Breast Implant-Makers Now Required To File Individual Reports On Each Adverse Event, FDA Says
Executive Summary
The agency is redoubling efforts to warn women about the risks of silicone and saline breast implants after feedback from a recent advisory panel meeting. On 2 May, the regulator said it is requiring manufacturers to file individual Medical Device Reports for each adverse event regarding implants – part of a bigger effort to end its Alternative Summary Reporting Program for all devices.