Transvaginal Mesh Implants

Just yesterday, Joint Committee Opinion issued by the American College of Obstetricians and Gynecologists (ACOG) and the American Urogynecologic Society (AUGS), recommended that the use of transvaginal mesh for the treatment of pelvic organ prolapse (POP) be limited to high-risk women for whom the benefit may justify the risk.

Additionally, the Joint Committee recommended that a national registry be created to track outcomes for all patients who receive transvaginal mesh implants. ACOG and AUGS reviewed several cases studies and randomized trials, which examined the nature and incidence of complications caused by transvaginal mesh when used to treat POP. The Joint Committee found that recent reports indicate that nearly 20% of POP repairs involving transvaginal mesh may result in mesh erosion.

According to AUGS President, Matthew D. Barber, M.D., “The incidence of POP continues to grow. . . More than 350,000 women undergo surgery for this condition each year.” In July, the U.S. Food and Drug Administration (FDA) issued a transvaginal mesh warning, advising patients and doctors to consider alternative treatments to transvaginal mesh. The Joint Committee recommendations echo the FDA warning. Former chair of ACOG’s Committee on Gynecologic Practice, Cheryl B. Iglesia, M.D., highlighted that complications resulting from transvaginal mesh often require corrective surgery, but that “complete removal of the mesh may not be possible. For this reason, it’s important to understand that, in many cases, POP can be successfully treated without mesh and women and their doctors really need to weigh the risks and benefits before deciding on a course of action.”

In addition to reiterating that the use of vaginal mesh should be limited and alternative options considered, the Joint Committee outlined that there is “an urgent need for the development of a national registry to track outcomes for all current and future patients who receive vaginal mesh implants.” The Joint Committee focused heavily on the need for continuous review of patient outcome rates, comparative trials, and the adoption of new mesh products and devices only with clinical long-term data evidencing safety and efficacy.