FDA Issues Surgical Mesh Safety Alert
The FDA recently issued a safety alert regarding placement of surgical mesh as a treatment for pelvic organ prolapse (POP).
In the alert, the agency states that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare and “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.”
In a report dated October 20, 2008, the FDA noted that the number of adverse events reported to the agency for surgical mesh devices used to repair POP and stress urinary incontinence (SUI) for a three-year period (2005-2007) was more than 1,000. Since then, from January 1 2008 through December 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP (1,503 reports) and SUI (1,371 reports), according to the agency.