Abstract
This study evaluates 12 years’ worth of clinical data on transvaginal mesh complications and depression or self-harm in women who received a midurethral mesh sling.
Midurethral mesh sling procedures are the criterion standard treatment for female stress incontinence and account for more than 90% of incontinence procedures. However, regulatory warnings about transvaginal mesh complications, lawsuits, and media scrutiny have resulted in substantial public doubts about their safety.1 A survey of women with transvaginal mesh complications identified the negative psychological trajectories for women after attempts at surgical correction,2 but the relative risk of psychiatric illness associated with these complications has not been quantified. Our objective for this study was to determine whether the risk of depression or self-harm behavior was greater among women with transvaginal mesh complications that required surgical intervention compared with women who did not undergo such surgical correction.
Methods
We conducted a population-based study using linked, routinely collected data from the universal health care system in Ontario, Canada, and we analyzed these data at the Institute for Clinical Evaluative Sciences. The use of data in this study was authorized by the Ontario Personal Health Information Protection Act, which does not require review by a research ethics board or patient informed consent.
Similar to previous methodology,3 we identified women who had their first midurethral mesh sling procedure between January 1, 2004, and December 31, 2015. Using the outcome definitions, we excluded from the respective analyses women with prior evidence of stress incontinence procedure and women with evidence of depression or self-harm before receiving the midurethral sling. The primary exposure was whether women had evidence of a surgical procedure likely associated with a transvaginal mesh complication.3 The primary outcome was the presentation to the medical system for treatment of depression (including either a hospital admission or physician visit for depression), using an algorithm with a sensitivity of 78% and specificity of 93%.4 The secondary outcome was evidence of self-harm, defined by the International Classification of Diseases, Tenth Revision, code X60-84, as a suicide attempt or parasuicide behavior presented at the emergency department or as a recent history of a suicide attempt or a parasuicide behavior or thoughts that result in admission to a psychiatric hospital.5 To assign exposure status and determine whether an outcome occurred, we used data from the date of the surgical procedure until death or March 31, 2017.
Relevant covariates (detailed in previous publications3,5) were measured, and those with a standardized difference greater than 10% were included in the adjusted model; on the basis of previous research,3 an interaction term between age and the primary exposure was included. Cox proportional hazards models were created, using SAS, version 9.4 (SAS Inc), and assumptions were verified. A 2-sided P < .05 was considered statistically significant.
Results
We identified 57 611 women who met the inclusion criteria and underwent a midurethral mesh sling procedure during the 12-year study period. Of those 57 611 women, 1586 (2.8%, with a mean [SD] age of 52.5 [11.8] years) underwent a surgical correction for a transvaginal mesh complication and 56 025 (97.2%; with a mean [SD] age of 54.6 [12.4] years) did not require an operation (Table 1). In the primary analysis, we identified a statistically significant increased risk of depression among women who required surgical correction (Table 2). Because of a statistically significant interaction between age and a transvaginal mesh complication, we stratified the study cohort by age groups. A statistically significant increased risk of depression was found only in women younger than 46 years of age (absolute risk increase, 5.18% [95% CI, 1.97%-8.40%]; adjusted hazard ratio [HR], 1.38 [95% CI, 1.09-1.75; P < .01]; Table 2). Similar models were created for the secondary outcome of self-harm, and a statistically significant increased adjusted HR was found for self-harm among women younger than 46 years (HR, 1.68; 95% CI, 1.05-2.67) and those between 46 and 66 years of age (HR, 2.36; 95% CI, 1.56-3.58).
Table 1. Patient Demographics, Socioeconomic Status, Comorbidities, and Health Care Use.
