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Breast Implants: A Research and Regulatory Summary

Diana Zuckerman, PhD, Elizabeth Santoro, RN, MPH, and Judith Faucette, JD

More than 313,000 women and teenagers underwent breast implant augmentation surgeries in 2018. In addition, approximately 102,000 women underwent breast implant surgery for reconstruction after mastectomy.[1] The popularity of breast implants has risen dramatically in the last 20 years, and is now more than three times the 1997 rate of 101,176.[2]
The 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.

As debate swirls over the risks of breast implants, 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 been 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 data to suggest that ALCL is more likely in implants with textured surfaces than with smooth surfaces.[36] The FDA is now requesting that physicians report cases of ALCL in women with breast implants to determine how great the risk is compared to women without implants and to talk with patients about the benefits and risks of textured-surface vs. smooth-surface implants.[64]

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 Disease

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 Scandinavian 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 warranty 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.

All NCHR articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff. 

 

References


[1] ASPS 2019 Report of the 2018 Statistics, American Society of Plastic Surgeons (ASPS), 2019. Available: https://www.plasticsurgery.org/documents/News/Statistics/2018/plastic-surgery-statistics-report-2018.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: https://wayback.archive-it.org/7993/20161024195702/http://www.fda.gov/ AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/ucm124757.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://wayback.archive-it.org/7993/20170113025556/http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm337828.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/complications-of-saline-breast-implants/

[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: https://breastimplantinfo.org/symptoms-silicone-gel-breast-implants-fdas-2003-inamed-implants/.

[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] https://jamanetwork.com/journals/jamasurgery/fullarticle/395179.

[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. Breast Implants: Update-Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Available: https://wayback.archive-it.org/7993/ 20170403231946/https://www.fda.gov/Safety/MedWatch /SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm547622.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] https://wayback.archive-it.org/7993/20170405094928/ https://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.  https://wayback.archive-it.org/7993/20161023020035 /http://www.fda.gov/ MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ ucm077303.htm.

[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.

[64] Food and Drug Administration. Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Released Summary of Safety and Effectiveness Data for Saline Breast Implants. Released March 2017. https://wayback.archive-it.org /7993/20170404175035/https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/ BreastImplants/ucm239995.htm.

 

 

Medicare Breast Implant Removal Policies by State


Click on your state (or territory) below to see it’s official Medicare policy on breast implant removal.

If your state/territory isn’t listed, it doesn’t have its own policy. You can look at this policy, which is usually borrowed by states that don’t have their own policy.  

Alabama

Alaska

American Samoa

Arizona

Arkansas

California

Colorado

Connecticut 

Delaware

District of Columbia

Florida

Georgia

Guam

Hawaii

Idaho

Illinois

Indiana

Iowa

Kansas

Kentucky

Louisiana

Maine

Maryland

Massachusetts

Michigan

Minnesota

Mississippi

Missouri

Montana

Nebraska

Nevada

New Hampshire

New Jersey

New Mexico

North Carolina

North Dakota

Northern Mariana Islands

Ohio

Oklahoma

Oregon

Pennsylvania

Rhode Island

South Carolina

South Dakota

Tennessee

Texas

Utah

Vermont

Virgin Islands

Virginia

Washington

West Virginia

Wisconsin

Wyoming

 

Beatrice R.


California

I am Beatrice R. I had hoped to be there in person, but my flight was canceled due to the hurricane. Thank you for showing this video instead.

I am currently a single mother, a photographer, and a multimedia consultant. I speak four languages and I was raised in Europe. I live in San Diego.

In 2005, I wanted a minor nipple procedure, to correct a cosmetic problem caused by breastfeeding. Two surgeons advised implants. Dr. Minniti in Beverly Hills convinced me that the implants were safe and that once they were in, I would never have to worry about them for the rest of my life, unless of course I had a capsule, and in that case he’d break it, a minor office visit.

The study documentation was presented to me for signing for the first time at the pre-op. appointment. I had no time to read the over a dozen pages, but I was reassured that all women were part of the trial and it was a mere formality. This is the Adjunct study referred to by the FDA.

Please note that no one ever followed up at any time, despite my sending many emails regarding my ailments to both FDA and Mentor.

Because I am the athletic type, I chose small implants. Without my consent, the surgeon implanted me with the whopping 450cc, about twice the size I wanted. I was a teacher and felt ridiculous and deformed after the surgery. I stopped going to the gym because even with two sports bras I could no longer run and men were obsessing with my chest size. My chest muscles were deformed because they were cut deeply to adjust to these enormous implants. I can never do any sports that put strain on my chest, which is most sports.

This is a point I’d love the FDA to pay attention to, as surgeons may use implants that are not the ones agreed on, but these details are not in writing.

The larger implant size was a problem, but not as big as a problem as the severe immune reaction I had to the implants.

Within days after the surgery, the skin on my arms and forearms felt very sore and sensitive, and a strange pain seemed to come and go at different locations in my body. Ankles and knuckles were the worst. The pain would take my breath away, and never stopped, day or night. The pain killers, anti inflammatory and muscle relaxant, prescriptions, nothing helped.

Nights were exhausting, trying to get comfortable and get more than 3 hours of sleep at a time. I had to lay down in bed either on my back or sideways and having to rotate continuously because the arms would go numb. After only a few hours of sleep I’d be awake and pacing around at home.

I had a burning sensation on my upper lip at all times. My eyes were dry in the morning and feeling like sand and very painful. Some days one eye would go completely blurry and a few hours later it seems like I had perfect vision. My hair started to fall off and I gained 15 pounds in just a few months.

I saw many specialists, who ran every possible test. One year after getting the implants I had a sinus infection that developed into bronchitis and lasted for months. I did three rounds of antibiotics and developed staph on my neck, which triggered an asthma attack and sent me to the emergency room. This is all documented with my doctors. The school wanted to fire me because I kept missing work.

One day the pain in my left ring finger was so strong that I had to go to the emergency room to get X-rays. They couldn’t figure out what was wrong. At times, pain would shoot in my right foot, and this was very dangerous while I was driving.

At times the gums in my mouth were pulsating at the root of my teeth. It felt like removing teeth would be relief. My labia were painful, my feet arches would get stiff and I’d feel a throbbing pain at the joints. Then the symptoms got worse. My vertebrae started to make loud popping noise upon waking up.

My immune system was completely out of control but none of the doctors could figure out what to do to help me. Then the brain. Driving home from L.A. one night, I no longer knew if I was in Italy, in France, or in the United States. This was incredibly scary, I was losing my mind. Everything was getting worse. Soon, I had to systematically walk up and down every row of cars in a parking lot to find where I had parked.

Over the next 20 months, I visited 12 specialists and met with three surgeons to discuss getting my implants removed. Waking up in the morning, I would look at my front door and feel completely overwhelmed, in tears, by everything I needed to do to get ready for work — simple steps as showering and getting dressed, brushing my hair, my teeth, and out into the world. This was like climbing the Kilimanjaro.

I felt like a woman in her 80s, at the end of her life. A vaginal ultrasound revealed I had three ovarian cysts, two fybroids and a mass that had to be operated right away. So now I had to postpone getting my implants removed until that surgery was completed.

