Plastic Surgeons who are members of the The American Society for Aesthetic Plastic Surgeons recently testified at the FDA Panel on Breast Implants. The Food and Drug Administration (FDA) conducted a panel hearing on silicone gel-filled breast implants, the purpose of which was to evaluate the progress of long-term studies mandated when silicone gel-filled breast implants were approved by the FDA to return to market in 2006. A key focus was to discuss innovative approaches to gathering data for future post-approval studies.
After two days of discussion and testimony, FDA officials said silicone breast implants were safe and the studies would continue. “Women should feel assured that the F.D.A. continues to believe that currently marketed silicone breast implants are safe,” said William Maisel, MD, MPH, chief scientist in the FDA’s Center for Devices and Radiological Health.
Excerpted from ASAPS E-Bulletin 9/8/11