The U.S. Food and Drug Administration (FDA) issued the final guidance, Breast Implant – Certain Labeling Recommendations to Improve Patient Communication. The final guidance is to help people who are considering breast implants have the information they need for a discussion with their doctors. These labeling recommendations are intended to enhance, but not replace, discussions between doctors and patients to talk about the benefits and risks of breast implants that relate to individual patients.
In addition, FDA has updated the final guidance Saline, Silicone Gel, and Alternative Breast Implants to provide consistency with these labeling recommendations. FDA intends to issue a more comprehensive update to the Saline, Silicone Gel, and Alternative Breast Implants guidance in a future revision.