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BREAST IMPLANT

A breast implant is a prosthesis used to enlarge the size of a woman's breasts (known as breast augmentation) for cosmetic reasons, to reconstruct the breast (e.g. after a mastectomy or to correct genetic deformities), or for the purposes of male-to-female gender 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]

There are two primary types of breast implants: saline and silicone gel implants. Saline implants have a silicone rubber shell filled with sterile saline liquid. Silicone gel implants have a silicone shell filled with a viscous silicone gel. Other materials used less frequently for breast augmentation include soybean oil[2] and polypropylene string.

Contents

History

Implants have been used since 1895 to augment the size or shape of women's breasts. The earliest known implant was attempted by Czerny, using a woman's own adipose tissue (from a lipoma, a benign growth, on her back). [2] Gersuny tried paraffin injections in 1889, with disastrous results. Subsequently, in the early to mid-1900s, a number of other substances were tried, including ivory, glass balls, ground rubber, ox cartilage, Terylene wool, gutta percha, Dicora, polyethylene chips, polyvinyl alcohol-formaldehyde polymer sponge (Ivalon), Ivalon in a polyethylene sac, polyether foam sponge (Etheron), polyethylene tape (Polystan) or strips wound into a ball, polyester (polyurethane foam sponge) Silastic rubber, and teflon-silicone prostheses.[3]

In recent history, various creams and medicaments have been used in attempts to increase bust size, and Berson in 1945 and Maliniac in 1950 performed a dermafat flap. Pangman introduced the Ivalon sponge in 1950, and various synthetics were used throughout the 1950s and 1960s, including silicone injections, which an estimated 50,000 women received.[3] . Development of silicone granulomas and hardening of the breasts were in some cases so severe that women needed to have to mastectomies for treatment. Women sometimes seek medical treatment for complications up to 30 years after receiving this type of injection.

Indications

Clinical indications for the use of breast implants are for breast reconstruction, gender reassignment surgery, and for other abnormalities that affect the shape and size of the breast. In some countries health insurers will reimburse insertion of breast implants only for these indications. Non-clinical indications (the most common reasons) are cosmetic.

Breast implants may be contraindicated in body dysmorphic disorder, since women with that disorder have a distorted sense of their own body. This may result in repeated plastic surgery for perceived imperfections.[4]

Types of implants

Silicone gel implants

Thomas Cronin and Frank Gerow, two Houston, Texas, plastic surgeons, developed the first silicone breast prosthesis with the Dow Corning Corporation in 1961. The first woman was implanted in 1962. The implant was made of a silicone rubber envelope (or sac), filled with a thick, viscous silicone gel.[5]

When originally introduced in the 1960s, medical devices were not regulated in the United States, and therefore no safety data were required. 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, these devices could continue to be sold although they had not been through the FDA approval process and long-term safety had never been documented. In 1991, the FDA required that safety studies be submitted by companies that sought to keep their implants on the market in the U.S. The FDA reviewed the data submitted by several implant manufacturers, and determined that the data were not adequate to prove safety. In 1992, the FDA therefore restricted silicone gel-filled breast implants to clinical trials, primarily for women needing reconstruction after mastectomy or breast deformity, or for women with implants that need to be replaced. The FDA has not lifted those restrictions, despite several subsequent applications for approval.[6]

In Canada, silicone gel-filled prostheses were banned by Health Canada on January 6, 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.[7]

First and second generation

The first generation Cronin-Gerow implants were redesigned in the 1970s with thinner gel and thinner shells. 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 1970s 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 1990s because of health concerns.[8] 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.[9] Plastic surgeons have found that removing polyurethane-coated implants can be disfiguring and lead to chronic infection, drainage from the breast and skin ulceration.[10] While still manufactured in Europe and South America, these implants are not FDA approved for sale in the United States.[11]

Second-generation implants also included various "double lumen" designs. These implants were essentially a silicone implant inside a saline implant. The double lumen was an attempt to provide the cosmetic benefits of gel in the inside lumen, while the outside lumen contained saline and its volume could be adjusted after placement. The failure rate of these implants is higher than for single lumen implants.[citation needed] The contemporary versions of these devices ("Becker Implants") are used primarily for breast reconstruction.

