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Long-Term Safety with Sling Mesh Implants for Stress Incontinence

2020; Lippincott Williams & Wilkins; Volume: 205; Issue: 1 Linguagem: Inglês

10.1097/ju.0000000000001312

1527-3792

Bilal Chughtai, Jialin Mao, Michael E. Matheny, Elizabeth Mauer, Samprit Banerjee, Art Sedrakyan,

Pelvic floor disorders treatments

You have accessJournal of UrologyAdult Urology1 Jan 2021Long-Term Safety with Sling Mesh Implants for Stress Incontinence Bilal Chughtai, Jialin Mao, Michael E. Matheny, Elizabeth Mauer, Samprit Banerjee, and Art Sedrakyan Bilal ChughtaiBilal Chughtai *Correspondence: Department of Urology, Weill Cornell Medicine, 425 E. 61st St., 12th Floor, New York, New York 10065 telephone: 646-962 4811; FAX: 646-962-0140; E-mail Address: [email protected] Department of Urology, Weill Cornell Medical College-New York Presbyterian, New York, New York , Jialin MaoJialin Mao Department of Healthcare Policy and Research, Weill Cornell Medical College-New York Presbyterian, New York, New York , Michael E. MathenyMichael E. Matheny Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee Geriatric Research Education and Clinical Care (GRECC) Service, Tennessee Valley Healthcare System VA, Nashville, Tennessee , Elizabeth MauerElizabeth Mauer Department of Healthcare Policy and Research, Weill Cornell Medical College-New York Presbyterian, New York, New York , Samprit BanerjeeSamprit Banerjee Department of Healthcare Policy and Research, Weill Cornell Medical College-New York Presbyterian, New York, New York , and Art SedrakyanArt Sedrakyan Department of Healthcare Policy and Research, Weill Cornell Medical College-New York Presbyterian, New York, New York View All Author Informationhttps://doi.org/10.1097/JU.0000000000001312AboutAbstractPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail Abstract Purpose: We examined long-term risks and predictors of mesh erosion and reoperation following mid urethral sling procedure for stress urinary incontinence. Materials and Methods: Women aged 18 years or older who received a mid urethral sling for stress urinary incontinence between 2008 and 2016 in outpatient surgical settings in New York State were included in our study. Those who underwent concomitant mesh pelvic organ prolapse repair were excluded. Primary outcomes were post-implantation time to erosion and reoperations. Kaplan-Meier analysis and Cox proportional hazard models were used to assess the risks of erosion diagnosis and reoperation. Results: Our cohort included 36,195 women with a mean±SD age of 53.7±12.4 years. Estimated risks of erosions and reoperations at 7 years after sling procedures were 3.7% and 6.7%, respectively. Older age (≥65 vs <65: HR 0.83, 95% CI 0.70–0.99) and high volume facilities (high vs low: HR 0.79, 95% CI 0.68–0.92) were associated with a lower risk of erosion. History of hysterectomy was associated with a higher risk of erosion (HR 1.62, 95% CI 1.36–1.92). Predictors of reoperation included concurrent abdominal or native tissue transvaginal prolapse repair, previous hysterectomy and depression. Conclusions: One in 27 women had sling erosions and 1 in 15 had invasive reoperations at 7 years after sling procedures. The highest erosion cases were observed among younger White women treated at low volume facilities. Continued and vigilant surveillance of mesh in stress urinary incontinence repairs, the nature and burden of stress urinary incontinence recurrence, different types of re-treatment, patient reported outcomes and information about treating surgeons are crucial. Abbreviations and Acronyms FDA U.S. Food and Drug Administration ICD International Classification of Diseases MUS mid urethral sling POP pelvic organ prolapse SPARCS Statewide Planning and Research Cooperative System SUI stress urinary incontinence Female stress urinary incontinence is a highly prevalent condition of involuntary loss of urine with coughing, sneezing or physical activity that has a debilitating social, psychological and economic impact.1 In 2000 the annual financial costs for incontinence were estimated at $19.5 billion in the United States, with this amount only growing.2 Approximately 14% of women undergo stress urinary incontinence surgery by the age of 80;3 this lifetime statistic is similar to the risk of breast cancer. More than 100 surgical procedures have been described to treat SUI, resulting in broad regional, specialty and provider variability in the delivery of care. The introduction of synthetic polypropylene mid urethral sling kits has led to the rapid