Fw: Press release on FDA study on rupture and disease

[Guest guest]

Dear Friends, Here is the press release that the National Women's Health Network sent out on the new FDA study. They are a wonderful membership organization that has been very supportive of the concerns of implant patients, and women consumers in general. Their website is www.womenshealthnetwork.org Zuckerman ------------------------------ NEWS RELEASE National Women's Health Network FOR IMMEDIATE RELEASE May 1, 2001 FOR MORE INFORMATION Amy Allina: 202 347-1140 Ruptured Silicone Breast Implants Linked to Pain, Disease FDA Study Links Silicone Migration to Several Diseases WASHINGTON, DC - Ruptured and leaking silicone breast implants were significantly linked to painful connective-tissue and soft-tissue diseases such as fibromyalgia, pulmonary fibrosis, dermatomyositis, and other debilitating diseases in a new study by a team of scientists from the Food and Drug Administration (FDA), and medical schools at Duke University, University of land, and University of California at San Diego. The study was published in the May issue of the Journal of Rheumatology. The study is the first to systematically evaluate the health of women with ruptured breast implants. Women with ruptured implants could potentially be at increased risk of health problems compared to other implant patients, because they have greater exposure to silicone, and because silicone sometimes migrates outside the breast area to other parts of the body, such as arms and lungs. The 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. The results indicated that the women who had silicone that had migrated outside the scar tissue surrounding the breast implant 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 "This study is the first of its kind -- the first study to examine the health of women with ruptured, badly leaking silicone gel implants. It's hard to believe that more than 35 years after the first silicone breast implants were sold, we have the first published study showing the effects of silicone implant rupture. The study supports what many women with implants have described -- a link between ruptured implants and debilitating pain and diseases" concludes Pearson, Executive Director of the National Women's Health Network. The study evaluated 344 women with silicone gel implants who had not sought to have the implants removed, and who were contacted from a list of all patients from two medical practices. They were selected from a sample of 907 augmentation patients for a study designed to determine the percent of implants that are ruptured in the population of women who have not sought treatment for problems with their implants; 70 women who had their implants removed were excluded from the original sample of women, as were women with saline implants. Eighty-one percent of the women who were invited to participate in the study accepted. The women were asked about their health, answering questions about five symptoms (such as rashes and joint pain) and seven physician-diagnosed connective tissue diseases and related conditions. After the interview, they were asked to undergo Magnetic Resonance Imaging (MRI) to determine whether their implants were ruptured. A majority of the 344 women had at least one ruptured implant, although the women appeared to be unaware of that fact. In addition, 21 percent of the women had silicone that had migrated outside the capsule of scar tissue that surrounds at least one of their breast implants. "This is a well-designed study with the surprising finding that many women with breast implants who are ill are not seeking medical help or advice, even in situations where leaking silicone gel sometimes causes rather obvious cosmetic symptoms" Pearson points out. The National Women's Health Network and the National Center for Policy Research (CPR) for Women & Families are urging the FDA to immediately update its consumer materials and provide information to physicians in a "Dear Doctor" letter to inform them of the results of this important study. "Women and their physicians need to be aware that silicone can spread from ruptured implants, and potentially increase the risk of serious diseases" concludes Dr. Zuckerman, Executive Director of CPR for Women & Families. The study results will be published in the first week in May, the same time as two recently reported major studies, which indicate that women who have breast implants are more likely to die from brain tumors, lung cancer, other respiratory diseases, and suicide compared to other plastic surgery patients. 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. The National Women's Health Network is the only national non-profit public interest membership organization dedicated exclusively to women's health. NWHN does not accept financial support from pharmaceutical companies, tobacco companies, or medical device manufacturers. ##