Important News from Your Texas Accident Lawyer
FDA Issues Warning on Serious Complications of Mesh Repair of Prolapse
Posted on Aug 27, 2011
On July 13, 2011, the FDA updated its previous statement on the use of transvaginal surgical mesh placement to repair POP (Pelvic Organ Prolapse) and SUI (Stress Urinary Incontinence). The FDA updated its 2008 statements with a strong warning that complications following the placement of surgical mesh through the vagina to replace POP are not rare. The FDA also warned that it remains unclear whether the use of surgical mesh to repair POP is much more effective than traditional non-mesh repairs, and mesh may expose patients to greater risks of injury.
The FDA warning noted that the agency continues to evaluate the use of mesh to repair SUI and that it will communicate these findings later. The agency notes that it received about 1,000 adverse event reports from 2005 through 2007 regarding mesh repairs for SUI and POP. From 2008 to date, it has received nearly 3,000 of these reports. The FDA warning says that the most common adverse events reported include erosion of the mesh through the vagina, mesh contraction, organ perforation, and recurrent prolapse, among others. The FDA's review of transvaginal surgical mesh placement to repair POP found that:
1. Transvaginal surgical mesh placement introduced patient risks not present with traditional non-mesh surgeries;
2. Abdominally-placed mesh to repair POP seems to produce lower rates of complications than transvaginal placement of mesh for the same purpose;
3. There's no evidence that the use of mesh to correct vaginal vault prolapse or to support the back wall of the vagina provides any benefits over traditional non-mesh surgeries; and
4. Transvaginal surgical repair of weakened tissues between the bladder and vagina may provide anatomical benefits, but it doesn't seem to provide better relief of symptoms than non-mesh repairs.
The FDA warning advises healthcare providers to carefully weight the benefits and risks before selecting transvaginal surgical mesh placement over non-mesh surgeries. The FDA warning also advises patients to ask many questions and to carefully consider alternatives before submitting to the procedure.
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