Federal regulators have toughened the requirements for surgeons and medical device makers to inform women in detail about rising risks associated with breast implants, which also now will carry the government’s sternest warning — a “black box” label cautioning about the products’ potential harms.
The implant alarms, announced after years of complaints by patients, include the Food and Drug Administration’s counseling women that implants carry significant complications and should not be considered long-lasting products, secure for extended periods after surgery. The agency also ordered manufacturers to disclose ingredients used to make the devices.
The FDA, which is seeking public comment on its new oversight, has issued a 22-page document that describes how doctors and makers should discuss with patients the risks of implants.