Fearing the worse, I made a video on Youtube telling my unfortunate guinea pig experience, for other women to find support and stay away from the damaging silicone. To my surprise dozens and dozens of women responded to my video. Women from all over the country and the world told me of the exhausting suffering, health deterioration and complications, lack of funds to see doctors and run tests, and the frustration of their families not being able to help them.

I am angry that the FDA allowed these potentially dangerous implants on the market, with studies that were not really aimed at collecting scientific evidence of safety. The silicone gel includes heavy metals and potentially dangerous chemicals, and each label should include all the ingredients, just like with the food industry. The FDA should also require that the labels should also include examples of the patient’s potential expenses for lab testing, the loss of time from work, and harm to one’s quality of life.

At today’s meeting you are supposed to decide what research needs to be done. The FDA has stated that serious health problems are rare with breast implants, but I can tell you that is not true. Based on my experiences, neither the plastic surgeons nor the implant companies can be trusted to do this research objectively. Certainly, neither reported my serious health problems to the FDA.

Beatrice submitted her story to be read at the FDA Advisory Committee Meeting on breast implants in August 2011.

Breast Implants and Autoimmune or Connective Tissue Disease: Is There Proof?

Patricia Lieberman, PhD and Diana Zuckerman, PhD, National Center for Health Research

Do breast implants cause the symptoms that women refer to as “breast implant illness?” Joint pain. mental confusion (“brain fog”), exhaustion, hair loss, dry eyes, depression, and “flu like symptoms that never go away” are just a few of the commonly reported health problems among women with implants that seem to be caused by connective tissue or autoimmune disorders. However, plastic surgeons, breast implant manufactures, and others continue to say that breast implants are “proven safe” and that there is no evidence that these symptoms are caused by breast implants.

These questionable safety claims date back to a meta-analysis of 20 studies, which was published in the New England Journal of Medicine in 2000, and was intended to determine whether breast implants cause connective-tissue diseases. This was essentially the same meta-analysis that was conducted by Judge Pointer’s scientific panel during the law suits against breast implant manufacturers.. The authors of the meta-analysis concluded that the studies show no association between silicone breast implants and connective-tissue disease. A careful review of the studies that were included in the meta-analysis reveals that hose studies have a number of flaws, however. The accuracy of any meta-analysis depends on the quality of the studies included in that analysis. We scrutinized these 20 studies in 2000 and pointed out their shortcomings as follows:

  • Five of 20 studies cited were not published in peer-reviewed journals. Instead they were papers presented at scientific meetings or unpublished doctoral dissertations. There was therefore limited information on methodology available to evaluate the validity of the study designs.
  • The studies do not provide a comprehensive evaluation of diseases among breast implant patients. Most evaluate a few connective-tissue diseases, including such rare diseases as scleroderma. Most do not evaluate the “atypical” connective-tissue disease symptoms or fibromyalgia-type symptoms that many patients report.
  • Even for the illnesses that they evaluate, the studies have limitations. In order to conduct an accurate study of implant patients’ health, patients should undergo a comprehensive medical exam. In contrast, most of these studies relied on medical records, which might omit vague symptoms that would be reported in the early stages of disease. Several studies relied on self-report, but only the one that found a significant risk due to implants was criticized because patients might exaggerate their health problems. In contrast, studies that determined whether women had implants based on self-report were included and not criticized as biased, even though it would be expected that some women would fail to mention that they have implants. This failure to report implants is especially likely when information was gathered in person or on the telephone, rather than in a questionnaire.
  • Several of the studies relied on hospital records. Very few implant patients would have been hospitalized for their symptoms, since most health problems that implant patients have reported do not require hospitalization.
  • The studies included women who had implants for a short period of time, such as a few months or years. If implants cause connective-tissue diseases, it would be expected that the disease would develop over a period of years. Diseases might also be more likely after a silicone gel implant breaks, which usually occurs after 7-10 years. Therefore, a well-designed study would include women who had implants for at least 7-10 years, not an average of 7-10 years.
  • Many of the studies do not evaluate the safety of implants for mastectomy patients, and therefore the results may not be relevant to them.
  • Many of the samples are too small to study rare diseases, and thus, have limited power to detect increases in the rates of disease, even increases as large as 50-100 percent.
  • Older implants (from 1964-75) were made of a thicker silicone shell than newer implants. Those implants were less likely to “bleed” silicone through the shell or to break. Therefore, studies with women who had implants for a wide range of years would not be expected to show a “dose” response, and studies with women having implants for an average of 7-10 years often include many women with implants for very short periods and women with these thicker, potentially less damaging, implants. That minimizes the likelihood of results showing significant risks from implants.
  • In at least one of the studies, women were included in study even if they had their breast implants removed shortly after they got them. It is impossible to tell from that study how long the women had breast implants. The other studies do not mention whether women who were identified by medical records as having implants still had them years later. Those omissions potentially bias the findings because women who had implants removed do not have the same amount of exposure as women who have implants continuously.

Cohort Studies

Cohort studies compare women with breast implants to a group of women who are similar in terms of age, race, and health who did not have breast implants.

A Clinical Study of the Relationship Between Silicone Breast Implants and Connective Tissue Disease  (Edworthy et al. 1998)1

Number of implant recipients: 1576
Number of controls: 727
Does the study include mastectomy patients receiving implants? NO
Diseases studied: Any classic connective-tissue disease including rheumatoid arthritis, lupus, scleroderma, and Sjogren’s syndrome.
Minimum length of time with implants included in study: Unclear
Average length of time with implants: 13.5 years

Additional notes: Women with breast implants were 44% more likely to have a diagnosis of rheumatoid arthritis (relative risk: 1.44). That difference was not statistically significant. When interviewed about their health, women with implants were significantly more likely to have difficulty solving thought problems, have numbness in their extremities, muscle pain, headache, and hand pain. However, those symptoms were not included in the meta-analysis. This study relied on medical records. The authors did not question or examine patients directly.

Connective Tissue Disease and other Rheumatic Conditions Following Breast Implants in Denmark (Friis et al. 1997)2

Number of implant recipients: 2,570
Number of controls: 11,023
Does the study include mastectomy patients receiving implants? YES
If so, how many? 1,435 of 2,570
Were mastectomy patients analyzed separately from augmentation patients? YES
Diseases studied: Any classic connective-tissue disease, including lupus, Sjogren’s syndrome, rheumatoid arthritis, and scleroderma. Also looked at “other and ill-defined” rheumatic conditions.
Minimum length of time with implants included in study: To be in this study a woman could have had implants for less than one year.
Average length of time with implants: 7.2 years for reconstruction group, 8.4 years for augmentation group.

Additional notes: Only women who were hospitalized for connective-tissue disease were categorized as ill, not outpatients. According to the authors, the study had only limited power to detect an increased risk of any specific connective-tissue disease. The control group consisted of women who had breast reduction surgery, or mastectomy without receiving implants. Although the difference was not significant, the rate of scleroderma, lupus, and Sjogren’s syndrome in mastectomy patients receiving implants was 30% higher than expected. The authors found an increase in rheumatic complaint in all of the groups and therefore concluded that breast surgery increases the risk of connective-tissue disease, and that the implants themselves do not cause connective-tissue disease. The authors did not question or examine patients directly.

