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One in 30 women treated for stress urinary incontinence with synthetic mesh slings might require mesh removal or revision 10 years post-SUI mesh surgery.
One in 30 women treated for stress urinary incontinence (SUI) with synthetic mesh slings might require mesh removal or revision 10 years post-SUI mesh surgery.
In addition, women who go to lower-volume surgeons have a 37% increased complication risk compared to patients whose surgeons are more experienced in the procedure, according to a new study.
These findings support the FDA’s warnings about vaginal mesh safety, write the authors, who measured the incidence of mesh removal or revision after SUI in nearly 60,000 women treated in Canada from April 1, 2002 through Dec. 31, 2012.
First author Blayne Welk, MD, MSc, of the University of Western Ontario, London, ON, found that high-volume surgeons, who were in the 75th or higher percentile of yearly mesh-based procedures, were less likely to perform a simultaneous hysterectomy, were more likely to work in an academic center, and saw the patient less frequently in the year prior to the procedure, according to the findings, which were published online in JAMA Surgery (Sept. 9, 2015).
Among the other findings: Overall, 2.2% of the women, or 1,307, had mesh removal or revision a median 0.94 years after receiving the mesh implants. Women who had their initial surgeries done by high-volume surgeons had a significantly lower risk of having surgical procedures related to removal or revision of the mesh slings.
Urologists and gynecologists in the study had similar complication rates. But multiple mesh-based SUI procedures were associated with an increased complication risk.
“This is a demonstration that the volume-outcomes relationship matters in all circumstances, not just for complex cancer surgeries requiring lengthy hospitalizations. ‘Practice makes perfect,' ” Quoc-Dien Trinh, MD, assistant professor of urology at Harvard Medical School, Boston, told Urology Times.
Dr. Trinh is co-author of an accompanying study commentary in JAMA Surgery, in which he and Christian P. Meyer, MD, research fellow at the Center for Surgery and Public Health at Harvard, wrote: “Should patients be expected to travel hundreds of miles for surgery by a designated high-volume surgeon? Similarly, if the community urologist or gynecologist is not to perform such procedures, then what are they supposed to do? 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. In all likelihood, such programs will be mandatory in the near future and tied to reimbursements. Ultimately, we surgeons should be the drivers for change rather than wait for payers or regulators to impose punitive measures.”
Dr. Trinh said some in the field have taken a big step in launching quality improvement initiatives, including Michigan Urological Surgery Improvement Collaborative, which specifically addresses prostate cancer care.
“We need similar initiatives for the full breadth of urological procedures, including procedures for stress urinary incontinence,” he said.
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