The older the implants are, the more health risks they pose, and those risks could require additional surgery.
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.”