adoption of this procedure and its mainstay as the gold standard for treatment among urologists and gynecologists.4 Mid urethral sling procedures have superseded previous operations due to a shorter operative time, shorter hospital stay and quicker patient recovery. Despite this, thousands of women have reported life altering long-term complications from MUS procedures to the FDA.5 More than 73,000 federal lawsuits have been filed against manufacturers of transvaginal mesh products including mesh placed for prolapse.6 The FDA's review of these devices found that while short-term safety of MUS procedures has been well established, evidence regarding long-term outcomes after MUS procedures is lacking.7 A small study with followup as long as 17 years suggested that MUS procedures are durable procedures with minimal complications. However, in that study only about half of the women were evaluated in person; the remaining women were only available via telephone.8 It is also unclear which patient groups tended to have a higher risk of reoperation and erosion following sling procedures. A Cochrane Review on long-term outcomes of MUS reported low incidence rates of bladder perforation (0.4%−3.9%), reoperation rates (0.8%−2.4%), urinary retention (0.5%−1.6%), pelvic hematoma (0.5%−1.9%), infection (0.6%−0.7%), vaginal tape erosion (0.4%−1.5%) and groin pain (0.4%−1.6%).9 It also reported high rates of de novo urgency symptoms (15%) and voiding difficulties (23%) in long-term observational studies that cover 15 to 17 years, noting the need to elucidate the risk factors for these long-term outcomes. Studies reported reoperation rates ranging from 11% to 50% following surgeries for incontinence or pelvic organ prolapse, which suggest perhaps reoperation may be an inherent aspect of SUI surgery.10 Currently both AUGS (American Urogynecologic Society) and SUFU (Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction) have issued statements on the safety and efficacy of the use of mesh for SUI but questions remain about the risk factors for these ouctomes.11 For these reasons we sought to determine the long-term risk of reoperation and erosions of MUS procedures, and predictors of these outcomes. Methods Data Source We used data from the New York State Department of Health SPARCS. SPARCS is a statewide, all-age and all-payer database that collects records of every hospital discharge, ambulatory and outpatient surgery, and emergency room admission. The database captures patient characteristics, primary and secondary diagnoses and procedures, and length of stay and charges. A unique personal identifier is assigned to every patient and encrypted to allow longitudinal analyses without compromising the confidentiality of the records. Study Population We included all women undergoing surgeries for SUI in outpatient surgical settings between 2008 and 2016 in New York State in this observational cohort study. Every patient's first record of SUI surgery was used. We excluded patients who underwent concurrent mesh based transvaginal POP repair. Procedures and the diagnosis of POP were identified using ICD-9- Clinical Modification, ICD-10- Clinical Modification and CPT-4 (Current Procedural Terminology Coding System, 4th ed) codes (supplementary Appendix, https://www.jurology.com). We further excluded nonNew York State residents and patients who underwent a previous sling or POP repair procedure back to 1995 (supplementary fig. 1, https://www.jurology.com). Patient and Public Involvement As this was an observational cohort study utilizing the medical records of patients, there was no patient or public involvement in the conduct of the study. No results were disseminated to the patient cohorts or to relevant patient communities. Predictors and Outcomes Our primary outcomes were reoperations and erosions after initial SUI repair procedures. Reoperation was defined as a subsequent SUI repair procedure or a mesh revision/removal procedure. Erosion was defined by ICD-9/10 codes that patients received during followup and identified from records of hospitalizations, emergency room visits and ambulatory surgery visits (supplementary Appendix, https://www.jurology.com). Patients were censored at death in health care facilities or at the end of the study (December 31, 2016), whichever happened first. We further evaluated the principal diagnosis associated with the record of reoperation. Predictors assessed in this study were patient age, race and ethnicity, insurance status, comorbidities, procedural variables and sling procedure volume of the operating