FDA Recommends New Warning for Breast Implants

The agency also suggested that manufacturers include a checklist to guide patients' conversations 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 Vice-Rector 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 healthcare professionals when breast implants are considered," they added.

About 75 percent of women who get breast implants do so for cosmetic reasons. Most of the rest receive implants as part of post-breast reconstruction surgery.

The proposed recommendations are in the form of a draft guidance to the manufacturers. The FDA requests public comment for 60 days before completing the guidance.

During a dramatic hearing in March, many women who said they were injured by breast implants demanded that the FDA take tougher steps to ensure that patients have more information on potential risk and to ban devices associated with the most serious complications, including cancer. In May, the agency said it would not ban any implants at the time because it did not believe the cancer-related product ̵[ads1]1; a structured implant – met the legal standard to be banned.

The FDA, in its proposed guidance on Wednesday, also requested new guidelines for screening for possible violations, as well as a recommendation that manufacturers include information on ingredients in the device that are easy to understand for the devices.