Breast Implants: A Research and Regulatory Summary

Updated July 2012

By Diana Zuckerman, PhD, Elizabeth Santoro, RN, MPH, Emily Moore, BA and Judith Faucette, JD

More than 307,000 women and teenagers underwent breast implant augmentation surgeries in 2011, which is back to 2008 levels after a small decrease during the economic downturn of the last two years. In addition, approximately 96,000 women underwent breast implant surgery for reconstruction after mastectomy.[1] The popularity of breast implants has risen dramatically in the last fifteen years, and is now more than three times the 1997 rate of 101,176. [2]

after breast implantsThe increase in breast implant surgery, however, does not necessarily reflect a similarly dramatic increase in the number of women with breast implants.  Many women who undergo surgery are replacing old implants that have broken or caused problems.  Some women report as many as ten or more surgeries as their implants are replaced over the years.  However, there are no available statistics on how many women undergo their first breast implant surgery every year.

Debate swirls over the risks of breast implants, and physicians and patients are justifiably confused by the conflicting information available. In 2011, an international scandal revealed that tens of thousands of breast implants had been made with industrial silicone instead of medical grade silicone, the FDA reassured women that the high complication rate for breast implants was no higher than expected, and research revealed that breast implants increased the risk of a rare type of lymphoma.  This summary provides information about what is known and not known about the risks of breast implants.

The Role of the Food and Drug Administration (FDA) in Safety Research

Breast implants were first sold in the 1960s, but the FDA did not have the authority to regulate them until 1976.  Sales were relatively slow until the 1980s, but by 1990 almost one million women had breast implants, even though there were no published studies about their safety and the FDA had never approved them.  Finally, in 1991, the FDA required the manufacturers of silicone gel breast implants to submit safety studies.  Unfortunately, these studies were inadequate; for example, in the McGhan prospective study, two out of three patients were followed for less than three months, and there were only three breast cancer reconstruction patients.[3] Because of the lack of clinical data, silicone implants were not approved at that time.

Instead, the FDA issued a compassionate need exemption policy on October 23, 1992, which restricted silicone gel implants in the U.S. to women willing to participate in studies, including a large “Adjunct Study” for reconstruction patients and women with broken implants (called “revision” patients).  Approximately 1,000 women, including first-time augmentation, reconstruction, and implant replacement patients participated in each company’s “Core Study.”  It is important to note that the companies defined reconstruction patients to include many women who are not mastectomy patients.  Women were also be “reconstructed” to correct “deformities” such as very droopy breasts and “severe” asymmetry (both subjectively defined by the plastic surgeons).   Implant manufacturers could have collected and published extensive safety data from these studies.  However, they did not do so.

Major shortcomings were reported regarding the Adjunct and Core studies in terms of entry criteria, data collection, and patients’ informed consent.  Many patients reported that their physicians encouraged them to enroll in the Adjunct study as a way to qualify for silicone implants, explaining that they could drop out immediately after getting implants. That anecdotal claim is supported by the enormous loss in participants between enrollment and follow-up-Inamed data discussed at the FDA’s October 2003 Advisory Panel meeting indicated that only 27% of the reconstruction patients and 20% of the revision patients were followed for three years. Mentor’s Adjunct study data similarly had low follow up rates, with only 18% of revision patients and 19% of reconstruction patients were followed for three years.  As a result of this very low follow-up rate, these Adjunct “studies” did not provide meaningful safety data.

After that same Advisory Panel meeting, the FDA considered the scientific data and decided not to approve Inamed silicone breast implants in January 2004.  At the same time, the FDA issued a new guidance specifying the type of research manufacturers would need to present to obtain approval of any breast implants in the future.  A major focus of the guidance document is the need to determine why breast implants break, how long they last, and the health consequences of broken and leaking implants.

On April 11-13, 2005, the FDA held another Advisory Panel meeting to consider new research on silicone breast implants that was subsequently submitted by two companies, Inamed (currently called Allergan) and Mentor (now a subsidiary of Johnson & Johnson). Their studies only followed women for three years, which was not responsive to the FDA guidance asking that they determine how long implants last or the health consequences of leaking or broken implants.

In late 2005, the FDA Office of Criminal Investigation started an investigation of Mentor, interviewing former Mentor employee about the sale of defective implants by the company.  One employee admitted that executives ordered him to destroy documents related to a high rupture rate of Mentor implants and admitted that some implants were contaminated with fleas.[4]

Despite the short-term studies and the investigation of Mentor the FDA approved silicone gel breast implants by Inamed (now Allergan) and Mentor as “reasonably safe” for women who are 22 or older in November 2006.  This was the first time that FDA had approved silicone gel implants, and because of serious concerns about safety, the FDA required each of the two implant makers continue their 2-3 year studies for 10 years, and also start new studies of at least 40,000 women with breast implants for 10 years, in order to prove long-term safety.  The reason for the safety studies was to provide the kind of long-term data that were still lacking.  With few exceptions, the only published data regarding long-term safety were studies funded by implant companies, plastic surgeons, or silicone manufacturer Dow Corning.

