S. Lori Brown, H.J. Duggirala, and G. Pennello. “An Association of Silicone-gel Breast Implant Rupture and Fibromyalgia.” Current Rheumatology Reports: August 2002.

In 2002, researchers at the FDA published an article reviewing several studies that looked at the association between breast implants and fibromyalgia. Fibromyalgia is a disorder characterized by widespread musculoskeletal pain and stiffness, fatigue, and sleep issues. One study compared the health problems of women with ruptured silicone breast implants to those with intact silicone breast implants. The researchers found that women with ruptured implants who had silicone gel migrate outside the scar tissue capsule were 2.7 times more likely to report fibromyalgia symptoms.

The researchers also analyzed several other studies, which concluded that nearly 55% of breast implant patients with symptoms, had fibromyalgia. However, these studies had many limitations, for example they did not differentiate between women with ruptured implants and intact implants, and between silicone and saline implants. The results of their review suggest that breast implants, and specifically ruptured silicone implants, may contribute to fibromyalgia.

Read the original study here.

Lori S. Brown. “Epidemiology of silicone-gel breast implants.” Epidemiology. 2002.

Silicone breast implants have been marketed in the United States since 1963. Questions remain unanswered on the safety of these medical devices despite their popularity and availability. In 1992, the Food and Drug Administration restricted the availability of silicone-gel breast implants to women requiring them for reconstruction after breast cancer or for other medical indications. Inflatable saline breast implants have remained available for either reconstruction or for cosmetic augmentation while manufacturers completed studies addressing issues of safety and effectiveness. The Food and Drug Administration (FDA) has less concern today regarding a putative association between breast implants and autoimmune disease because of epidemiologic studies that have indicated that there is not a large increase in risk for connective tissue disease in women with breast implants. These studies have not ruled out a small increase in risk of connective tissue disease to these women nor have they addressed the issue of an atypical syndrome related to silicone. The FDA has continuing concerns over local complications that are related to breast implants. The current review provides a brief discussion of the regulatory history of silicone implants and of FDA concerns over breast implants, implant prevalence, studies of systemic and local complications related to breast implants, and a brief description of the FDA study of silicone-gel breast implant rupture.

Read the original article here.

Brinton, Louise A., et al. “Cancer risk at sites other than the breast following augmentation mammoplasty.” Annals of Epidemiology: 2001.

In 2001, researchers at the National Cancer Institute studied cancer rates among more than 13,000 women who had breast implants for an average of 12 years. The women were 35 years old, on average. The researchers compared those results to the expected rates of cancer in the general population and to more than 3,000 women who had other types of plastic surgeries.

There were 359 cases of cancer in the women with breast implants, compared to approximately 295 cases of cancer that would be expected in the general population. Women with breast implants had double or triple the expected rates of leukemia and cancers of the stomach, cervix, vulva, and brain. When compared to other plastic surgery patients, these cancer rates as well as respiratory cancers were also higher among breast implant patients, but the differences were not statistically significant. The researchers were not able to determine if breast implants caused these cancers. Lifestyle differences might account for some of these differences, although there was no obvious lifestyle cause of increased respiratory or brain cancers; for example, there were no differences in smoking habits.

Read the original here.

Brown SL, Pennello G, Berg WA, Soo MS, Middleton MS. “Silicone Gel Breast Implant Rupture, Extracapsular Silicone, and Health Status in a Population of Women.” The Journal of Rheumatology 2001.

The first study to systematically evaluate the health of women with ruptured breast implants has raised serious concerns about silicone implants. A team of scientists led by Dr. Lori Brown of the Food and Drug Administration (FDA) reported that women whose ruptured breast implants leaked silicone outside the scar tissue surrounding the implant were significantly more likely to have been diagnosed with fibromyalgia (a painful soft-tissue disease), pulmonary fibrosis, and connective-tissue diseases such as dermatomyositis.

