More vaginal mesh tied to more postoperative complications

By Marilynn Larkin

NEW YORK (Reuters Health) - There may be a dose-response relationship between the amount of mesh used to correct pelvic organ prolapse and stress urinary incontinence and subsequent complications and repeated interventions, researchers suggest.

Dr. Art Sedrakyan of Weill Cornell Medical College in New York City told Reuters Health by email, "Currently, mesh used for pelvic organ prolapse is a class III (highest risk) device, upgraded from a class II (intermediate risk) device. However, the mesh slings used for incontinence remain a class II device."

He pointed out that in 2011, the U.S. Food and Drug Administration warned about the risk of mesh erosion and the potential for other postoperative complications (https://bit.ly/2h7PVzq).

In 2015, in a paper in The BMJ, Dr. Sedrakyan's team reported that mesh use had continued to rise and was associated with a higher risk of repeat surgery (https://bit.ly/1B5kTzH).

In the current study, he explained, "we addressed the risks of complications among patients exposed to various amounts of mesh - specifically, risk of mesh erosions that require management; risk of repeat surgery with concomitant diagnosis of erosion; and overall repeat surgery after transvaginal repairs for pelvic organ prolapse and surgery for incontinence."

The 41,604 women in the study had undergone transvaginal repair for pelvic organ prolapse or stress urinary incontinence, at an average age of 56, between 2008 and 2012.

As reported in JAMA Surgery, online November 30, Dr. Sedrakyan and colleagues stratified patients into four groups, based on mesh exposure. Three groups had pelvic organ prolapse repaired either with mesh and sling (5,070 patients), mesh only (3,798); or no mesh but a sling to correct their stress incontinence (10,484). The fourth group had stress urinary incontinence only, with no pelvic organ prolapse; these women received slings (22,252).

At one-year followup, the mesh plus sling group had the highest risk of erosions (2.72%), the highest risk of repeat surgery (5.64%) and the highest risk of repeat surgery with concomitant erosion (2.13%). The sling-only group had the lowest erosion risk (1.57%), the lowest repeat surgery risk (2.53%), and the lowest risk of repeat surgery with concomitant erosion (1.16%).

Erosion risk was similar in the mesh-only group and group that had prolapse repair without mesh but with a sling for incontinence.

Across the groups, the median number of days to erosion ranged from 115 to 135.

Dr. Sedrakyan said, "We found that no amount of mesh is completely safe and there is dose-response relationship - meaning the more mesh used, the more common are the erosions and complications. This large scale and generalizable study provides very important evidence related to mesh's real-world effectiveness."

"We believe our study provides important data for risk communication," he added. "We highlight the limitations of current technology so that manufacturers, innovators and regulators can work on improving the technology for use in the important public health areas of pelvic organ prolapse and incontinence."

Editorial coauthors Drs. Anne-Marie Boller and Bhumy Dave, both of Northwestern University in Chicago, Illinois, told Reuters Health by email, "Studies like (this) one are important because they provide insight into mesh complications and the timing of those complications."

"The authors' hypothesis regarding mesh erosions and dose-dependent risk is an important question which requires further investigation," they said. "Patients who undergo sacrocolpopexies and concurrent miduretheral slings may be an interesting area of future study."

SOURCE: https://bit.ly/2h84zZO

JAMA Surg 2016.