After receiving requests for a public meeting by Congresswoman Rosa DeLauro (D-CT0 and the National Research Center for Women & Families, the FDA held an Advisory Committee meeting in August 2011 to discuss the longitudinal data from the Mentor and Inamed/Allergan studies.  The data were provided on the FDA web site in June 2011 and discussed at the August meeting.  In addition to invited presentations by the implant companies and FDA officials, several hours were set aside for public comments.  Several women testified that they were thrown out of the implant studies when they reported serious health problems from their breast implants or decided to have their implants removed.[5] This raised questions about the accuracy of the data presented.  Nevertheless, the FDA accepted the studies and maintained that silicone implants were safe and effective.[6]

The FDA’s approval of several models of breast implants as “reasonably safe” does not mean safe for everyone or in the long-term.  In fact, the FDA found that most implant patients have at least one serious complication within three years after getting silicone or saline implants.[7]

Types of Breast Implants

The 40-year history of silicone breast implants is a history of trying to reduce complications, especially common problems such as breast hardness and pain caused by capsular contracture.  Although breast implants were not studied in clinical trials for the first 25 years that they were used, clinical experience indicated that design modifications would seem to improve outcomes when they were first introduced, but later be found ineffective at fixing targeted problems and often causing new ones.  For example, since the mid-1960s, implant modifications have included adding a Dacron patch, removing the Dacron patch, changing the thick gel to a thinner gel, changing the thinner gel to a thicker gel, making the silicone shell textured, covering the shell with polyurethane foam, removing the foam when it was found to break down to a carcinogen, making the shell smooth, changing the shape of the implants, and reducing “silicone bleed.”  All of these changes were “studied” informally when patients underwent surgery, rather than in clinical trials. A Congressional report summarizing these changes referred to the patients as “guinea pigs.” 3

The silicone gel breast implants that were reviewed by the FDA in 2005 and 2006 were essentially identical to those made in the early 1990s.  Inamed’s Senior Director of Regulatory and Clinical Affairs testified to the FDA in 2003 that “it is basically the same product it was 10 years ago…it is essentially the same product. [8]

In addition to changes in silicone gel breast implants, implant makers have tried to improve the product by using materials other than silicone gel.  Saline breast implants have a silicone envelope and are filled with salt water.  Saline breast implants have been available for decades, but it was not until May 2000 that the FDA approved saline implants for the first time.  Before approving these devices, the FDA required 3-year studies of local complications such as pain, infection, hardening, and the need for additional surgery.  They did not require studies of other health problems.  In addition to saline, three other kinds of implants were made available in the 1990′s, primarily outside the United States: Trilucent implants (with soybean oil filler), and Novagold and PIP hydrogel implants, which were filled with a plastic gel.  Although never approved as safe in the U.S., these implants were vigorously promoted by plastic surgeons and the media as a “natural” and safer alternative to silicone or saline implants.  Clinical trials, however, were apparently never conducted on humans with these implants, and all were removed from the market in 2000 due to safety concerns.[9], [10], [11],[12] Their removal from the market after being enthusiastically praised by doctors and patients serves as a reminder that the long-term risks of implants are not always obvious during the first few years of use.

In 2012, FDA approved silicone gel implants made by a third company, Silimed, without a public meeting to review the much more cohesive implants made by Silimed.[13] Silimed’s implants have been described as “gummy bear” implants by one of the Principal Investigators in the study submitted to the FDA, referring to the rubbery consistency of gummy bear candies.  The goal of using such cohesive gel is to prevent leakage if the implant breaks.  However, there is reason to be concerned about the safety of this gel, because of the metals and chemicals that are used to make it. [14]

FDA approval is for specific models of silicone or saline breast implants by Inamed, Mentor, and Silimed, and are not for other implants made by the same companies or by other companies.

Implants made by several other companies, such as those made by the French company PIP, have been sold in other countries but have not be en available in the U.S. for over a decade.   PIP silicone implants were taken off the market in Europe in 2011 because of a tendency to rupture sooner than other implants, and because testing indicated that the silicone was not intended for use in the human body but rather was intended for use in mattresses.[15],[16]

Public outrage and concern was so strong that several countries including France, the United Kingdom, Bolivia and Venezuela agreed to pay for implants to be removed, even for augmentation patients.[17]

Frequency of Local Complications

It is widely agreed that risks associated with implant surgery include infection, hematoma (blood or tissue fluid collecting around an implant), and the risks associated with anesthesia.

Pain and Capsular Contracture are also widely acknowledged complications: All implants are “foreign bodies,” and a woman’s body reacts to the foreign object by forming a capsule of scar tissue around the implants.  When this capsule becomes too hard or tight for the implant, it is called capsular contracture.  Capsular contracture can cause the breasts to become very hard or misshapen and can cause mild discomfort or severe, chronic pain.  Capsular contracture is common: research submitted in support of Inamed’s 2003 application to the FDA showed severe capsular contracture occurring in 16% of reconstruction patients and 8% of augmentation patients within 3 years.

Comparing Inamed data on saline breast implants and silicone gel breast implants shows many of the same types of complications; however, complication rates from silicone gel implants tend to be higher.[18], [19] For example, 46% of silicone gel reconstruction patients and 21% of saline reconstruction patients underwent at least one additional operation within three years, 25% of silicone patients and 8% of saline patients had implants removed, and 6% of silicone patients and 16% of saline patients had breast pain.18, 19 Complication rates were lower but still substantial for augmentation patients.

A study of Danish women who had breast implants for an average of 19 years found that women with implants were almost three times as likely to report breast pain compared to breast reduction patients.  The question was not asked of women in a control group since it was assumed they did not experience breast pain.[20] In addition, two-thirds of the women with implants in the Danish study reported moderate or severe breast hardness.

There are other well-documented local complications that can result from breast implants.  For example, some women lose sensitivity in their nipples, and others become overly sensitive.  These problems can interfere with sexual intimacy.  The cosmetic outcome is also sometimes disappointing, with breasts looking or feeling unnatural or asymmetrical.