hospital. Comorbidities were identified by diagnosis codes using algorithms validated by Elixhauser et al.12 Procedural variables were procedure year, concurrent native tissue POP repair, concurrent sacrocolpopexy (abdominal POP repair), concurrent hysterectomy, and previous hysterectomy and oophorectomy. Hospital volume at the time of surgical procedure was calculated as the average annual volume of SUI procedures and categorized into low, medium and high volume centers based on a cutoff of 47 and 108. Statistical Analysis Demographic and clinical characteristics of the cohort were described as number (%) or mean±SD. Differences between sling procedure groups (MUS procedure alone, sling with concurrent transvaginal POP repair with native tissue and sling with concurrent abdominal POP repair) were analyzed by chi-square/Fisher exact tests or ANOVAs. We used a Kaplan-Meier analysis to estimate risks of erosion as well as reoperation after the initial sling procedure for the entire population and stratified by the different procedure groups. We used univariate Cox proportional hazard models to explore the relationships between predictors and time to erosion and time to reoperation.13 We then constructed multivariable models for both erosion and reoperation, including predictors that had clinical relevance and/or statistical significance in the univariate analysis. All final models included age as a binary predictor (above or below 65) due to the distinct difference in the number of complications between these 2 cohorts. We additionally explored the nonlinear relationship between continuous age and outcomes using generalized additive Cox models with a penalized smoothing spline for continuous age.14 Lastly, machine learning models using random survival forests were constructed to predict time to erosion and time to reoperation, with demographic and clinical predictors.15 The prediction error was estimated with 1 Harrell concordance index16 in a third of the data set aside for this purpose. All p values were 2-sided with statistical significance evaluated at the 0.05 alpha level. Programming was performed using SAS® 9.3. Analyses were performed using R 3.5.1 (R Foundation for Statistical Computing, Vienna, Austria). The Weill Cornell Medical College institutional review board approved the study (IRB No. 1601016896). Results The total sample included 36,195 women with a mean±SD age of 53.7±12.4 years. The majority of women were White (74.8%) and had commercial insurance (62.3%). Most had isolated MUS procedures (76.8%), followed by sling with concurrent transvaginal POP repair with native tissue (20.1%) and sling with concurrent abdominal POP repair (3.2%, table 1). Over time the number of mesh MUS procedures in outpatient settings decreased from 4,053 to 3,280. The isolated sling procedure has been steadily declining in absolute frequency and the annual percentage of procedures (fig. 1). Table 1. Patient characteristics No. (%) Total pts 36,195 (100) Study period: 2008−2011 18,633 (51.5) 2012−2016 17,540 (48.5) Age (yrs): Less than 65 28,686 (79.3) 65 or Greater 7,509 (20.7) Race:* White 26,903 (74.8) Black 1,281 (3.56) Hispanic 4,361 (12.1) Other 3,412 (9.49) Insurance:* Medicare 7,741 (21.4) Medicaid 4,717 (13.0) Commercial 22,519 (62.3) Other 1,190 (3.29) Concurrent hysterectomy 4,090 (11.3) Previous hysterectomy 3,492 (9.65) Previous oophorectomy 2,249 (6.21) Coronary artery disease 795 (2.20) Hypertension 9,268 (25.6) Congestive heart failure 96 (0.27) Diabetes 2,958 (8.17) Chronic pulmonary disease 3,932 (10.9) Obesity 2,386 (6.59) Anemia 605 (1.67) Peripheral vascular disease 162 (0.45) Depression 2,417 (6.68) Chronic kidney disease 137 (0.38) No. comorbidities: 0 21,453 (59.3) 1 8,924 (24.7) 2+ 5,818 (16.1) Facility sling vol: Low 12,718 (35.1) Medium 12,014 (33.2) High 11,463 (31.7) Procedure group: Abdominal with sling 1,142 (3.16) POP/no mesh with sling 7,263 (20.1) Sling only 27,790 (76.8) Race/ethnicity information was missing in 0.7% of patients and insurance information was missing in 0.1%. Figure 1. Temporal trends in use of MUS procedures over time. A, frequency of MUS procedures. B, proportion of each group out of all MUS procedures. The median followup of the study was 4.8 years (IQR 2.3–6.8). Based on the Kaplan-Meier analysis, estimated risks of erosion and reoperation after sling procedures at 7 years in all patients were 3.7% and 6.7%, respectively. The estimated risks of erosion and reoperation among patients who had sling alone were similar to the overall estimates, as the isolated sling group represented the