Breast implants are 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.
Types of 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. In January 2006, FDA Week reported that the FDA Office of Criminal Investigations started an investigation of Mentor. The FDA has not announced a final decision regarding approval for either manufacturer.
Breast Implant 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 benign fatty tumor(lipoma) 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.
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.
When originally introduced by Cronin, medical devices were not regulated by the FDA. After the law was changed to give the FDA the authority to regulate all medical devices in 1976, 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. Since then, adjunct studies were created to obtain more data. The efficacy and follow-up of these studies have been challenged. At the FDA General and Plastic Surgery advisory panel meeting in April 2005, FDA scientists criticized both companies for failure to follow the majority of the patients in those studies, and explained that the studies would not be used as evidence of safety in FDA’s review. The FDA instead reviewed the much smaller Core studies conducted by the two companies.
According to the latest research, women exposed to silicone breast implants have platinum levels that significantly exceed that of the general population, and the oxidation states of the platinum indicate that the exposure may be toxic. This peer-reviewed published study is the first to document the various platinum oxidation states in samples from women exposed to silicone breast implants. The study found that platinum migrates from silicone implants via the lymphatic and blood systems into the urine, sweat, and breast milk, with deposits and accumulation in hair and nails. Platinum, including ionized forms of platinum, may persist years after the silicone gel breast implants have been removed. Like lead, platinum may accumulate in bone tissue.[The newest peer reviewed study on risks of silicone implants will be published in the May 1, 2006 journal of Analytical Chemistry. The article is entitled “Total Platinum Concentration and Platinum Oxidation States in Body Fluids, Tissue, and Explants from Women Exposed to Silicone and Saline Breast Implants by IC-ICP-MS”.]
In September of 2005, a Canadian Expert Advisory panel on Breast Implants reviewed available data, heard public concerns and asked questions of manufacturers. The review echoed the FDA’s concerns including recommending further outcome studies on device failure, rupture rates, and long term effects of silicone. The Canadian panel concluded that the implant manufacturers answered its questions about safety, but stated that peer-reviewed literature at least brings into question the potential of silicones and/or implant devices to induce autoimmune or hypersensitivity reactions.
Therefore, Inamed and Mentor should consider the following :
There should be a complete review of the published literature on the potential of silicones and/or implant devices to induce autoimmune or hypersensitivity and an appropriate critical analysis. Preclinical testing should address this point using animal models (according to peer-reviewed literature).
Included in clinical studies the monitoring of immunological endpoints to address this issue.
The panel also recommended to Health Canada that a breast implant registry be required, and advised Health Canada that current patient labeling was not sufficient. Modifications of the standardized informed consents have since been added to address this concern.
Dr. Frank Vasey, a board certified rheumatologist and professor of medicine who has long studied silicone implants and is an outspoken critic, recently had this to say about the studies related to systemic illness:
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.
Rupture and other local complications
Intracapsular rupture — Silicone implant and capsule created by the body to wall off foreign object
Extracapsular rupture — Single lumen silicone implants, that were ruptured a few years before they were removed in 2004The FDA states that “implants should not be expected to last a lifetime.” When saline breast implants break, they deflate quickly and can usually be easily removed. The FDA is more concerned about silicone gel breast implants, because when they 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.” The specific risk and treatment of extracapsular silicone gel is still controversial, and in response to their concerns, FDA scientists completed a study on the health effects of ruptured silicone gel breast implants, which was published in the May 2001 Journal of Rheumatology.study The scientists reported a significant increase in fibromyalgia and several other autoimmune diseases among women with extracapsular leakage, compared to women whose implants were not broken or leaking.
The FDA rarely conducts its own research, but this study was initiated because of the lack of data on the health impact of silicone leakage. It was funded by the FDA Office of Women’s Health; the National Cancer Institute, The National Institute of Health; the Office of Research on Women’s Health, and the U.S. Department of Health and Human Services.
The FDA stated that rupture is a concern because:
Rupture of silicone gel-filled implants may allow silicone to migrate through the tissues.
The relationship of free silicone to development or progression of disease is unknown.
Implant rupture is a device failure – the implant is no longer performing as intended.
Pathology reports of ruptured implants often show giant cell formation indicating an immune response, as well as chronic inflammation. In a 2004 article, scientists reported patients with implants demonstrated statistically significant elevation in anti-silicone antibodies compared with the unimplanted control groups. 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 clearly a relevant 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.
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.
The UK-IRC panel concluded that there was insufficient scientific evidence to support a link between silicone gel breast implants and specific connective tissue diseases, but noted the lack of information on rupture. Moreover, the panel concluded that this information is of relevance to questions concerning its possible pathogenic role. Implant registries in the European Union are collecting similar data as the American studies to provide better conclusions on this.
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. 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%). Unlike some other studies, all the women in the FDA study still had their implants, and had them for at least 7 years. The FDA was an independent study, that compared women with leaking implants to women with implants that weren’t leaking. Clearly, this is a controversial subject that needs to be further examined by independent studies.
Since the research clearly 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.[PMID 15900139]
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.
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 and Implants
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. 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.
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 studies funded by implant makers.
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. 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 due to Breast Implants
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. 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.
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”. The FDA points out that those studies have not been large enough to resolve 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.
Numerous studies have been conducted since the IOM report was completed. Studies conducted by the FDA and published in 2001 reported a significant increase in fibromyalgia among women with leaking silicone breast implants. 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.
Research also indicates 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. A recent report detailed HLA differences among women in whom inflammatory myopathy develops after they received silicone implants.
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.[Breiting VB, Holmich, LR, Brandt B, Long-term health status of Danish women with silicone breast implants. Plastic and Reconstructive Surgery. 2004; 114: 217-226] 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.”
In September of 2005, a Canadian Expert Advisory panel on Breast Implants reviewed available data, heard public concerns and asked questions of manufacturers. The panel included three paid consultants to implant manufacturers. 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.” 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: any sub-group of recipients at risk; the auto-antibodies provoked and their target antigen.
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), 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.
Additional Breast 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. 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.
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