FDA Tightens Breast Implant Safety Requirements, Updates Study Results

FDA is calling for stronger warnings on breast implants including a boxed warning, which lists such potential risks as infection, rupture, capsular contraction, breast implant illness, and breast implant-associated anaplastic large cell Lymphoma (BIA-ALCL).

In addition, manufacturers can only sell breast implants to healthcare professionals who review the potential health risks and side effects with patients before surgery. Patients must also complete and initial a “Patient Decision Checklist" demonstrating that professionals have communicated the risks, benefits, and alternatives for breast implants.

FDA is also requiring manufacturers to disclose the ingredients used to make breast implants within 30 days, and patients must also recieve a device card. The agency also released updated information on the status of breast implant manufacturer post-approval studies as well as updated silicone gel-filled breast implant rupture screening recommendations. 

“Protecting patients’ health when they are treated with a medical device is our most important priority,” says Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, in a news release.  “In recent years, the FDA has sought more ways to increase patients’ access to clear and understandable information about the benefits and risks of breast implants. By strengthening the safety requirements for manufacturers, the FDA is working to close information gaps for anyone who may be considering breast implant surgery. As the FDA continues to evaluate the overall effects of breast implants in patients, today’s actions help ensure that all patients receive the information they need to make well-informed decisions affecting their long-term, personal health.”