NEW YORK (Reuters Health) – Repairing vaginal prolapse with polypropylene mesh may cause more problems than it solves, according to results of a double-blind randomized study.
In the study, objective and subjective improvement was seen both with and without mesh, “so these surgeries do improve quality of life in women suffering from prolapse,” study investigator Dr. Andrew I. Sokol told Reuters Health.
However, mesh resulted in a higher reoperation rate and did not improve cure rates at 1 year, noted Dr. Sokol, who is Associate Director of Minimally Invasive Surgery, Section of Female Pelvic Medicine and Reconstructive Surgery, Washington Hospital Center, in Washington, D.C.
“While vaginally placed mesh for prolapse may have a role in properly selected patients (such as those with previous surgical failures, older patients, women who are minimally or not sexually active), well-designed studies need to be completed (some are underway) to define its role,” he said.
The study, reported online August 12 in American Journal of Obstetrics and Gynecology, involved 65 women with stage 2 or greater vaginal prolapse.
They were randomly assigned to traditional suture-based repair without mesh (primarily combined anterior/posterior colporraphy and uterosacral ligament suspension) or vaginal colpopexy with mesh (Prolift). The 32 women in the mesh group and the 33 in the no mesh group were followed for 12 months.
At 12 months, women in both groups had statistically significant improvement in prolapse – as defined as point change on the pelvic organ prolapse quantification (POP-Q) exam.
Recurrence of stage 2 prolapse or greater occurred in 20 women who received mesh (63%) and 23 who did not (70%); this difference was not significant.
For nearly all quality of life measurements, statistically significant improvement from baseline was observed in both arms of the study.
Subjective cure of bulge symptoms was reported by 96% of women in the mesh group and 91% in the no-mesh group (P = 0.62).
However, mesh was associated with a higher overall reoperation rate than traditional vaginal prolapse repair and resulted in a greater than 15% risk of exposure, the authors note.
When the predetermined mesh exposure rate of greater than 15% was reached, recruitment to the trial was halted; 5 women in the mesh group (15.6%) required reoperation for recurrent prolapse or mesh exposure compared with none in the no-mesh group (P = 0.017).
Because the study was stopped early for erosions, Dr. Sokol explained, “broad generalizations about the role of mesh cannot be addressed.”
However, he said it does “raise awareness of the need for continued study, close monitoring of surgical devices, and careful patient counseling about risks and benefits.”
He and his colleagues point out in their paper that a “lack of high quality evidence persists despite the widespread use of vaginal mesh procedures.”
They say more study is needed “to inform clinical decisions regarding mesh use in pelvic reconstructive surgery.”
The study did not receive funding from industry.
One-year objective and functional outcomes of a randomized clinical trial of vaginal mesh for prolapse
Am J Obstet Gynecol 2011.