USA – FDA Issues Final Guidance for Certain Labeling Recommendations for Breast Implants

Today, the U.S. Food and Drug Administration issued the final guidance, “Breast Implants – Certain Labeling Recommendations to Improve Patient Communication,” as part of the agency’s effort to help improve the information available to patients and health care professionals about the risks of breast implants. The draft guidance of this document was issued in 2019.

“As new information has become available about the risks and complications of breast implants, it is critical that women have access to information they need to make informed decisions,” said Binita Ashar, M.D., Director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health. “After working with stakeholders, including patients, today we are recommending format and content changes to breast implant labeling so the information is presented in an easy to understand way. It is important that patients discuss the risks and benefits of breast implants with their health care provider and we hope that these labeling recommendations will help in facilitating these discussions.”…