Risks of Connective-Tissue Diseases and Other Disorders after Breast Implantation (Gabriel et al. 1994)3

Number of implant recipients: 749
Number of controls: 1498
Does the study include mastectomy patients receiving implants? YES
If so, how many? 125 of 749
Were mastectomy patients analyzed separately from augmentation patients? YES
Diseases studied: Any classic connective-tissue disease, including lupus, Sjogren’s syndrome, rheumatoid arthritis, and scleroderma. Also looked at other disorders such as Hashimoto’s thyroiditis, cirrhosis, sarcoidosis, and cancer.
Minimum length of time with implants included in study: Women in this study could have had implants for less than one year.
Average length of time with implants: 7.8 + 5.5 years

Additional notes: Women with breast implants had a 35% higher rate of arthritis, which was not statistically significant (relative risk: 1.35). Morning stiffness was 81% higher for implant patients, which was significantly higher than for women without implants (relative risk: 1.81). The authors estimated that they would need to have studied 62,000 women with implants for an average of 10 years to detect a 100% increase (or less) in rare diseases such as scleroderma. This study relied on medical records. The authors did not question or examine patients directly.

Silicone Breast Prostheses and Rheumatic Symptoms: a Retrospective Follow Up Study (Giltay et al. 1994)4

Number of implant recipients: 235
Number of controls: 210
Does the study include mastectomy patients receiving implants? YES
If so, how many? Approximately 56 of 235
Were mastectomy patients analyzed separately from augmentation patients? NO
Diseases studied: Rheumatic complaints, use of anti-rheumatic drugs, and medical consultations regarding rheumatic symptoms. For those reporting rheumatic symptoms, a rheumatologist made an assessment of the likelihood of a rheumatic disease.
Minimum length of time with implants included in study: Two years
Average length of time with implants: 6.5 years with a range of two to 14 years

Additional notes: Women with silicone breast implants reported significantly more rheumatic complaints than controls, but there was no evidence of increased prevalence of common rheumatic diseases, such as fibromyalgia, rheumatoid arthritis, or Sjogren’s disease. If mastectomy patients are more vulnerable to diseases than augmentation patients, the results may not accurately describe the health risks for mastectomy patients, since they were a small minority of the women in the study. The control group consisted of women who had an unspecified cosmetic procedure that did not include silicone products. The study relied on questionnaires completed by the patients. The authors did not question or examine patients directly.

Self-Reported Breast Implants and Connective-Tissue Diseases in Female Health Professionals (Hennekens et al. 1996)5

Number of implant recipients: 10,830
Number of controls: 384,713
Does the study include mastectomy patients receiving implants? YES
If so, how many? 18% of 10,830
Were mastectomy patients analyzed separately from augmentation patients? YES
Diseases studied: Any classic connective-tissue disease including lupus, Sjogren’s syndrome, rheumatoid arthritis, and scleroderma. Also included mixed connective-tissue disease.
Minimum length of time with implants included in study: To be in this study, a woman could have had implants for one year.
Average length of time with implants: Not stated, but the authors analyzed the women in three groups: up to four years, five to nine years, and 10 or more years after receiving implants and showed no increased risk with increased duration of exposure.

Additional notes: Implant patients had a 25% higher rate of connective-tissue disease, whether they were reconstruction or augmentation patients (relative risk: 1.25). This was statistically significant and the researchers concluded that there is a small increased risk of connective-tissue disease among women with implants. Although it is a cohort study, this study was analyzed with case-control and cross-sectional studies in the meta analysis because information about the disease and the patient’s exposure to silicone breast implants was gathered at the same time. The study relied on questionnaires completed by the subjects, who were health professionals. The authors did not question or examine the women directly.

Risk of Connective Tissue Disease and Related Disorders Among Women with Breast Implants: A Nation-Wide Retrospective Cohort Study in Sweden (Nyren et al. 1998)6

Number of implant recipients: 7,442
Number of controls: 3,353
Does the study include mastectomy patients receiving implants? YES
If so, how many? 3,942 of 7,442
Were mastectomy patients analyzed separately from augmentation patients? YES
Diseases studied: Hospitalizations for classic connective-tissue disease including lupus, Sjogren’s syndrome, rheumatoid arthritis, and scleroderma. Also studied hospitalizations for related diseases.
Minimum length of time with implants included in study: One month
Average length of time with implants: Six years for reconstruction patients, 10.3 years for augmentation patients.

Additional notes: Only women who were hospitalized for connective-tissue disease were categorized as ill, not outpatients. The authors acknowledge that the sample size was too small to draw conclusions about links between breast implants and rare diseases they studied, such as scleroderma. The control group consisted of women who had breast reduction surgery. Both groups who had breast surgery had slightly higher than expected rates of connective-tissue disease. This study relied on hospital records. The authors did not question or examine patients directly.

Silicone Gel-Filled Breast Implants and Connective Tissue Diseases (Park et al. 1998)7

Number of implant recipients: 317
Number of controls:
419
Does the study include mastectomy patients receiving implants? YES
If so, how many? 207 of 317 implanted women
Were mastectomy patients analyzed separately from augmentation patients? YES
Diseases studied: Signs and symptoms of connective-tissue disease, such as a antinuclear antibodies, rheumatoid factor, joint pain, fatigue, Raynaud’s syndrome, etc.
Minimum length of time with implants included in study: Not specified
Average length of time with implants: Six years for reconstruction patients, five years for augmentation patients.

Additional notes: Because the sample size was so small, the authors acknowledge that a health risk would have to exceed 320% for reconstruction patients and 1600% for augmentation patients in order to be statistically significant. In addition, approximately half of the women had implants for less than six years. Because of these shortcomings, this study does not provide useful information. The study included two controls for each implantation patient. Half of the controls were maternity patients and half were outpatients from the plastic surgery department. The authors did not specify what types of procedures the plastic surgery controls received. The study subjects were interviewed and received a medical examination.

Silicone Breast Implants and the Risk of Connective-Tissue Diseases and Symptoms (Sanchez-Guerrero et al. 1995)8

Number of implant recipients: 1,183
Number of controls: 86,318
Does the study include mastectomy patients receiving implants? YES
If so, how many? 525 of 1183 for cancer or prophylaxis
Were mastectomy patients analyzed separately from augmentation patients? NO
Diseases studied: Any classic connective-tissue disease, including lupus, Sjogren’s syndrome, rheumatoid arthritis, and scleroderma. Excluded women with milder or atypical cases of connective-tissue disease.
Minimum length of time with implants included in study: One month
Average length of time with implants: 9.9 + 6.4 years

Additional notes: According to the authors, the study does not exclude small health risks of implants that would be of public health importance. The study was designed to minimize “reporting bias” of health problems by implant patients by excluding any health problems diagnosed after May 1990, which was six months before the major media coverage of implant problems. They did not minimize bias in the opposite direction; for example, they included women who only had implants for one month. Also, they should have excluded women who reported receiving breast implants from 1952 to 1961, since breast implants had not yet been invented. Including these women and their inaccurate statements increased the average years of implantation. The study relied on questionnaires completed by the subjects, who were health professionals. The authors did not question or examine the women directly, although, for a random sample of 100 women, they verified whether the women had breast implants by looking at her medical records.

