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Complications Seen wth Use of Vaginal Mesh

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Evidence continues to grow that vaginal mesh products are not the best choice for surgical repair of pelvic prolapse in women. According to a report in The New York Times, a clinical trial of vaginal mesh was halted last year because of the high number erosions seen in patients receiving the mesh.

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

According to the article, more than 15 percent of the patients who received the mesh experienced erosions. 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. Furthermore, subjective quality-of-life measurements did not differ between the two groups at baseline or 3 months, the researchers noted.

This is not the first time questions have been raised about the safety of vaginal mesh. 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.

These types of complications are already all-too familiar to victims of the Mentor ObTape Vaginal Sling. In 2006, the Journal of Urology published a study that examined an unusually high number of complications caused by Mentor ObTape. The study looked at 67 women who had been implanted with the Mentor ObTape Vaginal Sling, and found that more than 13 percent developed vaginal extrusions. Another eight developed a chronic vaginal discharge, and one patient developed an abscess of the left thigh that tracked to the incision site.

The poor design of the Mentor ObTape did not allow surrounding tissue to receive nutrients and oxygen, which impaired healing. As a result, between 17 and 18 percent of the women who were implanted with a Mentor ObTape Vaginal Sling suffered from complications, with many forced to undergo a difficult surgical procedure to have the device removed. The problems associated with the Mentor ObTape Vaginal Sling were so severe and widespread that finally, in 2006 Mentor Inc. pulled it from the market.

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