It has come to our attention that The U.S. Food and Drug Administration (FDA) has issued an updated safety alert to remind health care providers and patients that serious complications associated with surgical mesh for transvaginal repair of POP (pelvic organ prolapse) are NOT rare. Furthermore, 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.
The most frequently reported complications from surgical mesh used to repair POP include mesh becoming exposed or protruding out of the vaginal tissue (erosion), pain, infection, bleeding, pain during sexual intercourse, organ perforation from surgical tools used in the mesh placement procedure, and urinary problems. From 2008 to 2010, the FDA received 1503 adverse event reports associated with mesh used for POP repairs and 1,371 associated with SUI (stress urinary incontinence) repairs.
The FDA will provide updated recommendations for health care providers and patients and update the activities involving surgical mesh for the transvaginal repair of POP. The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date.
For more details of FDA's recommendations to healthcare providers, patients and their caregivers, please refer to the following links: