The Food and Drug Administration on Wednesday recommended a so-called boxed warning as part of labeling for breast implants, the highest-level warning the agency issues.
Recommended language for the warning states that “breast implants are not considered lifetime devices" and "breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma."
The draft guidance further recommends patients considering getting implants go through a “decision checklist” that includes information on the risks with their doctors and that labeling include descriptions of the types and quantities of heavy metals and chemicals found in or emitted by implants as well as recommendations for screening for ruptures of silicone-filled implants.
"Taken as a whole we believe this draft guidance, when final, will result in better labeling for breast implants that will ultimately help patients better understand breast implant benefits and risks, which is a critical piece in making health care decisions that fit patients' needs and lifestyle," FDA Principal Deputy Commissioner Dr. Amy Abernethy and Dr. Jeff Shuren, director of the Center for Devices and Radiological Health, said in a statement on Wednesday.
"After a period of public comment, once the guidance is finalized, manufacturers may choose to follow the recommendations in the final guidance or they may choose other methods of labeling their devices, so long as the labeling complies with applicable FDA laws and regulations,” they added.