FDA sets stronger safety warnings for breast implants

By MATTHEW PERRONE
AP Health Writer

WASHINGTON (AP) — The Food and Drug Administration is enforcing new warnings on breast implants. The federal rules announced Wednesday mainly apply to implant manufacturers. They must add a boxed warning message — the most serious type — to promotional and scientific materials. Patients also must be given information about implants’ potential risks and complications. Breast augmentation is the most common cosmetic surgical procedure in the U.S. Roughly 400,000 patients get implants each year, 100,000 of them after cancer surgery. The FDA announcement is the latest in a decades-long effort to manage safety issues with the devices. Recipients have called on the agency for years to provide more information about risks and complications.