majority of the patient population. The estimated risks of erosion and reoperation for POP or SUI diagnosis after sling procedures with concurrent native tissue POP repair at 7 years were 3.6% and 10.2%, respectively. The estimated risks of erosion and reoperation diagnosis for POP or SUI after sling procedures with concurrent abdominal POP repair at 7 years were 6.5% and 14.6%, respectively (fig. 2). The most frequent diagnosis associated with the first reoperation was repeat SUI surgery (34.1% of all reoperations), followed by mesh related complication (28.5%) and POP surgery (15.5%; supplementary table, https://www.jurology.com). The estimated risks of a reoperation associated with repeat SUI diagnosis and a reoperation associated with mesh complication at 7 years were 2.4% and 1.9%, respectively. Figure 2. Freedom from reoperation and erosion for patients undergoing MUS procedures based on Kaplan-Meier analysis. A, erosion. B, reoperation. In the univariate analysis (table 2) older age, previous hysterectomy, previous oophorectomy, chronic pulmonary disease and depression were significant predictors of erosion diagnosis after initial sling procedures. Hispanic and other races as well as higher hospital sling procedure volume were associated with a lower risk of erosion diagnosis after initial sling procedures. Previous hysterectomy and oophorectomy, depression and concurrent POP repair procedures were significant predictors of reoperation after initial sling procedures. Table 2. Univariate and multivariable Cox proportional hazards models of association between predictors and time to reoperation and time to erosion Time to Reoperation Time to Erosion Univariate Multivariable Univariate Multivariable HR (SE) p Value HR (95% CI) p Value HR (SE) p Value HR (95% CI) p Value Study period: 2008−2011 Reference Reference Reference Reference 2012−2016 0.989 (0.049) 0.816 0.93 (0.84, 1.03) 0.159 0.927 (0.068) 0.265 0.93 (0.81, 1.07) 0.309 Age (yrs): Less than 65 Reference Reference Reference Reference 65 or Greater 1.102 (0.055) 0.079 0.99 (0.89, 1.11) 0.876 0.987 (0.003) <0.001 0.83 (0.7, 0.99) 0.036 Race: White Reference Reference Reference Reference Black 0.952 (0.124) 0.692 0.89 (0.7, 1.13) 0.341 0.805 (0.183) 0.234 0.76 (0.53, 1.09) 0.138 Hispanic 0.782 (0.077) 0.001 0.74 (0.63, 0.86) <0.001 0.779 (0.105) 0.017 0.77 (0.62, 0.95) 0.014 Other 0.744 (0.090) 0.001 0.74 (0.62, 0.89) 0.001 0.520 (0.146) <0.001 0.53 (0.4, 0.7) <0.001 Payer: Medicare Reference Reference Medicaid 0.893 (0.079) 0.150 1.051 (0.107) 0.641 Commercial 0.831 (0.055) 0.001 0.876 (0.077) 0.086 Other 0.855 (0.134) 0.244 0.820 (0.149) 0.306 Concurrent hysterectomy 1.015 (0.076) 0.847 0.76 (0.65, 0.9) 0.001 1.085 (0.102) 0.425 1.09 (0.87, 1.36) 0.466 Previous hysterectomy 1.289 (0.069) <0.001 1.26 (1.1, 1.45) 0.001 1.672 (0.087) <0.001 1.62 (1.36, 1.92) <0.001 Previous oophorectomy 1.216 (0.085) 0.021 1.549 (0.106) <0.001 Coronary artery disease 1.197 (0.145) 0.214 1.17 (0.88, 1.56) 0.287 0.883 (0.232) 0.592 0.93 (0.59, 1.48) 0.762 Hypertension 1.030 (0.052) 0.570 0.966 (0.072) 0.636 Congestive heart failure 0.398 (0.707) 0.193 1.558 (0.501) 0.376 Diabetes mellitus 1.152 (0.079) 0.073 1.062 (0.113) 0.591 Chronic pulmonary disease 1.113 (0.070) 0.126 1.13 (0.99, 1.3) 0.08 1.235 (0.093) 0.024 1.22 (1.01, 1.47) 0.035 Obesity 0.852 (0.102) 0.117 0.83 (0.67, 1.01) 0.065 1.153 (0.124) 0.249 1.11 (0.87, 1.41) 0.417 Anemia 1.131 (0.171) 0.471 0.924 (0.260) 0.762 Peripheral vascular disease 0.835 (0.379) 0.634 1.146 (0.448) 0.762 Depression 1.274 (0.082) 0.003 1.29 (1.1, 1.52) 0.002 1.316 (0.111) 0.014 1.23 (0.99, 1.54) 0.063 Chronic kidney disease 0.919 (0.409) 0.836 0.882 (0.578) 0.828 No. comorbidity: 0 Reference Reference 1 1.091 (0.054) 0.104 0.998 (0.076) 0.976 2+ 1.105 (0.063) 0.113 1.152 (0.085) 0.095 Sling vol: Low Reference Reference Reference Reference Medium 0.809 (0.056) <0.001 0.78 (0.7, 0.87) <0.001 0.789 (0.076) 0.002 0.77 (0.66, 0.89) <0.001 High 1.010 (0.054) 0.847 0.93 (0.83, 1.03) 0.176 0.868 (0.075) 0.059 0.79 (0.68, 0.92) 0.002 Procedure group: 1.09 (0.87, 1.36) 0.466 Abdominal with sling 1.903 (0.119) <0.001 2.31 (1.79, 2.98) <0.001 1.372 (0.181) <0.001 1.45 (0.99, 2.14) 0.058 POP/no mesh with sling 1.706 (0.051) <0.001 1.87 (1.68, 2.08) 40% error for each outcome). However, variable importance measures obtained from the random forests are presented in supplementary figure 2 (https://www.jurology.com). For example according to the random forest analysis, the most important variable in predicting time to erosion was the year of the sling procedure, followed