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CommentaryMedscape, Inc., October 24, 2001Are Breast Implants Safe?

Zuckerman, PhD

IntroductionMore women are getting breast implants than ever before. In 2000, a total of 203,310 women underwent breast implant surgery for augmentation,[1] and 82,975 women underwent breast implant surgery for reconstruction after mastectomy in 1999 (the most recent statistics available).[2] The number of women and teenage girls who chose implants to augment their breast size more than doubled between 1997 and 2000.

This dramatic increase reflects a booming economy and other factors, including the widespread belief that breast implants are safe for long-term use. This belief is supported by press coverage of a meta-analysis of research on autoimmune diseases and the widely publicized report of the Institute of Medicine (IOM), both of which summarized research that was published prior to 1999 and both of which concluded that implants probably do not cause connective tissue disease.[3,4] It is therefore not surprising that a Medscape General Medicine editorial concluded that implants are safe and that silicone gel breast implants, which are available under restricted conditions, should be approved for sale to any women who want them.[5]

Still, the editorial seems to disregard the way that the US Food and Drug Administration (FDA) regulatory process works, and, even more surprising, the editorial, and several recent Medscape articles, do not adequately consider the most recent research evidence of serious health problems linked to all breast implants, and especially silicone gel implants.

The Role of the FDABreast implants were first sold in the 1960s, at a time when there was no government regulation of implants or most other medical devices. When the FDA finally obtained that authority in 1976, breast implants were still relatively rare, and the agency was confronted 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.

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. In 1991, pressured by Congressional hearings and media reports of illness and complications, the FDA finally required the manufacturers of breast implants to submit safety studies. As a Congressional investigator, I had access to all those studies and to internal FDA documents involving them. 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.[6] 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 breast cancer patients and their Congressional representatives, thanks in large part to public relations campaigns that were generously funded by the manufacturers and the plastic surgeons' organizations.[6,7] As a compromise, implants were allowed to remain on the market as a "public health need," and in 1992, the FDA limited their availability to clinical trials, primarily for women who have mastectomies, breast deformities, or who want to replace a gel implant that was put in for augmentation prior to these restrictions. 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, in order to provide safety data that the manufacturers will use to try to obtain FDA approval. Currently, a limited number of women can also receive gel implants for first-time augmentation as part of clinical trials.

Ten years have passed since the manufacturers submitted inadequate studies of silicone gel implants to the FDA. The manufacturers have the responsibility to submit new safety studies to the FDA as part of the "Premarket Approval" (PMA) process to get implants approved. The FDA has not required them to submit new studies, and the manufacturers have not chosen to do so. Silicone gel implants, like any other medical product, cannot be approved until those studies are submitted and reviewed by the FDA. This decision is not made on the basis of physicians' or patients' opinions, or research on implants that are no longer on the market. It is a decision that, according to law, must be based on the FDA's objective review of new empirical studies of the specific implants that would be sold. That decision cannot be made until each manufacturer submits its studies for review, and it seems premature for Medscape editors to speculate on that decision until they have seen that research. However, the information we have thus far raises several serious concerns.

Health RisksLocal ComplicationsThe IOM report concluded that local complications are the primary health concern of breast implants. These complications range from minor to serious -- for example, infections can be easily treated or can cause toxic shock syndrome that can cause death or gangrene.[8] The most common complications, such as scarring, asymmetry, loss of sensation, pain, hardness, and the need for additional surgery,[4,9] are usually not life-threatening but they can affect the quality of life -- and since implants' only benefits are to improve the quality of life, these complications should not be dismissed lightly.All implants are "foreign bodies," and the woman's body reacts by forming a capsule of scar tissue around the implants that can become too tight for the implant. If that occurs, the breasts can become very hard, misshapen, and cause mild discomfort or severe pain. This complication, called "capsular contracture," is widely acknowledged; the controversy is about how often it happens and how serious it is. The most likely treatment is to remove and replace the implants, but manufacturers' research indicates that the replacement implants are likely to cause even more complications than the original implants.[10] Also, additional surgery comes with additional risks and the expense can be much greater than the original surgery.

