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. Author manuscript; available in PMC: 2023 Apr 1.
Published in final edited form as: Female Pelvic Med Reconstr Surg. 2021 Sep 30;28(4):188–193. doi: 10.1097/SPV.0000000000001094

Long-term outcomes following midurethral mesh sling surgery for stress urinary incontinence

Sara Z DEJENE 1, Michele JONSSON FUNK 1, Virginia PATE 1, Jennifer M WU 2
PMCID: PMC9169553  NIHMSID: NIHMS1745901  PMID: 34608036

Abstract

Objectives:

Although midurethral mesh slings are the gold standard surgery for stress urinary incontinence (SUI), limited data exist regarding long-term outcomes. Thus, our objectives were to evaluate the long-term risk of sling revision and the risk of repeat SUI surgery up to 15 years after the initial sling and to identify predictors of these outcomes.

Methods:

Using a population-based cohort of commercially-insured individuals in the U.S., we identified women aged ≥ 18 who underwent a sling procedure between 2001 and 2018. For sling revision, we evaluated indications (mesh exposure or urinary retention). We estimated the cumulative risks of sling revision and repeat SUI surgery annually using Kaplan-Meier survival curves and evaluated predictors using Cox proportional hazards models.

Results:

We identified 334,601 mesh sling surgeries. For sling revision, the 10- and 15-year risks were 6.9% (95% CI: 6.7-7.0) and 7.9% (95% CI: 7.5-8.3), with 48.7% of slings revisions associated with mesh exposure. The 10- and 15-year risks of repeat SUI surgery were 14.5% (95% CI, 14.2-14.8) and 17.9% (95% CI: 17.3-18.6). Women aged 18-29 had an elevated risk for both sling revision (HR 1.20, 95%CI: 1.15-1.25) and repeat SUI surgery (HR 1.30, 95%CI: 1.25-1.37) compared to women 70 years and older.

Conclusion:

In our study population, the 15-year risk of sling revision was 7.9%, with nearly half of revisions due to mesh exposure. These findings provide critical long-term data to support informed decisions for women and providers considering midurethral mesh slings.

Keywords: stress urinary incontinence, mesh exposure, urinary retention, midurethral sling, slings

Introduction

Since its introduction in 1998, the midurethral mesh sling has become the gold standard surgical treatment for stress urinary incontinence (SUI), a highly prevalent condition among women.1,2 Midurethral slings currently comprise the vast majority of SUI surgeries,3,4 and they are the most extensively evaluated SUI procedure.1 They are highly effective in the short- and medium term and have a good safety profile; however, long-term data are limited.1

There has been heightened concern regarding the use of vaginal mesh in surgical procedures. In 2008 and 2011, the Food and Drug Administration (FDA) released two safety notifications regarding the use of vaginal surgical mesh for pelvic floor disorders.5 Then in April 2019, the FDA ordered manufacturers of vaginal mesh for pelvic organ prolapse to cease marketing these products.5 Although the FDA order focused on vaginal mesh for prolapse, midurethral slings became entangled in the controversy.

Despite evidence of efficacy and safety, midurethral slings are being threatetened.6,7 The National Health Service (NHS) in the United Kingdom implemented restrictions to midurethral slings, including a requirement that all mesh SUI operations be reported to a national database.8-10 In the US, lawsuits regarding mesh slings continue in several states, despite concerns that the lawsuits could force midurethral slings off the market and limit effective options for women seeking treatment for SUI.11 Due to the effectiveness and safety profile of midurethral slings, the importance of preserving these slings for SUI treatment has been supported by several national and international associations.12-14

While high-quality, short- and medium-term data exist for midurethral slings, long-term data are limited.1 This invaluable information would help to inform the discussions regarding these procedures. Currently, the highest quality data with longer-term outcomes is a robust analysis of nine-year outcomes in NHS data.7 In this study, we sought to estimate the longer-term risk of subsequent surgery, whether sling revision or re-operation for SUI, through 15-years after the initial sling procedure. Our secondary objective was to assess predictors of subsequent surgery.