| Variable | Intervention for Selected Transvaginal Mesh Complication, No. (%) | Standardized Difference, %a | |
|---|---|---|---|
| Without Surgical Correction (n = 56 025) | With Surgical Correction (n = 1586) | ||
| Demographic | |||
| Age, mean (SD), y | 54.6 (12.4) | 52.5 (11.8) | 18 |
| Rural residence | 10 698 (19.1) | 316 (19.9) | 2 |
| Socioeconomic status | |||
| Lowest quintile | 8685 (15.5) | 242 (19.9) | 1 |
| Highest quintile | 12 341 (22.0) | 311 (19.6) | 6 |
| Comorbidity (5 y before sling procedure) | |||
| Charlson-Deyo Comorbidity Index | 0.21 (0.70) | 0.19 (0.65) | 3 |
| No prior hospitalization | 12 423 (22.2) | 321 (20.2) | 5 |
| 0-1 | 41 247 (73.6) | 1204 (75.9) | 5 |
| 2 | 1632 (2.9) | 40 (2.5) | 2 |
| ≥3 | 723 (1.3) | 21 (1.3) | 0 |
| Prior chronic pain | 250 (0.4) | 10 (0.6) | 3 |
| Other mental health disease | 359 (0.6) | 17 (1.1) | 5 |
| Alcohol abuse | 253 (0.5) | 11 (0.70) | 3 |
| Stroke | 210 (0.4) | ≤5 (≤0.3)b | 4 |
| Cancer | 2819 (5.0) | 87 (5.5) | 2 |
| Coronary artery disease | 6439 (11.5) | 182 (11.5) | 0 |
| Procedures at the time of sling procedure | |||
| Concurrent anterior/posterior repair | 14 531 (25.1) | 349 (22.0) | 9 |
| Concurrent hysterectomy | 7737 (13.8) | 174 (11.0) | 9 |
| Health care use 1 y before sling procedure, mean (SD)c | |||
| Primary care visit | 6.51 (6.21) | 7.80 (7.19) | 19 |
| Prior hospitalization | 0.07 (0.31) | 0.11 (0.44) | 9 |
| Prior urologic visit | 1.08 (1.45) | 1.27 (1.66) | 12 |
| Prior gynecologic visit | 1.51 (1.71) | 1.64 (1.85) | 8 |
| Prior psychiatry visit | 0.22 (1.82) | 0.26 (1.67) | 2 |
Standardized differences were used to identify potential clinically significant differences (>10%) between groups. They were the preferred method (over traditional hypothesis tests) for assessing baseline differences in population-based studies.
Groups of 5 or fewer people were masked to comply with provincial privacy regulations.
Women who had a surgical correction tended to be younger and more likely to see a urologist and a general practitioner more frequently in the year before the midurethral mesh sling procedure.
Table 2. Depression and Self-harm Among Women With a Transvaginal Mesh Complication.
| Variable | Intervention for Selected Transvaginal Mesh Complication, HR (95% CI) | P Value | |
|---|---|---|---|
| Without Surgical Correction (n = 56 025) | With Surgical Correction (n = 1586) | ||
| Primary outcome: depression | |||
| No. (%) | 4 470 (7.98) | 175 (11.03) | |
| Patient-years of exposure | 367 607 | 10 700 | |
| Event rate (per 100 person-years) | 1.22 (1.18-1.29) | 1.64 (1.40-1.90) | |
| Unadjusted HR | 1 [Reference] | 1.35 (1.16-1.57) | <.01 |
| Adjusted HRa | 1 [Reference] | 1.21 (1.04-1.41) | .01 |
| Adjusted HR for depression stratified by age groups at the time of sling procedurea | |||
| <46 y | 1 [Reference] | 1.38 (1.09-1.75) | <.01 |
| 46-66 y | 1 [Reference] | 1.18 (0.95-1.46) | .13 |
| >66 y | 1 [Reference] | 0.92 (54-1.56) | .75 |
| Secondary outcome: self-harm | |||
| No. (%) | 647 (1.15) | 44 (2.77) | |
| Patient-years of exposure | 382 788 | 11 316 | |
| Event rate (per 100 person-years) | 0.17 (0.16-0.18) | 0.39 (0.28-0.52) | |
| Unadjusted HR | 1 [Reference] | 2.31 (1.17-3.13) | <.01 |
| Adjusted HRa | 1 [Reference] | 2.06 (1.52-2.80) | <.01 |
| Adjusted HR for self-harm stratified by age groups at the time of sling procedurea | |||
| <46 y | 1 [Reference] | 1.68 (1.05-2.67) | .03 |
| 46-66 y | 1 [Reference] | 2.36 (1.56-3.58) | <.01 |
| >66 y | 1 [Reference] | 1.07 (0.15-7.75) | .95 |
Abbreviation: HR, hazard ratio.
Based on a standardized difference greater than 10%, the Cox proportional hazards model was adjusted for age (when not stratified by age), the number of general practitioner visits, and the number of urologist visits in the year before the midurethral mesh sling procedure. In the adjusted models, the independent effect of more general practitioner visits and more urologic visits before the procedure also increased the hazard of a future depression diagnosis, likely representing an increased propensity to seek care.
Discussion
Women can be profoundly affected by complications from a midurethral mesh sling procedure, and even with surgical revision the symptoms of these complications may not be completely corrected.2,6 We found that women who required a surgical intervention for a complication after a midurethral mesh sling procedure had a statistically significantly higher risk of depression and self-harm compared with those who did not require a correction. This age-dependent interaction is potentially a result of a stronger association between transvaginal mesh complications and intimacy among younger women.2 When managing women with complications, surgeons should be aware of the potential serious psychological implications of these complications. Limitations of this study include potential residual confounding, variable misclassification, the inability to determine the degree of causality between transvaginal mesh complications and depression or self-harm episodes, and the fact that some women may not have received a surgical correction despite having a complication.
References
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