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Five Months After FDA Ban, New Study Finds Alternate Procedure Comparable to Hysterectomy

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Female doctor talking to a female patient.

AUSTIN, Texas – Five months after the U.S. Food and Drug Administration halted the sale of kits used to correct a common pelvic floor problem in women known as uterovaginal prolapse, novel research published in the Journal of the American Medical Association shows patient results from the procedure generally are positive and comparable to those of their common alternative, hysterectomy with vaginal suspension with sutures.

The new study indicates that the recently banned procedure known as mesh hysteropexy may provide an alternative for women suffering from uterovaginal prolapse, in which pelvic floor muscles and ligaments stretch and weaken and can no longer hold up the uterus and vagina. According to the study, about 13% of U.S. women have some form of pelvic organ prolapse surgery by age 80.

“This study offers some hope that women could possibly benefit from a less invasive surgery,” said study co-author Rebecca G. Rogers, M.D., associate chair, Clinical Integration and Operations, and professor in the Department of Women’s Health at Dell Medical School at The University of Texas at Austin. “Some women just don’t want their uterus removed, and the outcomes weren’t clear enough to be able to say one surgery was better than the other,” she said.

In mesh hysteropexy, the uterus is lifted into its normal position using a strip of synthetic mesh to hold it in place. By contrast, hysterectomy followed by suturing the vagina to ligaments is a more invasive alternative in which the uterus is surgically removed.

In 2016, the FDA reclassified mesh hysteropexy from a “moderate risk” device to one requiring additional studies. This past February, an FDA advisory panel concluded the mesh option needed to be shown as superior to the nonmesh options three years or 36 months after surgery. In April, the FDA announced superiority had not been demonstrated by that time, so it ordered a halt to sales and distribution of vaginal mesh hysteropexy products.

Meanwhile, the research team, which included Rogers, was completing a four-year, randomized clinical trial comparing the two options that included a three-year, 36-month follow-up. A total of 169 women at nine U.S. locations were involved in the SUPeR (Study of Uterine Prolapse Procedures Randomized) Trial. The women were treated by 34 female pelvic medicine and reconstructive surgery subspecialists between April 2013 and February 2015.

“Our study only had three years of follow-up, and the outcomes were very close,” Rogers said. “It’s hard to say if one might win out over the other in the long term – that’s part of what remains to be seen,” she said, adding that more research is needed.

Of the 169 women involved in the study, 85 underwent mesh hysteropexy procedures and 84 hysterectomy with suture suspension of the vagina. None was told which procedure she had to help ensure this would not impact study results.

Results show that mesh hysteropexy scored “12 percentage points better than the hysterectomy procedure” at the three-year follow-up point for anatomic and symptomatic prolapse, according to Charles W. Nager, M.D., the study’s lead author and chair and professor of Obstetrics, Gynecology and Reproductive Services at the University of California San Diego Health.

Plans call for continuing to follow this study’s patients for a total of 60 months or five years. Nager said, “Conclusions at 36 months could change with extended follow-up,” and then companies marketing mesh hysteropexy kits may be able to reapply with the FDA to make them available.

This study was conducted on behalf of the Pelvic Floor Disorders Network, established in 2001 to encourage collaborative research on PFDs and improve patient care.