Reports from thousands of women that breast implants are causing problems like debilitating joint pain and fatigue, claims long dismissed by the medical profession, are receiving new attention from the Food and Drug Administration and researchers.
This may be a long-awaited moment of validation for tens of thousands of women who have been brushed off as neurotic, looking to cash in on lawsuits or just victims of chance who coincidentally became ill while having implants.
The F.D.A. has begun to re-examine questions about implant safety that have long been disputed by doctors and implant manufacturers, and that most consumers thought had been resolved a decade or so ago.
Millions of women have implants, which are silicone sacs filled with either salt water or silicone gel, used to enlarge the breasts cosmetically or to rebuild them after a mastectomy for breast cancer.
On Tuesday, the agency warned two makers of breast implants that they had failed to conduct adequate long-term studies of the devices’ effects on women’s health. Those studies were mandated as a condition of approving the implants, and the agency cautioned that the devices could be taken off the market if the research wasn’t properly carried out.
The agency also issued a statement on Friday that applied to a broad array of medical devices, acknowledging that implanted devices may make some people sick. “A growing body of evidence suggests that a small number of patients may have biological responses to certain types of materials in implantable or insertable devices,” the agency said. Those effects can include “inflammatory reactions and tissue changes causing pain and other symptoms that may interfere with their quality of life.”
And next week, the agency will hold a two-day meeting about breast implants, hearing from researchers, patient advocacy groups and manufacturers.
One problem to be discussed is an uncommon cancer of the immune system called anaplastic large cell lymphoma, which has been detected so far in 457 women with breast implants, according to the F.D.A. Removing the implants usually eliminates the disease, but some women have also needed chemotherapy, and 17 deaths from the cancer have been reported worldwide.
The F.D.A. website says the agency “has not detected any association between silicone gel-filled breast implants and connective tissue disease.” But it adds, “In order to rule out these and other complications, studies would need to be larger and longer than these conducted so far.”
The new warnings are of potential concern to millions of women with implants. About 400,000 women in the United States get breast implants every year, including 300,000 for cosmetic reasons and 100,000 for reconstruction after mastectomies performed to treat or prevent breast cancer. Worldwide, about 10 million women have breast implants.