FDA adds boxed warning to breast implants

After hearing testimony in 2019 from women who said their doctors did not adequately warn them about the potential health complications of breast implants, the FDA said it decided to restrict the sale of breast implants to only health care providers who offer patients a standardized checklist that explains the risks. The changes require doctors to walk patients through these potential problems and to give the patient an opportunity to sign off on the checklist to show they were properly informed about the risks to their health.

The warning and the checklist will explain symptoms that some patients with implants have experienced, including fatigue, joint pain, tiredness, brain fog, and memory loss. It will also explain the possible link between implants and a rare type of cancer of the immune system known as anaplastic large cell lymphoma (BIA-ALCL). The cancer occurs more commonly in patients with textured breast implants than those who have the smooth implants. Many of the documented cases were tied to textured implants produced by Allergan that the company voluntarily recalled in 2019.

About 75% of those who get implants do so for cosmetic reasons. The rest get them following breast cancer surgery.

The FDA has also updated implant rupture screening recommendations for silicone gel-filled breast implants and updated its guidelines on what manufacturers will need to do with post-approval studies.

“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,” Dr. Binita Ashar, the director of the FDA’s Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, said in a statement.

“By strengthening the safety requirements for manufacturers, the FDA is working to close information gaps for anyone who may be considering breast implant surgery.”