Presentation Authors: Ashley Caron*, Colby Souders, Ndidiamaka Obi, Khasiah Clark, Karyn Eilber, Jennifer Anger, Los Angeles, CA
Introduction: The Manufacture And User Facility Device Experience (MAUDE) Database is a public information portal published by the Food and Drug Administration (FDA) conveying medical device-related adverse events and complications. The site allows for mandatory and voluntary reporters to submit device reports regarding intraoperative problems and adverse events associated with devices. These reports can be updated by the submitter. The MAUDE database has been cited in peer reviewed articles and by the news media regarding the safety of certain devices and is used by physicians to determine adverse events that may not yet be reported in medical literature. According to their public health notification, from January 2008 through December 2010, the FDA received 2,874 reports related to transvaginal mesh (mesh) for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). This was followed by mass media attention and class action lawsuits. Considering its purpose advising on the safety of medical devices, we aimed to evaluate the reliability of the MAUDE database using longitudinal analysis.
Methods: In 2014, data were collected from a 1% sample of reports made to the FDA from 2000-2014 regarding mesh for POP and SUI. The data included manufacturer, device, reporter, complainant diagnosis, and adverse events. The same 1% sample was reviewed again using the same methods in June of 2018 and edits made to each entry were analyzed.
Results: Of the total entries reviewed, 18.36% had been altered at least once in a four-year span. One entry involved change in manufacturer while three changed the reported device. The remaining changes consisted of adding more adverse events to existing entries. 47% of entries were reported by manufacturers and company representatives while 41% were reported by attorneys. Only 2% of entries were reported by patients and 10% by physicians.
Conclusions: Nearly 20% of entries submitted to the MAUDE database were altered over four years. Moreover, a sizeable percentage of the data is reported by attorneys, rather than physicians and patients, possibly as part of litigation against transvaginal mesh manufacturers. While intended to report device-related complications, the MAUDE database should be considered with caution and not relied upon as the sole source of evidence to confirm or reject a device.