May 18, 2001 -- In the early 1990s, the FDA declared silicone gel breast implants to be unsafe. But when continued research failed to reveal a significant health risk, the implants returned to the market -- for use in reconstructive surgery. Now a recent study introduces a new twist: Women whose ruptured implants leak silicone into their bodies seem to have a higher incidence of a painful syndrome called fibromyalgia, a study shows.
Fibromyalgia is a debilitating syndrome characterized by body aches and tenderness, morning stiffness, loss of mental sharpness, and sleep difficulties. A rheumatologist usually diagnoses the condition.
"This is the very first study in which the rupture status of every implant has been known," study leader S. Lori Brown, PhD, MPH, tells WebMD. While many studies have looked at health problems in women with implants, she says, none has looked specifically at the potential risk of extracapsular silicone -- gel that has spread into the body beyond the scar tissue capsule surrounding the implant. The study appears in May's Journal of Rheumatology.
The team surveyed women with silicone gel implants, asking if they thought they had fibromyalgia, if they had ever been diagnosed with it or a connective tissue disorder such as lupus or scleroderma, and about their health in general. None of the 907 respondents knew whether their implants had ruptured.
Nearly 350 of the women who returned the survey were available to have their breast scanned with an MRI to determine whether their implants had ruptured.
"We looked to see who had said they had [fibromyalgia] and other diseases, and how it correlated with the status of their breast implant -- as to whether it was intact or ruptured," says Brown, an epidemiologist with the FDA's Center for Devices and Radiological Health
They found that women with ruptured implants and with extracapsular gel, where silicone had leaked beyond the capsule, "were more likely to report to us that they had fibromyalgia than those whose implants were intact," she tells WebMD. Not everyone with ruptured implants had extracapsular gel, says Brown, but nearly everyone with extracapsular gel had a ruptured implant.
"The findings are not surprising. Most of us [doctors] think there is more fibromyalgia among women with implants than in the population in general," says Clarence W. Legerton III, MD, an associate professor of medicine in the division of rheumatology at the Medical University of South Carolina in Charleston. He reviewed the paper for WebMD.
On the other hand, extracapsular silicone means increased exposure to potential toxins, he tells WebMD, and "this is [yet] another study showing no connection between silicone implants and the connective tissue diseases like lupus or scleroderma." And that's important, he says, in light of ongoing legal actions.
"Our study compared women with implants to other women with implants, and the findings do suggest an association between extracapsular silicone and fibromyalgia," Brown tells WebMD. Keep in mind, however, that an association does not necessarily indicate actual risk, she says.
"This in no way shows a cause-and-effect relationship between extracapsular silicone and fibromyalgia," says Brown. "All we've observed here is a statistical association." As with all scientific research, the results must be replicated and confirmed independently before any strong conclusions can be drawn or suggestions made.
"If repeat studies do show a similar association," she says, "then women considering getting implants should be informed of a risk" of fibromyalgia.