The FDA Transvaginal Mesh Safety Communication Update Said it First: Serious Complications are NOT RARE

On July 13, 2011, the FDA released the UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse. Previously, on October 20, 2008 the FDA had issued an FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence report. These reports both discuss complications associated with surgical mesh placed through the vagina to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

Between October 20, 2008 and the FDA’s update in July of 2011, adverse events reported to the FDA and complications described in scientific literature prompted the FDA to update their original notification, alerting health care practitioners and patients that the associated risks of transvaginal mesh continued to be a serious concern. The update in 2011 confirmed that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare.” In addition, the communication noted that “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 2008 through 2010, the most frequent complications reported to the FDA concerning surgical mesh devices for POP repair were mesh “erosion,” “protrusion,” “exposure” or “extrusion” through the vagina, organ perforation, and urinary problems. There were reports of recurrent prolapse, vaginal scarring, vaginal shrinkage and neuro-muscular problems. As noted by the FDA, many of these complications necessitate additional intervention such as medical or surgical treatment and or hospitalization.

Out of all of these complications, the FDA found that erosion of mesh through the vagina was the “most common and consistently reported mesh-related complication from transvaginal POP surgeries using mesh.” Again noted by the FDA, mesh erosion in particular may require multiple revision surgeries and, sometimes, women find that their complications are not resolved even after multiple surgeries.

So there you have it. Complications from transvaginal mesh are not rare. Instead, they can be debilitating, time-consuming, expensive and physically and emotionally painful. And the FDA has known this since 2011.