For vaginal repair, benefits of mesh must be weighed against harms

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[February 17, 2016]  By Andrew M. Seaman

(Reuters Health) - Synthetic mesh is more effective for correcting vaginal prolapse than using a woman's own tissue, but the overall benefit is small, according to a fresh look at some past research.

In vaginal prolapse, the vagina may fall out of its normal position because of weakened muscles and ligaments. Often, nearby structures such as the uterus, rectum, and bladder fall down into the vagina as well.

Researchers have found that up to three years after surgery, women whose prolapse was repaired with artificial mesh were less likely to be aware of recurrent prolapse than those whose repair was done with natural tissue. But they were also more likely to have incontinence, exposed mesh or another surgery.

About one in 20 women whose prolapse was fixed with natural tissue had a second operation, compared to about one in 10 women who got artificial mesh, said lead author Dr. Christopher Maher, of the Royal Brisbane Women's Hospital in Australia.

Prolapse is seen in 40 to 60 percent of mothers, the researchers report in the Cochrane Library. Out of every 10,000 women in the U.S., about 10 to 30 undergo surgery to repair prolapses each year, they add.

 

Repairs using mesh became popular in the late 1990s and early 2000s after it was successfully used in other types of operations, wrote Dr. Cindy Farquhar, of the University of Auckland in New Zealand, in an accompanying editorial.

But at first, mesh repair of prolapse was adopted without rigorous studies to test the practice, and a rise in complications tied to the use of mesh led the U.S. Food and Drug Administration (FDA) to issue warnings and take other regulatory actions, Farquhar added.

The new review from the Cochrane Collaboration, which evaluates the best medical evidence for various treatments, looked at 37 randomized controlled trials that tested mesh repairs in a total of 4,023 women.

In general, recurrent prolapse was 60 percent less likely after mesh repair. In other words, the researchers say, if 38 percent of women have recurrence after repair with natural tissue, only 11 to 20 percent would have recurrence after repair with mesh.

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But those who had repairs with mesh were more likely to have incontinence, exposed mesh and other issues, like bladder injuries, and they were more likely to need another operation.

Women could consider these types of mesh surgeries if they fully understand the risk and benefits, Maher told Reuters Health.

He also said doctors "should await comparative data on new innovations to ensure they have been fully evaluated prior to introduction to treatment pathways." And "women should be cautious" when new innovations are recommended to them.

Dr. John Gebhart, who was not involved with the new review, said that in the next couple of years, more data about results with mesh for vaginal prolapse will likely be available, when studies ordered by the FDA are completed.

"I think the ultimate takeaway is that patients should continue to ask questions of their physicians and ask what the pros and cons of each approach are for the patient," said Gebhart, a urogynecologist at the Mayo Clinic in Rochester, Minnesota.

SOURCE: http://bit.ly/1PPoLWW and http://bit.ly/1Qjzkar Cochrane Library, online February 16, 2016.

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