In draft guidance released today, the US Food and Drug Administration (FDA) proposes labeling recommendations to manufacturers of breast implants to make sure women receive and understand information regarding the benefits and risks of breast implants.
“We have heard from many women that they are not fully informed of the risks when considering breast implants,” Amy Abernethy, MD, PhD, the FDA’s principal deputy commissioner, and Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement.
