FDA Bans Summary Reporting for Breast Implants

FDA appears to be making good on its promise to make all adverse event reports public. The agency ended all summary reporting of breast implant medical device reports in an effort to promote greater transparency.  This is part of a larger effort to end the alternative summary reporting program for all medical devices, which FDA said it intends to complete in the coming weeks. The agency was accused earlier this year of hiding millions of adverse event reports from the public under what is known as the alternative summary reporting program, which was established in 1997. Making all of the data regarding adverse event reports available to the public was among Scott Gottlieb's final efforts before he resigned his post as FDA commissioner in April. The intent behind the alternative summary reporting program was to allow FDA to more efficiently review adverse events for well-established risks but was not allowed for patient deaths and unusual, unique, or uncommon adverse events, which, in the case of breast implants, included breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). France recently banned several types of textured breast implants that have been linked to BIA-ALCL, and more countries appear to be following suit, including Canada and the Netherlands. The problem with the program is that alternative summary reports were not previously available in FDA's public database known as the Manufacturer and User Facility Device Experience (M...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news