Category Archives: How Safe Are They?

The History of the FDA & Breast Implants


Breast implants were first sold in the U.S. in the 1960s, at a time when there was no government regulation of medical devices, including implants. When a law was passed giving the FDA that authority in 1976, the agency was overwhelmed with an enormous backlog of devices that needed to be evaluated. Most devices were allowed to remain on the market until those reviews were completed, and breast implants were generally considered a much lower priority than potentially life-saving devices such as heart valves and shunts.

Scientists and physicians started expressing strong concerns about the safety of silicone breast implants in the late 1970’s, and their concerns were discussed at a 1978 FDA advisory committee meeting. By the early 1980’s, most of the risks that eventually led to the removal of silicone gel implants from the market were known or suspected, and included in a proposed rule in the Federal Register.1

Finally, in 1988 the FDA finalized the proposed rule. At an FDA advisory committee meeting, the warnings of earlier years had become more urgent, and a lawyer, a former Dow engineer, and other experts testified that they had seen protected court documents indicating that manufacturers were hiding safety information from FDA and the public. Several women described their own terrible experiences with implants.

The November 1988 FDA advisory panel on breast implants expressed considerable concern about their safety. They recommended that the FDA establish a national registry of women who have breast implants. This was opposed within FDA as too expensive and unlikely to be useful, and as setting a precedent that might cause problems for the agency. Moreover, the FDA was concerned about the viability of a registry because the American Society of Plastic and Reconstructive Surgeons did not support it.

The panel also recommended a mandatory program to inform the public of potential risks of breast implants, possibly including informed consent prior to surgery. However, it was decided that the regulations required for a mandatory program would be so strongly opposed by the plastic surgeons and manufacturers, that it was more practical to develop a voluntary program instead. At the January 1989 panel meeting, the FDA announced plans to develop a brochure and videotapes to educate women about the risks of implants prior to surgery.

The brochures and videotape were to be distributed voluntarily in the offices of plastic surgeons. The educational materials were to be developed by consensus by a diverse group of 23 individuals representing consumer organizations, manufacturers, and health professionals; each representative was given the authority to veto any decision. Because of disagreement within this group about what the materials should say, the brochures and videotapes were never completed.

By 1990, almost one million women had breast implants and the numbers were increasing substantially, but the FDA had not yet required the manufacturers to evaluate their safety and no empirical studies had been published regarding their effects on human health.

Silicone Gel-Filled Implants

In 1991, pressured by Congressional hearings in the House of Representatives chaired by Rep. Ted Weiss (D-NY) and media reports of illness and complications, the FDA finally required the manufacturers of silicone gel breast implants to submit safety studies. FDA scientists pointed out that the studies were inadequate — they included few women, the women had implants for very short periods of time, and many women were lost to follow-up. The law requires that products be proven safe and effective in order to be sold in the United States, but the FDA could not conclude whether the implants were safe or effective because of the shortcomings of the research. (There is no requirement that products be proven unsafe to keep them off the market.)

However, there was enormous pressure to keep breast implants on the market from manufacturers, plastic surgeons, and their Congressional representatives. In 1992, as a compromise, silicone gel breast implants were allowed to remain available as a “public health need,” with the FDA limiting their availability to clinical trials, primarily for women who have mastectomies, breast deformities, or to replace a broken gel implant. Any woman who has had implant surgery with silicone gel implants since 1992 is required to be regularly evaluated by her plastic surgeon as part of the study. Currently, a limited number of women can also receive gel implants for first-time augmentation as part of clinical trials.

In January, 2004, the FDA announced it would not approve silicone gel breast implants, because of the lack of long-term safety data. However, in April 2005, the FDA held a public meeting to once again consider approval of silicone gel breast implants, with almost the same data that they had rejected the year before. In November 2006, the FDA announced that they were approving silicone gel breast implants made by two manufacturers, Allegan and Mentor. However, the approval was on the condition that the implant makers each study 40,000 women with silicone gel implants for 10 years. In addition, the FDA stated that silicone breast implants were not approved for women under the age of 22.

