The Food and Drug Administration, under fire from women who say they were harmed by breast implants, proposed on Wednesday that manufacturers spell out warnings about possible complications from the devices, including rare cancers and the need for additional surgeries.
The agency recommended that manufacturers use a boxed warning - the FDA's most serious caution - to identify risks, including that implants are not lifetime devices, that the chances of developing complications increase the longer a woman has an implant, and that they have been associated with a rare form of lymphoma, as well as with symptoms such as fatigue and joint pain.
The agency also proposed the manufacturers include a checklist to guide patients' talks with their surgeons about the risks and benefits of implants. A checklist also gives patients the opportunity to ask doctors about their experience, education, training and credentials, the FDA said.
"We have heard from many women that they are not fully informed of the risks when considering breast implants," FDA Principal Deputy Commissioner Amy Abernethy and Jeff Shuren, director of the agency's Center for Devices and Radiological Health said in a statement Wednesday. The new recommendations are "designed to help inform conversations between patients and health care professionals when breast implants are being considered," they added.
About 75 percent of women who get breast implants do so for cosmetic reasons. Most of the rest get implants as part of reconstruction after surgery for breast cancer.
The proposed recommendations are in the form of a draft guidance to manufacturers. The FDA is asking for public comment for 60 days before finalizing the guidance.
At a dramatic hearing in March, many women who said they were hurt by breast implants demanded the FDA take tougher steps to ensure patients have more information about potential risks and to ban devices linked to the most serious complications, including cancer. In May, the agency said that it would not ban any implants at that time because it did not believe the product linked to cancer - a textured implant - met the legal standard for being banned.
But in July, implant maker Allergan announced a worldwide recall of its Biocell textured breast implants after the FDA found a sharp increase in a rare cancer and deaths linked to the products and asked the company to pull them from the U.S. market.
The FDA, in its proposed guidance on Wednesday, also called for new screening guidelines for possible ruptures, as well as a recommendation that manufacturers include product ingredient information in the device's labeling that is easy for patients to understand.