major muscle posteriorly and the breast tissue and subcutaneous fat anteriorly. A surgeon may select this technique in a patient with a moderate amount of pre-existing breast tissue (e.g. if one is able to "pinch an inch" or more of skin and subcutaneous tissue 3-5 cm about the nipple).
    • Advantages of this technique are that the implant will not move with contraction of pec major, and thus is appropriate for physically active women; some argue that this is the natural location of breast tissue (as opposed to under the mucle) and so looks more natural; also a sub-glandular implant may create a better result (and lift) in a ptotic breast (where the nipple lies below the level of the infra-mammary fold).
    • Disadvantages include an unpleasant cosmetic effect in patients with very little covering tissue - the outline of the implant may be more visible, "rippling" may be apparent, capsular contractures (leading to hard, uneven breasts) may be more common.
  • Sub-Fascial - in this technique the implant is placed into a pocket between the pectoralis major and its covering fascia.
  • Sub-Muscular - here the implant is placed entirely or partially beneath the pectoralis major muscle, lying on the ribcage. A surgeon may select this technique in a patient with very little pre-existing breast tissue (e.g. one is unable to "pinch an inch").
    • Advantages: mammograms may be more accurate than with subglandular implants, the implant may be less visible in very small-breasted women.
    • Disadvantages: the implant may move noticeably with contraction of pec major, producing a very bizarre visual effect that will probably be considered undesirable by the patient. This effect may be especially noticeable in physically active females with well defined pectoral muscles.

There are also several choices for incision:

  • Peri-Areolar - a semicircular incision around the lower half of the areola.
  • Infra-Mammary - a transverse incision following the line of the infra-mammary fold.
  • Axillary - an incision in the axilla (armpit) with a tunnel made through to the breast.


Specific Local Complications

Other documented complications specific to breast implants include the following:[7][8][9][[10]

  1. Capsular Contracture
    Capsules of tightly-woven collagen fibers naturally form around a foreign body (eg. breast implants, pacemakers, orthopedic joint prosthetics, etc..), tending to wall it off. Most of the time, these tissue capsules are soft-to-firm, and unnoticeable. Capsular contracture occurs when the capsule tightens and squeezes the implant. This contracture is a complication that can be painful and distort the appearance of the implanted breast. Bacterial contamination, gel implant rupture or leakage, and hematoma are the main identified factors in these complications. However, the exact mechanism of capsular contracture in most cases is never identified. Correction of capsular contracture ranges from surgical removal of the implant capsule tissue to removal (and possible replacement) of the implant itself. Capsular contracture may happen again after this additional surgery.
    There are four grades of capsular contracture:
    • Grade I - breast normally soft and looks natural
    • Grade II - breast little firm and looks normal
    • Grade III - breast firm and looks abnormal (visible distortion)
    • Grade IV - breast hard, painful and looks abnormal (greater distortion)

  2. Hematoma/Seroma
    Hematoma is a collection of blood inside a body cavity and a seroma is a collection of the watery portion of the blood around the implant or around healing. A small scar can form or a rupture may occur if the implant is damaged during draining the incision. Post-operative hematoma and seroma may contribute to infection or capsular contracture.
  3. Changes in Nipple and Breast Sensation
    Feeling in the nipple and breast can increase or decrease after implant surgery. The range of changes varies from intense to no feeling in the nipple or breast after surgery. Changes in feeling can be temporary or permanent and may affect sexual response or the ability to nurse a baby.
  4. Extrusion
    Unstable or weakened tissue covering and/or interruption of wound healing may result in extrusion, (when the breast implant comes through the skin). Surgery needed to correct this can result in unacceptable scarring or breast tissue loss.
  5. Necrosis
    Necrosis, the death of tissue around the implant, may prevent wound healing and require surgical correction and/or implant removal. A permanent scar may form.
  6. Tissue Atrophy/Chest Wall Deformity
    Pressure of the breast implant may cause the breast tissue to thin and shrink. This can occur while implants are still in place or following implant removal without replacement.


Risks and controversy

See also: Breast implant/Risks and debate
Intracapsular rupture - with capsule created by the body to wall off (silicone implant) foreign object

Particular problems for breast implants have been of capsule rupture and the local as well as systemic effects of leakage of the silicone contents.

Rupture

The FDA states that "implants should not be expected to last a lifetime." Whilst rupture of a saline breast implants results in deflation and they can usually be easily removed, there is more concern about silicone gel breast implants, because:

  1. Rupture of silicone gel-filled implants may allow silicone to migrate through the tissues.
  2. The relationship of free silicone to development or progression of disease is unknown.
  3. Implant rupture is a device failure - the implant is no longer performing as intended.

It has been suggested that ruptured silicone implants may predispose patients to chronic fatigue,[15] and immune responses.[16]

Systemic Illness

Conflicting studies make the issue of systemic illness an ongoing concern for women considering breast implants:

  • Rheumatological - A number of studies, some funded in part by manufacturers, have reported that there is no evidence of increased mortality or defined autoimmune diseases from silicone breast implants. However, 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.
  • Oncological - Concerns about the possible role of implants in causing breast cancer prompted three large studies which have shown that augmented women have equal or lower risk than non-augmented women of developing breast cancers. However there has been some reports of an increased risk of lung cancer deaths in comparison with other plastic surgery patients.
  • Neurological - Platinum is used as a catalyst in the manufacture of silicone for the implant devices and it has been reported that "women exposed to silicone breast implants have platinum levels that exceed that of the general population," and in oxidation states that may be more toxic.[17]