Materials and Methods

We used the IBM Watson Health MarketScan Commercial Claims and Encounters and Medicare Supplemental Coordination of Benefits database from 2001 to 2018. This database contains deidentified, individual-level health care utilization and enrollment data for inpatient and outpatient visits, as well as outpatient prescription records from approximately 100 employer-based plans in the United States. These data represent the healthcare experiences of privately-insured employees and retirees, their spouses, and their dependents. In 2016, these databases included approximately 29.9 million individuals. For additional context, in 2016, 55.7% of the U.S. population, or 178.5 million individuals, had employment-based insurance.15 Through rigorous evaluation, this database has determined to be valid and reliable and has previously been used to investigate surgical treatment SUI.6,16-18 This study was determined to be exempt from further review by the Institutional Review Board at the University of North Carolina at Chapel Hill.

The population at risk included all women aged 18 or older who underwent a sling procedure between 2001 and 2018. The first, or index, sling procedure was identified by using Current Procedure Terminology (CPT) code 57288, which includes both midurethal and pubovaginal slings. We required women to have at least 90 days of continuous enrollment prior to the index surgery and excluded women with a diagnosis of urethral diverticulum or a urinary-genital tract fistula, based on International Classification of Diseases, 9th and 10th revisions, clinical modification (ICD-9-CM, ICD-10-CM). A complete list of code definitions can be found in Supplementary Table 1. We chose 90 days as the look-back period to define index slings to be consistent with the methodology from prior studies.6,16

Our outcomes included sling revision and repeat SUI surgery. For sling revisions, we identified the indication, whether mesh exposure, urinary retention, or other indications, such as pain, based on ICD-9 or −10 codes. These diagnoses were not mutually exclusive, so a single revision could have been associated with more than one diagnosis. Repeat SUI procedures included: subsequent sling, colposuspension/urethropexy, Kelly plication, laparoscopic SUI procedures, needle suspension, or urethral bulking, identified with CPT codes. All codes are listed in Supplementary Table 1. We also assessed length of follow-up. It is important to note that women who underwent surgery in more recent years will have a shorter length of follow-up. Correspondingly, only those who underwent surgery in 2003 or earlier will have 15-year follow-up data. Patients were censored at the earliest disenrollment date or on Dec. 31, 2018.

The following characteristics of patients undergoing slings were assessed: age at index sling (18-29, 30-39, 40-49, 50-59, 60-69, and ≥ 70), US region (Northeast, Midwest, South, West, Unknown/Other), calendar year of index surgery, years of follow-up data available (categorized into 2-year intervals up to 14 years and ≥ 14 years), concurrent hysterectomy or pelvic organ prolapse procedure (anterior, apical, and posterior), and whether the surgery was an inpatient or outpatient procedure.

Descriptive statistics were used to characterize the population of women undergoing a sling surgery. Annual cumulative risks and 95% confidence intervals (CI) for each outcome were estimated using Kaplan-Meier survival curves for each year of follow-up, up to 15 years. We evaluated predictors of sling revision and repeat SUI surgery using Cox proportional hazards models. Predictors included age, year of index sling, U.S. region, concurrent hysterectomy and concurrent prolapse procedures. Adjusted hazard ratios (adjHR) and 95% CIs were estimated separately for each outcome.

We performed the following sensitivity analyses. Recognizing that 90 days may not be a long enough look-back period, we conducted an analysis requiring women to have at least one year of continuous enrollment prior to the index sling. All statistical analyses were performed using SAS, version 9.4 (SAS Institute, Cary, NC).

Results

A total of 334,601 mesh sling surgeries were identified during the study period. The median age was 52 (interquartile range (IQR), 45-61) and approximately 61% were performed on women between the ages of 40 and 59 (Table 1). The majority of procedures (55.0%) were performed between 2008 and 2013, and 24.6% were performed in the inpatient setting. The median follow-up time was 1.7 years (IQR 0.7-4.0). While 54.7% of patients in this cohort had fewer than two years of follow-up post index sling surgery, we observed at least four years of follow-up for 83,853 patients and at least 10 years of follow-up for 12,828 patients. Hysterectomies and prolapse surgeries were common in this population, occurring in 26.5% and 39.6% of the cohort, respectively.

