Effects of mesh-related complications in vaginal surgery on quality of life

The treatment of pelvic organ prolapse (POP) is challenging, since the recurrence rate after surgical treatment is high. It has been shown that 29% of women who undergo an operation for POP and/or urinary incontinence (UI) will have a reoperation [1]. In women with POP recurrence, a reoperation rate of 11.5% has recently been reported in a large Danish cohort study after 20 years of follow-up [2]. Polypropylene mesh was introduced as the possible solution to this high recurrence risk. The mesh induces a foreign body response and as part of that, new collagen and elastin are formed, consequently making the repair less dependent on the patient’s own connective tissue [3]. Altman and co-workers have shown that both objective and subjective cures are better following vaginal mesh surgery compared with native tissue repair. They reported a reintervention rate for mesh-related complications of 3.2%, but a recent multicenter randomized controlled trial (RCT) performed in the UK reported a reoperation risk for mesh-related complications in 9% of the patients [4, 5]. The risk on mesh-related complications was one of the main reasons for the US Food and Drug Administration (FDA) to issue public health notifications in 2008 and 2011 advising the restricted use of mesh and optimize patient counseling regarding the possible adverse events of mesh surgery [6].

Interestingly enough, the specific effects of mesh-related complications on the patient’s QoL have not yet been studied. Not all complications are symptomatic, and the advantages of restored anatomy and associated improved pelvic floor function may outweigh the discomfort related to surgery-related adverse events. To optimize patient counseling about mesh-specific adverse events, as recommended by the FDA and professional organizations, information about the effects of such complications on QoL is highly relevant. We hypothesized that HR-QoL is comparable in women after vaginal mesh surgery regardless of the presence or absence of a mesh-specific complication.

We performed a cross-sectional study in the Academic Medical Center (AMC) in Amsterdam, The Netherlands. The medical ethics committee of the AMC judged that the Medical Research Involving Human Subjects Act does not apply to this study, since the study only involved completing questionnaires and one additional pelvic floor examination that can be justified by the fact that mesh-related complications, if present, can be managed.

The response rate was 68% (128/188 patients). Of these women, ten refused to be contacted by mail, three were deceased, 14 could not be reached, and 21 refused participation after they had been contacted by phone. Of the 140 women who consented to participate, 128 actually filled out the questionnaires. Most women did not give a specific reason for not being willing to participate. Baseline characteristics of respondents are shown in Table 1. Women who filled out the questionnaire and visited the clinic were significantly younger at the time of surgery than women who did not want to participate (p = 0.04). Most women (78%) had a mesh procedure because of recurrence. Almost all women who underwent primary mesh surgery participated in a clinical study. Ten women had had a previous mesh implantation for POP.

From the respondents, 29 women (23%) had a complication during follow-up, 17 had an exposure, and 12 had long-lasting pain without exposure. The IUGA classification of these complications is depicted in Table 2.

Functional outcome of women with and without a complication during follow-up is compared in Table 3. UDI, DDI, and IIQ scores did not significantly differ between groups. Post hoc analyses showed no statistically significant differences between women in whom the complication was still present or had been resolved.

Whether refraining from sexual activity was caused by mesh complications is not known. Table 4 depicts the replies of sexually active women with and without complications. In the whole group of sexually active women, 69% was very or reasonably satisfied with their sex life (50/72). No statistically significant differences were found between total PISQ scores in women with [mean 35.1 (SD 6.7)] and without [mean 36 (SD 4.9)] mesh complications (p 0.61). Of the 29 patients with a complication, the complication resolved in 12. A post hoc analysis showed no statistical difference in total PISQ scores in women with a persistent complication or in whom the complication had been resolved.

This study shows that disease-specific HR-QoL was comparable between women with and without mesh-related complications. Overall domain scores were in the lower range for the UDI-6, IIQ, and DDI, indicating less bother, and in the higher range for the PISQ-12, indicating better sexual functioning. Women with mesh-related complications were more often sexually active as those without, although this difference was not statistically significant.