Third generation

Third-generation implants, developed in the late 1980s and early 1990s, used thicker shells that were coated to decrease gel bleed, and a thicker, more cohesive gel filler.

These implants are sold under restricted conditions in the U.S. and Canada, and more widely used in other countries. Two companies, Inamed and Mentor, applied for FDA approval for these implants in 1991 and 2003, and were rejected, and have resubmitted applications currently being considered by the FDA. These implants rupture as they age, and the rate of rupture has not yet been determined. Data presented to the FDA is limited to 3 and 4 year data. The increased cohesion of the gel filler is believed to reduce leakage of the gel compared to earlier devices, but no long-term studies have been conducted to compare leakage rates. FDA studies indicate that most women with these implants will have at least one ruptured implant within 11 years. One study funded by Dow Corning estimates that "at least 15%" of these implants rupture within the first 10 years, which translates to 27.75% of breast augmentation patients.[12]

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, there are no published long-term safety studies. It is speculated that the high degree of gel cohesion in these implants is likely to eliminate or significantly reduce silicone migration. [13][14][15]

Saline implants

Saline-filled breast implants were first manufactured in France in 1964, introduced by Arion[16] with the goal of being surgically placed via smaller incisions. These original devices had a high failure rate and were discontinued in the early 1970s. The current devices are manufactured with thicker, room temperature vulcanized (RTV) shells. These shells are made of silicone elastomer and the implants are filled with salt water after the implant is placed in the body. Since the implants are empty when they are surgically inserted, the scar is smaller than is necessary for silicone gel breast implants (which are filled with silicone before the surgery is performed).

Until 1992, most women getting breast implants used silicone gel implants rather than saline. After the FDA silicone gel implant moratorium in the U.S., Canada, and several other countries in the early 1990s, saline implants became the most popular type in the United States. Saline implants made by Inamed and Mentor were approved by the FDA in 2000. Saline implants made by other companies have not provided the FDA with sufficient safety data to gain FDA approval, but are sold in other countries.[17]

Local complications for saline breast implants are similar to those for silicone gel implants, and can be dangerous, debilitating, or relatively minor. The most common complications are capsular contracture and the need for additional surgery to fix implant problems or to remove ruptured implants. Other common complications include infection, chronic breast pain, and loss of nipple sensitivity. According to data provided by Inamed and Mentor to the FDA, most saline breast implant patients have at least one serious complication within the first 3 years.[4][5].

Cosmetic problems can result in a dissatisfied patient but are not medically worrisome. Compared to silicone gel implants, saline implants are more likely to cause cosmetic problems such as rippling, wrinkling, or being noticeable to the eye or the touch. Particularly for women with very little breast tissue, or for post-mastectomy reconstruction, some plastic surgeons believe that silicone gel implants have a better cosmetic outcome. In patients with more breast tissue, however, saline implants look very similar to silicone gel.

In addition, case reports of bacteria and fungal contamination have been described in medical journals.

Advantages of saline implants include easier removal, no silicone leakage, and lower cost (several hundred dollars less per implant than silicone). Another advantage is that the size of the implant can often be slightly adjusted without replacing the implant.

There are no long-term studies to determine if saline breast implants increase the risk of diseases such as cancer or autoimmune disease. However, breast implant manufacturers warn patients that women with autoimmune diseases were excluded from their safety studies of saline breast implants because of concerns about the risks. [6]

Mental Health Benefits

The mental health benefits of breast augmentation and reconstruction are widely acknowledged and supported by surveys, but objective research does not support those claims.

From 2001-2006, five studies were published indicating an increase in deaths from suicide among women with breast augmentation. [18] Most compared women with implants to women in the general population, raising questions about whether women who choose plastic surgery have other traits (age, race, social class, low self-esteem) that make them more likely to commit suicide than other women. However, a study by scientists at the National Cancer Institute found a higher suicide risk among breast implant patients compared to other plastic surgery patients, although the women were similar in terms of age, race, social class, health status and health habits. [18] These studies do not determine whether women choosing breast augmentation are less psychologically healthy than other women before surgery, or if the mental health problems contributing to suicide are related to pain or other complications from breast augmentation.

