Lessons Learned from the MAUDE Database on Transvaginal Synthetic Mesh and Sling Reports

The marked growth of transvaginal mesh and sling reports in the MAUDE database, as well as attorney submitted reports, correlated with the timing of the 2011 FDA issued notification warning the public about the risk of complications associated with transvaginal mesh placement. Despite some shortcomings, the MAUDE database offers an appropriate tool to measure overall trends of device complications and serves as a vehicle for the FDA to alert the public regarding potential dangers.