The FDA won’t ban breast implants linked to cancer at this time
A silicone gel breast implant. By Laurie McGinley Laurie McGinley Reporter covering health and medicine Email Bio Follow May 2 at 2:34 PM A month after a dramatic hearing in which many women called on the Food and Drug Administration to ban a type of breast implant linked to a rare cancer, the agency said it won’t take that action now but will increase efforts to collect and disseminate information about risks involving the device.
Some of those devices are not sold in the United States, the FDA said. In addition, while textured implants make up as much as 80 percent of the market share in some other countries, they represent only 10 percent or less of the implants sold in this country, the agency said. The FDA officials also addressed “breast implant illness” a constellation of autoimmune problems that includes joint and muscle pain and allergies and fatigue — a topic that was repeatedly raised at the March hearing.
Responding to such concerns, the agency said it is considering requiring implants to carry what’s called a boxed warning — the agency’s strongest safety warning. And it may require doctors and patients to sign checklists of risks to make sure women have the necessary information to make an informed decision.
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