The rate of revision or removal was low, about 1 in 30 after 10 years, among women who received a synthetic vaginal mesh sling as part of surgery for stress urinary incontinence, according to a population-based retrospective cohort study. The study also showed that patients of lower-volume surgeons were 37% more likely to require revision than those treated by high-volume surgeons.
“This population-based study addresses multiple key questions from the [US Food and Drug Administration] and Health Canada and substantiates their recommendation that surgeons should obtain training and experience in the use of vaginal mesh implants for [stress urinary incontinence],” Blayne Welk, MD, from the Department of Surgery, Western University, St. Joseph’s Health Care, London, Ontario, Canada, and colleagues write in an article published online September 9 in JAMA Surgery.
The study included 59,887 women who received the surgery from 2002 to 2012 in Ontario, Canada, with a mean follow-up time of 4.4 years. The rate of removal or revision surgery was 2.2%, occurring a median of 0.94 years (interquartile range, 0.35 – 2.49) after the initial surgery. Of women who had more than one mesh-based procedure for stress urinary incontinence, the rate of revision or removal was higher, at 4.87% (95% CI, 3.86% – 6.06%).
Patients of surgeons who were considered high-volume, defined as those performing more procedures than 75% of their peers, were less likely to require revision surgery. The lower-volume surgeons had a 37% higher relative risk (95% CI, 17% – 49%; P < .01) for removal or revision. The investigators compared outcomes from urologists and gynecologists, but there was no significant difference between the specialties.
The investigators suggest that the importance of surgeons’ experience is somewhat unusual in this type of surgery: “Although surgeon volume has been shown to be important for complex operations, such as oncologic and cardiac surgery, its role in less demanding procedures is not well defined,” the authors write.
This type of surgery, however, is a “commonly performed, same-day procedure with a low baseline risk for complications,” Christian Meyer, MD, from the Center for Surgery and Public Health and Quoc-Dien Trinh, MD, from the Division of Urologic Surgery, both at Brigham and Women’s Hospital, Boston, Massachusetts, write in an accompanying invited commentary. Therefore, recommendations that it should be performed by high-volume surgeons are somewhat impractical, they say. “Should patients be expected to travel hundreds of miles for surgery by a designated high-volume surgeon?… A more reasonable approach to achieve quality surgical care for common procedures may come from structured proctoring and/or coaching models and from mandatory outcomes reporting. Although physicians may not openly welcome these initiatives, they ultimately will help to establish surgical audits and improve outcomes.”
The study authors note several limitations, including an inability to distinguish which type of sling was used or the degree of incontinence a woman was experiencing before surgery. Also, the study did not consider complications that were treated without surgery or that were not treated.
Dr Welk reported receiving investigator-initiated grant funding from Astellas Canada. The other authors and editorialists have disclosed no relevant financial relationships.