FDA: Companies Must Stop Selling Vaginal Meshes for Pelvic Organ Prolapse

By Amy Orciari Herman

Edited by Lorenzo Di Francesco, MD, FACP, FHM

The manufacturers of surgical mesh products used for the transvaginal repair of pelvic organ prolapse must stop selling the devices immediately, the FDA said on Tuesday.

Just two companies are still making the meshes — Boston Scientific and Coloplast. The FDA says that neither company has "demonstrated a reasonable assurance of safety and effectiveness" of the devices, which is a prerequisite for marketing since the meshes were classified as high-risk in 2016.

Complications associated with the devices include mesh erosion through the surrounding tissue, pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems.

The agency says women who've had a transvaginal mesh placed should continue with routine follow-up; no additional action is required unless they experience complications.