by having a previous oophorectomy and being anemic. The most important variable in predicting time to reoperation was having a previous hysterectomy prior to the current sling procedure, followed by age and facility volume. Discussion We found that the risk of sling erosion was 1 in 27 patients and the risk of undergoing a reoperation for SUI or POP was 1 in 15 within 7 years after MUS procedure. We found that a considerable proportion of our cohort underwent de novo POP surgeries as reoperations following their index SUI surgery, which are additional long-term risks accounting for a higher reoperation rate than in previously reported studies that excluded concomitant POP surgeries.17,18 Younger women and those who received implants at low volume facilities were at the highest risk for erosion. Our findings demonstrate a rate of 3.7% for mesh erosion and 6.7% reoperation at 7 years, which is in line with the study by Welk et al, although it did not characterize the risk factors.17 Data from U.S. health maintenance organizations showed 3.7% for the 9-year rate of reoperation19 and a meta-analysis of clinical trial data showed 3.2% of patients requiring any secondary surgery.20 We also found that the risk of reoperation increased to 10.2% for the group who underwent a concurrent transvaginal POP repair and to 14.6% for those who underwent a concurrent abdominal POP repair.21 Our previous study demonstrated that increased mesh use was associated with increased reoperations. Specifically the combined treatment of incontinence and vaginal prolapse repair using mesh and sling was associated with almost doubled rates of erosion and reoperation, while treatment of incontinence repair with sling alone had the lowest erosion and reoperation risks. This could be due to the cumulative effect of each operation, the surgical complexity of combined treatment using mesh and sling, or patient or anatomical complexity. We also found that younger patients fared worse regarding erosion. A few studies have been conducted to examine outcomes after mesh use separately among different age groups. Age and sexual activity were reported as significant independent predictors of mesh exposure after transvaginal mesh prolapse repair, with younger patients more sexually active.22 We suspect that sexual activity may lead to dyspareunia as well as subsequent identification of otherwise asymptomatic mesh exposures. Overall, our findings suggest that the statements issued by AUGS and SUFU on the safety of the use of mesh for SUI should be revised to include these long-term complications. A previous study indicated that depressed patients have a tendency to lead a less than healthy lifestyle, eg tobacco smoking and excessive alcohol consumption.23 Studies have demonstrated an association between presurgical depression and higher postsurgical hospitalization and failure to return to previous activity,24 increased rates of postoperative complications and possible noncompliance with medical recommendations.25,26 There is also some evidence suggesting that patients with existing psychiatric morbidity may be more likely to undergo surgery by a lower quality surgeon.27 These factors are potential causes of the higher risk of operation we observed in depressed patients. We noted a decline in the number of isolated MUS procedures over time. We suspect, as found in a study by Anger et al, that isolated MUS procedures were likely to lead to POP repair in the first year of surgery.5 There are several limitations to our study. Erosion diagnoses during followup were identified from hospitalization, emergency department and ambulatory surgery records. Therefore, erosion diagnoses captured in this study tended to have a higher severity. The ICD-9/10 codes for mesh erosion are not categorical like the ICS/IUGA (International Continence Society/International Urogynecological Association) classification, which is another limitation of this study. However, at the population level the fact that these women undergo reoperation is of higher importance regardless of erosion classification. We were unable to identify recurrent SUI symptoms among patients choosing not to undergo surgical reoperation or to detect complications in patients opting for nonsurgical treatments of recurrent SUI, such as pessaries or absorbent pads. We were unable to capture erosions and reoperations if patients sought care in other states after initial surgery in New York State. We limited our study to New York State residents to minimize the impact of this limitation but some underestimation of the risk