The U.S. Food and Drug Administration's efforts on urogynecologic surgical mesh have focused on identifying benefit-risk concerns related to some of these devices, and strengthening the FDA's regulatory oversight to protect patients, while enabling those who need these devices to benefit from them.
The FDA has conducted epidemiological research on the safety and effectiveness of surgical mesh, as a part of an effort to better understand possible adverse events associated with surgical mesh for stress urinary incontinence (SUI) and pelvic organ prolapse (POP). They have also collaborated with professional societies and other stakeholders to fully understand the postmarket performance of urogynecologic surgical mesh devices, and the occurrence of and signs and symptoms associated with specific adverse events including low frequency but life-altering adverse events that may occur following repairs with surgical mesh.
On August 16, 2021 the FDA release the final results of the Boston Scientific Transvaginal Mesh for Pelvic Organ Prolapse (POP) 522 studies. The Boston Scientific and Coloplast devices for transvaginal repair of pelvic organ prolapse are no longer commercially available. However, the FDA required the manufacturers to continue follow-up of the subjects already enrolled in their postmarket surveillance studies, which looked at effectiveness and safety of transvaginal mesh for POP as compared to transvaginal native tissue repair (repairs without the use of mesh).
The two Boston Scientific 522 studies were completed, and the final reports (36-month follow-up data) were reviewed by the FDA. The study results showed that Boston Scientific transvaginal POP mesh had similar effectiveness and safety outcomes to native tissue repair at 36 months. However, patients with transvaginal POP mesh repair are exposed to additional risks, including mesh exposure and erosion, compared to patients who underwent native tissue repair. Therefore, the FDA continues to believe that these devices do not have a favorable benefit-risk profile.
An additional report on the Coloplast 522 study is expected in February 2022. As of April 16, 2019 the FDA issued an order to stop selling and distributing products.
After the reclassification of surgical mesh for transvaginal repair of pelvic organ prolapse into class III, the FDA began its review of two Premarket Approval Applications (PMA) from Boston Scientific for its devices, the Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair System, and a Premarket Approval Application from Coloplast for its device, Restorelle DirectFix Anterior. The FDA decided not to approve these PMAs because the data submitted did not provide a reasonable assurance of safety and effectiveness. In particular, the data submitted were not consistent with the recommendations of the February 2019 advisory panel. The FDA ordered the two manufacturers of the three mesh surgical products on the market for the transvaginal repair of pelvic organ prolapse to stop selling and distributing their products immediately. The companies subsequently withdrew their products from the market.
The FDA will continue to provide information to the public as it becomes available.
