Surgical mesh is a common medical product used to repair conditions in which body organs need extra support. For example, one of the most common uses has been to repair hernias. In women, surgical mesh is also used to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI), conditions that occur when the muscles and ligaments supporting internal organs weaken. Treatment can include surgery to shore up the organs, with surgical mesh being used to keep the organs from “sagging” inside the body cavity.
Over the past three years, the U.S. Food and Drug Administration (FDA) received nearly 4,000 reports of severe complications (including 3 fatalities) associated with surgical mesh used to treat POP and SUI. The most frequent complications include:
- erosion through vaginal epithelium (inner wall of the vagina);
- mesh contraction, leading to vaginal shortening and pain;
- urinary problems;
- recurrence of prolapse and/or incontinence.
There were also reports of surgical complications when the insertion of the mesh perforated bowel, bladder, or blood vessels. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia (painful sexual intercourse).
A recent study published in the New England Journal of Medicine revealed troubling results with these procedures. Compared with traditional surgery without mesh, women who had a transvaginal mesh (TVM) inserted to treat pelvic organ prolapse suffered higher rates of serious complications, including bladder perforation and pelvic hemorrhage… and they had an increased number of adverse events after the surgery, including newly acquired urinary incontinence.
On July 13, 2011, the FDA issued an update on TVM, which clarified its recommendations:
The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, 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. [emphasis added by the FDA]
The FDA recommends that surgeons recognize that most cases of POP can be treated successfully without surgical mesh.
Unfortunately, doctors and the FDA have known about the problems with surgical mesh for at least 3 years, without warning women about the serious risks of the surgery. If you or someone you care about has a transvaginal mesh (TVM) used to correct pelvic organ prolapse or urinary incontinence and suffered any of the above symptoms, our law firm may be able to help. Contact us today to learn how. We are available 24/7 at 1-800-4-LAWMED; or contact us via our website at www.lawmed.com.