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The 10-year incidence of serious complications after mesh-sling surgery for stress urinary incontinence is a relatively low 3.29, but patients treated by surgeons who perform a low volume of the procedures have a 37% higher relative risk of requiring further surgery for complications, compared with patients of experienced surgeons, according to a report published online Sept. 9 in JAMA Surgery.
“These findings support the regulatory statements that suggest that patients should be counseled regarding serious complications that can occur with mesh-based procedures for SUI and that surgeons should achieve expertise in their chosen procedure,” wrote Dr. Blayne Welk of the department of surgery and the department of epidemiology and biostatistics at Western University and St. Joseph’s Health Care, London (Ont.) and his associates.
The investigators performed a population-based retrospective cohort study to determine the incidence of surgical removal or revision after a mesh-sling procedure for SUI and to examine whether there are specific risk factors for mesh-related complications. They analyzed data for 59,887 women who underwent the procedure across Ontario during a 10-year period. Median follow-up was 4.4 years.
The procedures were performed by 1,068 surgeons: 293 urologists, 625 gynecologists, and 150 unspecified clinicians. Cases were classified according to whether the surgeon performed a high or low volume of mesh-sling procedures specifically for SUI. High volume was defined as a number at or above the 75th percentile for yearly volume in the province, or more than 16 procedures per year.
Overall, 1,307 women (2.2%) required mesh removal or revision a median of 1 year after the initial surgery. The cumulative incidence of the composite outcome of removal/revision of vaginal or urethral mesh, removal of a foreign body, endoscopic treatment of a urethral foreign body or mesh encrustation, uretrolysis, or repair of a urethrovaginal fistula was 3.29 at 10 years, Dr. Welk and his associates reported. Surgical specialty had no significant effect on complication risk.
This incidence is consistent with previous report from HMOs in the United States and a meta-analysis of clinical trial results, the investigators noted (JAMA Surg. 2015 Sept. 9. doi: 10.1001/jamasurg.2015.2590). Patients of low-volume surgeons had a 37% higher relative risk of complications requiring reoperation than did patients of high-volume surgeons. In a further analysis of the data, patients of low-volume surgeons were significantly more likely to experience the composite outcome than were patients of high-volume surgeons (hazard ratio, 1.37), and, again, the difference between surgical specialties was nonsignificant.
Urologists and gynecologists have very different surgical training and day-to-day practices, the researchers noted, and as a result they hypothesized that complication rates might differ between the two groups of clinicians. But that was not proven in the findings.
“This suggests that procedure-specific knowledge and experience is important for surgery to treat SUI, rather than general operative training,” Dr. Welk and his associates wrote.
Women who underwent multiple mesh-based procedures for SUI were at highest risk for the composite endpoint. Their absolute risk for later mesh removal or revision was 4.87%.
“This novel finding should temper the enthusiasm of case series that suggest that the use of multiple synthetic slings is safe and efficacious,” the researchers wrote.
This finding is also important in light of the fact that 1,307 of the study participants underwent more than one mesh implant procedure, presumably for recurrent SUI.
This study was supported by the Ontario Ministry of Health and Long-term Care and the Academic Medical Organization of Southwestern Ontario. Dr. Welk reported receiving grant funding from Astellas Canada.
The call to centralize complex, high-risk surgical procedures at expert centers is well known, but what about commonly performed, same-day procedures with low risks of complications, such as mesh-sling surgery for stress urinary incontinence? Must patients be referred only to high-volume surgeons?
This likely would be impractical if not impossible for a procedure that is performed so frequently. A more reasonable approach would be for low-volume surgeons to use structured proctoring and/or coaching models to develop expertise and mandatory outcomes reporting to assure high-quality care. Even though clinicians will not welcome this approach, it probably will become required in the near future and tied to reimbursements. Ultimately, surgeons should be the drivers for change and should not wait for payers or regulators to impose punitive measures.
Dr. Christian P. Meyer and Dr. Quoc-Dien Trinh are with the Center for Surgery and Public Health and the division of urologic surgery at Brigham and Women’s Hospital and Harvard Medical School, Boston. They reported having no relevant financial disclosures. These remarks are adapted from an invited commentary (JAMA Surg. 2015 Sept. 9. doi: 10.1001/jamasurg.2015.2596) accompanying Dr. Welk’s report.
The call to centralize complex, high-risk surgical procedures at expert centers is well known, but what about commonly performed, same-day procedures with low risks of complications, such as mesh-sling surgery for stress urinary incontinence? Must patients be referred only to high-volume surgeons?
