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

A woman with breast 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. In the 60 countries where silicone implants are available, they are used in approximately 90-95% of implant operations.

In the United States the implantation of silicone gel-filled breast implants is currently restricted to clinical trials. In many other countries they are in regular use. The General and Plastic Surgery advisory panel recommended FDA approval of Mentor and against Inamed silicone gel breast implants. Despite the panel's recommendation that Inamed's implants not be approved, the FDA sent Inamed a letter stating that the companies implants would be approvable if certain conditions could be met. The FDA has not announced a final decision regarding approval for either manufacturer.

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. Women sometimes seek 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.

These "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.[1] Polyurethane coating was believed to diminish capsular contracture by causing an inflammatory reaction that discouraged formation of fibrous tissue around the capsule. However, these Meme and Replicon implants were placed on the Canadian and U.S. market without a safety review. The Congressional report, which had access to internal industry and FDA documents, describes the foam as similar to the foam used in carpets and upholstery, and states that it was used under nonsterile conditions. The manufacturer later withdrew the product after FDA scientists determined that the foam broke down to TDA, a known animal carcinogen.[2] FDA scientists advised that the implants presented an "unacceptable" risk, but after the implants were removed from the market FDA officials advised women that the relatively low risk of cancer from one set of implants would not justify removing these implants solely over concerns about TDA.[3] Plastic surgeons have found that removing polyurethane-coated implants "can be disfiguring and lead to chronic infection, drainage from the breast and skin ulceration."[4] While still manufactured in Europe and South America, these implants are not FDA approved for sale in the United States.[5]

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.

Silicone gel-filled breast implants (3rd generation)

Around 1985, "third generation" gel implants were introduced using thicker shells, a barrier-coat elastomer to decrease gel-bleed, and a more cohesive gel filler. These 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 at this point. 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.

Research on complications and rupture for silicone-gel implants indicates:

  • First generation from 1963-1972 - Low rupture, higher complications like contracture
  • Second generation from 1972 - to mid 1980’s –50-95% rupture after 10 years,
  • Third generation from mid-1980’s to present — 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.[6] 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
4th generation Cohesive Gel Implant (form-stable)

Evaluation of high-cohesive, form-stable implants ("fourth generation" devices) 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. Implant companies and plastic surgeons believe that the high degree of gel cohesion in these implants is likely to eliminate or significantly reduce potential silicone oil 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.[7][8][9]

Saline-filled breast implants

Saline Implants

Saline implants were originally designed by plastic surgeon Henry Jenny because of his concerns about the safety of silicone gel breast. In addition, they can be implanted through a smaller incision (2.5-3 cm) than that required for a silicone implant. After the FDA silicone gel moratorium in the early 1990's, saline implants became the dominant type placed in the United States.

The complications for saline breast implants are similar to those for silicone gel implants, including infection, malposition, rupture, and capsular contracture. 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.

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.

Risks and controversy

In the US, implants made from silicone gel were restricted by the FDA in 1992, because of questions about the safety of such implants. More than one million women had implants at the time of the ban, and multi-million dollar jury awards and subsequent litigation led manufacturers to agree to a settlement of US$4.25 billion.[10]Although that information is considered anecdotal, peer reviewed studies indicate that the rheumatological symptoms of many women with implants improve when their implants are removed. [11] The authors reported a significant increase in fibromyalgia among women with extracapsular leakage, compared to women whose implants were not broken or whose rupture was intracapsular. Women with breast implant rupture were no more likely than women with intact implants to report a diagnosis of any of the studied definite CTDs, including scleroderma, systemic sclerosis,SLE, Sjogren’s syndrome or “other CTD,” which included dermatomyositis, polymyositis, Hashimoto’s thyroiditis, mixed CTD, pulmonary fibrosis, eosinophile fascitis, and polymyalgia.

The FDA stated that rupture is a concern 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.

A 2003 article by FDA scientists published in The Journal of Rheumatology stated that women with silicone breast implants report more severe pain and chronic fatigue.[12] 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%).

In contrast, a UK panel, funded by Dow Corning and the Danish Cancer Registry, concluded that there was insufficient scientific evidence to support a link between silicone gel breast implants and specific connective tissue diseases. However, the panel also noted the lack of information on rupture.[13] Rupture rate information is of relevance to questions concerning a possible pathogenic role. Implant registries in the European Union are collecting similar data as the American studies to provide better conclusions on this.

Pathology reports of ruptured implants often show giant cell formation indicating an immune response, as well as chronic inflammation. 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.[14] The highest anti-silicone antibody levels were measured in implanted women with either frank 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.[15]

Neither Inamed nor Mentor have collected MRI data on rupture or leakage for women implants for more than 3-4 years. 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, the data from Inamed and Mentor clearly indicate that clinical exams are inadequate to rule out suspected rupture.[16]

Other Local Complications

Other documented complications with breast implants include asymmetry, visibility, palpability, infection, scarring, necrosis (death of breast tissue) and capsular contracture, which is the tightening or hardening of the scar tissue that surrounds the implant.[17]

Capsules of tightly-woven collagen fibers naturally form around a foreign body (eg. breast implants, pacemakers, orthopedic joint prosthetics, etc..), in an attempt to wall it off. Most of the time, these tissue capsules are soft-to-firm, and unnoticeable. However, the capsule can tighten or contract. 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. The exact mechanism of capsular contracture in most cases is never identified.

