Vaginal Mesh for Repair of Pelvic Organ Prolapse Reclassified as High Risk

By the Editors

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 have included bleeding, infection, organ perforation, pain during intercourse, severe pelvic pain, and urinary difficulties caused by mesh eroding into adjacent tissue. Both new devices and those currently on the market will be subject to premarket approval applications.

Other indications for surgical meshes, such as stress urinary incontinence or pelvic organ prolapse repaired abdominally, are not affected by these actions.