This likely would be impractical if not impossible for a procedure that is performed so frequently. A more reasonable approach would be for low-volume surgeons to use structured proctoring and/or coaching models to develop expertise and mandatory outcomes reporting to assure high-quality care. Even though clinicians will not welcome this approach, it probably will become required in the near future and tied to reimbursements. Ultimately, surgeons should be the drivers for change and should not wait for payers or regulators to impose punitive measures.
Dr. Christian P. Meyer and Dr. Quoc-Dien Trinh are with the Center for Surgery and Public Health and the division of urologic surgery at Brigham and Women’s Hospital and Harvard Medical School, Boston. They reported having no relevant financial disclosures. These remarks are adapted from an invited commentary (JAMA Surg. 2015 Sept. 9. doi: 10.1001/jamasurg.2015.2596) accompanying Dr. Welk’s report.
The call to centralize complex, high-risk surgical procedures at expert centers is well known, but what about commonly performed, same-day procedures with low risks of complications, such as mesh-sling surgery for stress urinary incontinence? Must patients be referred only to high-volume surgeons?
This likely would be impractical if not impossible for a procedure that is performed so frequently. A more reasonable approach would be for low-volume surgeons to use structured proctoring and/or coaching models to develop expertise and mandatory outcomes reporting to assure high-quality care. Even though clinicians will not welcome this approach, it probably will become required in the near future and tied to reimbursements. Ultimately, surgeons should be the drivers for change and should not wait for payers or regulators to impose punitive measures.
Dr. Christian P. Meyer and Dr. Quoc-Dien Trinh are with the Center for Surgery and Public Health and the division of urologic surgery at Brigham and Women’s Hospital and Harvard Medical School, Boston. They reported having no relevant financial disclosures. These remarks are adapted from an invited commentary (JAMA Surg. 2015 Sept. 9. doi: 10.1001/jamasurg.2015.2596) accompanying Dr. Welk’s report.
The 10-year incidence of serious complications after mesh-sling surgery for stress urinary incontinence is a relatively low 3.29, but patients treated by surgeons who perform a low volume of the procedures have a 37% higher relative risk of requiring further surgery for complications, compared with patients of experienced surgeons, according to a report published online Sept. 9 in JAMA Surgery.
“These findings support the regulatory statements that suggest that patients should be counseled regarding serious complications that can occur with mesh-based procedures for SUI and that surgeons should achieve expertise in their chosen procedure,” wrote Dr. Blayne Welk of the department of surgery and the department of epidemiology and biostatistics at Western University and St. Joseph’s Health Care, London (Ont.) and his associates.
The investigators performed a population-based retrospective cohort study to determine the incidence of surgical removal or revision after a mesh-sling procedure for SUI and to examine whether there are specific risk factors for mesh-related complications. They analyzed data for 59,887 women who underwent the procedure across Ontario during a 10-year period. Median follow-up was 4.4 years.
The procedures were performed by 1,068 surgeons: 293 urologists, 625 gynecologists, and 150 unspecified clinicians. Cases were classified according to whether the surgeon performed a high or low volume of mesh-sling procedures specifically for SUI. High volume was defined as a number at or above the 75th percentile for yearly volume in the province, or more than 16 procedures per year.
Overall, 1,307 women (2.2%) required mesh removal or revision a median of 1 year after the initial surgery. The cumulative incidence of the composite outcome of removal/revision of vaginal or urethral mesh, removal of a foreign body, endoscopic treatment of a urethral foreign body or mesh encrustation, uretrolysis, or repair of a urethrovaginal fistula was 3.29 at 10 years, Dr. Welk and his associates reported. Surgical specialty had no significant effect on complication risk.
This incidence is consistent with previous report from HMOs in the United States and a meta-analysis of clinical trial results, the investigators noted (JAMA Surg. 2015 Sept. 9. doi: 10.1001/jamasurg.2015.2590). Patients of low-volume surgeons had a 37% higher relative risk of complications requiring reoperation than did patients of high-volume surgeons. In a further analysis of the data, patients of low-volume surgeons were significantly more likely to experience the composite outcome than were patients of high-volume surgeons (hazard ratio, 1.37), and, again, the difference between surgical specialties was nonsignificant.
Urologists and gynecologists have very different surgical training and day-to-day practices, the researchers noted, and as a result they hypothesized that complication rates might differ between the two groups of clinicians. But that was not proven in the findings.
“This suggests that procedure-specific knowledge and experience is important for surgery to treat SUI, rather than general operative training,” Dr. Welk and his associates wrote.
