FDA tightens rules for breast implants
The US Food and Drug Administration has announced several measures to strengthen breast implant risk communication and help patients make informed decisions.
First, the agency issued orders restricting the sale and distribution of breast implants to help ensure that patients considering breast implants are provided with adequate risk information so that they can make fully informed decisions. Additionally, the agency has approved new labeling for all legally marketed breast implants that includes a boxed warning, a patient decision checklist, updated silicone gel-filled breast implant rupture screening recommendations, a device description with a list of specific materials used in the device and a patient device card. Finally, the FDA released updated information on the status of breast implant manufacturer post-approval studies. These actions will help patients understand the risks and benefits of breast implants and make more informed decisions about their health.
“Protecting patients’ health when they are treated with a medical device is our most important priority,” said Binita Ashar, M.D., director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health. “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.”