RuptureSurgical risks are not a 1-time risk, since breast implants will eventually break and need to be removed and possibly replaced. Saline implants are removed because they quickly deflate; silicone gel implants require removal because the silicone will eventually leak out and the gel can migrate outside the breast area.[11] It has been reported that some implants break during the first few months or years, and some last more than 15 years. The IOM report suggested that implants do not last a lifetime, but did not draw conclusions about the rupture rate. A study conducted by FDA scientists that was published after the IOM report found that, among "satisfied" women who had not sought to have their implants removed, most had at least 1 broken implant within 15 years.[12] MRIs indicated that silicone migrated outside of the breast capsule for 21% of the women who had broken implants, even though the women had not sought treatment for the problem.Although the health risks of a ruptured implant are the subject of controversy, the "local complications," such as infection or pain, are well-documented. If the silicone migrates outside the scar tissue, it can destroy healthy breast tissue.[4] Women with ruptured silicone implants can lose breast tissue as part of the removal surgery; in some cases, this may result in surgery that is similar to a mastectomy.[4] However, there are no published data on how often this occurs.

Autoimmune DiseaseThe IOM report's analysis of 17 epidemiologic studies of autoimmune diseases, and a related meta-analysis of 20 studies (16 of which were the same studies that IOM reviewed), all available prior to 1999, concluded that implants probably do not cause a substantial increased risk for these diseases. However, a careful assessment of these studies indicate that several were never peer-reviewed, and most were not appropriately designed to study rare diseases or diseases that take many years to develop. For example:

Five of 20 studies[13-17] cited in the meta-analysis were not published in peer-reviewed journals. Instead, they were papers presented at scientific meetings or unpublished doctoral dissertations.

The studies included in the IOM report and in the meta-analysis 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.[13,18-22] Only 6 of these studies evaluate the "atypical" connective-tissue disease symptoms or fibromyalgia-type symptoms that many patients report, and the largest of these studies found a significantly higher risk for women with implants compared with controls.[19]

Only 1 of the studies was based on a medical exam done for the study.[18] Most of these studies instead 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 1 study that reported a significant risk due to implants was criticized by the IOM because it was based on self-report.[19] In contrast, studies that relied on self-reports regarding whether a woman had implants or when she got implants were not criticized as potentially inaccurate, even when the "Harvard Nurses' Study" included reports of women having implants since the 1950s -- the decade before breast implants were invented.[23]

Two of the studies relied on hospital records,[22,24] yet most autoimmune diseases do not require hospitalization during the early stages.

Virtually all the studies included women who had implants for a short period of time, such as a few months or years. One of the most widely praised of the studies, the "Harvard Nurses' Study," included women who had implants for as briefly as 1 month.[23] Another study included only 250 women, who had implants for an average of 30 months.[25] If implants cause connective-tissue diseases, it would be expected that the disease would develop over a period of years. Therefore, an appropriately designed study would include women who had implants for at least 10-15 years, and none of the studies in the meta-analysis or IOM report include such a population.

Many of the samples are small and, thus, have limited statistical power to detect increases in the rates of the rare diseases studied, even increases as large as 50% to 100%. For example, the study by Park and colleagues,[18] published in 1998, includes only 317 implant patients who had implants for an average of 5.7 years. The authors acknowledged that a health risk would have to exceed 320% for reconstruction patients and 1600% for augmentation patients in order to be statistically significant. Similarly, the authors of the often-quoted "Mayo Clinic Study" estimated that they would need to have studied 62,000 women with implants for an average of 10 years to detect a 100% increase in rare diseases such as scleroderma; instead, their study included less than 1000 women who had implants for an average of less than 8 years.[26]

Older implants (from 1964-1975) were made of a thicker silicone shell than newer implants. Those implants were less likely to "bleed" silicone through the shell or to break.[12] Therefore, studies with women who had implants for a wide range of years would not be expected to show a "dose" response; yet, the lack of a dose response was interpreted as further evidence that implants do not cause systemic disease.

Most of the studies do not specify whether women "with implants" had kept those implants or had them removed. In at least 1 of the studies, women were included in the study even if they had their breast implants removed shortly after they got them.[23] 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.

