On July 13, 2011, the FDA issued a new advisory warning about plastic surgical mesh used during transvaginal surgeries to correct common female gynecological problems. The surgical mesh is made from porous synthetic material and is permanently implanted to reinforce the weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat stress urinary incontinence. Physicians in the U.S. perform about 75,000 surgeries utilizing these mesh products each year. From 2008 to 2010, the FDA received more than 1,500 Adverse Event Reports related to complications associated with the plastic mesh.
Some of these serious complications include:
- Extreme Pelvic Pain
- Erosion/Protrusion of Mesh through the Vaginal Wall
- Vaginal Scarring/Deformity
- Multiple Surgeries to Remove imbedded mesh
- Urinary Problems
Studies indicate that about 10% of women who have the mesh placed transvaginally experience mesh erosion within 12 months of surgery and that more than half require additional surgeries to remove the mesh. Mesh erosion can require multiple surgeries to repair and can be debilitating for some women. In some cases, even multiple surgeries will not resolve the complications.
Thousands of women suffering pelvic organ prolapse are treated with plastic mesh each year, but reports indicate surgery can often be performed safely and effectively without the need for mesh. The FDA plans to convene an advisory committee of experts this Fall to determine whether to ban the mesh.
If you or a loved one have suffered a serious complication following mesh-repair surgery for pelvic organ prolapse or stress urinary incontinence, please contact Bill Robertson for information about your legal rights.