Fw: New implant study -- in the Washington Post

[Guest guest]

Dear Friends, I did not mean to imply that women with ruptured implants are the only ones that are very sick. Zuckerman Washington Post, May 1, 2001 Breast Implants Linked to Fibromyalgia By Marc Kaufman Women with ruptured silicone gel breast implants may be at increased risk of the painful condition fibromyalgia, according to the first study of women whose implants were known to have burst. The study, conducted by researchers from the Food and Drug Administration and the National Institutes of Health, found that when silicone gel spreads outside the border of scar tissue around the breast area, reports of fibromyalgia increased significantly. "We found an association between fibromyalgia reports and women who had silicone gel found outside the breast capsule," said Lori Brown, a senior researcher with the FDA's Center for Medical Devices and Radiological Health. "This doesn't mean there is a cause and effect relationship between the two, but that there might be." Her paper, published in the Journal of Rheumatology, concludes by saying that if the findings are confirmed in later studies, a screening of all women with silicone implants should be considered to determine if their devices had ruptured. The finding is the latest in a long scientific debate over the safety of silicone gel and saline breast implants. The FDA took silicone gel implants off the market in the early 1990s because of concerns they might cause health problems. But they were returned to the market for medical uses -- mostly for reconstruction after breast cancer surgery -- after researchers concluded they were safe. Two implant companies have announced they hope to resume use of silicone gel implants for cosmetic surgery, and are working with the FDA to demonstrate their safety. An official of McGhan Medical of Santa Barbara said his company already has one large study underway and is now working with the FDA to design a second for an improved silicone gel now widely used in Europe. The new study included 344 women from Birmingham who had undergone cosmetic breast augmentation before 1988. The women had their breasts examined with magnetic resonance imaging (MRI) to determine whether the implants had ruptured and whether the gel had spread beyond the breast area. The study found that about two-thirds of the implants had some rupture and that gel had spread in about one-quarter of the women. (Some companies, such as McGhan, had much better records on ruptures.) While the study found a significant association between that spread and reports of fibromyalgia, it showed no increase in risk for other major connective tissue diseases. Fibromyalgia is a syndrome with no clear biological cause that results in generalized pain and tenderness, sleep disturbance and complaints of mental loss. Zuckerman, director of the National Center for Policy Research for Women and Families, a Washington-based nonprofit group, said the new study was important because it was the first to focus on women with ruptured implants. "There is every reason logically to think these women might have different experiences, but there has been an obvious lack of research," she said. "People concerned about breast implants have long said the women with ruptured implants are the ones showing up very sick." Another recent study of breast implants conducted by the National Cancer Institute found that although women were not at increased risk for most cancers, they appear to suffer from brain and lung cancer at a higher rate than other women who undergo plastic surgery.