Long-Awaited Government Studies Raise New Concerns
about Silicone and Saline Breast Implants

     WASHINGTON, DC - Women who have breast implants are more likely to die from brain cancer, lung cancer, other respiratory diseases, and suicide compared to other plastic surgery patients, according to a comprehensive new study. Women with implants are more likely to develop cancer compared to other women their age, according to a second study. Women with leaking silicone breast implants are more likely to have several painful and potentially fatal autoimmune diseases or related illnesses, according to a third study. All three studies were federally-funded and published in medical journals in May 2001.

    "These articles are a wake-up call for the almost 300,000 women and teenagers who plan to get breast implants this year," according to Dr. Zuckerman, President of the National Center for Policy Research (CPR) for Women & Families, and author of numerous articles on women's health. "These studies remind us that we still know very little about the long-term dangers of breast implants -- because they have never been objectively studied until now."

    The first two studies, which were mandated by Congress in response to the controversy surrounding implants, were conducted by scientists from the National Cancer Institute (NCI). They were designed to answer questions of great importance to the almost 2 million U.S. women who have breast implants: 1) do breast implants increase the risk of cancer and 2) do women with implants die at a younger age than other women?

    The study on ruptured and leaking silicone breast implants was conducted by a team of scientists from the Food and Drug Administration (FDA), and several medical schools. This study was the first ever conducted to assess the health of women with ruptured breast implants.

Mortality

    The first study, "Morality among Augmentation Mammoplasty Patients" published in the medical journal Epidemiology, was the first to ever examine all causes of death among implant patients. It compares death rates of women with breast implants to death rates of other plastic surgery patients and to women of the same age in the general population. The study is based on medical records and death certificates of 13,000 women with breast implants, including silicone gel implants and saline implants, and more than 4,000 other plastic surgery patients. Previous studies of breast implants have focused on breast cancer and autoimmune diseases such as lupus and scleroderma, but not other serious illnesses.

    Although implant patients were relatively young, they were three times as likely to die from lung cancer, emphysema and pneumonia compared to other plastic surgery patients of similar ages. Deaths from brain cancer were twice as likely among implant patients, and suicide was four times as likely.

Cancer

    The second study, "Cancer Risk at Sites Other than the Breast Following Augmentation Mammoplasty" published in Annals of Epidemiology, found a statistically significant 21% overall increase in cancers for women with implants, compared to women of the same age in the general population. The number of women with stomach cancer, cervical cancer, vulvar cancer, brain cancer, and leukemia were all at least twice as high among women with implants. Cancer rates for other plastic surgery patients were also higher than the general population, but were lower than for women with breast implants.

    "These are groundbreaking studies because they evaluate women who had implants for at least eight years, and evaluate diseases that have never been studied before among implant patients. Cancer and other life-threatening diseases take many years to develop, so you need to study women with implants for 10-15 years or more to study long-term risks" explains Dr. Zuckerman.

Fibromyalgia and Autoimmune Diseases

    The third study, "Silicone Gel Breast Implant Rupture, Extracapsular Silicone, and Health Status in a Population of Women" published in Journal of Rheumatology, found that ruptured and leaking silicone breast implants were significantly linked to painful and debilitating auto-immune and soft-tissue diseases such as fibromyalgia and dermatomyositis. This study is the first to systematically evaluate the health of women with ruptured breast implants.

    This study compared three groups: 1) women with silicone gel implants that had not broken; 2) women with silicone implants that had ruptured with silicone gel spreading beyond the scar tissue surrounding the breast implants, and 3) women whose implants had ruptured but the silicone had not spread beyond the scar tissue surrounding the implants. Women who had silicone that had migrated outside the scar tissue were significantly more likely to report having been diagnosed with fibromyalgia (a painful soft-tissue disease) and other serious connective-tissue diseases and related conditions such as dermatomyositis, polymyositis, Hashimoto's thyroiditis, pulmonary fibrosis, eosinophilic fascitis, and polymyalgia.

    A majority of the 344 women in the study had at least one ruptured implant according to Magnetic Resonance Imaging (MRI), although the women appeared to be unaware of that fact. In addition, 21% of the women had silicone that had migrated outside the capsule of scar tissue that surrounds at least one of their breast implants.

    Since 1992, the FDA has restricted the availability of silicone gel breast implants to women with mastectomies, breast deformities, and for the replacement of broken gel implants. However, the FDA recently increased the availability of silicone breast implants for augmentation patients.

"These studies are a vital first step towards examining the long-term risks of silicone and saline breast implants. I hope these findings stimulate new independent and objective publicly-sponsored studies, and serve as a warning of potentially serious risks for women and teens who are considering implants" concludes Dr. Arthur Caplan, Director of the Center for Bioethics at the University of Pennsylvania Medical Center and member of the Board of Directors of CPR for Women & Families.

    CPR for Women & Families is a nonprofit, nonpartisan organization dedicated to improving the lives of women and families by explaining and disseminating objective research information. For additional information about breast implants, see the CPR website at www.center4policy.org.

 

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