is possible. In addition, information regarding the severity of POP and symptoms cannot be captured through our data set. Future long-term followup studies on the outcome of other types of incontinence procedures, such as autologous sling placement, which was excluded in this study, are needed to provide a more comprehensive finding of the risk factors for reoperation post-index procedure for SUI. Finally, the data set does not provide information about the training or experience of the implanting surgeon. We used hospital volume as a predictor to partially address this issue. Our study has several strengths. This real-world population based study addresses multiple key concerns from the FDA and respective societies in the specific training and experience in the use of mesh implants for SUI. SPARCS is a prospectively collected all-comer data set that is inclusive of all women and not limited by age or payer. This allows for the assessment of all patients, surgeons and hospital systems. Furthermore, we included all mesh types in use during this time period. Our results are generalizable compared to clinical trials where patients are highly selected, a single sling type is tested and only high volume surgeons are included. Conclusions Overall, 1 in 27 women had sling erosions and 1 in 15 underwent reoperations for POP or SUI at 7 years in our large and long-term study. The erosion was highest among younger White women treated at low volume facilities. Continued and vigilant surveillance of mesh in SUI repairs is essential, and should include comprehensive information about the nature and burden of SUI recurrence, different types of re-treatment, patient reported outcomes and information about treating surgeons. References 1. : Urinary incontinence and depression. J Urol 1999; 162: 82. Link, Google Scholar 2. Centers for Disease Control and Prevention: Prevalence of Incontinence among Older Americans. Atlanta, Georgia: Centers for Disease Control and Prevention 2014. Google Scholar 3. : Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol 2014; 123: 1201. Google Scholar 4. : Midurethral sling is the dominant procedure for female stress urinary incontinence: analysis of case logs from certifying American Urologists. Urology 2013; 82: 1267. Google Scholar 5. : Short-term outcomes of vaginal mesh placement among female Medicare beneficiaries. Urology 2014; 83: 768. Google Scholar 6. United States Judicial Panel on Multidistrict Litigation: MDL Statistics Report—Distribution of Pending MDL Dockets by Actions Pending United States Judicial Panel on Multidistrict Litigation. Washington, D.C.: Judicial Panel on Multidistrict Litigation 2019. Google Scholar 7. U.S. Food and Drug Administration: Considerations about Surgical Mesh for SUI. Silver Spring, Maryland: U.S. Food and Drug Administration 2019. Google Scholar 8. : Seventeen years' follow-up of the tension-free vaginal tape procedure for female stress urinary incontinence. Int Urogynecol J 2013; 24: 1265. Google Scholar 9. : Mid-urethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev 2015; 7: CD006375. Google Scholar 10. : Management of mesh complications following surgery for stress urinary incontinence or pelvic organ prolapse: a systematic review. BJOG 2020; 127: 28. Google Scholar 11. American Urogynecologic Society and Society of Urodynamics FPMaUR: Position Statement. Mesh Midurethral Slings for Stress Urinary Incontinence. Silver Spring, Maryland: American Urogynecologic Society 2018. Google Scholar 12. : Comorbidity measures for use with administrative data. Med Care 1998; 36: 8. Google Scholar 13. : Regression models and life-tables. J R Soc Med Ser B Stat Methodol 1972; 34: 187. Google Scholar 14. : Penalized Smoothing Splines. 2017. Google Scholar 15. : Fast Unified Random Forests for Survival, Regression, and Classification (RF-SRC). 2020. Google Scholar 16. : Evaluating the yield of medical tests. JAMA 1982; 247: 2543. Google Scholar 17. : Removal or revision of vaginal mesh used for the treatment of stress urinary incontinence. JAMA Surg 2015; 150: 1167. Google Scholar 18. : Long-term risk of reoperation after synthetic mesh midurethral sling surgery for stress urinary incontinence. Obstet Gynecol 2019; 134: 1047. Google Scholar 19. : Sling revision/removal for mesh erosion and urinary retention: long-term risk and predictors. Am J Obstet Gynecol 2013; 208: 73.e1. Google Scholar 20. : Complication rates of tension-free midurethral slings in the treatment of female stress urinary incontinence: a systematic review and meta-analysis of randomized controlled trials