In the only studies that objectively compared women before breast implants to two years later, studies by implant makers Inamed and Mentor indicate that women who undergo breast augmentation or reconstruction have the same or lower scores on most tests of self-esteem and quality of life two years after getting silicone breast implants compared to those same women just before surgery. [19] These research results were not published by the companies but are available on the FDA website.

Physiological health benefits of breast implants, if any, are not documented. In what may or may have not been a singular incident, however, one Israeli woman's life was saved by her breast implants as they captured shrapnel from an exploding Hezbollah rocket in the course of the 2006 Israel-Lebanon conflict, preventing lethal injury to her heart. [20]

Local Complications

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

Rupture

Implants do not last a lifetime. When saline breast implants break, they often deflate quickly and can be easily removed. However, when silicone implants break they rarely deflate, and the silicone from the implant can leak and migrate outside of the scar tissue that the body creates around the implant. This is known as "extracapsular silicone", which can migrate to other parts of the body. Extracapsular silicone can cause granulomas (inflammatory nodules) and axillary lymphadenopathy [21] [11]

The health risks of implant rupture are not known, but the cosmetic risks are clear, with some women losing significant breast tissue when the silicone has leaked. The potential risks of silicone migration is still controversial.

The FDA states on their website (www.fda.gov)that rupture is a concern because:

1. Rupture of silicone gel-filled implants may allow silicone to migrate through the tissues to the lymph nodes and from there to organs such as the lungs, where it can't be removed.

2. The health effects of leaking silicone is unknown.

3. Implant rupture is a device failure - the implant is no longer performing as intended.

A 2001 FDA study reported a significant increase in fibromyalgia and several other connective tissue diseases among women with extracapsular leakage, compared to women whose implants were not broken or leaking outside the capsule. [22]

In a 2004 article in Journal of Autoimmunity, scientists reported patients with implants demonstrated statistically significant elevation in anti-silicone antibodies compared with the unimplanted control groups. -->[23] The highest anti-silicone antibody levels were measured in implanted women with either implant ruptures or leakage of their silicone gel implants.

The age of the implant is an important factor in rupture. The FDA rupture study was superior to previous rupture studies because it was limited to women who had silicone gel implants for at least 6 years and had not removed their implants or reported problems with them. Based on magnetic resonance imaging (MRI) they found that 77% of the women had at least one ruptured implant, even though most had no symptoms and were unaware of the leakage. [24]

Neither of the two US implant manufacturers have collected MRI data on rupture or leakage for women implants for more than 3-4 years.[6] Therefore, it is impossible to determine if the implants that those companies currently sell have a different rupture rate or likelihood of leakage compared to the implants in the FDA study, which included Mentor and Inamed implants as well as implants made by other companies.

Since the research indicates that most ruptures of silicone gel implants are "silent," with no symptoms, the FDA recommends MRIs as the gold standard for detecting rupture. The FDA General and Plastic Surgery Advisory Panel has considered recommending annual MRIs, but determined that the cost would be prohibitive for screening purposes. However, manufacturer data provided on the FDA website (www.fda.gov)clearly indicate that clinical exams are inadequate to rule out suspected rupture.

Capsular contracture

Capsules of tightly-woven collagen fibers form as an immune response around a foreign body (eg. breast implants, pacemakers, orthopedic joint prosthetics), tending to wall it off. Capsular contracture occurs when the capsule tightens and squeezes the implant. This contracture is the most common complication from silicone and saline breast implants, and can be very painful and distort the appearance of the implanted breast. The exact cause of contracture is not known. However, some factors include bacterial contamination, silicone rupture or leakage, and hematoma. Correction of moderate to severe capsular contracture includes removal of the implant capsule or removal (and possible replacement) of the implant itself. Capsular contracture tends to recurr 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)

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.

Changes in nipple and breast sensation

Feeling in the nipple and breast can change after implant surgery. Changes vary from intense to no feeling in the nipple or breast after surgery. This altered sensation can be temporary or permanent and may affect sexual response or the ability to nurse a baby.

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.

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.