Even with these methodologic biases, many of the 20 studies indicated an increase in some autoimmune diseases or symptoms, but only 1 -- the largest study (which also included women who had implants for the longest period of time) -- indicated that the difference was statistically significant. That study was conducted at Harvard on women who were health professionals, but the study was criticized for relying on self-reported health information.[19] In addition, 2 European studies indicated that breast surgery (whether for breast implants or to reduce the size of breasts) was associated with increased risk of scleroderma, rheumatoid arthritis, and other autoimmune diseases.[22,24]

Overall, the most important limitations of these studies are the following:

They used medical records and self-reports rather than clinical exams.

They focused on classically defined autoimmune diseases and did not study most other diseases or atypical types of autoimmune disease.

Most studies included samples that were too small to meaningfully study increases in the rare diseases they were studying.

Most of the women in most of the studies had implants for too short a period of time to develop and be diagnosed with the serious illnesses that were the major focus of the studies. Since connective-tissue and autoimmune diseases may take years to develop and be diagnosed, studies that include women who had implants for just a few months or years cannot determine whether breast implants increase the long-term risks of getting these diseases.

The data from these studies clearly support the view that most women do not become ill from well-defined autoimmune diseases after having implants for a short period of time. However, any conclusions about the long-term safety of implants in terms of systemic disease are premature.

Studies Since 1999Perhaps most important, while the scientific information about silicone gel implants that was available to the IOM and to other experts has been relatively limited, 3 new studies published in May 2001 found statistically significantly increased health risks that raise questions about the long-term safety of implants. One of these studies, conducted by FDA scientists, found a statistically significant link between ruptured silicone gel implants and fibromyalgia and several connective-tissue diseases.[11] This study of patients who had silicone breast implants for at least 6 years found that when the silicone had migrated outside of the scar tissue surrounding the implant, women were significantly more likely to report that they had been diagnosed with fibromyalgia, dermatomyositis, polymyositis, Hashimoto's thyroiditis, mixed connective-tissue disease, pulmonary fibrosis, eosinophilic fasciitis, or polymyalgia. The association with disease remained even after controlling for patient's age, implant age, location, and implant manufacturer.

Another study, of 95 women who had silicone gel-filled breast implants and rheumatologic symptoms, found that the symptoms improved in 42 (97%) of the 43 women who had their breast implants removed.[27] In contrast, rheumatologists reported that rheumatologic symptoms worsened in 50 (96%) of the 52 women who did not have their implants removed. This important study, presented at the American College of Epidemiology (1998) by a scientist at the National Cancer Institute (NCI), has not yet been published.[27]

Breast CancerBreast implants interfere with the detection of breast cancer because implants can obscure the mammography image of a tumor.[28-30] 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, approximately 30% of the breast tissue will still be obscured.[28] Mammograms tend to be considerably less accurate and are sometimes very difficult to perform if the woman has capsular contracture.[29,30]

There is no research evidence that implants cause breast cancer, but the delay in diagnosis could potentially necessitate more radical surgery or could be fatal. In contrast, a recent meta-analysis performed by Dow Corning, the manufacturer of silicone for implants, found that women with implants were less likely to have breast cancer than other women.[31] Dow Corning's meta-analysis, reported on Medscape in May 2001 under the headline "Silicone Breast Implants May Protect Women Against Breast Cancer," did not include the largest study of women with breast implants, conducted by the NCI and published in 2000.[32] In contrast to the Dow Corning study, the NCI study found no difference between women with implants and other women -- neither an increase nor a decrease.

Other Systemic DiseaseVery few published studies have medically evaluated enough women with implants for enough years to determine whether implants cause other systemic diseases in the long-term. Two recent federally funded studies by scientists from the NCI have demonstrated a link between implants and cancer, lung diseases, and suicide. One of the studies found that women with breast implants are more likely to die from brain tumors, lung cancer, and suicide compared with other plastic surgery patients.[33] The other study found a 21% overall increased risk of cancer for women with implants, compared with women of the same age in the general population.[34] The increase was primarily due to an increase in brain cancer, respiratory tract cancers, cervical cancer, leukemia, and vulvar cancer. The dramatic findings regarding lung disease and brain cancer were described as "unexpected" by the authors, but the findings are consistent with other newly published research. For example, the previously described FDA study of women with ruptured breast implants reported an increase in pulmonary fibrosis for women with ruptured and leaking implants,[11] and another recent NCI study reported an increase in fatal lung diseases.[33] A recent case report, 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 that was identical to the kind in her implant.[35] The physicians involved believe that this case report suggests that silicone from a ruptured gel implant can migrate to the lungs.