Apart from our study, only one publication specifically evaluated the relationship between disease-related QoL and the occurrence of mesh-related complications. In the observational study among 114 patients undergoing transvaginal repair with mesh, no significant impact of mesh exposure on the patient’s QoL was observed, as with our observation. In addition, mean QoL scores were improved after mesh surgery in both the exposure and nonexposure group [17]. A possible explanation for the similar QoL between women with and without a mesh complication may be that micturition, defecation, and sexual function are mostly related to vaginal anatomy, which is optimized after surgery. The positive impact of restoration of anatomy and elimination of bothersome micturition and defecation symptoms after vaginal mesh surgery counters the negative impact of mesh-related complications.

No statistically significant differences were found in total PISQ scores between women with and without a complication. This is in contrast to the study by Milani et al., who performed an RCT comparing sexual function in women with recurrent POP having either native tissue repair or trocar-guided vaginal mesh surgery. They found that the presence of mesh exposure was independently associated with deterioration of PISQ scores [18]. The probable reason for not observing worsening sexual functioning in women with mesh-related complications is that we used implants with a lower density than Prolift, which was used in the study by Milani et al. [18]. It has been shown that lower mesh density is associated with less fibrosis and contraction compared with higher-density mesh [19].

The sexually active women in our study were relatively satisfied, with the interesting observation that women with a mesh complication, although not statistically significant, appeared to be more satisfied with their sex life. A possible explanation might be that after recovery of a complication, the mere fact of being able to have sexual intercourse again or the absence of pain complaints might be a big relief. Women with a mesh complication were more frequent sexually active. An explanation may be that more sexual activity increases the risk of exposure, as friction is a risk factor for exposure. Future research is needed to investigate whether this observation is a real phenomenon or related to low numbers.

Some design-related issues in this study need to be addressed: Even though health domain scores were in the low range, they were slightly higher in our study compared with other studies that report on QoL in women having a vaginal mesh implant [4, 20]. This might be explained by the difference in duration of follow-up. We report domain scores after a median of 40 months, in contrast with the 12-month follow-up in those studies [4, 20]. We describe vaginal mesh procedures with implants that are no longer marketed. The Elevate® system implanted in most patients in our study was a single-incision technique that provided anterior or posterior repair as well as apical suspension by attachment of the mesh to the sacrospinous ligaments.

We believe results of this study can be extrapolated to other vaginal meshes that are at the market today. Currently available meshes often have similar insertion techniques and are also made of polypropylene, with a similar or even lighter mesh density. This study could be affected by selection bias. Women who consented to participate were of significantly younger age, and younger women may theoretically have better health and therefore may be prone to report a better subjective QoL. Only 58% of our study population reported to be sexually active. We do not know whether refraining from sexual activity was due to a mesh complication; however, this percentage of sexually active women is comparable with previous studies among women with mesh repair and conventional surgery [4, 20]. Comparison of PISQ scores between women with and without a complication showed no difference; however, groups were small.

Several points strengthen our study findings: First, the median follow-up was >3 years, and thus our study represents long-term data. Second, we used disease-specific validated HR-QoL questionnaires to assess subjective outcome measures. Disease-specific questionnaires provide higher face validity and more in-depth assessment of specific issues and concerns to the population under study compared with generic questionnaires, which reliably assess effects of treatment on HR-QoL [12]. Third, this report is one of few that specifically quantify the effect on sexual functioning in women with mesh-related complications.

In conclusion, this study shows that HR-QoL regarding micturition, defecation, and sexual function is comparable between women with and without a mesh-related complication after vaginal mesh surgery. This is important information in light of the ongoing debate regarding vaginal mesh surgery. The risk of (irreversible) effects of mesh-related complications is the reason many physicians and their patients refrain from vaginal mesh surgery. However, some patients, like women with prolapse recurrence, may benefit from vaginal mesh surgery. Based on this study, women could be informed that there is a risk of complications related to vaginal mesh surgery but that improved QoL related to pelvic floor function is likely to counteract the impact of the mesh-specific complication. This information facilitates a well-balanced treatment selection.