Transvaginal placement of surgical mesh for pelvic organ prolapse: more FDA concerns—positive reactions are possible

Recently (July 13, 2011), the United States Food and Drug Administration (FDA) issued a document entitled “FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse” [1]. This was stated as an update of a previous document issued on October 20, 2008, entitled “A Public Health Notification and Additional Patient Information on serious complications associated with surgical mesh placed through the vagina (transvaginal placement) to treat pelvic organ prolapse (POP) and SUI (stress urinary incontinence)”. Accompanying the recent FDA concerns was a 15-page document entitled “Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse” which has a literature review identifying 27 key references [2]. The FDA’s aims in this update are to inform that: (1) “serious complications with surgical mesh for transvaginal repair of POP are not rare” (a change from the previous FDA notification) and (2) “it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk”. From January 1, 2008 through December 31, 2010, using the Manufacturer and User Device Experience (MAUDE) database, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs. The scope of the current safety communication was limited to POP surgery. The FDA noted mesh exposure (“erosion”) as the most common mesh-related complication and with mesh shrinkage (“contraction”), the leading cause of symptoms including bleeding, pelvic pain, dyspareunia, or apareunia. The results of the literature review [2], summarized in the FDA Safety Communication [1], were: (1) mesh used in transvaginal POP repair introduces risks not present in traditional non‐mesh surgery for POP repair; (2) mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh; (3) there is no evidence that Further contributions to this debate can be found at doi:10.1007/ s00192-011-1581-2, doi:10.1007/s00192-011-1596-8 and doi:10.1007/s00192-011-1597-7.