Bilal Chughtai1, Jialin Mao, Tirsit S Asfaw, Carl Heneghan, Charles R Rardin, Art Sedrakyan. 1. Departments of Urology, Healthcare Policy and Research, and Obstetrics and Gynecology, Weill Cornell Medical College-New York Presbyterian, New York, New York; the Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom; and the Division of Urogynecology, the Warren Alpert Medical School of Brown University, and Women & Infants Hospital, Providence, Rhode Island.
Abstract
OBJECTIVE: To evaluate the longer-term safety and reintervention outcomes of mesh implants in pelvic organ prolapse (POP) repairs. METHODS: We conducted a population-based cohort study of women undergoing POP repairs in inpatient and outpatient surgical settings between 2008 and 2016 in New York State. Multivariable logistic regression was used based on patient and procedural characteristics and hospital volume between mesh and nonmesh groups to obtain propensity scores for each individual. Long-term safety events and reinterventions were assessed using time-to-event analysis. RESULTS: We identified 54,194 women undergoing POP repairs (12,989 with mesh, and 41,205 without mesh). Mean age was 59.8 (±13.1) years, and median follow-up was 4.7 years (interquartile range, 2.4-6.8 years). In the propensity score-matched 12,284 pairs of women, POP repair with mesh was associated with a higher risk of reintervention when compared with POP repair without transvaginal mesh (hazard ratio 1.40, 95% CI 1.27-1.54, P<.001). The estimated risk of undergoing a reintervention at 5 years was 8.8% (95% CI 8.2-9.3%) in the mesh group and 6.3% (5.9-6.8%) in the nonmesh group. Among patients who had reinterventions, 18.5% of those operated with mesh had a reintervention related to mesh-related complications. CONCLUSION: Even though transvaginal mesh has been removed from the market, the risk of mesh complications did not diminish over time and these women warrant close follow-up. Continued surveillance of mesh in POP repairs is essential to ensure safety for the women who have already been implanted.
OBJECTIVE: To evaluate the longer-term safety and reintervention outcomes of mesh implants in pelvic organ prolapse (POP) repairs. METHODS: We conducted a population-based cohort study of women undergoing POP repairs in inpatient and outpatient surgical settings between 2008 and 2016 in New York State. Multivariable logistic regression was used based on patient and procedural characteristics and hospital volume between mesh and nonmesh groups to obtain propensity scores for each individual. Long-term safety events and reinterventions were assessed using time-to-event analysis. RESULTS: We identified 54,194 women undergoing POP repairs (12,989 with mesh, and 41,205 without mesh). Mean age was 59.8 (±13.1) years, and median follow-up was 4.7 years (interquartile range, 2.4-6.8 years). In the propensity score-matched 12,284 pairs of women, POP repair with mesh was associated with a higher risk of reintervention when compared with POP repair without transvaginal mesh (hazard ratio 1.40, 95% CI 1.27-1.54, P<.001). The estimated risk of undergoing a reintervention at 5 years was 8.8% (95% CI 8.2-9.3%) in the mesh group and 6.3% (5.9-6.8%) in the nonmesh group. Among patients who had reinterventions, 18.5% of those operated with mesh had a reintervention related to mesh-related complications. CONCLUSION: Even though transvaginal mesh has been removed from the market, the risk of mesh complications did not diminish over time and these women warrant close follow-up. Continued surveillance of mesh in POP repairs is essential to ensure safety for the women who have already been implanted.