Incidence of Autoimmune Disease in Patients after Breast Reconstruction with Silicone Gel Implants Versus Autogenous Tissue: A Preliminary Report (Schusterman et al. 1993)9

Number of implant recipients: 250
Number of controls: 353
Does the study include mastectomy patients receiving implants? YES, all were mastectomy patients.
Diseases studied: Patients were considered to have rheumatic disease if they had been seen by a physician who made the diagnosis on clinical grounds with corroborating laboratory evidence and had prescribed therapy.
Minimum length of time with implants included in study: 10 months
Average length of time with implants: Less than 2.5 years

Additional notes: Length of follow-up was too short to be meaningful. The authors state that the report must be considered preliminary because the onset of autoimmune disorders could occur two to 21 years after implantation. Also, if Friis and Nyren are correct, any breast surgery patient would be at increased risk for an autoimmune disease.

The Health Status of Women Following Cosmetic Surgery (Wells et al. 1994)10

Number of implant recipients: 222
Number of controls: 80
Does the study include mastectomy patients receiving implants? NO
Diseases studied: Study looked at the incidence of 23 symptoms and the diagnosis of connective-tissue disease such as rheumatoid arthritis, lupus, scleroderma, and Raynaud’s disease.
Minimum length of time with implants included in study: Not specified
Average length of time with implants: 4-5 years

Additional notes: The authors compared women who had breast implants to those who had liposuction, nose jobs, or eyelid lifts. The average age of women getting breast implants was almost 10 years younger than those getting the other cosmetic procedures. Tender and swollen glands under the arm were more likely in implanted women. Symptoms that were more frequent in implanted women but did not achieve statistical significance were: easily tired, muscle pain, swollen and tender glands in the neck, change in hand color with cold, weight gain, swollen and painful joints, and general stiffness. The authors acknowledged that the small sample size could explain why the differences did not achieve statistical significance. The authors reported no cases of scleroderma or lupus. Arthritis was present in 5% of implanted women and 3% of controls. One implanted woman reported Raynaud’s disease. The study relied on questionnaires completed by the subjects. The authors did not question or examine the women directly.

Case-Control or Cross-Sectional Studies

These studies compare women suffering from a particular disease (cases) to those who are healthy (controls) and determine whether breast implants are more common in the ill women.

The Epidemiology of Scleroderma Among Women: Assessment of Risk from Exposure to Silicone and Silica (Burns et al. 1996)11

Number of cases: 274
Number of controls: 1184
Diseases studied: Scleroderma

Additional notes: This study revealed no increased likelihood that women with scleroderma reported having silicone breast implants. However, women with scleroderma were significantly more likely to report other exposures to silicone. Women with scleroderma were identified by contacting rheumatologists, hospitals, and a scleroderma support group. They were then interviewed on the telephone to determine past exposure to silicone or silica.

Silicone Breast Implants and Risk for Rheumatoid Arthritis. (Dugowson et al. 1992)12

Number of cases: 300
Number of controls: 1,456
Disease studied: Rheumatoid arthritis

Additional notes: This study was a non-peer-reviewed abstract from a scientific meeting. One case and 12 controls had breast implants before diagnosis. There was no increase in the likelihood that rheumatoid arthritis patients reported having breast implants. The study was based on a questionnaire sent to women with rheumatoid arthritis and age-matched controls asking if they had breast implants.

Scleroderma and Augmentation Mammoplasty — A Casual Relationship? (Englert et al. 1994)13

Number of cases: 286
Number of controls: 253
Disease studied: Scleroderma.

Additional notes: This study found no increased likelihood that women with scleroderma reported having breast implants, although the authors acknowledged that the study lacked the power to detect an increased risk of lower than 150-200%. The study was based on a telephone questionnaire. The information on whether the women had implants was self-reported to the interviewer on the telephone and unverified.

Breast Implants, Rheumatoid Arthritis, and Connective Tissue Diseases in a Clinical Practice (Goldman et al. 1995)14

Number of cases: 721
Number of controls: 3,508
Disease studied: Rheumatoid arthritis and other connective-tissue disease.

Additional notes: Instead of comparing sick women to healthy women, all of the women in this study were patients in a rheumatology practice. The authors found no increased likelihood that women with rheumatoid arthritis and other connective-tissue disease reported having breast implants. The women who had breast implants were significantly younger than those who did not have implants. The authors acknowledged that since the study took place in the practice of a single clinician, there is the potential for referral or selection bias. Also, many patients were seen for only a single assessment (Fewer than half were seen in that practice for more than one year). Additionally, the author acknowledged that losing women to follow up could have resulted in a selection bias. The authors relied on medical records to determine who had breast implants.

Lack of Association Between Augmentation Mammoplasty and Systemic Sclerosis (Scleroderma) (Hochberg et al. 1996)15

Number of cases: 837
Number of controls: 2,507
Disease studied: Scleroderma.

Additional notes: The study revealed no difference in the likelihood that women with scleroderma reported having breast implants, although the authors noted that 1,000 cases and 3,000 controls would be needed in order to detect a two-fold increase in scleroderma. For women with scleroderma, information about whether she had breast implants was gathered using a self-administered questionnaire. Controls were given the identical questionnaire over the telephone. For both groups, the information was unverified.

Reply to Letter: Epidemiology of Scleroderma Among Women: Assessment of Risk from Exposure to Silicone and Silica (Lacey et al. 1997)16

Number of cases: 189
Number of controls: 1,043
Disease studied: Scleroderma

Additional notes: This study was briefly described in a letter in the Journal of Rheumatology. It was not peer-reviewed. In a telephone interview, researchers asked who were diagnosed with scleroderma about their exposure to silicone (including silicone gel breast implants) and compared the likelihood with similarly aged controls. One case and 10 controls reported having silicone breast implants. There was no increased likelihood that women with scleroderma reported having breast implants.

The Association Between Silicone Exposure and Undifferentiated Connective Tissue Disease Among Women in Michigan and Ohio (Laing et al. 1996)17

Number of cases: 206
Number of controls: 2,239
Disease studied: Undifferentiated connective-tissue disease

Additional notes: This study was a non-peer-reviewed abstract from a meeting. In a telephone interview, researchers asked women with undifferentiated connective-tissue disease about their silicone exposure and compared the exposure with similarly aged controls. Although there were no raw data in the abstract, the authors state that women with undifferentiated connective-tissue disease were significantly more likely to report having all types of implanted devices, including breast implants. For silicone breast implants, the adjusted odds ratio was elevated, but did not achieve statistical significance (women with undifferentiated connective-tissue disease were 127% more likely to report having silicone breast implants than controls). Women with undifferentiated connective-tissue disease were significantly more likely to report having other types of devices containing silicone, such as, internal fixation devices, artificial joints, pacemakers, non-CNS shunts or catheters.