Rupture: All breast implants will eventually break.  When silicone gel breast implants break, there are often no symptoms, so accurate estimates of rupture rates depend on breast magnetic resonance imaging (MRIs).  Patient testimony before the FDA and clinical evidence indicate that some breast implants break during the first few weeks or months, while others last more than 15 years.  In a study conducted by researchers at the FDA and published in 2010, most women had at least one broken implant within 11 years, and the likelihood of rupture increased over time.[21] The women in the FDA study had not had their implants removed, did not know that their implants were broken, and were not seeking help because of implant concerns.  Despite the fact that these women were “satisfied customers” rather than women seeking medical care, MRIs indicated that silicone had migrated outside of the breast capsule for 21% of the women in the study. Most of the women were unaware that this had happened.  Inamed’s study of their silicone gel implants found that 1-6% break within three years.19 A Danish study of ruptured silicone gel implants reported that most lasted for ten years; however, by the time the women in that study had implants for 15 years or more, a substantial percentage of the implants broke every year.[22]

When the FDA approved saline implants in 2001 and silicone gel implants in 2006, it was based on studies of women who had Allergan and Mentor breast implants for 4 years or less, and rupture rates were quite low.  In 2011, the two companies provided data for women who had breast implants for 8 years (Mentor) and 10 years (Allergan).  Most of the women in the Mentor studies had dropped out before the 8-year follow-up, and problems with inaccurate complication rates make their findings questionable.  Many women also dropped out of the Allergan studies, but most reconstruction patients remained in their study.  After 10 years, the reported rupture rate was 27% for Allergan reconstruction patients.[23] This is not much higher than it was at 4 years, which is surprising.  Some patients report that they were dropped from the Mentor and Allergan studies when they told their plastic surgeons that they were having problems, raising questions about the accuracy of these findings. [24]

Leakage: Numerous studies have shown silicone leaks into the scar capsules surrounding breast implants, even for implants that are not ruptured.  More worrisome, researchers at Case Western Reserve and the Armed Forces Institute of Pathology reported finding silicone in the lymph nodes of women with breast implants, which can then migrate to other organs.[25] , [26] Recent case studies have also confirmed that silicone can migrate to the lymph nodes. [27], [28] Silicone in the lymph nodes can only be removed by removing the lymph nodes.  Silicone in organs such as the lungs, liver, and brain cannot be removed.  The health risks associated with migrated silicone gel in these organs are unknown.  However, case reports have indicated fatalities and serious health risks when liquid silicone injected in the breasts migrated to the lungs or other organs.[29], [30] Although silicone implants are filled with gel rather than the liquid form of silicone, the implants sometimes leak a silicone liquid or thin gel.

A study published by the Royal Academy of Medicine in Scotland found that a woman with a broken silicone gel implant in her calf was coughing up silicone identical to the kind in her implant.[31] This has potentially serious implications for women with leaking breast implants, since silicone gel breast implants are considerably larger and closer to the lungs than calf implants.

Mammography: Breast implants interfere with the detection of breast cancer because implants can obscure the mammography image of a tumor.  Implants therefore have the potential to delay the diagnosis of breast cancer.  Although special techniques are designed to minimize the interference of the implants, the most recent research indicates that 55% of breast tumors will still be obscured.[32] That is much higher than the 33% obscured in women without implants in the same study.  Mammograms also tend to be less accurate if the woman has capsular contracture.  In addition, a study by FDA scientists indicates that silicone or saline implants sometimes rupture when women undergo mammograms.[33] For that reason, women with implants may be reluctant to undergo mammograms because of fear of rupture.  The alternative, undergoing a regular breast coil MRI to check for cancer, is prohibitively expensive for many women at an average cost of $2,000 each time.

There is no research evidence that implants cause breast cancer, and research findings on whether there is a delay in diagnosis have been inconsistent.  A delay in diagnosis could have serious health implications and decrease women’s options for breast-conserving surgery.  Such delays have been reported by patients.33

Breastfeeding: According to the Institute of Medicine (IOM), women who have had any kind of breast surgery, including breast implant surgery, are up to three times more likely to have an inadequate milk supply for breastfeeding.[34] Concerns about the chemicals from the implants passing to infants through breastfeeding have also been raised.  There is insufficient research information available to make a determination on this risk.  However, a study presented at the American Chemical Society’s 2004 August meeting found exceptionally high concentrations of platinum, a known potential toxin, both in women with silicone breast implants and in the children they bore and breastfed.[35] The American Academy of Pediatrics always encourages breastfeeding unless there is clear evidence of risk, whether from implants or any other exposure.  However, they have not yet reviewed or formally commented on the aforementioned study.

Cancers, Lymphoma, and Lung Disease

In January 2011, the FDA announced that women with breast implants seem to be more likely to develop ALCL (anaplastic large cell lymphoma), a rare cancer of the immune system. The risk of developing ALCL is very low, but much higher in women with implants than it is in the general population.  ALCL is especially rare in the breast area, but for women with implants it has been found in fluid surrounding the implant and in the scar capsule, but not the breast tissue itself.  There is not enough evidence to suggest that ALCL is more likely in a particular implant type, or to determine its cause in women with implants.[36] As a result of this concern, the FDA is now requesting that providers report cases of ALCL in women with breast implants, to determine how great the risk is compared to women without implants.