comparing tension-free midurethral tapes to other surgical procedures and different devices. Eur Urol 2008; 53: 288. Google Scholar 21. : Association between the amount of vaginal mesh used with mesh erosions and repeated surgery after repairing pelvic organ prolapse and stress urinary incontinence. JAMA Surg 2017; 152: 257. Google Scholar 22. : Age and sexual activity are risk factors for mesh exposure following transvaginal mesh repair. Int Urogynecol J 2011; 22: 307. Google Scholar 23. : Associations between lifestyle and depressed mood: longitudinal results from the Maastricht Aging Study. Am J Public Health 2007; 97: 887. Google Scholar 24. : Presurgical depression predicts medical morbidity 6 months after coronary artery bypass graft surgery. Psychosom Med 2003; 65: 111. Google Scholar 25. : Persistent depressive symptoms lower aspirin adherence after acute coronary syndromes. Am Heart J 2006; 152: 922. Google Scholar 26. : Patients with depression are less likely to follow recommendations to reduce cardiac risk during recovery from a myocardial infarction. Arch Intern Med 2000; 160: 1818. Google Scholar 27. : Are patients with coexisting mental disorders more likely to receive CABG surgery from low-quality cardiac surgeons? The experience in New York State. Med Care 2007; 45: 587. Google Scholar The data used to produce this publication was provided by the New York State Department of Health (NYSDOH). However, the conclusions derived and views expressed herein are those of the author(s) and do not reflect the conclusions or views of NYSDOH. NYSDOH, its employees, officers and agents make no representation, warranty or guarantee as to the accuracy, completeness, currency or suitability of the information provided here. The study was funded in part by U.S. Food and Drug Administration cooperative agreement 1 U01 FD006936-01: Novel Approaches to Advance Coordinated Registry Networks (CRNs). Editor's Note: This article is the fourth of 5 published in this issue for which category 1 CME credits can be earned. Instructions for obtaining credits are given with the questions on pages 313 and 314. © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited BySmith J (2020) This Month in Adult UrologyJournal of Urology, VOL. 205, NO. 1, (1-3), Online publication date: 1-Jan-2021. Volume 205Issue 1January 2021Page: 183-190Supplementary Materials Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.Keywordssurgical meshurinary incontinencetreatment outcomestresssuburethral slingsMetricsAuthor Information Bilal Chughtai Department of Urology, Weill Cornell Medical College-New York Presbyterian, New York, New York *Correspondence: Department of Urology, Weill Cornell Medicine, 425 E. 61st St., 12th Floor, New York, New York 10065 telephone: 646-962 4811; FAX: 646-962-0140; E-mail Address: [email protected] More articles by this author Jialin Mao Department of Healthcare Policy and Research, Weill Cornell Medical College-New York Presbyterian, New York, New York More articles by this author Michael E. Matheny Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee Geriatric Research Education and Clinical Care (GRECC) Service, Tennessee Valley Healthcare System VA, Nashville, Tennessee More articles by this author Elizabeth Mauer Department of Healthcare Policy and Research, Weill Cornell Medical College-New York Presbyterian, New York, New York More articles by this author Samprit Banerjee Department of Healthcare Policy and Research, Weill Cornell Medical College-New York Presbyterian, New York, New York More articles by this author Art Sedrakyan Department of Healthcare Policy and Research, Weill Cornell Medical College-New York Presbyterian, New York, New York More articles by this author Expand All The data used to produce this publication was provided by the New York State Department of Health (NYSDOH). However, the conclusions derived and views expressed herein are those of the author(s) and do not reflect the conclusions or views of NYSDOH. NYSDOH, its employees, officers and agents make no representation, warranty or guarantee as to the accuracy, completeness, currency or suitability of the information provided here. The study was funded in part by U.S. Food and Drug Administration cooperative agreement 1 U01 FD006936-01: Novel Approaches to Advance Coordinated Registry Networks (CRNs). Editor's Note: This article is the fourth of 5 published in this issue for which category 1 CME credits can be earned. Instructions for obtaining credits are given with the questions on pages 313 and 314. Advertisement Advertisement Loading ...