Manufacturer and User Facility Device Experience Reporting of Events Related to Transvaginal Mesh: Understanding the Data.

Overview

abstract

OBJECTIVE: The aim of this study was to examine potential bias in reports to the Manufacturer and User Facility Device Experience (MAUDE) database involving vaginal mesh by identifying the party submitting the report, the nature of the complaints, and whether the reports were edited. METHODS: All reports submitted to the MAUDE database involving synthetic transvaginal mesh from January 2000 through December 2017 (40,266 safety reports) were identified. A random 2% sample (900) of these reports was reviewed in depth to determine the specific relevant details, including reporter type (patient, manufacturer, lawyer) and details of the complaint/injury. RESULTS: Of the 40,226 reports to MAUDE identified, 28,473 (70.7%) were sling reports, and 11,793 (29.3%) described mesh products augmenting pelvic organ prolapse repair. Of the 900 reports reviewed in depth, 46%, 41%, 10%, and 2% of entries were reported by the manufacturer, attorney, health care provider, and patients, respectively. In the 4 years after submission, 18.6% of reports were modified at least once. CONCLUSIONS: The MAUDE database allows physicians, manufacturers, and patients to immediately report adverse events experienced due to medical devices. While this database is an important means to identify potential danger to patients, any individual can file a report and, thus, it should not be the sole source of evidence to consider when assessing device safety. Further, the MAUDE database provides no information into the total number of cases performed without complication.