Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse

The US Food and Drug Administration (FDA) has issued a Public Health Notification (PHN) to inform clinicians and patients of adverse events related to urogynecologic use of surgical mesh, as well as to provide recommendations on how to mitigate risks and counsel patients.

Following the PHN, the FDA continued to monitor outcomes of urogynecologic use of surgical mesh and determined serious adverse events are not rare, contrary to what was stated in the 2008 PHN. Transvaginally-placed mesh in pelvic organ prolapse (POP) repair does not conclusively improve clinical outcomes over traditional non-mesh repair.

The FDA conducted a search of the Manufacturer and User Device Experience (MAUDE) database for medical device reports (MDRs) of adverse events associated with all urogynecologic surgical mesh products received from January 1, 2005 until December 31, 2010.

The search identified 3,979 reports of injury, death or malfunction, which also included 1,503 reports associated with POP repairs and 1,371 associated with stress urinary incontinence (SUI) repairs.