Table 1.

Baseline characteristics of women receiving mesh sling surgery (n=362,639)

Characteristic N (%)
Age at Index Sling (mean (SD)) 53.4 (11.7)
Age categories
     18-29 2,073 (0.6)
     30-39 33,043 (9.9)
     40-49 101,020 (30.2)
     50-59 102,057 (30.5)
     60-69 62,870 (18.8)
     70+ 33,538 (10.0)
Region
     Northeast 34,729 (10.4)
     Midwest 87,178 (26.1)
     South 153,383 (45.8)
     West 55,739 (16.7)
     Unknown 3,559 (1.1)
Year of index surgery
     2001 2,538 (0.8)
     2002 5,301 (1.6)
     2003 9,171 (2.7)
     2004 13,624 (4.1)
     2005 17,758 (5.3)
     2006 20,784 (6.2)
     2007 23,469 (7.0)
     2008 30,636 (9.2)
     2009 34,252 (10.2)
     2010 34,709 (10.4)
     2011 36,204 (10.8)
     2012 28,754 (8.6)
     2013 20,313 (6.1)
     2014 17,925 (5.4)
     2015 10,528 (3.2)
     2016 10,285 (3.1)
     2017 9,342 (2.8)
     2018 9,008 (2.7)
Years of follow-up
     0 to <2 183,039 (54.7)
     2 to <4 67,709 (20.2)
     4 to <6 36,340 (10.9)
     6 to <8 21,083 (6.3)
     8 to <10 13,602 (4.1)
     10 to <12 7,512 (2.3)
     12 to <14 3,626 (1.1)
     14+ 1,690 (0.5)
Concomitant hysterectomy 88,578 (26.5)
Concomitant POP procedure 132,538 (39.6)
     Anterior 106,655 (31.9)
     Apical 52,356 (15.7)
     Posterior 77,916 (23.3)
Inpatient Index Procedure 82,321 (24.6)

Data are presented as N (%) unless otherwise specified.

The 10-year cumulative incidence of sling revision for any indication was 6.9% (95% CI, 6.7-7.0). The cumulative incidence was 3.0% at one year, which rose to 5.2% at five years and 7.9% at 15 years (Table 2; Figure 1). Of the 12,652 cases of sling revision, 6,167 (48.7%) had an indication of mesh exposure and 3,757 (29.7%) had an indication of urinary retention. The remaining 4,473 (35.4%) patients had other indications listed, including pain. For mesh exposure, the cumulative incidence rose from 1.5% at one year to 2.7% at five years and leveled off at 3.6% by 13 years through 15 years. The cumulative incidence associated with urinary retention experienced a similar plateau, starting at 1.0% at one year, then increasing to 1.4% at five years and remaining steady at 1.7% from 10 years onwards. The majority of sling revisions occurred relatively early, within the first five years of follow-up.

Table 2.

Cumulative risk of sling revision and repeat surgery by years of follow-up and 95% confidence interval

