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Original Investigation |

Removal or Revision of Vaginal Mesh Used for the Treatment of Stress Urinary Incontinence

Blayne Welk, MD, MSc1,2,3; Hana’a Al-Hothi, MD4; Jennifer Winick-Ng, MSc3
[+] Author Affiliations
1Department of Surgery, Western University, St Joseph’s Health Care, London, Ontario, Canada
2Department of Epidemiology and Biostatistics, Western University, St Joseph’s Health Care, London, Ontario, Canada
3Institute for Clinical Evaluative Sciences, London, Ontario, Canada
4Department of Surgery, Hamad Medical Corporation, Doha, Qatar
JAMA Surg. 2015;150(12):1167-1175. doi:10.1001/jamasurg.2015.2590.
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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.

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Figure.
Predicted Probability of Mesh-Related Complication in the Treatment of Stress Urinary Incontinence by Annual Surgeon Volume

The overlying histogram plot shows the distribution of annual surgeon volume. Predicted probability (solid line) was calculated using a logistic regression model with the same covariates as the primary analysis and was based on the observed sample means and proportions for each of the covariates. Dashed lines represent the 95% CI.

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