Saline-Filled Breast Implants

In 2000, the FDA reviewed the safety of saline-filled breast implants for the first time. Saline implants have a silicone outer envelope and are filled with salt water. The FDA required studies of local complications, such as pain, infection, hardening, and the need for additional surgery. They did not require studies of diseases or other systemic health problems. Despite extremely high complication rates during the first three years (approximately three out of four reconstruction patients and almost half of first-time augmentation patients), the FDA approved saline implants. As part of the approval process, the FDA made information about the risks of breast implants more available.

New Developments in 2011

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 other women of the same age. 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.  It seems that ALCL can develop in women with different types of breast implants, but the cause is unknown.[2] That is why the FDA requests  that healthcare providers notify the FDA of any cases of ALCL in women with breast implants, to determine how great the risk is compared to women without implants.

In June 2011, the FDA released the preliminary results of the long-term studies of silicone breast implants that were required as a condition of FDA approval in 2006. This included long-term follow-up of the two-year and three-year studies that were the basis of FDA approval for Mentor and Allergan silicone gel implants. It also includes each company’s study of more than 40,000 breast implant patients, that were started after the 2006 approval decision and that will be followed for 10 years.

The results indicated that complications were frequent and increased as the implants aged in the body. The most common complications were capsular contracture (hardening of the area around the implant), the need for additional surgeries to fix implant problems, and implant removal.

The FDA reported that three out of four women with Mentor implants that were enrolled in the Mentor study of 40,000 women had dropped out by the third year of the study, thus making the results meaningless. The Allergan study of augmentation patients was slightly better, with just over half of the patients still participating in the study after two years. The Allergan study of reconstruction patients was the only one of the large studies that could provide useful information, with more than 70% of those patients still enrolled after 2 years.


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



Safety and Benefits of Inamed Silicone Breast Implants


In January, 2004, Inamed’s application for approval of silicone breast implants was turned down by the FDA.  In rejecting the application, the FDA noted the lack of safety data and requested better information about the rupture rate over the lifetime of the implants and the health consequences of implant rupture.  Inamed’s 2005 data do not answer these essential safety questions, and in fact contains alarming data on the frequency and risks of implant rupture.

Inamed Fails to Provide Rate of Implant Rupture

The FDA specifically asked Inamed to provide data from its Core Study with follow-up of sufficient duration . . . to measure or reasonably estimate how the shape of the curve of implant rupture changes over the lifetime of the device.

Inamed failed to do so. FDA’s summary of Inamed’s 2005 submission states that, it is difficult to reasonably predict the probability of rupture through year 10 with the available data from Inamed’s Core Study. [2]

Inamed Fails to Provide Information on Health Consequences of Rupture

FDA also requested that Inamed’s Core Study be extended sufficiently to characterize the potential local health consequences of ruptured implants. [3]

Inamed has failed to do this as well. With respect to assessing the health consequences of implant rupture, the FDA concludes that the Core Study data in the current application is of limited value and that the published articles referred to by Inamed do not completely address all the health consequences of rupture.Further, Inamed’s Adjunct Study, which the FDA had suggested could provide information on the health consequences of rupture, was also deemed to be of limited value in providing the necessary data, because of under-ascertainment of rupture and inadequate patient follow-up. [4]

FDA Predicts High Rupture Rates as Implants Age

The table below presents the rupture rate in the Inamed Core Study among the implant patients who received MRs.  Almost all ruptures were detected by MRI.   Although some patients were followed for 4 years, this is essentially a 3-year rupture study because MRIs were performed in the first and third year, but not during the 4th year. Thus, any rupture occurring after third year are not likely to be detected until year 5.

Type of Patient

Women with Ruptures in First 3 Years







The FDA concluded that Inamed had submitted insufficient information to calculate a longer-term rupture rate.However, the FDA did determine that the risk of rupture would most likely increase exponentially, so that the rupture rate at 10 years would be much higher than percentage reported after three or four years. [5]

Signs and Symptoms of Connective Tissue Disease

The FDA presented slides indicating an increase in several signs and symptoms of connective tissue disease, such as joint pain and fatigue, for women who have had implants for two years, compared to prior to getting breast implants. The analysis was conducted on all women in Inamed’s Core Study, not just those with a ruptured implant. [6] Although not provided by the FDA, an analysis presented by Advisory Panel member Dr. Brent Blumenstein indicates that these differences are maintained even when the impact of aging is statistically controlled.

