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 (MAUDE).
Moving forward, breast implant manufacturers will be required to file individual medical device reports that will be publicly available in MAUDE. For past data received through summary reporting, the agency said it will also be making this data, including alternative summary reports for all devices under the program, publicly available in the coming weeks.
"We believe these steps for more transparent medical device reports will contribute to greater public awareness of breast implant adverse events," said FDA Principal Deputy Commissioner Amy Abernethy, and Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a statement released Thursday.
Abernethy and Shuren said increased public awareness of the number of adverse events may contribute to a woman’s own understanding of the risks of breast implants, but, as with any medical device report, they noted that generally the number of reports received cannot be used to determine the frequency with which a particular adverse event occurs.
"The information in medical device reports is important, but they are only one tool that contributes to our understanding of breast implants," they said. "Further, it is important that people understand that the reports are just that – a report by an outside party. The agency has not verified that they are accurate, nor that the issue was in fact caused by the device. For this reason, among others, these reports cannot be used alone to determine an incidence rate, causation, or associations as many reports can be duplicative or incomplete."