Complications Reported to the Food and Drug Administration: A Cross-sectional Comparison of Urogynecologic Meshes

This study is a cross-sectional analysis of medical device reports (MDRs) of urogynecologic mesh from January 2004 to March 2019, using the Reed Tech Navigator (LexisNexis), which codes MDRs. The percentage of reports containing specific complaints (not an adverse event rate) were compared with χ2 tests with Dunn-Sidak correction. Correlations with time on market, mesh weight, stiffness, and porosity were determined. Results The 34,485 reports examined included 6 transvaginal meshes, 4 sacrocolpopexy meshes, and 10 midurethral slings. Most reported events were pain, erosion, and infection. For transvaginal prolapse, less than 10% of Uphold Lite (Boston Scientific) reports contained pain or erosion versus greater than 90% of Prolift/Prolift+M (Ethicon, P
Source: Female Pelvic Medicine and Reconstructive Surgery - Category: OBGYN Tags: Original Articles Source Type: research