Breast Silicone Implants and Risk of Systemic Lupus Erythematosus (Strom et al. 1994)18

Number of cases: 133
Number of controls: 100
Disease studied: Lupus

Additional notes: The study did not detect an increased likelihood that women with lupus had breast implants, although the small number of cases and controls severely limited the statistical power of this study. Only one woman in the study reported that she had breast implants. Information was gathered by telephone interview.

A Population-Based Case-Control Study of Risk Factors for Connective Tissue Diseases (Teel et al. 1997)19

Number of cases: 427
Number of controls: 1577
Disease studied: All connective-tissue diseases

Additional notes: Non-peer-reviewed doctoral dissertation. No information available.

Silicone Breast Implants and the Risk of Fibromyalgia and Rheumatoid Arthritis (Wolfe et al. 1995)20

Number of cases: 1,270
Number of controls: 1,134
Disease studied: Compared women with rheumatoid arthritis and fibromyalgia (though fibromyalgia data not included in meta-analysis) to women with osteoarthritis and healthy women.

Additional notes: This study was a non-peer-reviewed abstract from a meeting. It compared 533 patients with fibromyalgia and 637 with rheumatoid arthritis to 479 with osteoarthritis and 655 women from the general population. Only fourteen women reported having breast implants in the study. Women with fibromyalgia or rheumatoid arthritis were no more likely to report having silicone breast implants than controls. The information on whether the women had implants was self-reported and unverified. Patients were asked to fill out questionnaires and controls (healthy women) were questioned on the telephone.

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.

Breast Implants and Mammography: What We Know and What We Don’t Know

Elizabeth Santoro, RN, MPH, National Center for Health Research

There has been a lot of attention given to mammography screening. Some of this information has been confusing to women—at what age should I first have a mammogram, how frequently should I have repeat mammograms, and are mammograms even effective? These are questions that women both with and without breast implants have been trying to understand. Despite this confusion, the U.S. Preventive Services Task Force recommends screening every two years for women ages 50  to 74 who have an average risk of breast cancer. Women at high risk because of family history, BRCA gene mutations, or other reasons should discuss a screening schedule with their doctor. But, what does this mean for women who have breast implants? Are women with breast implants faced with different risks when undergoing mammography screening? will women with implants require special considerations during the procedure? A study by FDA scientists helps to answer these questions.

What did the Study Show?

A study by FDA scientist Dr. S. Lori Brown and colleagues describes adverse events that were reported to the FDA related to breast implants and mammography screening.21 The authors found 66 adverse events that were reported as either occurring during the mammogram or involving breast implants interfering with the mammogram. Forty-one reports of either silicone and saline breast implants- – almost two out of three reports– pertained to ruptures that were suspected as happening during mammography. The other 25 reports included delayed breast cancer detection, inability to perform the mammogram due to capsular contracture or because of fear that the implant would rupture, and pain/soreness during and after the procedure.

Description of the Study

This study examined data from the Manufacturer and User Facility Device Experience (MAUDE) database. This FDA database collects mandatory or voluntary reports of medical device adverse events from physicians, breast implant manufactures, consumers, and others. The reports were received between June 1992 and October 2002 for events that occurred between June 1972 and June 2002. The mean age of the implant was 14.5 years, and ranged from 2-29 years.

The use of the MAUDE database has limitations. There were multiple sources that contributed to the database, and the FDA does not verify the information that is provided. Therefore, the FDA cannot guarantee that the information is accurate and complete. Another problem is under-reporting of adverse events, since patient and physician reporting is voluntary. It is well-documented that the vast majority of problems arising from medical products are not reported to the FDA. As a result of these shortcomings, these data cannot be used to calculate the number of new adverse events expected for a given number of people in a defined time period.

Key Implications of the Studies on Implants and Mammograms

Potential Implant Rupture

It has been previously reported by the FDA that all implants will eventually break, and that most women who have implants for ten years or longer will have at least one broken implant.22 The risk of breast implant rupture is known to increase as the implant ages. A study by Holmich and colleagues suggested that during the first ten years a woman has implants, most implants do not break, between 11-20 years most will break, and by the time they are more than 20 years almost all have broken.23

Women with implants have been told that mammography is safe for them, but the results of this latest FDA study suggest that the risk of rupture can be exacerbated by mammography.

Brown and her colleagues also reviewed the published research on implant rupture during mammography and found an additional 17 cases reported in medical journals. According to the American Society of Plastic Surgery, approximately half of the women who get breast implants are in their 20’s or early 30’s,24 which means that the implants are already broken or vulnerable by the time these women are old enough for screening mammograms.

Mammography may therefore increase the risk of a rupture earlier in the typical lifespan of implants, and the squeezing involved in mammography probably increases the risk of leakage in implants that are already ruptured. The potential risk of rupture or leakage needs to be weighed against the benefits of mammography by each individual woman. For women who are concerned about breast cancer, knowledge of mammography problems might discourage women from getting breast implants, or encourage them to have their implants removed and not replaced. Current guidelines encourage women with breast implants to have regular mammograms provided that the technician knows the woman has implants prior to the procedure and that special techniques are utilized.25 In light of this research, those guidelines need to be reconsidered, especially for women with silicone gel breast implants, where leakage can cause permanent disfigurement and has unknown health risks.

Delayed Breast Cancer Detection

Breast implants can interfere with the detection of breast cancer, because the implants can obscure the mammography image of a tumor. Implants therefore have the potential to delay the diagnosis of breast cancer. Although mammography can be performed in ways that minimize the interference of the implants, research by Miglioretti and colleagues indicated that even so 55% of breast tumors were missed, compared to 33% of tumors for women without implants.26 In fact, a study found that women tend to be diagnosed with breast cancer at a later stage if they have breast implants than if they don’t, probably because their mammograms were less accurate.27 A delayed diagnosis could necessitate more radical surgery: a cancer that could have been treated at an earlier stage with breast-sparing treatments, such as lumpectomy, may instead require a mastectomy.28 29 A delay in diagnosis could also potentially result in death, and there is evidence that women with breast implants who develop breast cancer do not live as long as other breast cancer patients.7 Miglioretti and colleagues also found that among newly diagnosed breast cancer patients who did not have any symptoms, the augmented women had larger tumors than those who did not have implants.7 However, there is no evidence that implants cause breast cancer.

Avoidance of Mammography

This study also found that implants sometimes make it impossible to perform a mammogram. This can happen for two reasons. First, conditions such as capsular contracture, where the scar tissue around the implant tightens and causes the breast to become hard and misshapen, can make it very difficult or even impossible to perform the mammogram.30 31 The compression of the breast that is required in order to perform the mammogram can be extremely painful if there is capsular contracture, and in some cases the hardness of the breast makes it impossible to compress the breast for the mammogram. Some women avoid getting mammograms because they are afraid of rupture and the latest research indicates that this is a reasonable concern.

Biomaterials testing of breast implants indicates that implants should only break under the most traumatic circumstances, and yet implants break for no apparent reason, as well as under pressure from mammograms.32 It is difficult to know how much risk a mammogram increases the risk of rupture since so little is understood about why implants break and under what circumstances.

