Blayne Welk1, Hana'a Al-Hothi2, Jennifer Winick-Ng3. 1. Department of Surgery, Western University, St Joseph's Health Care, London, Ontario, Canada2Department of Epidemiology and Biostatistics, Western University, St Joseph's Health Care, London, Ontario, Canada3Institute for Clinical Evaluative Sciences, Lond. 2. Department of Surgery, Hamad Medical Corporation, Doha, Qatar. 3. Institute for Clinical Evaluative Sciences, London, Ontario, Canada.
Abstract
IMPORTANCE: Synthetic mesh slings are the most common surgical treatment for female stress urinary incontinence (SUI). However, the US Food and Drug Administration has released warnings that question the safety of vaginal mesh. OBJECTIVES: To measure the incidence of mesh removal or revision after SUI procedures and to determine whether significant surgeon and patient risk factors exist. DESIGN, SETTING, AND PARTICIPANTS: Population-based retrospective cohort study that included all adult women undergoing an incident procedure for SUI with synthetic mesh in Ontario, Canada, from April 1, 2002, through December 31, 2012 (N = 59 887). The end of potential follow-up was March 31, 2013. Data were analyzed from November 1, 2014, through February 28, 2015. EXPOSURES: Yearly volume of mesh-based procedures for SUI performed by the treating surgeons and their surgical specialty. MAIN OUTCOMES AND MEASURES: The primary outcome was a composite of surgical procedures related to removal or revision of mesh slings (owing to erosion, fistula, pain, or retention). We hypothesized a priori that surgeon volume would be inversely correlated with complications. RESULTS: Among the identified 59 887 women who underwent a mesh-based procedure for SUI, the median age was 52 (interquartile range [IQR], 45-63) years. High-volume surgeons (≥75th percentile of yearly mesh-based procedures) were less likely to perform a simultaneous hysterectomy (performed in 11.5% vs 16.5% of patients; standardized difference, 0.14), were more likely to work in an academic center (28.9% vs 16.3% of patients; standardized difference, 0.30), and saw the patient less frequently in the year before the procedure (median, 2 [IQR, 1-3] vs 3 [IQR, 2-4] visits; standardized difference, 0.26). Complications were treated in 1307 women (2.2%), and the 10-year cumulative incidence rate was 3.29 (95% CI, 3.05-3.53). In our multivariable survival model, patients of high-volume surgeons had a significantly lower risk (95% CI) for experiencing our composite outcome (hazard ratio [HR], 0.73 [0.65-0.83]; absolute risk reduction, 0.63% [0.36%-0.92%]; P < .01). Gynecologists were not significantly associated with more complications compared with urologists (HR, 0.94 [95% CI, 0.83-1.08]; P = .38). Among our secondary exposures of interest, multiple mesh-based SUI procedures increased the risk for complications (HR, 4.73 [95% CI, 3.62-6.17]; P < .01). However, traditional high-risk patient features did not increase the risk (HR, 0.58 [95% CI, 0.08-4.13]; P = .59). CONCLUSIONS AND RELEVANCE: Ten years after SUI mesh surgery, 1 of every 30 women may require a second procedure for mesh removal or revision. Patients of lower-volume surgeons have a 37% increased likelihood of having a complication. These findings support the recommendations of the US Food and Drug Administration related to the use of vaginal mesh for treatment of SUI.
IMPORTANCE: Synthetic mesh slings are the most common surgical treatment for female stress urinary incontinence (SUI). However, the US Food and Drug Administration has released warnings that question the safety of vaginal mesh. OBJECTIVES: To measure the incidence of mesh removal or revision after SUI procedures and to determine whether significant surgeon and patient risk factors exist. DESIGN, SETTING, AND PARTICIPANTS: Population-based retrospective cohort study that included all adult women undergoing an incident procedure for SUI with synthetic mesh in Ontario, Canada, from April 1, 2002, through December 31, 2012 (N = 59 887). The end of potential follow-up was March 31, 2013. Data were analyzed from November 1, 2014, through February 28, 2015. EXPOSURES: Yearly volume of mesh-based procedures for SUI performed by the treating surgeons and their surgical specialty. MAIN OUTCOMES AND MEASURES: The primary outcome was a composite of surgical procedures related to removal or revision of mesh slings (owing to erosion, fistula, pain, or retention). We hypothesized a priori that surgeon volume would be inversely correlated with complications. RESULTS: Among the identified 59 887 women who underwent a mesh-based procedure for SUI, the median age was 52 (interquartile range [IQR], 45-63) years. High-volume surgeons (≥75th percentile of yearly mesh-based procedures) were less likely to perform a simultaneous hysterectomy (performed in 11.5% vs 16.5% of patients; standardized difference, 0.14), were more likely to work in an academic center (28.9% vs 16.3% of patients; standardized difference, 0.30), and saw the patient less frequently in the year before the procedure (median, 2 [IQR, 1-3] vs 3 [IQR, 2-4] visits; standardized difference, 0.26). Complications were treated in 1307 women (2.2%), and the 10-year cumulative incidence rate was 3.29 (95% CI, 3.05-3.53). In our multivariable survival model, patients of high-volume surgeons had a significantly lower risk (95% CI) for experiencing our composite outcome (hazard ratio [HR], 0.73 [0.65-0.83]; absolute risk reduction, 0.63% [0.36%-0.92%]; P < .01). Gynecologists were not significantly associated with more complications compared with urologists (HR, 0.94 [95% CI, 0.83-1.08]; P = .38). Among our secondary exposures of interest, multiple mesh-based SUI procedures increased the risk for complications (HR, 4.73 [95% CI, 3.62-6.17]; P < .01). However, traditional high-risk patient features did not increase the risk (HR, 0.58 [95% CI, 0.08-4.13]; P = .59). CONCLUSIONS AND RELEVANCE: Ten years after SUI mesh surgery, 1 of every 30 women may require a second procedure for mesh removal or revision. Patients of lower-volume surgeons have a 37% increased likelihood of having a complication. These findings support the recommendations of the US Food and Drug Administration related to the use of vaginal mesh for treatment of SUI.