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Study Raises Questions About Mesh Repairs

Clinical trial ended after complications mount.

Published: October 27, 2010

The effectiveness and safety of using mesh in vaginal prolapse repair surgery is in question after researchers halted a clinical trial due to a high rate of complications.

In a study appearing in the August issue of the journal Obstetrics & Gynecology, the researchers suggest that the synthetic polypropylene mesh's tendency toward erosion and failure to heal patients more effectively than traditional, non-mesh prolapse repair does may necessitate a reconsideration of its of clinical benefit.

Between January 2007 and August 2009, when the trial ended, multi-center researchers observed 3-month outcomes for 65 women who underwent prolapse repair surgery. Mesh was used in 32 of the patients' procedures, while the other 33 involved traditional, ligament-based repairs.

After 5 patients (15.6%) in the mesh group suffered erosion - that is, a protrusion of the mesh through splitting skin, resulting in pain and infection - the trial was forced to stop early. No difference in cure rate was observed between the mesh and non-mesh groups.

"The bottom line is not only were there more complications, but the mesh didn't prove any better than traditional surgery," says study co-author Cheryl B. Iglesia, MD, FACOG, director of female pelvic medicine and reconstructive surgery at the Washington Hospital Center and associate professor of obstetrics, gynecology and urology at Georgetown University School of Medicine. In October 2008, the U.S. Food and Drug Administration issued a Public Health Notification on what it deemed rare but serious complications originating from the use of transvaginal mesh in prolapse repair and stress urinary incontinence surgery.

David Bernard

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