The new evidence regarding ALCL is an important reminder that it usually takes many years for cancer or other serious diseases to be diagnosed after an exposure.  For years, implant manufacturers have claimed that there are dozens of long-term studies proving that implants are safe.  Most of these “long-term” studies include large numbers of women who have had implants for a short period of time, ranging from one month to several years.  Although the women may have implants for an average of 5 or 8 or even 10 years, the number of women with implants for more than 10 years is quite small.  Epidemiologists estimate that at least 15-20 years of follow-up – and perhaps considerably more — would be necessary to conduct a well-designed study of cancer after exposure, whether to asbestos, tobacco, or breast implants.  For more than a decade, most published implant studies have been funded by Dow Corning, conducted by a core group of researchers at a research institute that receives substantial funding from Dow Corning, and have been used to defend the company from liability from their silicone implants and the silicone they sell to other companies.

There are very few published studies that have medically evaluated sufficient numbers of women with implants for a long enough period of time to evaluate whether or not implants cause cancer.  A study by scientists from the NCI found that women with breast implants were more likely to die from brain cancer, lung cancer, and other respiratory diseases, compared with other plastic surgery patients.[37] The NCI study compared augmentation patients to other plastic surgery patients, who were very similar in socio-economic status, health status, and health habits (including smoking).  Another strength of the study was that all the women had implants for at least 12 years.  Although this is not a long enough follow-up period for a conclusive cancer study, it is considerably longer than other implant studies.

A second NCI study found a 21% overall increased risk of cancer for women with implants, compared with women of the same age in the general population.[38] The increase was primarily due to an increase in brain cancer, respiratory tract cancers, cervical cancer, and vulva cancer. Swedish and Danish studies also found a significantly increased risk of lung cancer among augmentation patients, but did not control for smoking.[39], [40]

Autoimmune and Connective Tissue Diseases

The greatest controversy regarding the risks of breast implants concerns the question of whether they increase the risk of autoimmune disease and connective tissue disease. This issue has been raised again because ALCL is a cancer of the immune system, and is significantly associated with breast implants.  Studies from the 1990s tended to show no increase in risk of most autoimmune diseases, but more recent studies suggest that there is an increased risk of autoimmune symptoms and diseases.

A study conducted by FDA scientists found a statistically significant link between implants and fibromyalgia, as well as several connective tissue diseases.[41] The study focused on women who had silicone breast implants for at least six years, and found that women with leaking silicone implants were significantly more likely to report a diagnosis of painful and debilitating diseases such as fibromyalgia, dermatomyositis, polymyositis, Hashimoto’s thyroiditis, mixed connective tissue disease, pulmonary fibrosis, eosinophilic fasciitis, and polymyalgia.  The risk of fibromyalgia remained even after controlling for patient’s age, implant age, and implant manufacturer.  Extracapsular leakage was evaluated in the study using an MRI.

A study by Aziz et al examined 95 women who had silicone gel-filled breast implants and rheumatologic symptoms.  These researchers found that the symptoms improved in 42 (97%) of the 43 women who had their breast implants removed and not replaced.[42] In contrast, rheumatologic symptoms worsened in 50 (96%) of the 52 women who did not have their implants removed.

At the time that Mentor and Allergan were applying for approval for their silicone gel implants in 2005, they submitted data comparing the signs and symptoms of connective tissue diseases before and two years after patients got breast implants.  The companies reported that these signs and symptoms increased significantly, although they blamed the changes on age.  Nevertheless, according to the official FDA Summary for Inamed patients, dated March 2, 2005, there was an increase in “5 out of 8 of the [connective tissue disease signs and symptoms] categories including muscle pain, joint pain and fatigue for augmentation patients, even after adjusting for age.”[43] For Mentor implants, the FDA reported statistically significant increases in fatigue, exhaustion, joint swelling, frequent muscle cramps, joint pain, and fibromyalgia among augmentation patients, which the FDA concluded were not due to age.31

Scientists at the National Cancer Institute (NCI) found a statistically significant increase in reported connective tissue diseases among breast augmentation patients, but also found that many of the women made errors in their self-reported diagnoses.[44] For example, many women who reported having rheumatoid arthritis had osteoarthritis instead, according to their medical records.  The NCI study included women who had breast implants for at least seven years.  The findings suggest that there are increased symptoms among women with breast implants, but it is not clear if there is an increase in specific diagnoses.  As a result, the researchers concluded that the associations between breast implants and arthritis, scleroderma, Sjogren’s syndrome, and other connective tissue diseases need further study.

The Danish study mentioned above, focusing on Danish women who had breast implants for an average of 19 years, found that they were significantly more likely to report fatigue, Raynaud-like symptoms (white fingers and toes when exposed to cold), memory loss, and other cognitive symptoms than women of the same age in the general population.20 Ten percent of the women with implants had already had their implants removed and not replaced, which might have reduced these symptoms.  Despite stating that women with implants were between two and three times more 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.”  The study was funded by silicone implant manufacturer Dow Corning.

Prior to these recent studies, most published research that focused on autoimmune or connective tissue diseases studied women who had implants for a relatively short time, ranging from a few months to a few years.  The minimum exposure to breast implants was usually one month.  These studies were the basis for a report on implants by the IOM, a report by Federal District Judge Sam Pointer’s National Science Panel, and a meta-analysis published in the New England Journal of Medicine regarding the lack of evidence that implants cause systemic disease.34, [45], [46] All three of these reports are based on the same 17-20 epidemiological studies that were published prior to 1999.  Since many connective tissue and autoimmune diseases are relatively rare among young women and most take many years to develop and be diagnosed, these studies are not designed to answer questions about long-term safety.  Their major flaws are as follows:

  • The case-control studies relied on women accurately telling a stranger whether they had breast implants, and most included very few women who admitted to having breast implants. The accuracy of their responses was not verified.The studies include substantial numbers of women who had implants for just a few months or years, and therefore do not have the statistical power to determine whether or not breast implants increase the long-term risks of getting these diseases.The number of women in the studies who had breast implants for 10-15 years or more is too small to conclusively evaluate an increased risk of disease.Disease diagnoses were based on medical records or self-reports, not medical exams. Several studies had an even greater flaw-autoimmune disease was based on hospital records rather than medical diagnoses. Most women with autoimmune symptoms or diseases are not treated in hospitals.

