Between 1997 and June 2019, the US Food and Drug Administration (FDA) allowed some medical device manufacturers to submit summary reports of adverse events related to their products through a hidden “Alternative Summary Reporting” (ASR) program that enabled these manufacturers to bypass the publicly accessible Manufacturer and User Facility Device Experience (MAUDE) database.1 This meant that until recently, the adverse events that were reported through the program to the agency remained concealed from the public.
The FDA has now released the previously hidden data, including those reported through Postmarket Spreadsheet Reports (PSRs), which the agency called in an email “a type of ASR available specifically for silicone gel-filled breast implant manufacturers.” One file with these data published on the FDA’s website includes more than 6600 adverse events linked to products manufactured by Allergan, Sientra, and Mentor.1
Among the products included in the formerly hidden data file listing adverse events reported to the FDA in the first quarter of 2019 are some of Allergan’s implants that have recently been recalled due to being linked to an increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).2
Older files recently released by the FDA contain numerous other adverse events linked to breast implants. The agency revealed a few months ago that it had received more than 350,000 reports that involved breast implants since 2009, which sources estimate to be between 7 to 20 times the number of reports the FDA had published in its publicly accessible database.3,4
The agency’s ASR files also list adverse events related to dental implants, blood glucose meters, and surgical staplers, along with other medical devices.
The FDA says that its alternative reporting programs had been implemented for reporting adverse events that were already well known, in an effort to make the reviewing process of these events more efficient. But Diana Zuckerman, PhD, president of the National Center for Health Research in Washington, DC, is not convinced by the agency’s rationale. “The justification does not make sense,” she said. “Because while it would make sense to say that the FDA thought having summary information would be less burdensome for everyone, including the FDA, that doesn’t explain why the information was also not public.”
The FDA’s decision to allow the summaries and not make them available to the public was “very inappropriate and unfair to patients and to physicians,” she said.