Long-term Device Outcomes of Mesh Implants in Pelvic Organ Prolapse Repairs

© 2020 Lippincott Williams and Wilkins. All rights reserved. During the past 2 decades, more than 2 million women in the United States have been implanted with transvaginal mesh as surgical treatment for both stress urinary incontinence and pelvic organ prolapse (POP). Several mesh devices were adopted and widely used to address the high failure rates of traditional POP repairs. In the years after the introduction of transvaginal mesh products, increasing numbers of women who had been implanted with these devices complained about pain, vaginal bleeding, and other symptoms. Thousands of such complications were reported by women to the US Food and Drug Administration (FDA). Starting in 2008 and in subsequent years, the FDA issued a number of warnings about transvaginal mesh devices. To date, more than 73,000 federal lawsuits have been filed against manufacturers of transvaginal mesh products. On April 6, 2019, the FDA-finding no reasonable assurance of safety and effectiveness for these devices-ordered all mesh manufacturers to stop selling and distributing mesh products for transvaginal repair of anterior prolapse. In a previous population-based cohort study, the authors demonstrated that use of mesh in the United States was associated with a higher risk of repeat intervention compared with nonmesh surgeries within 1 year after POP repair. Large randomized trials from Great Britain confirmed evidence of harm and higher risk of reintervention with transvaginal mesh. This and other accumulating evidence led to the restriction of mesh implants in Australia, New Zealand, and the United Kingdom. No long-term studies have investigated adverse outcomes and rates of reinterventions. The aim of this population-based cohort study was to evaluate the long-term incidence of mesh-related complications and reintervention after POP repairs. Participants were women undergoing POP repairs in inpatient and outpatient surgical settings in New York State between 2008 and 2016. Reintervention after initial POP repair was the primary study outcome and defined as a subsequent POP repair procedure, mesh revision, or mesh removal procedure. To account for differences in patients' baseline characteristics between these 2 groups, propensity score matching was performed. Propensity scores for each individual were obtained using multivariable logistic regression based on patient and procedural characteristics and hospital volume between mesh and nonmesh patient groups. Time-to-event analysis assessed long-term safety events and reintervention. Kaplan-Meier analysis was used for the unmatched and matched cohort to estimate cumulative risks of reintervention at 5 years after the index POP repair procedure. A total of 54,194 women undergoing POP repairs were identified:12,989 having surgery withmesh and 41,205 having surgery without mesh. Mean patient age at time of surgery was 59.8 (±13.1) years, and median follow-up was 4.7 years (interquartile range, 2.4-6.8 years). There was a higher risk of reintervention among the propensity score-matched women at 5 years following POP repair with mesh compared with POP repairwithout transvaginal mesh; the hazard ratio was 1.40, with a 95% confidence interval (CI) of 1.27-0.54, P < 0.001. Kaplan-Meier analysis showed that among women who had mesh implanted, the estimated risk of undergoing a reintervention at 5 years was higher (8.8%; 95% CI, 8.2%-9.3%) than for women with no mesh implanted (6.3%; 95% CI, 5.9%-6.8%). Of patients who had reinterventions, 18.5% had a reintervention related to mesh complications. With time-to-event analysis, the risk of reintervention related to mesh complications persisted during the entire 8-year study period. Although transvaginal mesh has been removed from the US market in 2019, these data support that the risk of mesh complications does not diminish over time. Therefore, continued surveillance of these women is essential to ensure their safety. Data obtained from transvaginal mesh device registries should include comprehensive information about the nature and burden of POP recurrence, the different types of retreatment, patient-reported outcomes, and information about clinicians implanting these devices.