Long-term mesh exposure after minimally invasive total hysterectomy and sacrocolpopexy

In this longitudinal cohort study with a mean follow-up of almost 4 years post-minimally invasive total hysterectomy and SCP using a lightweight polypropylene y-mesh, we demonstrate a very low rate of new incident mesh exposure (2 cases, 1.8%), no cases of permanent suture exposure, and an absence of any associated bothersome symptoms of vaginal discharge, bleeding, or pain. There was only 1 case of mesh exposure that required surgical excision of the exposed mesh in the operating room, which occurred during the first year of follow-up. The remaining cases were managed with transvaginal estrogen or office trimming. Carrying cases of mesh exposure forward that were diagnosed within the first year postoperatively, the overall prevalence of mesh exposure was 7.7%. This is considerably lower than was demonstrated in the extended-CARE trial [5] despite 100% of PACT participants undergoing total hysterectomy, a known risk factor for mesh exposure. We attribute our findings to the use of a lightweight, type 1 polypropylene mesh material. Our results are comparable with several other studies in which a similar mesh material was used [20, 21], although none studied a homogenous group that all underwent minimally invasive total hysterectomy [13]. The suture type for vaginal graft attachment did not affect our long-term mesh exposure rates. A factor that likely impacts mesh exposure is the method of vaginal cuff closure. This was not standardized in the original trial as no evidence-based method was deemed superior for this outcome. We did not have sufficient power to determine an interaction between a particular method of cuff closure and subsequent mesh exposure in either the original PACT trial or in this extension study.

Long-term evaluation of rare adverse events related to polypropylene mesh for pelvic organ prolapse repair is important for patient safety [22]. We report that no patients within our cohort experienced a serious late-term mesh complication such as erosion into the bladder or bowel, fistula, severe pain, or bowel obstruction. Our minimally invasive approach, in which either laparoscopic or robotic assistance was employed with no conversions to an open approach, likely contributes to a lower rate of bowel adhesions and subsequent obstruction than open SCP [23].

The third important finding of this longitudinal study is sustained procedural efficacy with 88% of our cohort reporting the absence of a vaginal bulge, no prolapse beyond the hymen, and no retreatment. In our high-risk group of younger women with advanced uterovaginal prolapse, only 1 patient required retreatment with a pessary for stage IV prolapse and there were zero reoperations. Interestingly, women in the delayed absorbable suture group had significantly better pelvic floor symptoms according to the PFDI questionnaire. There is a significant paucity of long-term data of minimally invasive SCP with the use of modern, lighter weight mesh materials. Culligan et al. performed a longitudinal study with almost 5 years of follow-up in which 76% had concomitant hysterectomy, but these were all supracervical. Although they reported a 0% rate of mesh exposure with the use of an ultralightweight mesh, 4% required reoperation for symptomatic recurrence in the mid-vaginal compartments [24]. We believe that cervical removal enhances the ability to successfully reduce significant anterior vaginal wall prolapse as the anterior vaginal wall is shortened and this likely translates into a lower reoperation rate [11].

Mesh weight may also have a significant impact on recurrence risk. Askew et al. reported a higher rate of failure in the anterior compartment when an ultralightweight mesh (<20 g/m2) was used compared with a heavier weight mesh [21]. In our study, we used the Upsylon™ (Boston Scientific, Boston, MA, USA) mesh, which is considered a lightweight (25 g/m2) but not an ultralightweight material. Surgeons may have to evaluate the relative risks of mesh exposure as opposed to recurrence risk when deciding on choice of preferred synthetic graft.

There are some important limitations of our study, most notably of which is a follow-up rate of 106 out of 182 (58%) eligible women. This is quite similar to the attrition experience in the extended-CARE study in which 59% of women had follow-up examinations [5]. It is plausible that incident mesh exposure was considerably higher and was simply missed owing to loss to follow-up. We conducted this study during a challenging era in medicine in which the COVID pandemic hampered efforts to engage patients in elective studies. We attempted to overcome this barrier by offering phone interviews only, but recognize that a query regarding symptoms of mesh exposure may not be a valid substitute for visual inspection of the vagina. In addition, the original PACT study was not powered to detect differences in risk of recurrence or rare complications, and therefore, we cannot assume that the choice of suture material for vaginal graft attachment has no impact on these outcomes.

In conclusion, this longitudinal follow-up study provides reassurance to pelvic floor surgeons who are considering offering minimally invasive total hysterectomy and SCP for primary uterovaginal prolapse. We have provided important data regarding low rates of incident mesh exposure, continued procedural efficacy, and an absence of serious late complications. As we are committed to continued monitoring of safety and efficacy regarding the use of abdominal mesh for prolapse repair, additional longitudinal follow-up of this cohort is planned.

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