Safety of Ruptured Implants

No one knows the health consequences of implant rupture and silicone leakage, and one aim of the Inamed Core Study is to examine this question. The table below compares local complications among patients with confirmed ruptured implants to patients with confirmed intact implants.


It is clear from the table that patients with confirmed ruptures have higher rates of infection, lymphadenopathy, redness, seroma, and skin rash, which are shown shaded above. These symptoms are generally associated with an inflammatory reaction and/or with infection. While these data are based on a small number of patients (only 17 in the confirmed rupture group), they point to the conclusion that implant rupture may cause an inflammatory process in the body. (The much larger Adjunct Study does not provide reliable rupture data because of its low follow-up rate and the lack of MRIs, which are the most reliable way to determine if an implant that is still inside the body has ruptured.

Danish data submitted by the implant manufacturers show that women with ruptured implants are twice as likely to report non-serious pain in the affected breast that women with intact implants and are six times more likely to report breast hardness. In addition, women with extracapsular rupture are 3 times more likely to report a connective tissue disease, 2 times more likely to report pleuritis, and 1.7 times more likely to report than women with intact implants, though these numbers were not statistically significant.

The next table presents Inamed data on the symptoms of connective tissue disease experienced by women with ruptured and intact implants. The number of patients is small since only 11 women in the study with confirmed rupture completed the questionnaire. However, the data show a higher percentage of reports of new gastro-intestinal, general, muscle, and skin complaints among the women with ruptured implants.

New Symptoms

Confirmed Ruptured Implants (11 patients)

Confirmed Intact Implants (72 patients)


























In addition to evaluating the risks of implants, the companies were required to evaluate the benefits as well. It is clear that breast implants increase breast size, but plastic surgeons and implant makers also claim that breast implants help women feel better about themselves and their lives. For that reason, the FDA required implant makers to use objective measures of emotional health, comparing women before they had implants and two years later.

Inamed data show that most patients say they are satisfied with their implants after three years. However, their answers to several scientifically developed scales and questionnaires shows that overall, their quality of life remained the same or declined two years after receiving implants.  The table below summarizes these results. The MOS-20 scale assesses six important health concepts including physical functioning, social functioning, mental health, and current health perceptions. In the table, a change that was not statistically significant is listed as no change.


In summary, neither the evidence presented by industry, nor the published literature, support the claim that Inamed silicone gel breast implants improve a women’s self-esteem or mental health, and on average augmentation patients feel worse about their physical and emotional health and vitality.  Augmentation patients report some improvements in feelings of physical attractiveness.

[1] FDA Summary Memorandum, Inamed PMA Review Team, March 2, 2005, p.12 (ISM)
[2] ISM, p. 40
[3] ISM, p. 12
[4] ISM, p. 40
[5] ISM, p. 37
[6], slides 45 and 55.

The European Perspective: Do Silicone Breast Implants Cause Disease?

Elizabeth Santoro, RN, MPH & Diana Zuckerman, PhD: March 2004

Several studies have been conducted on breast implant patients in Europe, primarily Scandinavia. There is one consistent thread that runs through them: they have spun their findings to make the data appear less damaging. In some cases, the study designs are flawed and therefore cannot support the conclusions that are made. In other cases, findings are inconsistent with those of other independent researchers at the Food and Drug Administration and the National Cancer Institute. These European studies have examined several health topics, such as the risk of autoimmune disease, implant rupture, suicide, and lung cancer.

What Do European Studies Say About Breast Implants and Autoimmune Disease?

A major health question about breast implants has been whether they cause autoimmune disease. Most of the research that has been conducted finds no statistically significant connection between silicone implants and diseases such as lupus, fibromylagia, scleroderma, rheumatoid arthritis, and Sjogren’s syndrome. However, many of these studies have shortcomings that limit their usefulness for drawing meaningful conclusions.

