United States Food and Drug Administration continues to release warnings to physicians and their patients regarding use of surgical mesh to treat women’s urinary incontinence and pelvic organ prolapse. Pelvic organ prolapse (POP) occurs when the internal structures that support the pelvic organs such as the bladder, uterus and bowel, become so weak or stretched that the organs drop from their normal position and bulge or prolapse into the vagina.
The use of surgical mesh to treat this problem is becoming increasingly common. With its increasing use, however have come increasing problems. In 2008 the FDA issued a warning that use of vaginal mesh was associated with complications, but the FDA also indicated these complications were rare. Since 2008 however the FDA is receiving increasing reports of adverse events associated with use of the surgical mesh when used for POP repair. From 2008 to 2010 the FDA received 1,503 adverse event reports associated with mesh used for POP repair, five times as many as the agency received from 2005 to 2007.
More importantly studies suggest that women do not benefit from the use of surgical mesh. The FDA conducted a review of scientific literature published between 1996 and 2010 comparing mesh surgeries to non-mesh surgeries. The agency review suggests that many patients undergo trans-vaginal POP repair with mesh are exposed to additional risks, compared to patients who undergo POP repair with stitches alone. While the mesh often corrected the anatomy, there was no evidence that mesh provided any greater clinical benefits than non-mesh surgeries.
The FDA now recommends that health care providers:
1. Recognize that in most cases, POP can be treated successfully without mesh;
2. Know that surgical mesh is a permanent implant that can make any future surgical repairs more challenging and can put the patient at risk for additional complications and surgeries;
3. Consider that mesh placed abdominally for POP repair may result in more rates of mesh complications compared to trans-vaginal POP surgery with mesh; and be sure that patients are aware of the risks and benefits of trans-vaginal POP repair with mesh, and inform patients that mesh is being used.
The FDA further recommends that patients:
1. Ask the surgeon before surgery about all POP treatment options, including those that do not involve mesh, and understand why the surgeon may be recommending treating POP with mesh;
2. Continue with routine check-ups and follow-up care after surgery. Notify the surgeon if complications develop (persistent vaginal bleeding or discharge, pelvic or groin pain during sex); and those who have POP surgery but don’t know if the surgeon used mesh should find out if mesh was used during the next scheduled visit with their health care provider.