Mammography

Pressure on the breast (compression) during mammography can cause implant rupture. Breast implants also can interfere with finding breast cancer during mammography, because the implant shows up as a solid white shape, obscuring tumors above or below. In addition to making tumors more difficult to detect, implants cause "false positive" results as well when extensive scarring and calcium deposits mimic the appearance of cancer, making the deposits difficult to distinguish from tumors on a mammogram.[18] Biopsy may be necessary to determine whether these are cancerous.

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, although the extra images were used.[19] 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. The impact of possible delayed detection has not been clinically significant in several related studies.

The displacement views do not protect against rupture, which becomes a greater problem as implants age. Dr. Lori Brown, an FDA scientist, published an article in 2004 in the Journal of Women's Health, indicating that the FDA has received dozens of reports of implants rupturing or leaking during mammography.[20]

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

Systemic Illness

Conflicting studies make the issue of systemic illness an ongoing concern for women considering breast implants. Thousands of women have reported that they became ill from their implants, particularly when silicone implants ruptured. Complaints include systemic fungus, neurological and rheuamtological problems. Although that information is considered anecdotal, peer reviewed studies indicate that symptoms of many women with implants improve when their implants are removed. [21]

In 2003 Professor Frank Vasey, a rheumatologist, outspoken critic stated:

"Epidemiologic studies on silicone implants focused on defined connective tissue diseases as well as undefined symptom complexes. Studies of defined diseases were either negative or showed only a small but statistically significant relative risk. Studies of systemic lupus erythematosus (SLE) and systemic sclerosis did not show an association with silicone breast implants, but studies of symptoms did.. Because of a lack of consistency in methodology of symptom searches and in study findings some reviewers do not believe implants cause systemic problems. Since then, a Dow Corning-funded study (2496 reduction mammoplasty patients versus 1546 silicone breast implanted women, 1/6 of whom had saline-filled silicone envelope implants) has documented that all 28 symptoms were increased in silicone patients (16 of 28 were statistically increased). In a comparison study, there was a statistical correlation between local problems and systemic problems."[21] .

Rheumatological

In a 1999 review of previous studies, the US Institute of Medicine (IOM) concluded that there was not "sufficient evidence for an association of silicone gel- or saline-filled breast implants with defined connective tissue disease".[22]

In 2001 a review was done of existing literature for the court appointed National Science Panel regarding breast implants in relation to rheumatologic disorders. The authors evaluated both established and undifferentiated connective tissue diseases. The panel concluded that there was no evidence of an association between breast implants and these CTDs. However, there studies were conflicted regarding arthralgias, lymphadenopathy, myalgias, sicca symptoms, skin changes, and stiffness. [PMID 11710703] [2]

A 2001 retrospective study in Australia of 458 women who received cosmetic breast implants between 1979 and 1983 and 687 women with other types of plastic surgery found an increase in night sweats, lethargy, breast pain, impaired mentation, reflux, paraesthesiae, hand muscle weakness and myalgia in women with breast implants. Also found was an increase in axillary adenopathy and low titre positive antinuclear antibody (ANA). However, this study did not find a statistical increase in defined connective tissue disease.[3][PMID 11480483]

The FDA points out that these 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. 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.

Scientists from the National Cancer Institute published a peer-reviewed article on 2001 reporting that women with breast implants for at least seven years were twice as likely to die of brain cancer and three times as likely to die of lung cancer, compared to other plastic surgery patients. The augmentation patients did not differ from the other plastic surgery patients in terms of smoking or other health habits.[23]

Studies reported by the FDA have shown that some women with silicone gel-filled breast implants produced antibodies to their own collagen (a connective tissue protein),[24] but we do not know how often these antibodies occur in the general population, and there are no data as yet that show these antibodies cause CTDs and related disorders.

In 2005, studies also indicate that dermatomyositis, an inflammatory muscle disease that causes muscle weakness and a skin rash, may be initiated or exacerbated by silicone breast implants or collagen injections.[25] A recent report detailed HLA differences among women in whom inflammatory myopathy develops after they received silicone implants.

In September of 2005, a Canadian Expert Advisory panel on Breast Implants reviewed available data, heard public concerns and asked questions of manufacturers.[26] The review echoed the FDA's concerns including recommending further outcome studies on device failure, rupture rates, and long term effects of silicone. The panel found that both companies provided appropriate information to show that silicones are not immunosuppressive materials. However, the panel did note that peer-reviewed literature raises questions about the potential of silicones and/or implant devices to induce autoimmune or hypersensitivity reactions.