Several of these studies were conducted in Europe, although they were co-authored by scientists at the International Epidemiology Institute, a Maryland company that receives money from the company that makes silicone, Dow Corning. The articles that were quoted in the Institute of Medicine report on breast implants include those by Friis and colleagues in 1997, Giltay and colleagues in 1994, and Nyren and colleagues in 1998.1 2 3

Which Diseases Were Studied?

Autoimmune diseases typically present with relatively common and subjective complaints such as pain, fatigue, muscle aches, and sleep disturbances. As a result, it can be difficult to properly diagnose these disorders. For some disorders, such as Sjogren’s syndrome, it can take more than six years to correctly diagnose the problem.4 Since many of the symptoms characteristic of autoimmune diseases are subjective and most do not require surgery or inpatient care, it seems unlikely that the women will be hospitalized for them. The treatment of lupus, for example, is managed mostly by medications, diet, exercise, and the pacing of daily activities. This regimen can be handled on an outpatient basis.5 Similarly, researchers believe that scleroderma takes years to develop and even longer to properly diagnose.6 Several autoimmune conditions, such as scleroderma and Sjogren’s, are rare and require large numbers of study participants in order to ensure that increases risks can be detected. These characteristics that are typical of autoimmune diseases should be addressed in the study designs. Unfortunately, many of these factors were not properly incorporated into the study methodologies.

Description of the Three Studies

Friis and colleagues evaluated the presence of connective tissue diseases including lupus, Sjogren’s syndrome, rheumatoid arthritis, scleroderma, and other rheumatic conditions with a sample of 2,570 women with implants and 11,023 controls in Denmark. The minimum time that women had implants was less than one year and the average time with implants was 7.2 and 8.4 years for the reconstructive and augmentation groups, respectively. The control group was of women who had breast reduction surgery or mastectomy without receiving implants. The outcome measure was women who were hospitalized for connective tissue diseases, and did not include women who were treated on an outpatient basis.

Giltay and colleagues studied a sample of 235 women with implants and 210 controls from The Netherlands who were matched for age and year of the operation. They administered a questionnaire to determine if women with breast implants reported more rheumatic symptoms than the controls. They also looked at the use of anti-rheumatic drugs and the number of medical consultations that were for rheumatic symptoms. The minimum length of time with implants was two years and the average amount of time with implants was 6.5 years. The control group was composed of women who had cosmetic procedures that did not include silicone.

Nyren and colleagues studied 7,442 Swedish women with implants and 3,353 Swedish controls. They evaluated the number of women with connective tissue type disorders including lupus, Sjogren’s syndrome, rheumatoid arthritis, and scleroderma among women with breast implants. One month was the minimum time required to be in the study and the mean length of time with implants was six years and 10 years for the reconstructive and augmentation patients, respectively. This control group was comprised of women who had breast reduction surgery. This study used hospitalization as its outcome measure.

Methodological Flaws

There were four major types of flaws in these studies. One of these was the choice of the outcome measure, which in two of the studies was hospitalization. This outcome assumes that the people with autoimmune diseases are treated in the hospital for their symptoms. Another flaw of the studies was the amount of time that women were exposed to implants. Ideally, implants that were only a few months or years old would not be permitted in the study because the chance of illness from exposure to breast implants is likely to increase as the implant ages and leaks. An additional flaw is the size of the samples. Many autoimmune diseases, such as scleroderma, are rare (affecting less than one woman in 10,000) and require very large samples in order to detect even small significant changes. The comparison samples were also inappropriate, often consisting of women who had breast reduction surgery. A better designed study would have included a comparison group who did not have breast surgery, but were otherwise similar to the implant group.

These flaws in the study design can skew the findings so that a particular outcome is more likely to occur. In the case of these European studies, the study methodologies can diminish the possibility of a relationship between breast implants and autoimmune diseases. As published, the articles suggest breast implants are not associated with autoimmune disease. However, after careful scrutiny, the possibility of a relationship becomes much more plausible. Being able to determine what the studies actually show, requires a reader with expertise in research, statistics, and study design.

How Do You Evaluate Who is Sick?