Year Revision, Any reason % (95% CI) Revision, Mesh exposure % (95% CI) Revision, Urinary retention % (95% CI) Revision, Other indications % (95% CI) Repeat Surgery % (95% CI)
1 3.0% (3.0 - 3.1) 1.5% (1.4 - 1.5) 1.0% (1.0 - 1.1) 1.0% (1.0 - 1.1) 4.2% (4.1 - 4.2)
2 3.8% (3.7 - 3.9) 1.9% (1.9 - 2.0) 1.2% (1.2 - 1.2) 1.3% (1.2 - 1.3) 5.9% (5.9 - 6.0)
3 4.3% (4.3 - 4.4) 2.2% (2.2 - 2.3) 1.3% (1.3 - 1.3) 1.5% (1.4 - 1.5) 7.3% (7.2 - 7.4)
4 4.8% (4.7 - 4.9) 2.5% (2.4 - 2.6) 1.4% (1.3 - 1.4) 1.6% (1.6 - 1.7) 8.6% (8.4 - 8.7)
5 5.2% (5.1 - 5.3) 2.7% (2.6 - 2.8) 1.4% (1.4 - 1.5) 1.8% (1.8 - 1.9) 9.8% (9.6 - 9.9)
6 5.6% (5.5 - 5.7) 2.9% (2.8 - 3.0) 1.5% (1.5 - 1.6) 2.0% (2.0 - 2.1) 10.9% (10.7 - 11.1)
7 6.0% (5.8 - 6.1) 3.1% (3.0 - 3.2) 1.6% (1.5 - 1.6) 2.2% (2.1 - 2.3) 11.9% (11.7 - 12.1)
8 6.3% (6.2 - 6.5) 3.2% (3.1 - 3.3) 1.6% (1.6 - 1.7) 2.4% (2.3 - 2.5) 13.0% (12.8 - 13.2)
9 6.6% (6.5 - 6.8) 3.4% (3.3 - 3.5) 1.6% (1.6 - 1.7) 2.6% (2.5 - 2.7) 13.8% (13.6 - 14.1)
10 6.9% (6.7 - 7.0) 3.5% (3.3 - 3.6) 1.7% (1.6 - 1.7) 2.7% (2.6 - 2.9) 14.5% (14.2 - 14.8)
11 7.1% (6.9 - 7.3) 3.5% (3.4 - 3.7) 1.7% (1.6 - 1.8) 2.9% (2.7 - 3.0) 15.1% (14.8 - 15.4)
12 7.2% (7.0 - 7.4) 3.5% (3.4 - 3.7) 1.7% (1.6 - 1.8) 3.0% (2.9 - 3.2) 16.0% (15.6 - 16.4)
13 7.4% (7.1 - 7.6) 3.6% (3.4 - 3.7) 1.7% (1.6 - 1.8) 3.1% (2.9 - 3.3) 16.7% (16.2 - 17.1)
14 7.9% (7.5 - 8.2) 3.6% (3.4 - 3.7) 1.7% (1.6 - 1.8) 3.7% (3.3 - 4.0) 17.5% (17.0 - 18.1)
15 7.9% (7.5 - 8.3) 3.6% (3.4 - 3.7) 1.7% (1.6 - 1.8) 3.7% (3.4 - 4.1) 17.9% (17.3 - 18.6)

Figure 1.

Figure 1.

Cumulative incidence and 95% confidence intervals of subsequent surgery following sling procedure, stratified by type of surgery

For repeat SUI surgery, the 10-year cumulative incidence of repeat surgery was 14.5% (95% CI, 14.2-14.8), rising from 4.2% at one year to 9.8% at five years and eventually increasing to 17.9% at 15 years (Table 2). Throughout the study period, the most commonly performed repeat SUI procedure was an additional sling operation, comprising 54-70% of repeat surgeries each year (Figure 2). Results from sensitivity analyses requiring one year of continuous enrollment prior to index were similar to results from the primary analysis.

Figure 2.

Figure 2.

Most common repeat SUI procedures by year of repeat surgery

Adjusted hazard ratios for predictors of slings revisions and repeat SUI surgery within one year of index sling surgery are presented in Table 3. Compared to women 70 and older, women age 18-29 were at a higher risk for all outcomes, with an adjHR of 1.20 (95% CI, 1.15-1.25) for sling revision with any indication and 1.30 (95% CI, 1.25-1.37) for SUI repeat surgery. The risks for women age 30-39 were more modest, though still elevated, in comparison to those of women 70 or older. Inpatient index procedures were associated with a slightly decreased risk for any revision surgery (adjHR, 95% CI: 0.95 [0.94-0.96]) but were not associated with repeat surgery (adjHR, 95% CI: 0.99 [0.98-1.00]). Concurrent hysterectomies and pelvic organ prolapse procedures were not associated with an increased risk for any outcome.

Table 3.