Unlike many other studies of women with implants, the federally funded epidemiologic studies controlled for potentially confounding variables such as smoking and social class and included 2 comparison samples: the general population of women in the same age range, and a population of other plastic surgery patients. The results of the 2 NCI studies indicated that women with breast implants, like other plastic surgery patients, tend to live longer than other women, apparently because women who will undergo plastic surgery tend to have relatively good baseline health and can afford adequate healthcare. However, implant patients were more likely to die from the diseases mentioned above than other plastic surgery patients. Therefore, a recent article in Medscape (April 26) titled "Augmentation Mammoplasty Associated with Reduced Mortality" was misleading.

Alternatives to Silicone Gel Breast ImplantsWhen silicone gel breast implants were allowed to remain on the market in 1992 as a "public health need," the main concern was to keep this option for mastectomy patients. However, since that time, the number of women getting mastectomies rather than breast-conserving surgery has decreased dramatically, and the number of women choosing autologous tissue transfer instead of implants has increased exponentially.[36] And, in 2000, saline-filled breast implants were approved by the FDA; saline implants became a popular alternative to silicone gel after silicone gel implants were restricted in the early 1990s.

The Importance of Empirical ResearchMany plastic surgeons and implant patients believe that silicone gel breast implants are safe. Medical opinion is not the standard for selling medical products in the United States, however. A recent example involving a different kind of breast implant illustrates the importance of empirical research. Trilucent breast implants, which have a soybean oil-based filler, were designed to interfere less with mammograms than saline or silicone implants. In recent years, these products were widely praised by the doctors who used them (mostly in the United Kingdom) and were embraced as the safe alternative to silicone implants by women and the media. The manufacturers had not sought FDA approval, however, and some plastic surgeons and patients criticized the FDA because the implants were not widely available in the United States. In 2000, Trilucent implants were removed from the market when serious problems were reported. The soya oil implants were found to cause swelling and, in some cases, leaking soybean oil had emulsified and turned rancid.[37] Moreover, the Trilucent implant filler was found to break down into aldehydes, which are genotoxic, raising concerns that the implants could increase cancer risk or reproductive toxicity. Because implant leakage or rupture would lead to increased exposure, the British Medical Device Agency advised women to avoid pregnancy until their Trilucent breast implants were removed. They also recommended that breastfeeding be avoided because the toxic chemical could migrate from the implants to the milk.[38]

The removal of Trilucent implants from the market, after doctors and patients involved had enthusiastically praised them, serves as a reminder that the long-term risks of implants are not always obvious during the first few years of use. That is why studies of the risks of long-term use are essential to establish the safety of implants, and why it is important to refrain from drawing conclusions until objective, comprehensive, long-term research is completed.

In summary, some of the most recent research raises serious questions about the long-term safety of breast implants, and most of the conclusions of the Medscape editorial are based on shorter-term studies that examined relatively few women and relatively few diseases. The fact that silicone gel implants can rupture without warning, and the silicone can migrate to organs where it can't be removed, raises concerns. Since the health risks of broken implants have been evaluated in only 1 study -- which found a statistically significant link to disease -- this should raise the threshold when the FDA finally reconsiders whether to approve silicone gel implants.

The bottom line, however, is that the studies that have been published thus far are not the basis for approval or disapproval of silicone gel implants. The law requires that the review of silicone gel implants must be based only on studies of the specific types of implants that are seeking approval -- not of implants no longer on the market, or studies of women with implants made by a variety of manufacturers. Since the currently used implants have been on the market for more than a decade, the FDA review should include long-term data, and an assessment of the health of women with ruptured implants, to examine whether systemic diseases are linked to long-term implant use.

AcknowledgementThe author thanks Flynn, MPH, and Jae Hong Lee, MD, MPH, for their comments, suggestions, and research assistance.

References:

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