Among the studies reviewed by the IOM, only one study, by Schusterman et al, included a diagnosis based on a medical exam, and all the women in that study had implants for less than two years-too short a time to meaningfully evaluate disease risk.  In addition, several European studies that purported to show no increased risk of autoimmune diseases actually indicated an increased risk of neurological or autoimmune disease that was similar for women who had breast augmentation or breast reduction. [47], [48] When comparing breast augmentation patients to breast reduction patients, the researchers reported that the augmentation patients were not significantly more at risk.  However, the articles clearly stated that both groups had a higher proportion of women with these diseases than expected.  Therefore, the interpretation of “no increased risk” was inappropriate.  Rather, both types of breast surgery patients were apparently at increased risk compared to the general population.

These findings raise concerns about autoimmune disease that need to be answered with long-term studies.  In addition, former FDA researchers have reported that silicone stimulates an immune response, and their cellular analyses indicate that these responses are associated with atypical forms of connective tissue disease.[49]

In summary, research on connective tissue and autoimmune diseases raises unanswered questions about long-term safety.  Results are not conclusive because of relatively short-term follow-up and limitations of the outcome measures.  Self-reports tend to show significant increases in health risks, whereas studies that rely on medical records and hospitalization are less likely to show significant increased risks.  In industry-funded studies, even when studies indicate an increase in symptoms among women with implants, the authors sometimes conclude that there is no evidence of increased health problems.  Overall, there is evidence of increased symptoms in several studies, and more research is needed to draw conclusions about the safety of implants in terms of systemic autoimmune disease.

Suicide and Depression

The same Swedish and Danish studies cited in the previous section, as well as a Finnish study, all found that women who have breast implants for augmentation were three times as likely to commit suicide as women in the general population of those countries.39, 40, [50] The NCI study cited in the previous section also found a statistically significant increase in suicides for women with breast implants, but that study compared augmentation patients to other women plastic surgery patients of the same age, race, and education.44 A recent study of mastectomy reconstruction patients in the U.S. also found a higher rate of suicide among implant patients compared to women who underwent mastectomies without reconstruction.[51]

The statistically significant increase in suicide in five studies has been subject of considerable debate.  Review articles funded by the American Society of Aesthetic Plastic Surgeons[52] and by Dow Corning[53] conclude that the increased risk of suicide is likely to predate implant surgery, and that women who choose breast implants are more likely to be depressed or have low self-esteem, as well as demographic traits that put them at higher risk of suicide. However, these assumptions are not supported by research data.  For example, the NCI study controlled for all the demographic variables associated with suicide (such as age and race) and compared augmentation patients with other plastic surgery patients, who are as likely to be insecure about their appearance as augmentation patients.44 Similarly, the most important demographic predictors of suicide, which are age, race, and sex, were already controlled in the Scandanavian studies finding an increased risk of suicide.39 ,40, 50

In support of the theory that poor mental health predates augmentation, one study pointed out that 8% of Danish augmentation patients had a psychiatric admission prior to augmentation surgery, compared to 6% of women undergoing other cosmetic procedures.  Like other plastic surgery patients in an era where plastic surgery is quite common and generally accepted, patients tend to be less satisfied with the body part that they are having surgically altered, but not less satisfied with their general appearance or themselves.[54] However, Danish women needed a psychiatric referral in order to qualify for free augmentation surgery, which could easily explain this small, non-significant difference.[55]

It is also important to note that a Danish study funded by Dow Corning found an increase in depression among women who had undergone breast augmentation.20 In that study, the women with breast implants were five to seven times more likely to be taking antidepressants than comparison samples of women who underwent breast reduction surgery or women of the same age from the general population.  Among the augmentation patients, the women who had their implants removed and replaced at least once were more likely to be taking antidepressants than those who still had their original implants.  Although it is impossible to determine whether the women were also more depressed prior to breast augmentation, the relationship between multiple surgeries and use of anti-depressants suggests that complications from the implants may contribute to depression.

General Health, Quality of Life, and Self-Esteem

It is difficult to assess the impact of breast implants on health and mortality generally, because women who undergo breast augmentation tend to be healthier and more affluent than women in the general population. For example, NCI researchers found a lower mortality rate among augmentation patients compared to the general population of women their age, but a higher mortality rate among augmentation patients compared to other plastic surgery patients.  The authors concluded that plastic surgery patients are a more appropriate comparison sample, because they are more similar to augmentation patients in social class, health, health habits, and other key variables.39

A Canadian study of women with implants compared to the general population of women of the same age found that the augmentation patients were greater than four times more likely to be hospitalized, experienced more hospitalizations, and visited physicians and specialists more often.  In other words, augmentation patients cost the healthcare system significantly more than other patients of the same age and geographic location.[56]