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."[13] 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 disproved. Further studies would be necessary to identify:

  1. any sub-group of recipients at risk;
  2. the auto-antibodies provoked and their target antigen.

Neurological

Research published in 2006 reports that "women exposed to silicone breast implants have platinum levels that exceed that of the general population, and the first report, to date, to document the various platinium oxidation states present in samples from women exposed to silicone breast implants" that may be more toxic.[27]

The study found that platinum migrates from silicone implants via the lymphatic and blood systems and may accumulate in bone tissue persisting years after the silicone gel breast implants have been removed. The study also reported that 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.

The Washington Post quotes Lykissa saying "Implant manufacturers have said for years that their platinum is not harmful, and when the device is manufactured, they are correct, but in the body, we know that the implants degrade and the platinum can disperse and take on a more reactive form."[28] In contrast, the article quotes a past consultant to Inamed, Michael Brook, who expressed his skepticism of "finding platinum in a highly unstable form never before known to exist in the presence of air or water, as existing in the human body".

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.[18] 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.[29]

See also

Wikimedia Commons has media related to Category:Breast implants.

Notes and References

  1. ^ The Implant Information Project. "The FDA's Regulation Of Silicone Breast Implants". The National Research Center for Women & Families.
  2. ^ 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)
  3. ^ "TDA and Polyurethane Breast Implants". FDA. 1995-06-28. {{cite web}}: Text "author Cruzan, Susan" ignored (help)CS1 maint: year (link)
  4. ^ 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)
  5. ^ 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)
  6. ^ 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)
  7. ^ 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)
  8. ^ 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)
  9. ^ 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)
  10. ^ Segal,Marian. "Silicone Breast Implants Available Under Tight Controls". FDA.
  11. ^ Brown SL, Pennello G, Berg WA, Soo MS, Middleton MS (2001). "Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women". J Rheumatol. 28 (5): 996–1003. PMID 11361228 FDA Summary.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  12. ^ 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.
  13. ^ a b The Report of the Independent Review Group. "Immune responses to silicone gel implants". Silicone gel breast implants. UK Government. {{cite web}}: Unknown parameter |accessyear= ignored (|access-date= suggested) (help)
  14. ^ 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)
  15. ^ Brown SL, Middleton MS, Berg WA, Soo MS, Pennello G (2000). "Prevalence of rupture of silicone gel breast implants revealed on MR imaging in a population of women in Birmingham, Alabama". AJR Am J Roentgenol. 175 (4): 1057–64. PMID 11000165.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  16. ^ Holmich LR, Fryzek JP, Kjoller K, Breiting VB, Jorgensen A, Krag C, McLaughlin JK (2005). "The diagnosis of silicone breast-implant rupture: clinical findings compared with findings at magnetic resonance imaging". Ann Plast Surg. 54 (6): 583–9. PMID 15900139.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  17. ^ 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". Plast Reconstr Surg. 114 (1): 217–26, discussion 227-8. PMID 15220596.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  18. ^ a b Carol Rados (September-October 2004 issue). "Making an Informed Decision About Breast Implants". FDA Consumer magazine. {{cite web}}: Check date values in: |year= (help); Unknown parameter |accessyear= ignored (|access-date= suggested) (help)CS1 maint: year (link)
  19. ^ 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)
  20. ^ Brown SL, Todd JF, Luu HM (2004). "Breast implant adverse events during mammography: reports to the Food and Drug Administration". J Womens Health (Larchmt). 13 (4): 371–8, discussion 379-80. PMID 15195650.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  21. ^ a b 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 Full text.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  22. ^ Brinton LA, Malone KE, Coates RJ, Schoenberg JB, Swanson CA, Daling JR, Stanford JL (1996). "Breast enlargement and reduction: results from a breast cancer case-control study". Plast Reconstr Surg. 97 (2): 269–75. PMID 8559808.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  23. ^ Brinton LA, Lubin JH, Burich MC, Colton T, Hoover RN (2001). "Mortality among augmentation mammoplasty patients". Epidemiology. 12 (3): 321–6. PMID 11337605 PDF full text.{{cite journal}}: CS1 maint: multiple names: authors list (link) with its followup of 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.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  24. ^ FDA (2004). Breast Implant Consumer Handbook.
  25. ^ Caramaschi P, Biasi D, Volpe A, Carletto A, Bambara LM (2005). "A new case of dermatomyositis following the rupture of a silicone gel breast implant". Clin Exp Rheumatol. 23 (3): 430–1, author reply 431. PMID 15971442.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  26. ^ Expert Advisory Panel on Breast Implants (2005-09-29/30). "Record of Proceedings". Health Canada. {{cite web}}: Check date values in: |year= (help)CS1 maint: year (link)
  27. ^ 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)
  28. ^ Kaufman, Marc (2006-04-07). "Platinum Found in Women With Breast Implants". Washington Post. p. A06. Retrieved 2006-04-08.
  29. ^ 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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