What Does this Mean for Women?

Women considering breast implants and women with breast implants need to be informed consumers, and that includes knowing about the problems that arise from having mammograms with breast implants. This is true for all women, but especially breast cancer patients who may use implants on a healthy breast so that it will match the reconstructed breast after a mastectomy. (Detection of cancer in the reconstructed breast is unlikely to be a problem because the risk of cancer in that breast is so small). Since breast cancer survivors are at greater risk for breast cancer in the breast that was not removed, compared to women who have not had breast cancer, survivors should have regular mammograms of the surviving breast, and need to know the risks.

Women with breast implants and those considering breast implants need to know that they will have a different mammography experience than women without implants, since standard techniques for compression and imaging are ineffective with implants. The special techniques used will push the implant back to try to move it out of the way, and extra views will be taken. Even so, mammograms performed on women with implants will still miss more tumors than is typical of mammograms for women who do not have implants.7 33 In addition, women with implants should expect that mammography will require more views and take longer, thus costing more and exposing them to increased levels of radiation. Unfortunately, the most common problem, capsular contracture, can make mammography more painful, less accurate, or even impossible to perform. In such cases other, more expensive tests, such as an MRI or ultrasound, may be required.

Women also need to understand that even if breast implants do not cause contracture or other problems, they will still interfere with mammography and mammograms might still cause rupture and leakage.

The bottom line is that women considering breast implants and those who already have them need to be informed about potential problems with mammography so that they can make the decisions that will help them reduce the risk of breast cancer and avoid the problems that arise with implant breakage and leakage.

 

Symptoms and Complications from Silicone Gel Breast Implants FDA’s October 2003 Summary of Research on Inamed Implants

Diana Zuckerman, PhD, Elizabeth Santoro, RN, MPH, and Nicole Hudak, The National Center for Health Research

On October 14-15, 2003, the FDA held a public meeting to discuss Inamed’s research on their silicone gel implants. The company is asking the FDA to approve their implants as safe and effective, but the company’s own research shows substantial complication rates and worrisome increases in symptoms for women using their implants. This issue brief is based on the FDA’s analysis of the research by Inamed.

Augmentation Patients

There were 494 augmentation patients enrolled in Inamed’s “core study” of silicone breast implants. Ninety percent of these 494 patients participated in follow-up after two years, and 81% completed follow-up after three years.

Complications after Three Years with Implants

Graph of Complication Rates after Three Years for Augmentation Patients
Source: FDA’s slide # 39
* Baker III or IV capsular contracture is a painful condition where scar tissue around the implant tightens, thus causing the breast to become firm, hard, and distorted.

Symptoms before Implants vs. Two Years after Implants

The augmentation patients in the “core study” were asked about numerous health symptoms both before they were implanted and after two years with silicone gel breast implants. Overall, there were substantial increases in the number of augmentation patients reporting fatigue, pain, joint problems, and other symptoms — in some cases, the numbers tripled from before surgery to two years later.

Table of Augmentation Patients Symptoms Before Implants vs. Two Years after Implants

Source: FDA’s slide # 45

Reconstruction Patients

Complications after Three Years with Implants

There were 221 breast cancer reconstruction patients enrolled in the “core study” of silicone gel breast implants. Ninety-five percent of these 221 patients participated in follow-up after two years but many had not yet completed three years when the analyses were completed.

Graph of Complication Rates after Three Years for Reconstruction Patients

Source: FDA’s slide # 49
* Baker III or IV capsular contracture is a painful condition where scar tissue around the implant tightens, thus causing the breast to become firm, hard, and distorted.
** Necrosis is a painful and disfiguring condition where the skin or tissue dies

Symptoms before Implants vs. Two Years after Implants

The reconstruction patients in the “core study” were asked about numerous health symptoms both before they were implanted, and after two years with silicone gel breast implants. Overall, there were substantial increases in the number of reconstruction patients reporting joint pain, neurological symptoms, hair loss, rashes, and morning stiffness.

Symptoms of Reconstruction Patients before vs. Two Years after Implant
Source: FDA’s slide # 55

Revision Patients 

Complications after Three Years with Implants

There were 225 revision patients enrolled in the “core study” of silicone gel breast implants. These women had new breast implants that replaced problem implants, and their complication rate was generally higher than augmentation patients but lower than reconstruction patients. Eighty-seven percent of these 225 patients participated in follow-up after two years, and 83% completed follow-up after three years.

Graph of Complication Rates after Three Years for Revision Patients

Source: FDA’s slide # 59
* Baker III or IV capsular contracture is a painful condition where scar tissue around the implant tightens, thus causing the breast to become firm, hard, and distorted.

Symptoms before Implants vs. Two Years after Implants

The revision patients in the “core study” were asked about numerous health symptoms both before and after they were implanted, and after two years with silicone gel breast implants. Overall, there were substantial increases in the number of revision patients reporting skin, muscle, joint, and neurological symptoms.

Table of Revision Patients Symptoms Before Implants vs. Two Years after Implants

Source: FDA’s slide #65

Key Points to Summarize Complications and Symptoms

  • The most frequent complication is re-operation, which means that most women getting breast implants will require more than one surgery and additional visits to the doctor.
  • Most implants are removed to treat complications. The most frequent reason for re-operation is for capsular contracture, which is the most common complication and can be painful and disfiguring.
  • Autoimmune disease signs & symptoms increase over time.

Source: FDA’s slide # 69

Do Breast Implants Improve Quality of Life?

Inamed also used several measures of health and mental health to evaluate implant patients’ quality of life before and after receiving breast implants. On average, women reported poorer health or mental health after implants compared to before.

  • Almost every measure of emotional and physical health, including social relationships and self-esteem, declined after getting breast implants. The only improvements were in self-reported sexual attractiveness.
  • Most patients who were studied two years after getting implants reported being satisfied with their silicone breast implants. However, they were more satisfied immediately after getting implants than they were two years later.

Reach the original FDA materials here

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.

25 Reasons Not to Get Breast Implants

Dr. Nalini Chilkov, The Huffington Post: Dec 7, 2017

Last week the FDA reported that breast implants put women’s lives in danger. The big news last week was that a small number of women can get a very rare type of cancer (ALCL: anaplastic large cell lymphoma). It confirmed that death is a possible side effect of breast implants. […]

According to Diana Zuckerman, Ph.D., Elizabeth Nagelin-Anderson, M.A.
and Elizabeth Santoro, R.N., M.P.H.: In 2008, more than 300,000 women and teenagers underwent surgery to have their breasts enlarged with silicone or saline implants, and almost 80,000 breast cancer patients had reconstruction after mastectomy, often with implants. The popularity of breast augmentation has more than tripled since 1997, when there were just over 101,000 of these procedures. More than 40,000 implant removal procedures were also reported in 2008. […]

In a study conducted by FDA scientists, most women had at least one broken implant within 11 years, and the likelihood of rupture increases every year. Silicone-7 migrated outside of the breast capsule for 21 percent of the women, even though most women were unaware that this had happened.