A study of women who had breast implants after mastectomy came to the surprising conclusion that women with implants had a significantly better survival rate than other women of similar age, race, and diagnosis.51 However, a critique of that study by NCI researchers pointed out that the better survival rates could have been the result of other advantages of the implant sample: including lower rates of obesity, higher social class, better prognosis, treatment at designated cancer centers, and use of adjuvant treatment.[57]

It is often assumed that breast implants improve the self-esteem and quality of life of women who undergo augmentation, as well as those having reconstruction after breast cancer.  However, the research does not support this assumption.  Studies of augmentation patients show no difference or improvement in self-esteem, compared to women who do not undergo augmentation.54 Studies by NCI researchers and other national experts indicate that women who have undergone reconstruction report the same quality of life as women who did not have reconstruction after mastectomy.  In fact, implant patients are more likely to report that cancer harmed their sex life than women who underwent mastectomy without reconstruction.[58] Self-selection makes it difficult to interpret these data, but the Inamed/Allergan data presented at the October 2003 FDA meeting indicated a decrease in all quality of life measures two years after implants compared to before surgery.

Despite claims that breast implants would improve self-esteem and quality of life, most of the data presented in 2005 FDA summaries, based on the manufacturers’ data after two years of having implants, do not support those claims.  For Inamed/Allergan augmentation patients, 12 quality of life scores differed significantly in the pre-test and post-test, and nine of these 12 (75%) were worse in the post-test.  These include emotional health, physical health, general health, social like, vitality, and mental health.  The only improvements were in body esteem and feelings of physical attractiveness.[59]

Similar to the Inamed/Allergan findings, when there were statistically significant changes from pre-test to post-test for Mentor patients, almost all were worse in the post-test compared to the pre-test.  For augmentation patients, scores on physical health and mental health were significantly worse, scores on the Rosenberg self-esteem scale were better, and there was no change on the Tennessee self-concept scores or body esteem scale. 59

Overall, these studies and their findings indicate that implant companies have yet to prove that implants objectively improve women’s quality of life, and 2-year studies suggest that most quality of life measures decline.[60]

The Hidden Costs

The initial surgery for breast implants is the first, but not the greatest expense for implant patients.  If silicone breast implants last approximately 7-10 years before breaking, replacement surgery will add greatly to the cost.  The implant itself may have a warrantee for free replacement, but the surgical and anesthesia costs are not free, nor are the costs of the medical facility.  These expenses may not be affordable for all implant patients, especially since the initial breast augmentation is often available on an installment plan, while additional surgeries often need to be paid for upfront.

Cosmetic surgery is not covered by health insurance, and problems resulting from cosmetic surgery are usually excluded from coverage.  In some states, major health insurance providers have refused to insure women with breast implants.  Some insurers have sold health insurance to women with implants, but charged them more, and some insurers have refused to cover certain kinds of illnesses for women with breast implants, or refused to cover any problems in the breast area.  For women who were diagnosed with diseases that were excluded, it would not matter if those diseases were unrelated to the implants.

What if a woman no longer wants breast implants?  Implants can be removed and not replaced, but the breast tissue stretches from the implant, and the breast is unlikely to be as attractive as it was before the implant surgery.[61] Women with leaking silicone implants often lose breast tissue as part of the removal surgery.  According to testimony presented at the October 2003 FDA meeting, this may result in surgery that is similar to a mastectomy.

Conclusions

In 1990, breast implants had been sold for more than 25 years but there were no published epidemiological studies or clinical trials.  There are now more than 100 studies of women with implants, most of them funded by Dow Corning, implant companies, or medical associations with a financial interest in the outcome.  These studies are persuasive in showing that breast augmentation does not dramatically increase the risk of diseases in the short-term.  A co-author of most of those studies, who served as a consultant to Inamed, argues that studies “with a mean follow-up of a decade and almost three decades of follow-up for the longest-term implant recipients” is “long enough.”[62], [63] However, there are numerous shortcomings in the studies he cites and co-authored, such as including many women whose implants were only a few months or a few years old at the time of the study, and therefore did not have the statistical power to draw meaningful conclusions about long-term safety.  The small number of women providing relevant long-term data is especially a problem when studying diseases such as cancer, scleroderma, and lupus which take years to develop and diagnose.  Careful scrutiny of the research indicates an increase in symptoms in many studies, but it is primarily in the studies where all the augmentation patients had implants for at least six years that increases in disease risks are statistically significant.  It is also notable that the independently funded studies tend to focus on women with implants for longer periods of time, and often show increased risks that are not apparent in the industry-funded studies.
References:


[1] ASPS 2012 Report of the 2011 Statistics, p. 6. American Society of Plastic Surgeons (ASPS), 2012. Available:  http://www.plasticsurgery.org/Documents/news-resources/statistics/2011-statistics/2011_Stats_Full_Report.pdf

[2] ASAPS 1997 Statistics on Cosmetic Surgery. American Society for Aesthetic Plastic Surgery (ASAPS), Inc., 1998. Available: http://www.surgery.org/sites/default/files/ASAPS1997Stats_0.pdf.

[3] The FDA’s Regulation of Silicone Breast Implants: A Staff Report Prepared by the Human Resources and Intergovernmental Relations Subcommittee of the House Government Operations Committee, December 1992. Available: http://implantawareness.com/PDF/FDAReg1.pdf.

[4] Harris G, “Implant Maker Hid Defects, Workers Said.” New York Times, May 22, 2005. Available: http://www.nytimes.com/2005/05/22/national/22implant.html?_r=1.

[5] Susan Dorsey. Testimony at the FDA Advisory Committee panel. August 23, 2011. http://www.breastimplantinfo.org/per_stories/susand.html.

