Lara C. Pullen, PhD

October 19, 2012

CHICAGO — The use of mesh for anterior vaginal wall prolapse is associated with an increased risk for repeat surgery, according to a new study.

Most repeat surgeries are driven by a need for mesh removal, said Jennifer M. Wu, MD, MPH, from Duke University in Durham, North Carolina. She presented the study results here at the American Urogynecologic Society 33rd Annual Scientific Meeting.

To estimate the rate of repeat surgery in patients who had undergone surgery for anterior vaginal wall prolapse, Dr. Wu and colleagues analyzed the MarketScan Commercial Claims and Encounters database and the Medicare supplemental database. The MarketScan database collects longitudinal, adjudicated healthcare claims data from employer-based health plans. In 2005, these 2 databases encompassed 28.3 million patients; in 2010, they encompassed 48.8 million patients — one sixth of the population of the United States.

Dr. Wu and colleagues analyzed 27,809 women who underwent anterior colporrhaphy: 6871 with vaginal mesh and 20,938 with native tissue. The women were classified according to concurrent placement of vaginal mesh. Women were excluded if it was unclear whether the vaginal mesh was placed in the anterior compartment or if they had concurrent or recent (within 180 days) vaginal, abdominal, or laparoscopic prolapse procedure. Women who received concurrent slings were included in the analysis.

The primary analysis looked at long-term (up to 5 years) outcomes. Median follow-up time in the vaginal-mesh group and the native-tissue group was similar (1.4 vs 1.3 years; P = .44).

Women in the vaginal-mesh group were older than those in the native-tissue group (59 vs 55 years; P < .0001), were more likely to have a concurrent/recent sling (70.6% vs 62.4%; P < .0001), and were less likely to have a concurrent hysterectomy (18.4% vs 39.3%; P < .0001).

The 5-year risk for any repeat surgery was higher in the vaginal-mesh group than in the native-tissue group (15.2% vs 9.8%; P ≤ .001). The mesh removal/revision rate at 5 years was 5.9%.

At 5 years, the risk for recurrent prolapse was similar in the vaginal-mesh and native-tissue groups (10.4% vs 9.3%; P = .70). On adjusted Cox model (adjusted for age, concurrent hysterectomy, and concurrent/recent sling), the hazard ratio was 0.94 (95% confidence interval, 0.84 to 1.05).

John O. DeLancey, MD, from the University of Michigan in Ann Arbor, who was not involved in the study, discussed the outcomes with Medscape Medical News. He explained that the desire to understand the proper role of vaginal mesh "dominates things now." He added that, "I think eventually, there will be some role, but it has to be safe first."

He described the complications from vaginal mesh as difficult. "For these poor women, it is life altering," he said. It is a challenge to remove the mesh because "you can't get all of the mesh out because the arms go deeper into the body," he explained.

Vaginal mesh is used primarily because of the potentially lower risk for recurrent prolapse. However, there are limited long-term data on the subject. This study stemmed from the US Food and Drug Administration (FDA) statement that vaginal mesh might not result in superior symptomatic outcomes. The FDA also reported that vaginal mesh was associated with complications.

Dr. Wu and Dr. DeLancey have disclosed no relevant financial relationships.

American Urogynecologic Society (AUGS) 33rd Annual Scientific Meeting: Presentation paper 28. Presented October 5, 2012.