Don’t forget the financial burden and increased health insurance costs that go with multiple surgeries and medical complications. In some cases the surgery to remove implants can be like a mastectomy, complete removal of the breast tissue and sometimes the muscle underneath.

Read the original article here.

 

Breast Implants and Cancer of the Immune System (ALCL): A History of Who Knew What When


Experts now agree that breast implants can cause a type of cancer of the immune system known as anaplastic large cell lymphoma (ALCL). The Food and Drug Administration (FDA) finally admitted this risk of cancer in 2017, but other experts – including plastic surgeons – were aware of the risk years before. 34 Why did it take so long for the FDA, the media, and women with implants to find out that choosing breast implants could increase their chances of developing a potentially fatal disease?

Anaplastic large cell lymphoma (ALCL) is a rare type of cancer of the immune system that was estimated to affect 1 in half a million women. It usually develops in the lymph nodes, skin, lungs, or liver. However, ALCL sometimes develops in the breast area of women with breast implants.

In 2008, Dutch researchers published a report of 11 women with breast implants and ALCL, and concluded that the implants seemed to be associated with ALCL.35 Although published in the Journal of the American Medical Association (JAMA), this information was not widely reported.

The link between ALCL and breast implants was first reported by the FDA in January of 2011. In 2013, researchers at MD Anderson Cancer Center studied 60 women with breast implants who were diagnosed with ALCL in the breast. Since ALCL was thought to be diagnosed in only 1 woman in half a million, this was much higher than would be expected. In 2014, the National Comprehensive Cancer Network (NCCN), a nonprofit network of cancer experts, released a worldwide oncology standard for surgeons and oncologists to test for and diagnose “breast implant associated ALCL (BIA-ALCL). NCCN includes a guided algorithm for surgeons and oncologists to test for and diagnose the disease.  They concluded that any abnormal accumulation of fluid or a mass that develops near the breasts in women with breast implants must be evaluated.  In 2016, the World Health Organization (WHO) officially recognized BIA-ALCL.36

And yet, it was not until March 2017 that the FDA finally updated its website to officially report that breast implants could cause ALCL. At the time of the FDA announcement, the agency reported that they had received 359 reports of ALCL among women with breast implants. Reports to the FDA of problems from medical devices are acknowledged to be the “tip of the iceberg” since surgeons frequently do not do these online reports.

Diagnosing and Treating ALCL

How did the women find out they had ALCL before the official announcement of BIA-ALCL was made? Most of them approached their doctors with symptoms such as pain, lumps, swelling, or asymmetry in their breasts years after getting implants. Since breast implants are a “foreign body,” the body forms scar tissue around the implant to protect their body from this “foreign invader.” The scar tissue surrounding the implant is known as the scar capsule. It is natural for the body to form scar tissue, and the scar tissue is only a problem if it tightens or hardens around the implants, causing pain and hardness known as “capsular contracture.” Breast implant-associated ALCL is almost always found in the scar capsule surrounding the implant, not the breast tissue itself, and has been reported in women both with and without capsular contracture.37

ALCL is diagnosed by testing the fluid that collects around the implant, called a seroma.38 Seroma is usually not caused by ALCL. It is important to understand that even when ALCL is in the breast, it is not breast cancer, but rather a cancer of the immune system.  Most breast implant-associated ALCL has cancer cells within the fluid inside the scar capsule. That ALCL can be treated by removing the implant and the surrounding scar tissue. This surgery is known as a capsulectomy.

One study of nine women who had a capsulectomy after being diagnosed with breast implant-associated ALCL found that all nine were healthy and disease free when they were studied 3.5 years later, and neither chemotherapy nor radiation treatment was necessary. However, some types of ALCL are more aggressive and need to be treated with chemotherapy or radiation. NCCN oncologists also state that even if the BIA-ALCL is confined to the scar capsule that surrounds the implant and even if that capsule is totally removed through proper explant surgery, the patient must be followed for 2 years.39

In December 2013, the study of 60 patients with breast implant-associated ALCL showed that the ALCL was more likely to be fatal for women who had a solid ALCL tumor than for women who had ALCL cancer cells in the surrounding fluid (known as effusion ALCL). All of the patients with effusion-type ALCL were still alive 5 years after their diagnosis, compared to only 75% of the patients with solid ALCL tumors. ALCL returned in only 14% of patients with effusion-type ALCL, compared to 50% recurrence of solid ALCL tumors.40

Longer studies with more patients are needed to determine if some kinds of breast implants are more likely to cause ALCL. However, current research suggests that BIA-ALCL is more common in women with textured breast implants. Meanwhile, women with all types of implants should have routine follow-ups and should immediately see a doctor if one or both of their breasts become swollen.

A statement on ALCL from Allergan, a manufacturer of both smooth and textured, silicone and saline breast implants, said, “A woman is more likely to be struck by lightning than to get this condition”.41  However, 400 people are injured or killed by lightning every year, which is why most people avoid situations where lightening can harm them.42

Should All Textured Implants be Banned?

In July 2019, the US Food and Drug Administration (FDA) requested that Allergan recall their Biocell textured breast implants and tissue expanders. The FDA made this request after concluding that the Biocell textured implants are six times as likely as other textured breast implants to cause BIA-ALCL.

This was just 7 months after these breast implants were taken off the European market.   In Europe, breast implants are allowed to be sold if one country provides what is called a CE mark. The CE mark does not require clinical trials and is based on a private company’s review of the product to ensure health, safety, and environmental protection standards are met. The CE mark for Allergan’s textured breast implants was suspended after the company failed to provide French health officials with requested data regarding the textured implants and their link to lymphoma.43

Following the FDA request for a recall in July 2019, Allergan announced a worldwide recall of their Biocell textured breast implants and tissue expanders. See a full list of recalled models here. The FDA also published an updated safety notice, informing patients to communicate with their health-care professionals if they have any concerns or symptoms of BIA-ALCL.

The controversy about whether other types of textured breast implants should remain on the market has focused on what percentage of women with these implants will develop ALCL.  That is not known, because some women who developed ALCL did not know what brand of breast implants they had.  Other types of textured implants are still being sold in the United States, although the FDA recommends women with textured implants have routine check-ups with their doctors.

Although rare, it seems that BIA-ALCL is not “very rare.” The Australian version of the FDA (called the Therapeutic Goods Administration) estimates that between 1 in 1,000 and 1 in 10,000 women with breast implants will develop ALCL.44 More than 300,000 women get breast implant surgery every year. If the Australian estimates are correct, about 30-300 of those women will develop ALCL every year. The estimates were much lower in the U.S., but there is no reason to think BIA-ALCL is less likely to develop in women in the U.S.  Given the dramatic increase in diagnoses, it is clear that BIA-ALCL was under-diagnosed and under-reported for many years.  Although awareness of BIA-ALCL is increasing, many doctors are still unaware of the risks and symptoms.

As of July 2019, the U.S. Food and Drug Administration (FDA) reports that it has received 573 reports of ALCL, including 33 deaths, in women with breast implants.

Many women would not want to take the chance of developing cancer as a result of breast implants, and this is especially true for women who underwent mastectomies that were not medically necessary in an effort to reduce their chances of cancer returning.

