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Fixing Vaginal Prolapse: Two Methods, Similar Results

Mesh Implants, Now Banned by FDA, Work as Well as Hysterectomy

Two surgical procedures used to correct vaginal prolapse—one to remove the uterus and one that supports the uterus with mesh—have comparable three-year outcomes, according to a study funded by the National Institutes of Health. The FDA halted the use of mesh for such cases in April 2019 based on a lack of assurance that the mesh was safe and effective.

The randomized clinical trial provides the longest-term comparison of the procedures, and researchers will continue to follow the patients for a total of five years. The study results were reported in the Journal of the American Medical Association.

Vaginal prolapse is a pelvic floor disorder that occurs when support muscles weaken and pelvic organs press down on the vagina, sometimes forcing it to bulge or protrude from the vaginal opening. This condition is more likely as a woman ages.

Traditionally, surgeons treat vaginal prolapse by removing the uterus, thereby providing access to deep pelvic ligaments. The top of the vagina can then be attached to those ligaments in a procedure known as uterosacral ligament suspension. Other procedures, such as mesh hysteropexy, do not require removal of the uterus and instead use mesh to suspend the uterus and pelvic organs so they no longer fall out of place.

In the Study of Uterine Prolapse Procedures—Randomized Trial, conducted at nine U.S. sites, 93 women were randomized to mesh hysteropexy and 90 were randomized to hysterectomy with uterosacral ligament suspension. The researchers compiled a failure rate for each procedure using a standard examination called the Pelvic Organ Prolapse Quantification System and whether women reported new symptoms of prolapse or needed retreatment for prolapse. After three years, mesh hysteropexy had a 26% failure rate, while hysterectomy had a 38% failure rate. The difference in rates was not statistically significant.

“More long-term research is needed to determine if one procedure is better than the other,” said Charles W. Nager, the lead author of the study and chair of the Department of Obstetrics, Gynecology, and Reproductive Sciences at UC San Diego Health. “After the five-year follow-up period, we’ll reanalyze the results.”

No differences were found in patient-reported outcomes on surgical pain, pelvic pain, and body image. Similar proportions in each group reported “much better” or “very much better” improvements in their symptoms at three years. Both groups reported improvements in sexual function and lower incidence of painful sex.

Sources: NIH, September 17, 2019; FDA, July 10, 2019

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