Adjusted hazard ratios for predictors of sling revision and repeat surgery within one year of index sling surgery with 95% confidence intervals

Variable Revision, Any reason Adjusted HR (95% CI) Revision, Mesh exposure Adjusted HR (95% CI) Revision, Urinary retention Adjusted HR (95% CI) Revision, Other indication Adjusted HR (95% CI) Repeat surgery Adjusted HR (95% CI)
Age at Index Surgery
    18-29 1.23 (1.18 - 1.29) 1.23 (1.18 - 1.29) 1.24 (1.18 - 1.29) 1.24 (1.19 - 1.30) 1.30 (1.24 - 1.36)
    30-39 1.10 (1.08 - 1.11) 1.10 (1.08 - 1.11) 1.11 (1.09 - 1.12) 1.11 (1.09 - 1.12) 1.15 (1.13 - 1.17)
    40-49 1.06 (1.04 - 1.07) 1.06 (1.04 - 1.07) 1.07 (1.05 - 1.08) 1.06 (1.05 - 1.08) 1.10 (1.09 - 1.12)
    50-59 1.04 (1.02 - 1.05) 1.03 (1.02 - 1.05) 1.04 (1.03 - 1.06) 1.04 (1.03 - 1.05) 1.07 (1.06 - 1.08)
    60-69 1.10 (1.08 - 1.11) 1.09 (1.08 - 1.11) 1.10 (1.08 - 1.11) 1.10 (1.08 - 1.11) 1.12 (1.11 - 1.14)
    70+ (ref) - - - - -
Year of Index Surgery
    2001 0.89 (0.85 - 0.93) 0.90 (0.86 - 0.94) 0.89 (0.85 - 0.93) 0.89 (0.85 - 0.93) 0.85 (0.81 - 0.88)
    2002 0.90 (0.87 - 0.92) 0.90 (0.88 - 0.93) 0.89 (0.87 - 0.92) 0.90 (0.87 - 0.92) 0.88 (0.85 - 0.91)
    2003 0.91 (0.89 - 0.94) 0.92 (0.90 - 0.94) 0.91 (0.89 - 0.93) 0.92 (0.90 - 0.94) 0.91 (0.89 - 0.93)
    2004 0.91 (0.89 - 0.93) 0.92 (0.90 - 0.94) 0.92 (0.90 - 0.94) 0.92 (0.90 - 0.93) 0.92 (0.90 - 0.94)
    2005 1.10 (1.08 - 1.13) 1.10 (1.08 - 1.12) 1.10 (1.08 - 1.12) 1.10 (1.08 - 1.12) 1.10 (1.08 - 1.12)
    2006 0.92 (0.91 - 0.94) 0.93 (0.91 - 0.94) 0.93 (0.91 - 0.94) 0.92 (0.91 - 0.94) 0.93 (0.91 - 0.94)
    2007 0.93 (0.92 - 0.95) 0.93 (0.92 - 0.95) 0.93 (0.92 - 0.95) 0.93 (0.92 - 0.95) 0.94 (0.93 - 0.96)
    2008 0.96 (0.94 - 0.97) 0.96 (0.94 - 0.97) 0.96 (0.94 - 0.97) 0.95 (0.94 - 0.97) 0.96 (0.94 - 0.98)
    2009 1.08 (1.07 - 1.10) 1.08 (1.07 - 1.10) 1.08 (1.06 - 1.10) 1.08 (1.06 - 1.10) 1.10 (1.08 - 1.12)
    2010 1.00 (0.98 - 1.01) 1.00 (0.98 - 1.01) 1.00 (0.98 - 1.01) 1.00 (0.98 - 1.01) 1.00 (0.98 - 1.02)
    2011 (ref) - - - - -
    2012 0.89 (0.85 - 0.93) 1.23 (1.21 - 1.25) 1.23 (1.21 - 1.25) 1.23 (1.21 - 1.25) 1.24 (1.22 - 1.26)
    2013 0.90 (0.87 - 0.92) 1.04 (1.02 - 1.06) 1.03 (1.02 - 1.05) 1.03 (1.02 - 1.05) 1.02 (1.00 - 1.03)
    2014 0.91 (0.89 - 0.94) 1.35 (1.33 - 1.38) 1.35 (1.32 - 1.37) 1.34 (1.32 - 1.37) 1.34 (1.31 - 1.36)
    2015 0.91 (0.89 - 0.93) 1.00 (0.98 - 1.02) 0.99 (0.97 - 1.01) 0.97 (0.95 - 0.99) 0.98 (0.95 - 1.00)
    2016 1.10 (1.08 - 1.13) 1.14 (1.12 - 1.17) 1.14 (1.11 - 1.16) 1.11 (1.08 - 1.13) 1.11 (1.08 - 1.13)
    2017 0.92 (0.91 - 0.94) 1.12 (1.10 - 1.15) 1.11 (1.09 - 1.14) 1.08 (1.05 - 1.10) 1.08 (1.06 - 1.11)
Region
    Midwest 1.00 (0.99 - 1.01) 1.00 (0.99 - 1.01) 1.00 (0.99 - 1.01) 1.00 (0.99 - 1.01) 0.99 (0.98 - 1.00)
    South 1.07 (1.06 - 1.08) 1.07 (1.06 - 1.08) 1.07 (1.06 - 1.08) 1.07 (1.05 - 1.08) 1.00 (0.99 - 1.01)
    West 1.04 (1.03 - 1.06) 1.04 (1.02 - 1.05) 1.04 (1.03 - 1.05) 1.04 (1.03 - 1.05) 1.01 (0.99 - 1.02)
    Northeast (ref) - - - - -
Concurrent surgery
    Hysterectomy 1.00 (0.99 - 1.01) 1.00 (0.99 - 1.01) 0.99 (0.99 - 1.00) 1.00 (0.99 - 1.01) 1.01 (1.00 - 1.02)
    Anterior POP 1.00 (1.00 - 1.01) 1.01 (1.00 - 1.02) 1.01 (1.00 - 1.02) 1.01 (1.00 - 1.02) 1.01 (1.01 - 1.02)
    Apical POP 0.99 (0.98 - 1.00) 0.99 (0.98 - 1.00) 0.99 (0.98 - 1.00) 0.99 (0.98 - 1.00) 1.01 (1.00 - 1.02)
    Posterior POP 0.99 (0.98 - 1.00) 0.99 (0.98 - 1.00) 0.99 (0.98 - 1.00) 0.99 (0.98 - 1.00) 1.00 (0.99 - 1.01)
Inpatient Index Procedure 0.97 (0.97 - 0.98) 0.98 (0.97 - 0.98) 0.98 (0.97 - 0.98) 0.98 (0.97 - 0.99) 1.00 (0.99 - 1.01)