Mammography

Doctors recommend that women with breast implants have mammograms. However, according to the FDA, pressure on the breast (compression) during mammography can cause implant rupture. In 2004, Brown et al reported that the FDA had received dozens of reports of implants rupturing or leaking during mammography.[20]

Breast implants also can interfere with the accuracy of mammograms because the implant appears as a solid white shape, obscuring tumors above or below. Specific mammogram techniques have been developed to ensure that as much breast tissue as possible is examined in the woman with implants. This requires taking extra images, called displacement views, which expose the woman to more radiation. In 2004, Miglioretti and her colleagues published a study in the Journal of the American Medical Association indicating that 55% of breast tumors were not initially detected on mammograms for women with implants, even though the extra images were used. [25] This compares to about 30% of tumors that were not initially detected for women who did not have breast implants. These tumors were subsequently detected in later mammograms.

In addition to making tumors more difficult to detect, implants cause "false positive" results when extensive scarring and calcium deposits mimic the appearance of cancer, making the deposits difficult to distinguish from tumors on a mammogram. Calcium deposits may be felt as modules or bumps under the skin around the implant [19] Biopsy may be necessary to determine whether these are cancerous.

Ultrasound and MRIs can be used to detect breast cancer instead of mammograms, but this adds to the cost of screening and probably would not be covered by health insurance.

Controversy

Systemic illness

Thousands of women have claimed that they have become ill from their implants, particularly when silicone implants ruptured. Complaints include systemic fungus, neurological and rheumatological problems. Although information from hundreds of individual reports is considered anecdotal, peer-reviewed studies indicate that subjective and objective symptoms of many women with implants improve when their implants are removed. For example, in a comparison study, women with rheumatological symptoms who had their implants removed and not replaced reported improvement in their health, and women whose implants were not removed or removed and replaced did not."[26]

Numerous reports, based primarily on studies funded by Dow Corning, have reported that there is no evidence of increased mortality or classically defined autoimmune diseases among women with silicone breast implants. These include the Canadian Expert Advisory Committee review in 1992, ANDEM in France in 1996, the UK Independent Review Group 1998, and the U.S. Institute of Medicine in 1999, and the Scientific Technical Opinions Assessment (STOA) report commissioned by the European Parliament in 2001 (updated in 2003).

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. [27] The researchers seemed to ignore these findings when they concluded that long-term exposure to breast implants "does not appear to be associated with autoimmune symptoms or diseases".

A large study by the National Cancer Institute found a decreased standardized mortality ratio in breast implant augmentation patients and other plastic surgery patients, reflecting the fact that plastic surgery patients tend to be healthier and more affluent than the general population.[18] However, the women with implants were twice as likely to die from lung cancer compared to other plastic surgery patients, with no evidence of a difference in smoking history. The implant patients did not have an increased risk of death from breast cancer compared with either the general population or other plastic surgery patients

Platinum

Platinum is a catalyst used in the making of silicone implant polymer shells. The literature indicates that the platinum leaches (leaks) from these implants and is present in the surrounding tissue. FDA reviewed the available studies from the medical literature on platinum and breast implants in 2002; however, the studies had evaluated platinum in the implants, but not in the women's bodies. [28]

In May 2006, researchers published a peer-reviewed study concluding that "women exposed to silicone breast implants have platinum levels that exceed that of the general population." [29] This was the first report "to document the various platinium oxidation states present in samples from women exposed to silicone breast implants." The study reported that platinum migrates from silicone implants via the lymphatic and blood systems and may accumulate, persisting years after the silicone gel breast implants have been removed. Women with silicone breast implants had approximately 100 times higher platinum levels in their breast milk than women with no known platinum exposure. Platinum levels were as much as 1,700 times higher in urine. However, more important than the levels of platinum was the oxidation state; the platinum in breast milk and other body fluids was ionized, in the form of platinum salts, and therefore potentially toxic.

The FDA reviewed the study, criticized the small sample, and noted that previous research reviewed by Brook, an Inamed consultant, has indicated that the platinum in implants is not ionized and therefore would "not represent a significant risk to women." [12] According to the FDA website, the FDA has been asked to conduct additional research by researchers without financial ties to implant makers, to replicate or refute the study of ionized platinum in the bodily fluids of women with breast implants.

