A 2001 FDA study shows an increased risk for fibromyalgia in women whose silicone breast implants have ruptured. These ruptured implants cause silicone gel to spread beyond the area of the implant and this appears to be a cause of fibromyalgia.
For the purposes of this study, the FDA questioned 344 women with silicone implants about symptoms such as joint pain, stiffness or swelling, fatigue, and localized rashes on their chest areas. The participants were also asked if any physician had diagnosed them with autoimmune diseases such as fibromyalgia, chronic fatigue, scleroderma, Sjögren’s syndrome or Raynaud’s disease. Fibromyalgia is a condition that causes chronic musculoskeletal aches and pains, sleep disturbances, and fatigue.
The women were administered magnetic resonance imaging studies (MRI) to check whether their breast implants were still intact, and if the implants were ruptured, to see whether silicone gel had worked its way past the implant’s surrounding scar tissue. It was discovered that women with ruptured implants did not have a higher risk than women with intact implants for these conditions as long as the silicone had not migrated beyond the surrounding scar tissue. However, women in whom the silicone gel had traveled beyond the fibrous scar surrounding the implant were found to have tripled their chances of developing fibromyalgia or other diseases affecting the connective tissue.
Lead investigator for the study, S. Lori Brown, Ph.D., M.P.H. at the FDA’s Center for Devices and Radiological Healthy comments, “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.”
This study was supported by the National Institutes of Health as well as the FDA’s Office of Women’s Health and was published in the Journal of Rheumatology’s May 2001 issue. It is believed that 6-8 million Americans suffer from fibromyalgia syndrome (FMS). Some 80% of those afflicted are women.
Silicone gel breast implants were removed from the market by the FDA back in 1992 when they lost their approval for general use. This is because of the dangers posed by leaking, ruptured implants. They are still allowed for use in studies that have obtained FDA approval, such as are conducted in women who are seeking to modify an existing breast implant or for those in need of breast reconstruction. Also, women who have existing implants that must be replaced due to rupture or for other medical reasons may take part in these studies.
In 2000, the FDA’s continued approval was granted to saline breast implants marketed by two different manufacturers.