[6] Food and Drug Administration. FDA Update on the Safety of Silicone Gel-Filled Breast Implants, Executive Summary. Released June 2011. http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/UCM260139.pdf

[7] Food and Drug Administration. Summary of Safety and Effectiveness Data for Saline Breast Implants. Released My 2000. http://www.accessdata.fda.gov/cdrh_docs/pdf/P990074b.pdf.

[8] General and Plastic Surgery Devices Panel Transcript, 2003. 14 October 2003; 231. Available:www.fda.gov/ohrms/dockets/ac/03/transcripts/3989T1.htm.

[9] Device Alert – Breast Implants: NovaGold. United Kingdom: Medical and Health Care products Regulatory Agency. Available: http://www.mhra.gov.uk/index.htm.

[10] Medicines and Health Care products Regulatory Agency. Available: http://www.mhra.gov.uk/index.htm.

[11] Laurance J, “Agonizing wait for 5,000 women told that their breast implants might leak and cause cancer.” The Independent, 7 June 2000.

[12] Device Alert: Trilucent (soya bean oil filled) breast implants. United Kingdom: Medical and Health Care products Regulatory Agency. Available: http://www.mhra.gov.uk/index.htm.

[13] Food and Drug Administration. FDA News Release: FDA approves new silicone gel-filled breast implant. Released March 9, 2012. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm295437.htm .

[14] United States Centers for Disease Control and Prevention. Occupational Health Guideline for Soluble Platinum Salts (as Platinum). At: < http://www.cdc.gov/niosh/docs/81-123/pdfs/0520.pdf>. Accessed  6 June 2012.

[15] “L’afssaps lance l’alerte aux prothèses mammaires défecteuses.” AFP, March 31, 2010. Available: http://www.lemonde.fr/societe/article/2010/03/31/l-afssaps-lance-l-alerte-aux-protheses-mammaires-defectueuses_1326644_3224.html.

[16] Macrae F & Randall C, “Thousands of British women in dangerous breast implants alert.” Daily Mail, June 18, 2010. Available: http://www.dailymail.co.uk/health/article-1287564/Thousands-British-women-dangerous-breast-implants-alert.html.

[17] Jones, Bryony. Breast Implant Scandal: What Went Wrong?. CNN. 27 January 2012. Available: http://www.cnn.com/2012/01/27/world/europe/pip-breast-implant-scandal-explained/index.html. Accessed 28 June 2012.

[18] Nagelin-Anderson, E & Zuckerman, D. Complications of Saline Breast Implants: What You Should Know Before You Decide on Augmentation. Available: http://www.breastimplantinfo.org/recon/ibrief-aug042003.html.

[19] Zuckerman D, Santoro E, Hudak N. Silicone Breast Implants: Illnesses and Complications, The Latest Research from Inamed’s Core Study. National Research Center for Women & Families. Washington: DC; 2003. Available:www.breastimplantinfo.org/what_know/oct03_summary.html

[20] 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.

[21] Brown SL, Middleton MS, Berg WA, et al. Prevalence of rupture of silicone gel breast implants revealed on MR imaging in a population of women in Birmingham, Alabama. American Journal of Roentgenology. 2000; 175: 1057-1064.

[22] Holmich L, Friis S, Fryzek J, et al. Incidence of silicone breast implant rupture. Archives of Surgery. 2003; 138: 801-6.

[23]http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/UCM269715.pdf

[24] Dr. Diana Zuckerman. Testimony to the FDA’s Advisory Panel Meeting on Breast Implants. Released August 23, 2011.

[25] Beekman WH, Feitz R, van Diest PJ, and Hage JJ. Migration of silicone through the fibrous capsules of mammary prostheses. Annals Plastic Surgery. 1997; 38: 441-445.

[26] Katzin WE, Centeno JA, Feng LJ. Pathology of lymph nodes from patients with breast implants: A histologic and spectroscopic evaluation. Modern Pathology. 2002; 15: 246A. (abstract).

[27] Adams ST, Cox J, GS Rao. Axillary silicone lymphadenopathy presenting with a lump and altered sensation in the breast: a case report. Journal of Medical Case Reports. 2009; 3: 6442.

[28] Dragoumis DM, Assimaki AS, Vrizas TI, Tsiftsoglou AP. Axillary silicone lymphadenopathy secondary to augmentation mammaplasty. Indiana Journal of Plastic Surgery. 2001 Jul-Dec; 43(2): 206-209.

[29] Hilts, Philip J. “Doctors Continuing to Inject Silicone Despite FDA Warnings, Agency Says. New York Times. Published February 2, 1992. http://www.nytimes.com/1992/02/02/us/doctors-continuing-to-inject-silicone-despite-fda-warnings-agency-says.html?pagewanted=all&src=pm

[30] Restrepo CS, Artunduaga M, Carrillo JA, Rivera AL, Ojeda P, Martinez-Jimenez S, Manzano AC, Rossi SE. Silicone pulmonary embolism:  report of 10 cases and  review of the literature. J Comput Assist Tomogr. 2009 Mar-Apr; 33(2):233-7.

[31] James SE, Tarr G, Butterworth MS, et al. Silicone in the sputum after rupture of a calf implant. Journal of the Royal Society of Medicine. 2001; 94:133-134.

[32] Miglioretti DL, Rutter CM, Geller BM, et al. Effects of breast augmentation on the accuracy of mammography and cancer characteristics. Journal of the American Medical Association. 2004; 291: 442-50.

