Restriction of Surgical Options for Pelvic Floor Disorders.

Abstract

Abstract: The purpose of this document is to update the 2013 AUGS Position Statement based on subsequent decisions made by the U.S. Food and Drug Administration, published clinical data, and relevant society and national guidelines related to the use of surgical mesh. Urogynecologists specialize in treating pelvic floor disorders, such as pelvic organ prolapse (POP) and urinary incontinence, and have been actively involved and engaged in the national and international discussions and research on the use of surgical mesh in the treatment of POP and stress urinary incontinence. In 2019, the U.S. Food and Drug Administration ordered manufacturers of transvaginally placed mesh kits for prolapse to stop selling and distributing their devices, stating that the data submitted did not provide a reasonable assurance of safety and effectiveness. Evidence supports the use of mesh in synthetic midurethral sling and abdominal sacrocolpopexy. The American Urogynecologic Society (AUGS) remains opposed to any restrictions that ban currently available surgical options performed by qualified and credentialed surgeons on appropriately informed patients with pelvic floor disorders. The AUGS supports the U.S. Food and Drug Administration's recommendations that surgeons thoroughly inform patients seeking treatment for POP about the risks and benefits of all potential treatment options, including nonsurgical options, native tissue vaginal repairs, or abdominally placed mesh. There are certain clinical situations where surgeons may assert that the use and potential benefit of transvaginal mesh for prolapse outweighs the risk of other routes/types of surgery or of not using mesh. The AUGS recommends that surgeons utilize a shared decision-making model in the decision-making process regarding surgical options, including use of transvaginally placed mesh.