Discussion

In this large population cohort study of commercially insured women, the 10-year and 15-year risk of sling revision surgery were relatively low at 6.9% and 7.9%, respectively, with mesh exposure accounting for approximately half of the revisions. The 10-year and 15-year risk of repeat surgery were 14.5% and 17.9%, respectively. Women in the youngest age category had the highest risk of all outcomes, relative to women age 70 or older, although they made up a small proportion of the cohort. Women age 40-59, who comprised the majority of the study population, also had elevated risks of each outcome compared to women 70 or older, although not as high as younger women.

Relatively similar findings have also been reported in the literature. We previously reported 9-year risks of 3.7% and 13.0% for sling revision surgery and repeat operations, respectively, based on data from 2001-2010.6,16 The higher estimates in our current study may be due to the fact that this analysis evaluates data from 2001-2018, which reflects the impact of the 2008 and 2011 FDA safety notifications that heightened public awareness and likely prompted evaluations and interventions for mesh complications.19 Prior studies from the US and other countries have reported lower reoperation rates after slings, which may be attributable to differences in study population, insurance coverage, geographic location and time period evaluated, especially if study periods occurred prior to or soon after the FDA safety notifications. A recently study based in a large managed care organization in southern California estimated a lower 9-year risk of 6.0% for repeat operations.20 This lower rate may be due to patients from one geographic region with Kaiser Permanente insurance, missing data regarding surgeries for complications occurring outside the system, and slings being performed by experienced, higher volume surgeons.20 A study from 2006-2015 in the United Kingdom estimated 9-year risks of 3.3% and 6.9% for sling removal and SUI reoperations, respectively.7 A Canadian study from 2002-2012 reported a 10-year risk of sling revision to be 3.3%,21 and a Finnish national register-based study with data from 1987 to 2009 estimated the rate of SUI reoperation after midurethral sling to be 4.8 per 1,000 person-years.22 Our current analysis incorporates data from more recent years through the end of 2018 and includes slings performed by any provider across the US.

