Surgical meshes for vaginal prolapse reclassified high-risk
8th January 2016
The FDA has reclassified surgical meshes used to repair pelvic organ prolapse transvaginally from moderate-risk devices (class II) to high-risk (class III) following thousands of reports of adverse events.
In addition, surgical mesh manufacturers will be required to submit a premarket approval application to demonstrate the devices' effectiveness and safety for transvaginal repair.
Device complications