Long-term mesh complications and reoperation after laparoscopic mesh sacrohysteropexy: a cross-sectional study

We report a low incidence of patient-reported mesh complications requiring mesh removal surgery confirmed by case note review, of 0.4% at a median follow-up of nearly 4 years, from a cohort of 1,121 women who underwent laparoscopic mesh sacrohysteropexy. Notably, there were no reported cases of vaginal mesh erosion.

This is the largest reported study of women who have undergone mesh-augmented uterine-preserving prolapse surgery, and the incidence of reoperation for a mesh-associated complication compares favourably with other gynaecological uses of mesh. For comparison, the risk of reoperation for a mesh complication following two of the most common such procedures, sacrocolpopexy and the synthetic mid-urethral sling, are 5% and 2.4% respectively [25, 26]. According to the Cochrane review by Maher et al. [27] the risk of reoperation for mesh exposure following placement of transvaginal mesh for prolapse is 8%, and in the PROSPECT trial, the largest randomised trial of transvaginal mesh, 4% of women required reoperation for a mesh complication [12, 27].

Comparison of our findings with the literature for sacrohysteropexy is difficult owing to the heterogeneity of reporting mesh complications. Long-term cohort studies have reported mesh erosion rates of 4% following robotics-assisted sacrohysteropexy, and 5% following open sacrohysteropexy, with no details regarding reoperation [28, 29]. A variety of surgical techniques exist for sacrohysteropexy, with no clear evidence to support one particular approach over another. Our technique differs from others reported in the literature in that there is limited dissection on the vagina, and mesh arms are sutured to the anterior cervix. It may be that the avoidance of mesh placement on the vagina explains the absence of vaginal mesh erosions at an average follow-up of nearly 4 years in contrast to the complications seen in these other series. Comparing mesh sacrohysteropexy and vaginal hysterectomy in a systematic review, Meriwether et al. did not report any cases of mesh erosion or reoperation following abdominal mesh sacrohysteropexy [1]. Most of the studies included in this part of the review either failed to report these outcomes, or they were only seen in the comparator groups undergoing hysterectomy and concurrent sacrocolpopexy, where the risk of reoperation for a mesh complication was between 2 and 3%.

With respect to the other mesh-associated complications, the risk of utilising chronic pain services in our study appears relatively low; following vaginal hysterectomy, the risk of chronic pain may be as high as 25% [30]. Our finding of a 5.8% risk of subsequent diagnosis of a systemic autoimmune disorder is higher than the 2.8% risk reported by the largest and most methodologically robust available study looking at the association between gynaecological mesh and autoimmune disease [20]. However, in that matched cohort study, over 40% of women undergoing mesh-augmented POP surgery had pre-existing diagnoses of autoimmune conditions, and were not included in the analysis. We were unable to account for pre-existing autoimmune disease in our participants to allow for exclusion from our analysis, and therefore this finding should be interpreted with caution.

It is noteworthy that in our study only 3.7% of our patients underwent a subsequent apical prolapse procedure, compared with the 6–8% risk reported following vaginal hysterectomy [31]. It is uncertain if this finding supports the role of mesh augmentation for repair of apical prolapse; the issue remains controversial. Reoperation rates for prolapse of any compartment in our study are comparable with the overall reoperation rate for POP following VH, which was estimated to be 11% at 5 years in a recent large Danish registry study [32]. It is significantly lower than reoperation rates following suture hysteropexy, which was reported to be 30% in the same study. The 9% risk of subsequent colporrhaphy in our study may reflect surgical practice within participating centres. Concurrent anterior and posterior compartment repair for prolapse above the hymenal ring is generally avoided, as evidence suggests that such prolapse might be less likely to be symptomatic, and could be considered normal [33]. The authors acknowledge that this may lead to higher rates of colporrhaphy at a later date; indeed, our own reoperation rates in this study are higher than those reported in our previous cohorts, likely a feature of the longer follow-up [9, 10]. Reoperation for SUI is a recognised risk of POP surgery; the incidence of this in our study is comparable to the 2% risk quoted in large national studies [34]. The PGI-I prolapse has been validated as a measure for POP surgery, and we report high rates of improvement in prolapse symptoms [35].

The findings from our study are important given the large cohort, long-term follow-up, and importantly, the patient-reported nature of our outcomes. Despite well-publicised controversies surrounding the use of mesh in pelvic floor surgery, the majority of patients would recommend laparoscopic mesh sacrohysteropexy to friends or family. This, in combination with a low risk of reoperation for mesh complications and low rates of chronic pain service use, should provide reassurance to both clinicians and women considering the procedure, as well as regulatory bodies.

The role of mesh-augmented prolapse surgery, specifically sacrohysteropexy, deserves ongoing scrutiny. Although the hierarchy of evidence-based medicine would favour the need for large, multicentre prospective studies, these are notoriously difficult for surgical interventions. Additionally, the controversies surrounding mesh in pelvic floor surgery are likely to make such studies difficult to undertake. Although large database studies would be helpful, researchers often depend on data from clinicians or hospital coders, who have their own issues with respect to accuracy. Therefore, such studies are valuable in providing a pragmatic evidence base for women considering surgery for POP, as well as clinicians and regulators.

The principle strengths of our study include the long-term follow-up of a large number of participants, operated on by several surgeons at different institutions using a standardised follow-up in the form of a questionnaire. The value of patient-reported data cannot be understated given the current climate surrounding mesh use, with anecdotal concerns about a potential breakdown in trust between patients and their clinicians [36].

There are methodological limitations inherent within our study design, such as a lack of a comparison group, the use of patient-reported data without routine clinical or case note review to confirm the reported outcomes, and a paucity of demographic data to allow for regression analysis. Owing to the rare nature of our primary outcome, the use of a validated patient-reported outcome measure questionnaire was not possible. Study participants underwent their procedures in centres with specific expertise in laparoscopic pelvic floor surgery, and therefore the research setting and findings may not be applicable to other centres. As with all questionnaire studies, results are affected by recall and response bias of participants. Participants may well not recall undergoing a subsequent surgical procedure or the nature of such surgery. Consideration of these biases also applies to the interpreting the use of chronic pain services, and subsequent diagnosis of a systemic autoimmune disorders. Finally, owing to the lack of demographic data, we cannot comment on how representative our participants are of the whole cohort of potential participants. Those greatly troubled by mesh complications may have opted not to participate or, conversely, were keenest to respond. Similarly, our subjective outcomes of PGI-I prolapse and the “friends and family” test may be adversely influenced by mesh concerns and media coverage.