We found an increased risk for all outcomes among younger women, aged 18-29, compared to women 70 or older. This is also consistent with our previously published findings.16 This finding may be due to several reasons. One explanation may be that mesh exposure is more bothersome to younger, more sexually active women; thus, they may be more likely undergo a sling revision. Younger women may also be less tolerant of urinary retention and more likely to pursue a sling revision. Younger women may also be more bothered by recurrent SUI and more likely to opt for repeat surgery. We also found that there was a higher risk of sling revision and repeat surgery in 2012 compared to most other years. One potential explanation is the impact of the 2011 FDA safety notification, which increased awareness among women regarding mesh complications, prompting those with prior mesh for SUI or POP to seek evaluation and management.23

One of the strengths of this study is that it provides comprehensive data on over 350,000 index sling procedures, with follow-up for at least 10 years in more than 12,000 in a large, population-based cohort. Healthcare claims data provides comprehensive, longitudinal information on patients’ experiences with the healthcare systems. Even if patients seek care at multiple institutions, those encounters will all be captured, given that those patients have continuous insurance coverage. To our knowledge, this is the largest study of long-term outcomes following sling procedures for SUI. Another advantage of using the MarketScan databases is the inclusion of women over 65 in the Medicare supplemental data.

One key limitation is the inability to distinguish between different types of sling procedures with CPT codes. Currently, there is only one CPT code, 57288, used for all sling procedures, which is a limitation noted in other publications on national trends.24,25 Prior publications have also demonstrated that the rate of pubovaginal, autologous slings is quite low compared to midurethral slings, with pubovaginal slings comprising less than 1.0% of all slings.26,27 We were also unable to capture some sociodemographic and clinical information, which are not included in a healthcare claims database, such as socioeconomic status, race and ethnicity, BMI, or severity of SUI. Commercial insurance databases are also limited in that findings may not be as generalizable to uninsured or underinsured women. Finally, the proportion of women with 15 years of follow-up is relatively small, as 15-year outcome data can only be derived from those who underwent surgery in 2003 or earlier. These 15-year results provide valuable insights and contribute to the limited long-term outcome data following a sling procedure.

In conclusion, after an index sling procedure, the cumulative risk of sling revision was 8% after 15 years of follow-up and the risk of re-operation remained under 20%. Approximately half of the sling revisions were associated with mesh exposure. Age at index sling surgery was associated with both sling revisions and re-operations. Given concerns regarding the risks of midurethral mesh slings, up-to-date evidence is needed, and our study includes recent data through 2018. These findings may provide critical long-term data to support informed decisions for women and providers considering midurethral slings for stress urinary incontinence.

Supplementary Material

Supplemental Table 1

Disclosure and funding:

Funding for this project was supplied by the following sources. SZD receives tuition and stipend support from the Center for Pharmacoepidemiology in the UNC Department of Epidemiology and the North Carolina Translational and Clinical Sciences Institute. Current member companies include GlaxoSmithKline, AbbVie, Boehringer Ingelheim, UCB BioSciences, and Takeda. MJF receives salary support the Center for Pharmacoepidemiology in the Department of Epidemiology, UNC (current members: GlaxoSmithKline, AbbVie, Boehringer Ingelheim, UCB BioSciences, Takeda), and consulting fees via UNC from GlaxoSmithKline. The project described was supported by the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, through Grant Award Number ULTR002489. The database infrastructure used for this project was funded by the Pharmacoepidemiology Gillings Innovation Lab (PEGIL) for the Population-Based Evaluation of Drug Benefits and Harms in Older US Adults (GIL200811.0010), the Center for Pharmacoepidemiology, Department of Epidemiology, UNC Gillings School of Global Public Health, the CER Strategic Initiative of UNC’s Clinical Translational Science Award (UL1TR002489), the Cecil G. Sheps Center for Health Services Research, UNC, and the UNC School of Medicine. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. None of the authors have any conflicts of interest to declare with respect to this work.

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Supplemental Table 1

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