[33] Brown SL, Todd JF, and Luu HD, Breast Implant Adverse Events during mammography: Reports to he Food and Drug Administration, Journal of Women’s Health 2004, 13: 371-378.

[34] Bondurant S, Ernster V, Herdman, R, eds. Safety of silicone breast implants. Washington, DC: Institute of Medicine; 1999.

[35] “Platinum found in women with implants.” The Associated Press, 26 August 2004; and Maharaj, SVM. Platinum and platinum species in explanted silicone gel breast prosthetic devices using IC-ICP-MS. Presented at the American Chemical Society, 22-26 August 2004.

[36] Food and Drug Administration. Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses. Available: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239996.htm.

[37] Brinton LA, Lubin, JH, Murray MC, et al. Mortality among augmentation mammoplasty patients: An update. Epidemiology. 2006; 17: 162-9.

[38] Brinton, LA, Lubin JH, Burich MC, et al. Cancer risk at sites other than the breast following augmentation mammoplasty. Annals of Epidemiology. 2001; 11: 248-256f.

[39] Koot VCM, Peeters PHM, Granath F, et al. Total and cause specific mortality among Swedish women with cosmetic breast implants: prospective study. British Medical Journal. 2003; 326: 527-528.

[40] Jacobsen PH, Holmich LR, McLaughlin JK Mortality and suicide among Danish women with cosmetic breast implants. Archives of Internal Medicine. 2004; 164: 2450.

[41] Brown SL, Pennello G, Berg WA, et al. Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women. Journal of Rheumatology. 2001; 28:996-1003.

[42] Aziz NM, Vasey FB, Leaverton PE, et al. Comparison of clinical status among women retaining or removing gel breast implants. Presented at the American College of Epidemiology,1998.

[43] http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_tab-1_fda-Inamed%20Panel%20Memo.pdf

[44] Brinton LA, Buckley LM, Dvorkina O et al. Risks of connective tissue disorders among breast implant patients. American Journal of Epidemiology. 2004; 180: 619-27.

[45] Silicone Breast Implants in Relation to Connective Tissue Diseases and Immunologic Dysfunction. Summary of Report of National Science Panel.  Available: www.fjc.gov/BREIMLIT/SCIENCE/summary.htm.

[46] Janowsky EC, Kupper LL, Hulka BS. Meta-analyses of the relation between silicone breast implants and the risk of connective tissue diseases. New England Journal of Medicine. 2000; 342:781-790.

[47] Friis S, Mellemkjaer L, McLaughlin JK, et al. Connective tissue disease and other rheumatic conditions following breast implants in Denmark. Annals of Plastic Surgery. 1997; 39: 1-8.

[48] Nyren O, Yin L, Josefsson S, et al. Risk of connective tissue disease and related disorders among women with breast implants: A nation-wide retrospective cohort study in Sweden. British Medical Journal. 1998; 316: 417-422.

[49] O’Hanlon TP. Restricted and shared patterns of TCR b-chain gene expression in silicone breast implant capsules and remote sites of tissue inflammation. Journal of Autoimmunity. 2000; 14: 283-293.

[50] Pukkala E, Kulmala I, Sirpa-Liis H, et al. Causes of death among Finnish women with cosmetic breast implants. Annals of Plastic Surgery. 2003; 51: 339-42.

[51] Le GM, O’Malley CD, Glaser SL et al. Breast implants following mastectomy in women with early-stage breast cancer: prevalence and impact on survival. Breast Cancer Research. 2005.

[52] Joiner TE. Does breast augmentation confer risk of or protection from suicide. Aesthetic Surgery Journal. 2003; 370-375.

[53] McLaughlin JK. Do Cosmetic breast implants cause suicide? Plastic and Reconstructive Surgery. 2003; 112: 1721-23.

[54] Sawrer DB, LaRosa D, Bartlett SP. Body image concerns of breast augmentation patients.Plastic and Reconstructive Surgery. 2003; 112: 83-90.

[55] Jacobsen PH, Hölmich LR, and McLaughlin JK. Mortality and suicide among Danish women with cosmetic implants. Archives of Internal Medicine. 2004; 164(22): 2450-55.

[56] Tweed A. Health care utilization among women who have undergone breast implant surgery.British Columbia Centre of Excellence for Women’s Health. Available: http://www.bccewh.bc.ca/publications-resources/documents/hcubreastimplants.pdf.

[57] Brinton LA. Do breast implants after a mastectomy affect subsequent prognosis and survival? Breast Cancer Research. 2005; 7: 61-63.

[58] Rowland JH, Desmond KA, Meyerowitz BE. Role of breast reconstructive surgery in physical and emotional outcomes among breast cancer survivors. Journal of the National Cancer Institute. 2000; 92: 1422-29.

[59] Food and Drug Administration. FDA Summary Panel Memo, P020056- Inamed Corporation Silicone-Filled Breast Implants.  Released March 2, 2005. http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_tab-1_fda-Inamed%20Panel%20Memo.pdf.

[60] Zuckerman D. Reasonably safe? Breast implants and informed consent. Reproductive Health Matters. 2010; 18(35): 94-102.

[61] See photo #3 at  http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/UCM064348.

[62] McLaughlin JK. Long-term follow-up of women with cosmetic breast implants: How long is long enough? Plastic and Reconstructive Surgery. 2004; 114: 801-03.

[63] McLaughlin JK, Lipworth L, Murphy DK, Walker PS. The safety of silicone gel-filled breast implants: a review of the epidemiologic evidence. Annals of Plastic Surgery. 2007 Nov; 59(5): 569-80.