FDA bans transvaginal mesh for prolapse

April 23, 2019

The U.S. Food and Drug Administration (FDA) has halted sales after manufacturers failed to demonstrate long-term benefits of the devices.

The U.S. Food and Drug Administration (FDA) has ordered manufacturers of all remaining surgical mesh indicated for transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing the products in the United States immediately. The companies have 10 days to submit plans for withdrawing the mesh from the market.

Midurethral slings and mesh for sacrocolpopexy midurethral slings and mesh for sacrocolpopexy are not included in this recommendation. Sling devices and sacrocolpopexy mesh implants will remain on the US market.

“Fortunately, midurethral tapes and mesh used for abdominal sacral colpopexy were appropriately not targeted for elimination,” said Contemporary OB/GYN Editorial Board member John O. DeLancey, MD. “If the FDA had banned these appropriate uses of mesh that have proven to have excellent outcomes with minimal risk, patients would have been harmed.”

Over the past several years, the FDA has seen a significant increase in the number of reported adverse events associated with use of surgical mesh for transvaginal POP repair. In 2016, mesh devices were reclassified from class II (moderate risk) to class III (high risk) and manufacturers were required to submit premarket approval applications (PMA) in order to continue marketing their devices in the United States. 

Boston Scientific filed two PMAs for its devices, Uphold LITE Vaginal Support System and Xenform Soft Tissue Repair System, while Coloplast filed one for its device, Restorelle DirectFix Anterior. In its review, the FDA found that both manufacturers failed to adequately assess the long-term safety of these devices and to demonstrate an acceptable long-term benefit compared to transvaginal surgical tissue repair without use of mesh.

In February 2019, the FDA organized an advisory panel to gather input from experts on how to evaluate the safety and effectiveness of the devices. The panel recommended that to support a favorable benefit-risk profile, surgical mesh’s effectiveness for transvaginal repair of POP should be superior to native tissue repair at 36 months and safety outcomes should be comparable for the two substances. 

“There has been hope among some gynecologic surgeons that transvaginal mesh repairs for prolapse would improve on native tissue repair results with no increased risk of complications,” said Dr. De Lancey, who is Norman F. Miller Professor of Gynecology, Director, Pelvic Floor Research, and Group Director, Fellowship in Pelvic Medicine and Reconstructive Surgery at the University of Michigan Medical School. “An expert panel of surgeons affirmed that this standard should be used to judge the most recent post market surveillance data. The FDA determined that the data submitted by the companies in their required post-market analysis did not reach this standard. They have therefore required the manufacturers to discontinue these products.”