The investigators stopped study recruitment early when five of 32 women experienced mesh erosion.
According to the American Urogynecologic Society, about half of all women between the ages of 50 and 79 have some form of prolapse, and about 11% in the U.S. will have it surgically treated. Approximately 200,000 procedures for correction of pelvic organ prolapse are performed each year in the United States.
Physicians at three academic centers in the U.S., led by Dr. Cheryl B. Iglesia at Washington Hospital Center, Washington, DC, treated 65 women (mean age 65) with uterovaginal or vaginal prolapse. They randomly assigned 32 women to colpopexy with Prolift mesh (Ethicon Women’s Health & Urology) and 33 to vaginal colpopexy without mesh. Women with a uterus also underwent vaginal hysterectomy.
Patients were blinded as to group assignment, as were evaluators at months 3 and 12.
The women in both groups reported very high subjective satisfaction with their procedures, with no significant differences in scores on quality-of-life questionnaires at 3 months.
During median follow-up of 9.7 months, 59% of women in the mesh group and 73% in the no-mesh group had recurrence of their prolapse, a nonsignificant difference.
Erosion of mesh support developed in 15.6% of patients within 2.1 months of surgery. Three erosions required surgical removal.
“This study questions the value of additive synthetic polypropylene mesh for prolapse repairs considering that there are no statistically significant differences in subjective or objective cure rates,” the investigators conclude.
The authors note that in 2008, the US Food and Drug Administration reported on complications from mesh use, such as erosions, infection, pain, incontinence and rare but serious visceral injury. In response, manufacturers have developed lighter weight and mixed composite meshes, including the next generation Prolift +M, but they have no long-term data.
Vaginal Mesh for Prolapse: A Randomized Controlled Trial
Obstet Gynecol 2010;116:293-303.