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Vaginal Mesh Complications Halt Clinical Trial

Oct 25, 2010 | Parker Waichman LLP

Vaginal mesh may not be the best choice for repairing pelvic organ prolapse, according to an article published in the journal Obstetrics & Gynecology. According to the article, a clinical trial involving vaginal mesh was halted early because women who received the mesh had a far higher rate of complications compared to those who underwent a more traditional procedure called colpopexy.

In October 2008, the US Food & Drug Administration (FDA) warned that the use of vaginal mesh to treat pelvic organ prolapse and stress urinary incontinence had been linked to serious complications. At the time, the agency said it had received more than 1,000 repots of vaginal mesh complications, including erosion of the mesh through the vaginal epithelium, infection, pain, urinary problems, and recurrence of the prolapse or the incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in quality of life due to discomfort and pain, including dyspareunia. Despite the FDA warning, the use of vaginal mesh has become increasingly popular. 

The halted trial detailed by the Obstetrics & Gynecology article involved 65 women with pelvic organ prolapse. They were randomly assigned surgical repair with the mesh or colpopexy, a procedure that uses the patient’s own ligaments to support the sagging muscles. Thirty-two women underwent mesh colpopexy, and 33 had the traditional procedure.

According to the article, more than 15 percent of the patients who received the mesh experienced erosion. Overall, there were five vaginal mesh erosions. Two cystotomies and one blood transfusion occurred in the mesh group only.

The mesh did not work any better than the traditional surgery for fixing pelvic prolapse. Subjective cure of bulge symptoms was noted in 93.3 percent of vaginal mesh patients and 100 percent of no-mesh patients. Furthermore, subjective quality-of-life measurements did not differ between the two groups at baseline or 3 months, the researchers noted.


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