Implants and Fibromyalgia

[Guest guest]

http://stacks.msnbc.com/news/567146.asp#BODYThe FDA took silicone gel implants off the market in the early 1990sbecause of concerns they might cause health problems. But they werereturned to the market for medical uses after researchers concluded theywere safe.Breast implant ruptures tied to fibromyalgia

Finding fuels debate over safety of silicone gelBy Marc KaufmanTHE WASHINGTON POST May 1 ‹ Women with ruptured silicone gel breast implants may be atincreased risk of the painful condition fibromyalgia, according to thefirst study of women whose implants were known to have burst. ŒWe found an association between fibromyalgia reports and women who hadsilicone gel found outside the breast capsule. This doesn¹t mean there isa cause and effect relationship between the two, but that there might be.¹‹ LORI BROWNsenior researcher with the FDA's Center for Medical Devices andRadiological Health

THE STUDY, conducted by researchers fromthe Food and Drug Administration and the National Institutes of Health,found that when silicone gel spreads outside the border of scar tissuearound the breast area, reports of fibromyalgia increased significantly. ³We found an association between fibromyalgia reports and women whohad silicone gel found outside the breast capsule,² said Lori Brown, asenior researcher with the FDA¹s Center for Medical Devices andRadiological Health. ³This doesn¹t mean there is a cause and effectrelationship between the two, but that there might be.² Her paper, published in the Journal of Rheumatology, concludes bysaying that if the findings are confirmed in later studies, a screening ofall women with silicone implants should be considered to determine iftheir devices had ruptured. The finding is the latest in a long scientific debate over thesafety of silicone gel and saline breast implants. The FDA took siliconegel implants off the market in the early 1990s because of concerns theymight cause health problems. But they were returned to the market formedical 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 siliconegel implants for cosmetic surgery, and are working with the FDA todemonstrate their safety. An official of McGhan Medical of Santa Barbarasaid his company already has one large study underway and is now workingwith the FDA to design a second for an improved silicone gel now widelyused in Europe. The new study included 344 women from Birmingham who had undergonecosmetic breast augmentation before 1988. The women had their breastsexamined with magnetic resonance imaging (MRI) to determine whether theimplants had ruptured and whether the gel had spread beyond the breastarea. The study found that about two-thirds of the implants had somerupture and that gel had spread in about one-quarter of the women.While the study found a significant association between that spread andreports of fibromyalgia, it showed no increase in risk for other majorconnective tissue diseases. Fibromyalgia is a syndrome with no clearbiological cause that results in generalized pain and tenderness, sleepdisturbance and complaints of mental loss. Zuckerman, director of the National Center for PolicyResearch for Women and Families, a Washington-based nonprofit group, saidthe new study was important because it was the first to focus on womenwith ruptured implants. ³There is every reason logically to think these women mighthave different experiences, but there has been an obvious lack ofresearch,² she said. ³People concerned about breast implants have longsaid the women with ruptured implants are the ones showing up very sick.² Another recent study of breast implants conducted by the NationalCancer Institute found that although women were not at increased risk formost cancers, they appear to suffer from brain and lung cancer at a higherrate than other women who undergo plastic surgery. © 2001 The Washington Post Company