Women who underwent multiple mesh-based procedures for SUI were at highest risk for the composite endpoint. Their absolute risk for later mesh removal or revision was 4.87%.
“This novel finding should temper the enthusiasm of case series that suggest that the use of multiple synthetic slings is safe and efficacious,” the researchers wrote.
This finding is also important in light of the fact that 1,307 of the study participants underwent more than one mesh implant procedure, presumably for recurrent SUI.
This study was supported by the Ontario Ministry of Health and Long-term Care and the Academic Medical Organization of Southwestern Ontario. Dr. Welk reported receiving grant funding from Astellas Canada.
The 10-year incidence of serious complications after mesh-sling surgery for stress urinary incontinence is a relatively low 3.29, but patients treated by surgeons who perform a low volume of the procedures have a 37% higher relative risk of requiring further surgery for complications, compared with patients of experienced surgeons, according to a report published online Sept. 9 in JAMA Surgery.
“These findings support the regulatory statements that suggest that patients should be counseled regarding serious complications that can occur with mesh-based procedures for SUI and that surgeons should achieve expertise in their chosen procedure,” wrote Dr. Blayne Welk of the department of surgery and the department of epidemiology and biostatistics at Western University and St. Joseph’s Health Care, London (Ont.) and his associates.
The investigators performed a population-based retrospective cohort study to determine the incidence of surgical removal or revision after a mesh-sling procedure for SUI and to examine whether there are specific risk factors for mesh-related complications. They analyzed data for 59,887 women who underwent the procedure across Ontario during a 10-year period. Median follow-up was 4.4 years.
The procedures were performed by 1,068 surgeons: 293 urologists, 625 gynecologists, and 150 unspecified clinicians. Cases were classified according to whether the surgeon performed a high or low volume of mesh-sling procedures specifically for SUI. High volume was defined as a number at or above the 75th percentile for yearly volume in the province, or more than 16 procedures per year.
Overall, 1,307 women (2.2%) required mesh removal or revision a median of 1 year after the initial surgery. The cumulative incidence of the composite outcome of removal/revision of vaginal or urethral mesh, removal of a foreign body, endoscopic treatment of a urethral foreign body or mesh encrustation, uretrolysis, or repair of a urethrovaginal fistula was 3.29 at 10 years, Dr. Welk and his associates reported. Surgical specialty had no significant effect on complication risk.
This incidence is consistent with previous report from HMOs in the United States and a meta-analysis of clinical trial results, the investigators noted (JAMA Surg. 2015 Sept. 9. doi: 10.1001/jamasurg.2015.2590). Patients of low-volume surgeons had a 37% higher relative risk of complications requiring reoperation than did patients of high-volume surgeons. In a further analysis of the data, patients of low-volume surgeons were significantly more likely to experience the composite outcome than were patients of high-volume surgeons (hazard ratio, 1.37), and, again, the difference between surgical specialties was nonsignificant.
Urologists and gynecologists have very different surgical training and day-to-day practices, the researchers noted, and as a result they hypothesized that complication rates might differ between the two groups of clinicians. But that was not proven in the findings.
“This suggests that procedure-specific knowledge and experience is important for surgery to treat SUI, rather than general operative training,” Dr. Welk and his associates wrote.
Women who underwent multiple mesh-based procedures for SUI were at highest risk for the composite endpoint. Their absolute risk for later mesh removal or revision was 4.87%.
“This novel finding should temper the enthusiasm of case series that suggest that the use of multiple synthetic slings is safe and efficacious,” the researchers wrote.
This finding is also important in light of the fact that 1,307 of the study participants underwent more than one mesh implant procedure, presumably for recurrent SUI.
This study was supported by the Ontario Ministry of Health and Long-term Care and the Academic Medical Organization of Southwestern Ontario. Dr. Welk reported receiving grant funding from Astellas Canada.
FROM JAMA SURGERY
Key clinical point: The complication rate after mesh sling surgery for SUI is relatively low and highly correlated with the surgeon’s experience with the procedure.
Major finding: Patients of low-volume surgeons had a 37% higher relative risk of complications requiring reoperation than did patients of high-volume surgeons.
Data source: A population-based retrospective cohort study of 59,887 women who had SUI mesh surgery across Ontario during a 10-year period.
Disclosures: This study was supported by the Ontario Ministry of Health and Long-term Care and the Academic Medical Organization of Southwestern Ontario. Dr. Welk reported receiving grant funding from Astellas Canada.
