FDA Consumer Magazine, November/December 2001
Women whose silicone breast implants have ruptured and spread silicone gel beyond the fibrous scar that forms around the implant may be at increased risk for fibromyalgia, an FDA study indicates.
FDA researchers asked 344 women with silicone gel implants if they had experienced persistent joint pain, swelling or stiffness; rash on their breasts or chest; or fatigue. Those in the study also were asked whether a physician had diagnosed them with Raynaud’s disease, Sjögren’s syndrome, scleroderma, chronic fatigue, or fibromyalgia–a chronic condition marked by fatigue, musculoskeletal aches and sleep disturbances.
The women also had a magnetic resonance imaging (MRI) examination to detect whether their implants were intact or ruptured, and whether silicone gel had leaked outside of the scar tissue immediately surrounding the implant.
The study found that women with a ruptured implant in which the silicone hadn’t leaked beyond the scar tissue were no more likely than women with intact implants to report that they had either the persistent symptoms or diagnosed illnesses listed on the questionnaire.
However, the women with silicone gel that had migrated outside the fibrous scar around the implant were nearly three times more likely to report that they had been diagnosed with fibromyalgia or other connective tissue disease than women without extracapsular silicone gel.
“If other studies are consistent with these findings, women should be informed of the potential risk of developing fibromyalgia if their breast implants rupture and silicone gel escapes outside the fibrous scar capsule,” says lead study investigator S. Lori Brown, Ph.D., M.P.H., of the FDA’s Center for Devices and Radiological Health.
The study, supported in part by the FDA’s Office of Women’s Health and the National Institutes of Health, was published in the May 2001 Journal of Rheumatology. An estimated 6 million to 8 million Americans have fibromyalgia. About 80 percent of those affected are women.
The FDA took silicone gel breast implants off the market for general use in 1992 because of safety concerns. They continue to be allowed in FDA-approved studies for women seeking breast reconstruction or revision of an existing breast implant. Additionally, those who need to have an existing implant replaced for medical reasons, such as implant rupture, are also eligible for these studies.
In 2000, the FDA approved the continued use of two manufacturers’ saline breast implants. (See “Saline Breast Implants Stay on Market as Experts Warn About Risks” in the July-August 2000 FDA Consumer.)