E-Posters-Complications Reported to the Food and Drug Administration - A Comparison of Vaginal Mesh Products

Complications Reported to the Food and Drug Administration - A Comparison of Vaginal Mesh Products - Amanda M. Artsen, MD

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This document discusses complications reported to the FDA regarding vaginal mesh products. Mesh complications led to the upgrade of vaginal mesh from a Class II to a Class III product and ultimately to the removal of transvaginal mesh from the market in 2019. The aim of the study was to compare vaginal prolapse mesh problems reported to the FDA.<br /><br />The study analyzed six mesh products found in the FDA's MAUDE database, including Gynecare Prolift, Uphold, Avaulta Plus, Apogee/Perigee, Exair Anterior and Posterior Repair System, and Ascend. Complication proportions were compared using statistical tests.<br /><br />The reports to the FDA on transvaginal mesh describe a wide range of adverse events, but the quality of data varies widely. Complication proportions may be influenced by factors such as mesh groupings, market share, duration of time on the market, and trends in surgical placement.<br /><br />The most common device problem reported was "adverse event without identified device problem." Other common issues included material erosion, leakage/splash, loose/intermittent connection, break, and detachment of device/component. Patient complaints included pain, erosion, and infection, with Uphold having a significantly lower proportion of reports for these issues.<br /><br />The document emphasizes the need for randomized trials to determine the true benefits and complications of vaginal mesh products compared to other prolapse repairs.<br /><br />Overall, the document highlights the significance of complications reported to the FDA in influencing public opinion and contributing to the removal of transvaginal mesh from the market. However, it also acknowledges the limitations of the data and the need for further research on the benefits and risks of vaginal mesh.

Keywords

complications

FDA

vaginal mesh products

Class II

Class III

transvaginal mesh

vaginal prolapse mesh problems

MAUDE database

mesh products

adverse events