In all three of these studies, the patients were neither questioned nor directly examined by a healthcare professional. Moreover, in the Nyren and Friis studies, the outcome measure was hospitalization rather than diagnosis. This would inevitably result in underreporting, since most women would not be hospitalized for these diseases unless they had the diseases for such a long enough time that their condition had greatly deteriorated. The Giltay study sent a questionnaire to women who had silicone breast augmentation surgery and to a matched control who had a cosmetic operation not involving silicone in that same year and department. The questionnaire queried whether the women experienced rheumatic complaints and symptoms. The information obtained in questionnaires must always be critically assessed since responders can be different than non-responders. The response rate was 82% for patients and 73% for controls. However, a more serious problem for the Giltay study was the small sample.

Exposure to Implants

A related weakness of all three studies is that they included women who had implants for a short period of time. These studies had inadequate minimum requirements for the length of time a woman had implants: one month (Nyren), less than a year (Friis), and two years (Giltay). The average years that the women had implants ranged from six to fourteen. Even if a woman with breast implants immediately developed an autoimmune disease, it would probably take several years for her to be diagnosed, and even longer for her to be ill enough to be hospitalized. If a disease develops after years of exposure, or after silicone leaks from the implant, that would take even longer before she was diagnosed or hospitalized. Including women who had implants for just a few months or years obviously biased the results, making it less likely to find a significant association between implants and autoimmune disease. Women should have been implanted for at least 6-10 years instead of having implants for an average of 6-14 years.

Sample Size

A very large sample size is essential in a study of implants and autoimmune diseases, because so many of these diseases are rare and because half the patients had implants for a short period of time. Nyren and Friis acknowledge that the size of their samples was inadequate. Nyren had a sample of 7,442 women who chose implants for cosmetic purposes or for reconstruction after mastectomy and 3,353 women who had breast reduction surgery. Friis included 2,570 women with implants and 11,023 controls. These sample sizes do not seem that small, but given the rare nature of these diseases, more study participants are needed. The Giltay study included only 287 women with silicone breast implants, and each was age-matched to a control who in that same year had a cosmetic operation. The limited power of these studies made it unlikely that an increased risk of disease — even a doubling or tripling — would be statistically significant.

Comparison Sample

Another weakness of two of these studies was the use of breast reduction patients for a comparison sample in the Nyren and Friis studies. This comparison group helps control for any health impact of surgery, which is an appropriate design if the goal is to determine the health risks of the implant itself. However, if the goal is to determine the health risks of getting breast implants, surgery is an essential component of that product and the impact of surgery therefore should be part of the “treatment” variable. And of course, women are not deciding whether to get their breasts increased or decreased in size. Women considering implants want to know if getting implants will pose health risks compared to not getting implants, so the comparison group should be women who did not undergo breast surgery, but who are like the implant group in as many other ways as possible.

In the study by Giltay, breast implant patients were compared with patients who had other unspecified cosmetic procedures which did not include silicone. It seems likely that this is an appropriate comparison group since the women were matched according to age and the other year of operation. Unfortunately, the authors do not report the comparison surgeries.

Even with the various methodological flaws, all of which were likely to minimize health risks associated with implants, the results indicated potential health problems among women with implants. Although not statistically significant, Friis and colleagues found a 30% increase in scleroderma, lupus, and Sjogren’s syndrome for mastectomy patients with implants compared to women who had breast reduction surgery, or mastectomy without implants. Giltay and colleagues found that women with silicone breast implants report more rheumatic symptoms when compared with controls who had an unspecified plastic surgery that did not involve silicone. Similarly, Nyren and colleagues found that breast surgery patients (either reduction or augmentation) had slightly higher rates of connective tissue disorders than was expected based on rates in the general population of the same age. Had these studies been larger, with more women who had implants for a longer period of time, and had they been based on diagnoses or self-reported symptoms rather than hospitalization, these differences might have been statistically significant. Because of these study flaws, it is impossible to know if implants are linked to autoimmune diseases.

What Do European Studies Say About Implant Rupture?

