Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
FDA adverse event reports and recall history for mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed (product code OTO), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 4,774
- Deaths
- 24
- Injuries
- 4,679
- Malfunctions
- 67
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2013-05-20TerminatedLabeling mix-ups
Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.
Coloplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. The incorrect Instructions For Use (IFU) pamphlet is included in the packaging.
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