Repair or revision surgery

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.[30] Reoperation rates are more 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. [31]

References

  1. ^ 10.2 Million Cosmetic Plastic Surgery Procedures in 2005. American Society of Plastic Surgeons. 15 March 2006. Retrieved 17 April 2006.
  2. ^ Czerny V. Plastischer Ersatz der Brusthus durch ein Lipoma. Zentralbl Chir 1895;27:72.
  3. ^ Anderson N. Lawsuit Science: Lessons from the Silicone Breast Implant Controversy. "New York Law School Law Review" 1997; 41 (2), 401-407.
  4. ^ Sarwer DB, Pertschuk MJ, Wadden TA, Whitaker LA. Psychological investigations in cosmetic surgery: a look back and a look ahead. Plast Reconstr Surg 1998;101:1136-42. PMID 9514352.
  5. ^ Cronin TD, Gerow FJ. Augmentation mammaplasty: a new "natural feel" prosthesis. Excerpta Medica International Congress Series 1963;66:41.
  6. ^ Segal, Marian. Silicone Breast Implants Available Under Tight Controls. FDA.
  7. ^ Health Canada. It's Your Health: Breast Implants. Health Canada.
  8. ^ U.S. House of Representatives Subcommittee on Human Resources and Intergovernmental Relations. The FDA’s Regulation Of Silicone Breast Implants. U.S. Congress.
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  10. ^ Johnson, Judith (1992-09-09). Implants: Safety and FDA Regulation. SPR CRS Report for Congress Congressional Research Service, The Library of Congress.
  11. ^ 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.
  12. ^ 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.
  13. ^ 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.
  14. ^ 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.
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  16. ^ Arion HG (1965). "Retromammary prosthesis". C R Soc Fr Gynecol 5.
  17. ^ FDA approves saline breast implants. CNN.com (May 11 2000). Retrieved on 10 July 2006.
  18. ^ a b c Brinton LA, Lubin JH, Murray MC, Colton T, Hoover RN (2006). "Mortality rates among augmentation mammoplasty patients: an update". Epidemiology 17 (2): 162-9. PMID 16477256.
  19. ^ {{DA Summary Panel Information Mentor P030053 http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_Tab-1_fda-Mentor%20Panel%20Memo.pdf, pg 66-67, 70; Inamed P020056 – FDA Summary Panel Memorandum http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_tab-1_fda-Inamed%20Panel%20Memo.pdf}}
  20. ^ "Breast implants save Israeli's life in rocket attack", Reuters, August 15, 2006.
  21. ^ Katzin, William E, Centeno, Jose A, Feng, Lu-Jean et al (2001). "Pathology of Lymph Nodes From Patients With Breast Implants: A Histologic and Spectroscopic Evaluation.". American Journal of Surgical Pathology 29 (4): 506-511. [1].
  22. ^ 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.
  23. ^ 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.
  24. ^ { Brown SL, Pennello G, Berg WA, Soo MS, Middleton MS. Silicone Gel Breast Implant Rupture, Extracapsular Silicone, and Health Status in a Population of Women. The Journal of Rheumatology 2001;28:996-1003.}}
  25. ^ 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.
  26. ^ Vasey FB, Zarabadi SA, Seleznick M, Ricca L (2003). "Where there's smoke there's fire: the silicone breast implant controversy continues to flicker: a new disease that needs to be defined". J Rheumatol 30 (10): 2092-4. PMID 14528500.
  27. ^ Breiting VB, Holmich LR, Brandt B, Fryzek JP, Wolthers MS, Kjoller K, McLaughlin JK, Wiik A, Friis S (2004). "Long-term health status of Danish women with silicone breast implants". Plastic and Reconstructive Surgery 114: 217-226. PMID 15220596.
  28. ^ Arepelli S, et al. (2002). "Allergic reactions to platinum in silicone breast implants.". J Long-Term Effects Medical Implants: 299-306. PMID 12627791.
  29. ^ Lykissa E.D. and Maharaj S.V.M. (April 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 on 2006-04-06 (Web).
  30. ^
  31. ^ Zuckerman D, Nagelin-Anderson E & Santoro E (2005). What You Need to Know About Breast Implants. The National Research Center for Women & Families.

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