European studies on rupture tend to be favorable about implants, and their findings are inconsistent with studies conducted in the United States on the same topic. A Danish study by Lisbet Holmich and colleagues on rupture rates of silicone breast implants illustrates this point.7 It reported that 10% of implants had definitely ruptured and 7% had possibly ruptured over a two year period. Based on that information, the authors conclude that at least 15% of modern implants will probably rupture within three to ten years following implantation. This conclusion seems to conflict with a study by the FDA, which found that all breast implants will eventually break, and that most augmentation patients have at least one broken implant within ten years.8

Is it possible that implants last longer in Denmark than in the U.S.? Apparently not. First of all, by focusing on implants rather than women, the Holmich article estimates 15% of implants will break, which is approximately 30% of women with at least one broken implant. Secondly, by saying “at least 15%” they are focusing on the low number but not denying that the percentage could be considerably higher. Even more important, in a table in Holmich’s paper, the data indicate that the chances of implant rupture increases dramatically after 10 years. According to their own data, while most implants are intact for ten years, most will break between 11-20 years, and almost all will be broken in 20 years. For example, during the two years of the study, 41% of the implants that were between 22 and 25 years old definitely ruptured and 23% had possibly ruptured. These data suggest that as the age of the implant increases, the chance of having a ruptured implant also increases substantially. Although these trends are presented in the table, they are barely mentioned in the paper and ignored in the summary and conclusions. Instead, the authors focused on the estimated rupture rate of “at least 15%” during the first ten years of having implants, and ignore the bad news after that.

Like the autoimmune studies, this research was conducted with researchers from the International Epidemiology Institute, which was funded by Dow Corning.

What Do European Studies Say About Implants and Suicide or Lung Cancer?

Two European studies found that breast augmentation patients were more likely to kill themselves compared to women without implants. The study of Swedish women by Dr. V.C.M. Koot and colleagues as well as the study of Finnish women by Dr. Eero Pukkala and colleagues report that women with implants are three times as likely to commit to suicide when compared to the general population of Sweden and Finland, respectively.910

The authors explain the high suicide rates by claiming that women who decide to get plastic surgery such as breast implants have a pre-existing propensity toward suicide due to mental problems and low self-esteem. However, this conflicts with findings by Brinton and colleagues at the National Cancer Institute, who reported that breast augmentation patients were four times as likely to kill themselves as other female plastic surgery patients of the same age. There is no reason to believe that women who decide to undergo breast augmentation have lower self-esteem or poorer mental health than other plastic surgery patients.

Women with breast implants who testified before the FDA in October 2003 explained the suicide data differently than the Scandinavian researchers. Several women described being depressed and suicidal because of debilitating pain, fatigue, and mental confusion years after getting silicone breast implants. They explained that when their implants were removed, their health improved, and their depression and suicidal feelings diminished.11

The Koot study also found an excess number of deaths from lung cancer. However, the authors assumed it was due to smoking, even though they did not evaluate whether women with implants were more likely to smoke than other women in the study. The National Cancer Institute study by Brinton and colleagues had also found an increase in deaths from lung cancer among breast augmentation patients compared to other plastic surgery patients, even though the implant patients were not more likely to smoke than other plastic surgery patients. It therefore is inappropriate to assume that smoking explains the increase in lung cancer. Research is needed to determine if that is the most likely explanation.

The Koot and Pukkala studies were conducted with the help of the International Epidemiology Institute, which was funded by Dow Corning.

What Can Be Learned From The European Studies?

What do all of these studies have in common? They all found problems associated with breast implants, but they were described with rose-colored lenses to make the findings sound like a clean bill of health for breast implants. In some cases, the study design minimized problems by including women who had implants for just a few months, or by studying rare diseases in small samples. Even when the findings are consistent with studies conducted by independent researchers at the FDA or NCI, the summaries and conclusions sound dramatically different — and much less worrisome. In some cases, damaging findings are ignored, or spun to neutralize the findings. Only when the studies are carefully scrutinized and compared with other research does it become obvious that the findings are quite troubling. The bottom line: even studies funded by Dow Corning find a link between breast augmentation and poor health outcomes and show that most implants break in a relatively short period of time. These findings add to the growing evidence that implants may be associated with increased morbidity and mortality over the long-term.