Fw: FDA Study Links Silicone Migration to Several Diseases

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Sent: Thursday, May 03, 2001 12:00 PM

Subject: FDA Study Links Silicone Migration to Several Diseases

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. ## The following has been sent to us by Rosemarie. . .Thanks Rosemarie for sending our way. Myrl Silicone Gel Breast Implant Rupture, Extracapsular Silicone, and Health Status in a Population of Women S. LORI BROWN, GENE PENNELLO, WENDIE A. BERG, MARY SCOTT SOO, and MICHAEL S. MIDDLETON ABSTRACT. Objective. To assess whether breast implant rupture or extracapsular silicone are associated with selected symptoms of self-reported physician-diagnosed connective tissue disease (CTD). Methods. Women with silicone gel breast implants responded to a questionnaire that included questions on health status, satisfaction with implants, symptoms of CTD, and physician-diagnosed disease. These women then had magnetic resonance imaging (MRI) of their breasts to determine the status of the implants with respect to rupture and extracapsular silicone. Results. Women with breast implant rupture diagnosed by MRI were no more likely to report a diagnosis of selected CTD than those with intact implants or those with implants of indeterminate status. Women with extracapsular silicone (silicone gel outside of the fibrous scar that forms around breast implants) were more likely to report having fibromyalgia (FM, p = 0.004) or other CTD, which included dermatomyositis, polymyositis, Hashimoto's thyroiditis, mixed CTD, pulmonary fibrosis, eosinophilic fasciitis, and polymyalgia (p = 0.008) than other women in the study. The association with FM remained statistically significant when adjusted for multiple comparisons (7 diagnoses) and implant age, implant location, or implant manufacturer (p < 0.05 in all cases), but became of borderline statistical significance when adjusted for multiple comparisons and self-perceived health status (p = 0.094) or self-perceived rupture status (p = 0.051). The association with other CTD remained statistically significant when adjusted for multiple comparisons and implant location or implant manufacturer, but became borderline or insignificant when adjusted for multiple comparisons and for implant age (p = 0.051), self-perceived health status (p = 0.434), or self-perceived rupture status (p = 0.145). Logistic regression was used to compute odds ratios of self-reported diagnoses comparing women with and without extracapsular silicone. The odds ratios were 2.8 (95% CI 1.2 to 6.3) for FM, and 2.6 (95% CI 0.8 to 8.5) for other CTD after adjustment for implant age, implant location, implant manufacturer, implant type, self-perceived health, self-perceived rupture status, and site of surgery practice. Conclusion. These data suggest an association between extracapsular silicone from ruptured silicone breast implants and FM. If this association persists in other studies, women with silicone gel breast implants should be informed of the potential risk of developing fibromyalgia if their breast implants rupture and the silicone gel escapes the fibrous scar capsule. (J Rheumatol 2001;28:996-1003) Key Indexing Terms: BREAST IMPLANTS BREAST PROSTHESES SILICONE FIBROMYALGIA ADVERSE EVENTS Return to May 2001 Table of Contents © 2001. The Journal of Rheumatology Publishing Company Limited.