Mammography

Compression on the breast during mammography can cause implant rupture. Breast implants may also obscure tumors requiring additional images to be taken. However this exposes the woman to more radiation and may still miss some tumours.[18]

Additional Surgeries

Regardless of the type of implant, it is likely that women with implants will need to have one or more additional surgeries (reoperations) over the course of their lives. Common reasons for reoperations include cosmetic concerns, capsular contracture, and rupture.[19] Reoperation rates are less frequent in breast reconstruction cases. The major implant manufacturers, Mentor and Inamed, both reported that almost half their reconstruction patients underwent additional surgeries within three years to fix implant problems, whether their implants were silicone or saline. The exact statistics are available on the FDA website. More than 50,000 implant removal procedures were also reported in 2004. In fact, the American Society of Plastic Surgeons reports that in 2000, about 26% of augmentation and 16% of reconstruction surgeries were for replacement of implants – due to capsular contracture, rupture, implant shift, chronic infection, or other causes.[20]

Notes

  1. ^ 10.2 Million Cosmetic Plastic Surgery Procedures in 2005. American Society of Plastic Surgeons. 15 March 2006. Retrieved 17 April 2006.
  2. ^ Natasha Singer. Injecting Silicone, and Risk. The New York Times. 26 January 2006. Retrieved 17 April 2006.
  3. ^ Segal,Marian. "Silicone Breast Implants Available Under Tight Controls". FDA.
  4. ^ Health Canada. "It's Your Health: Breast Implants" (PDF). Health Canada.
  5. ^ The Implant Information Project. "The FDA's Regulation Of Silicone Breast Implants". The National Research Center for Women & Families.
  6. ^ Luu HM, Hutter JC, Bushar HF (1998). "A physiologically based pharmacokinetic model for 2,4-toluenediamine leached from polyurethane foam-covered breast implants". Environ Health Perspect. 106 (7): 393–400. PMID 9637796 Full text.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  7. ^ "TDA and Polyurethane Breast Implants". FDA. 1995-06-28. {{cite web}}: Text "author Cruzan, Susan" ignored (help)CS1 maint: year (link)
  8. ^ Johnson,Judith (1992-09-09). "Implants: Safety and FDA Regulation". SPR CRS Report for Congress Congressional Research Service, The Library of Congress.{{cite web}}: CS1 maint: year (link)
  9. ^ Hester TR Jr, Tebbetts JB, Maxwell GP (2001). "The polyurethane-covered mammary prosthesis: facts and fiction (II): a look back and a "peek" ahead". Clin Plast Surg. 28 (3): 579–86. PMID 11471963.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  10. ^ Holmich LR, Friis S, Fryzek JP, Vejborg IM, Conrad C, Sletting S, Kjoller K, McLaughlin JK, Olsen JH (2003). "Incidence of silicone breast implant rupture". Arch Surg. 138 (7): 801–6. PMID 12860765.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  11. ^ Brown MH, Shenker R, Silver SA (2005). "Cohesive silicone gel breast implants in aesthetic and reconstructive breast surgery". Plast Reconstr Surg. 116 (3): 768–79, discussion 780-1. PMID 16141814.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  12. ^ Fruhstorfer BH, Hodgson EL, Malata CM (2004). "Early experience with an anatomical soft cohesive silicone gel prosthesis in cosmetic and reconstructive breast implant surgery". Ann Plast Surg. 53 (6): 536–42. PMID 15602249.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  13. ^ Heden P, Jernbeck J, Hober M (2001). "Breast augmentation with anatomical cohesive gel implants: the world's largest current experience". Clin Plast Surg. 28 (3): 531–52. PMID 11471959.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  14. ^ Bellin, Howard (2002-08-05). "Breast Augmentation, Subglandular". eMedicine.{{cite web}}: CS1 maint: year (link)
  15. ^ Vermeulen RC, Scholte HR (2003). "Rupture of silicone gel breast implants and symptoms of pain and fatigue". J Rheumatol. 30 (10): 2263–7. PMID 14528527 Abstract.
  16. ^ Wolfram D, Rainer C, Niederegger H, Piza H, Wick G (2004). "Cellular and molecular composition of fibrous capsules formed around silicone breast implants with special focus on local immune reactions". J Autoimmun. 23 (1): 81–91. PMID 15236756.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  17. ^ Lykissa E.D. and Maharaj S.V.M. (2006). "Total Platinum Concentration and Platinum Oxidation States in Body Fluids, Tissue, and Explants from Women Exposed to Silicone and Saline Breast Implants by IC-ICPMS". Anal. Chem. (due publication May 2006). Retrieved 2006-04-06 (Web). {{cite journal}}: Check date values in: |accessdate= (help); Unknown parameter |month= ignored (help)
  18. ^ Miglioretti DL, Rutter CM, Geller BM, Cutter G, Barlow WE, Rosenberg R, Weaver DL, Taplin SH, Ballard-Barbash R, Carney PA, Yankaskas BC, Kerlikowske K (2004). "Effect of breast augmentation on the accuracy of mammography and cancer characteristics". JAMA. 291 (4): 442–50. PMID 14747501.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  19. ^ Cite error: The named reference FDA2004-Informed was invoked but never defined (see the help page).
  20. ^ Diana Zuckerman, Elizabeth Nagelin-Anderson, Elizabeth Santoro (December 2005). "What You Need to Know About Breast Implants". The National Research Center for Women & Families.{{cite web}}: CS1 maint: multiple names: authors list (link) CS1 maint: year (link)

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See also

Wikimedia Commons has media related to Category:Breast implants.
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