Magnetic resonance imaging (MRI) was used to examine the status of the breast implants of the women participating in the study. Based on the implant’s condition, researchers assigned cases to three groups: intact, ruptured, or indeterminable. (Those implants that appeared ruptured but were not able to be confirmed, were classified as indeterminable.) Radiologists also determined which ruptured cases had silicone that migrated outside of the scar capsule that surrounds the breast implant. A majority of the women had at least one ruptured implant, even though they were often unaware of that condition. Also, 21% had silicone that migrated outside of the breast area from at least one broken and leaking implant.

Women with ruptured implants where the silicone had traveled outside of the scar tissue were compared to women in the intact and indeterminable groups; investigators found an increase in fibromyalgia, dermatomyositis, polymyositis, Hashimoto’s thyroiditis, pulmonary fibrosis, eosinophilic fascitis, and polymyalgia. The significant association with fibromyalgia remained even after controlling for patient’s age, implant age, location, and manufacturer. Therefore, once the silicone from a broken implant migrates outside of the breast area, the woman’s risk for these serious diseases increases considerably.

This study raises serious concerns for women with ruptured implants, because it indicates that women who are unaware that an implant is ruptured and leaking could be at increased risk for health problems due to their exposure to silicone.

Read the original study here.

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

Brinton, LA, Lubin, JH, Burich, MC, Colton, T, and Hoover, RN. “Mortality Among Augmentation Mammoplasty Patients”, Epidemiology 2001; 12: 321-326.

A 2001 study raises questions about the long-term safety of breast implants. A team of researchers led by Louise Brinton, Ph.D., of the National Cancer Institute (NCI) found that women with breast implants are more likely to die from brain tumors, lung cancer, other respiratory diseases, and suicide compared to other plastic surgery patients.

This study is the first to look at all types of cancer and all causes of death among breast implant patients. While the authors were not able to determine whether implants caused these illnesses, the results show a doubling of brain cancer and a tripling of lung cancer, emphysema, and pneumonia for women with implants. Even though these findings were described as “unexpected,” they are consistent with previous research that shows brain abnormalities and lung problems related to breast implants. There was also a four-fold increase in suicide for breast implant patients, which seems to contradict the manufacturers’ assertion that implants improve a woman’s feeling of self-worth.

Read the original article here.

Read an update from the authors here.

Institute of Medicine. Safety of Silicone Breast Implants. Washington, DC: The National Academies Press. 1999.

The Institute of Medicine (IOM) of the National Academy of Sciences produced a report in 1999 concluding that though many local and sometimes serious complications occur with breast implants (such as pain, capsular contracture, and rupture), the existing evidence did not prove that breast implants cause disease. The report did not involve any new research; instead, it was a summary and review of the existing scientific literature on silicone breast implants. It reviewed only 17 studies concerning the health of women with implants. The report was never meant to be the “final word” on the topic, and since it was published in 1999 the research behind it is outdated.  However, it is still quoted so it is important to understand what the report did and did not include.

The report was also limited by the serious shortcomings of the research that had been conducted at the time the report was written. The flaws in the study designs are substantial, for example:

• Studies with too few women. For example, the study by Dr. Sara Strom and her colleagues compared women with rheumatologic diseases with women without diseases, but only one woman with breast implants was in the study.
• The women didn’t have implants long enough to develop a disease. For example, a study by Dr. Mark Schusterman and his colleagues did not include any women who had breast implants for more than 2 years. Most autoimmune diseases take much longer than 2 years to develop and be diagnosed.
• Studies did not include a medical exam of the women with implants. Most of the studies relied on medical records, some of hospitalization records, and a few on self-reported illness.
• Studies only evaluated a few diagnosed autoimmune diseases, not the kinds of autoimmune symptoms that are most widely reported by women with implants, such as pain, memory loss, and fatigue.

Most of the studies that were included in the IOM review were funded by implant manufacturers. In the years afterwards, there were several well-designed, long-term studies to show that women who have had implants for more than 7 years had an increase in cancer and suicide compared to other plastic surgery patients and an increase in fibromyalgia among women with leaking silicone implants. Recently, experts have also concluded that breast implants can cause a type of cancer of the immune system, which adds credibility to the reports of women who say that the autoimmune symptoms they developed after getting breast implants were cured after their implants were removed. To draw conclusions about the health risks of breast implants would require well-designed research on women with implants for at least 10 years.

Read the original report here.