What are the Implications for other Diseases?

The link between breast implants and autoimmune diseases has been hotly debated for two decades, with many women reporting serious autoimmune symptoms that went away when their implants were removed.45 The scientific evidence regarding ALCL and implants once again raises questions about the possible impact of breast implants on autoimmune disease or symptoms such as joint pain, body pain, memory loss, and chronic fatigue.

For many years, women with breast implants were assured by implant companies, plastic surgeons, and the FDA that breast implants did not cause breast cancer or any other type of cancer. Evidence of a link to some types of cancer and to autoimmune diseases, including studies conducted by researchers at FDA and the National Cancer Institute, was dismissed. However, as everyone knows from data on lung cancer, emphysema, and smoking, it can take decades to determine if an exposure causes cancer or other serious diseases. Even a very strong carcinogen, such as tobacco, is very unlikely to cause lung cancer for at least 30 years. For this reason, it is essential that physicians and researchers take a closer look at the link between breast implants and cancer of the immune system, as well as other immune disorders.

Read the FDA’s report on the risks of ALCL here

To read more about what you need to know about ALCL, click here.

Breast Implants After Mastectomy: Risks You Need to Know


The complication rate for getting breast implants after mastectomy has been described by experts as “alarmingly high and arguably unacceptable,”46 even though most of the information about complications is based on studies that were paid for by companies that make breast implants or silicone.

How safe are breast implants and how many women have complications after getting reconstruction with breast implants after a mastectomy? When the Food and Drug Administration (FDA) approved breast implants, they acknowledged that the complication rate is very high for all women, especially those undergoing reconstruction after a mastectomy. What the FDA did not know, however, is that early-stage breast cancer patients that undergo mastectomy and reconstruction with breast implants are 10 times as likely to commit suicide as other early-stage breast cancer mastectomy patients.

Complications from Implants

We do not know why the suicide rate is so high for mastectomy patients with breast implants, but we do know that complications are very common. For example, a study conducted by implant manufacturer Inamed (now called Allergan) found that 46% of reconstruction patients needed additional surgery within the first 2 to 3 years after getting silicone gel breast implants 47. Not surprisingly, the implant maker did not publish an article describing this high complication rate, which was more than twice as high as the 21% reported in a study funded by a company that makes silicone (Dow Corning).1

Why was the complication rate lower in the Dow Corning study? One explanation is that the women in that study had breast implants for an average of only 23 months, compared to 2-3 years in the Inamed study. Even so, the Dow study found that 31% of the women developed at least one serious complication and 16% developed at least 2 serious complications in that short period of time. The Inamed study reported that 25% underwent implant removal, 16% experienced Baker III-IV capsular contracture (which is painful breast hardness), 6% experienced necrosis (death of breast tissue), 6% had other types of breast pain, and 6% had an implant that ruptured, and other women reported infections and other complications.2  This shows that both studies found very high complication rates despite a short follow-up of less than 3 years.

The Dow-funded study concluded that “reconstruction failure (loss of implant) is rare.” Of course, it should be rare after less than 2 years. In contrast, when Inamed used Magnetic Resonance Imaging (MRIs) to detect rupture, they found that 20% of reconstruction patients had ruptured implants by the third year;48 but very few ruptures were detected without MRIs. Since Henriksen did not use MRIs. Since the Dow Corning study did not use MRIs to detect rupture, they couldn’t accurately count the number of failed implants.  Moreover, FDA scientists concluded that the risk of rupture would likely increase exponentially every year.49

Many plastic surgeons claim that the Institute of Medicine concludes that breast implants are safe. However, the Institute of Medicine report was completed in 1999, years before most research was conducted. Most research on breast implant patients was published after 1999, making the report very outdated. Many of the studies reported higher levels of diseases or symptoms among women with breast implants, which would have reached statistical significance if the studies were larger and women were followed for a longer period of time.

Can implants cause cancer or other serious diseases?

Experts around the world now agree that breast implants can cause a type of cancer of the immune system called ALCL (anaplastic large cell lymphoma).  In fact, there is now a specific diagnosis called breast implant associated ALCL (BIA-ALCL).  If caught early, removal of the breast implants can be very effective, but if not treated quickly it can be fatal. 50

The link between breast implants and other cancers remains controversial.  Studies paid for by plastic surgeons or implant companies tend to conclude that breast implants are safe. Since breast implants can cause cancer of the immune system, it seems logical that implants might have an impact on other diseases of the immune system or other cancers.  For example, FDA scientists reported a significant increase in fibromyalgia and several other autoimmune diseases among women whose silicone gel breast implants were leaking, compared to women with silicone implants that were not leaking outside the scar tissue capsule.4 In addition, scientists at the National Cancer Institute (NCI) found a doubling of deaths from brain cancer, lung cancer, and suicides among women with breast implants compared to other plastic surgery patients.51 National Cancer Institute scientists concluded that more research was needed to determine if implants increase the risk of cancer or autoimmune diseases.5,6

The Bottom Line

Many women choose mastectomies to “get rid of the cancer once and for all” hoping that it is the safest strategy for dealing with breast cancer.  However, research shows that women who have lumpectomies live longer than women with the same diagnoses that chose mastectomies instead. Research makes it clear that there are many complications from breast implants that often keep women needing additional surgery and medical help in the years after breast cancer is removed, including the possibility of cancer of the immune system.  Unfortunately, many women tell us that their doctors did not warn them about these risks. [Read a New York Times article about a woman with ALCL here.]

Some of the information from this article was based on Dr. Zuckerman’s article published in Archives of Surgery, Vol 141, pages 714-715. The original article can be found here.

Woman with Rare Cancer Linked to Breast Implants Seeks to Spread Awareness

CBS NewsJuly 13, 2017.

[…] The American Society of Plastic Surgeons says around 550,000 women last year received breast implants, but the FDA published a report this year linking a rare cancer to the implants.

So far, there have been 359 reported cases globally, including nine deaths.

The risk is low, but one in 30,000 women with implants could develop it, including one patient who says she is battling the disease and her insurance company, reports CBS News correspondent Anna Werner.

Kimra Rogers was shocked to find a tumor under her arm. […]

Then she learned it was cancer, possibly connected to the cosmetic breast implants she’d had put in 17 years ago. […]

It’s called breast implant-associated anaplastic large-cell lymphoma, a rare cancer the FDA says can develop following breast implants, something doctors at MD Anderson Cancer Center in Houston have been studying for five years.

“This is a type of lymphoma. It is not a breast cancer. It’s actually a cancer that develops in the scar tissue around a breast implant,” said Dr. Mark Clemens. […]

But insurance companies don’t always agree to pay. Rogers says her insurer, Blue Cross Blue Shield of Montana, denied payment for removal of her implants three times, telling her it was a contract exclusion because her implants were cosmetic. […]

But Dr. Clemens said, “We can’t wait months or years till an insurance company say, ‘okay, we’re gonna cover it.'” […]

But if you notice any changes in the implants or your breasts, such as swelling, head to your doctor’s office as soon as possible to have any problems checked out.

Read the original article here.