FDA Cautions Against Using Mesh in Pelvic Organ Prolapse

In treating pelvic organ prolapse, use of mesh, especially if placed transvaginally, "may expose patients to greater risk than other surgical options," the FDA warned this week. The agency estimates there were at least 100,000 prolapse repairs done with mesh last year, most done transvaginally.

The FDA reports that the most frequent complications resulting from mesh include protrusion of the mesh out of vaginal tissue, pain, infection, bleeding, and pain during intercourse. Its review of the literature since the mid-1990s found "no evidence that mesh provided any greater clinical benefit than non-mesh surgeries."

The agency reminds clinicians that mesh placement is permanent and can complicate future procedures in the patient. Also, there is evidence that if mesh must be used, abdominal placement may bring fewer complications than the transvaginal approach. Finally, FDA recommends discussing the risks and benefits of transvaginal repair with patients and informing them if mesh is used.

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