Long-Term Mesh Exposure 5 Years Following Minimally Invasive Total Hysterectomy and Sacrocolpopexy.

INTRODUCTION AND HYPOTHESIS: The objective was to assess long-term mesh complications following total hysterectomy and sacrocolpopexy. METHODS: In this second extension study, women from a multicenter randomized trial were followed for more than 36 months after surgery. Owing to COVID-19, participants were assessed through either in-person visits or telephone questionnaires. The primary outcome was the incidence of permanent suture or mesh exposure. Secondary outcomes included surgical success and late adverse outcomes. RESULTS: Out of the 200 initially enrolled participants, 82 women took part in this second extension study. Among them, 46 were in the permanent suture group, and 36 in the delayed absorbable group. The mean follow-up duration was 5.3 years, with the cumulative mesh or suture exposure of 9.9%, involving 18 cases, of which 4 were incident cases. Surgical success after more than 5 years stood at 95%, with few experiencing bothersome bulge symptoms or requiring retreatment. No serious adverse events occurred, including mesh erosion into the bladder or bowel. The most common adverse events were vaginal pain, bleeding, dyspareunia, and stress urinary incontinence, with no significant differences between suture types. CONCLUSION: The study found that mesh exposure risk gradually increased over time, reaching nearly 10% after more than 5 years post-surgery, regardless of suture type. However, surgical success remained high, and no delayed serious adverse events were reported.

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

INTRODUCTION AND HYPOTHESIS: The objective was to evaluate total and incident mesh exposure rates at least 2 years after minimally invasive total hysterectomy and sacrocolpopexy. Secondary aims were to evaluate surgical success and late adverse events. METHODS: This extension study included women previously enrolled in the multicenter randomized trial of permanent vs delayed-absorbable suture with lightweight mesh for > stage II uterovaginal prolapse. Owing to COVID-19, women were given the option of an in-person (questionnaires and examination) or telephone visit (questionnaires only). The primary outcome was total and incident suture or mesh exposure, or symptoms suggestive of mesh exposure in women without an examination. Secondary outcomes were surgical success, which was defined as no subjective bulge, no prolapse beyond the hymen, and no pelvic organ prolapse retreatment, and adverse events. RESULTS: A total of 182 out of 200 previously randomized participants were eligible for inclusion, of whom 106 (58%) women (78 in-person and 28 via questionnaire only) agreed to the extension study. At a mean of 3.9 years post-surgery, the rate of mesh or suture exposure was 7.7% (14 out of 182) of whom only 2 were incident cases reported after 1-year follow-up. None reported vaginal bleeding or discharge, dyspareunia, or penile dyspareunia. Surgical success was 93 out of 106 (87.7%): 13 out of 94 (13.8%) failed by bulge symptoms, 2 out of 78 (2.6%) by prolapse beyond the hymen, 1 out of 85 (1.2%) by retreatment with pessary, and 0 by retreatment with surgery. There were no serious adverse events. CONCLUSIONS: The rate of incident mesh exposure between 1 and 3.9 years post-surgery was low, success rates remained high, and there were no delayed serious adverse events.

Thirty-six-month Prospective Study of Transvaginal Bovine Graft vs Native Tissue Repair for the Treatment of Pelvic Organ Prolapse.

OBJECTIVE(S): To compare the safety and effectiveness of dermal bovine transvaginal graft, Xenform, to native tissue in the surgical treatment of anterior and/or apical pelvic organ prolapse. This study was designed in conjunction with Food and Drug Administration requirements. METHODS: This was a prospective, non-randomized, parallel cohort, multi-center trial. The primary objective was to demonstrate noninferiority between transvaginal graft and native tissue repair at 36 months compared to baseline. Treatment success was based on a composite of objective and subjective measures. The co-primary outcome was the rate of serious device- or procedure-related adverse events. A total of 228 patients at 25 sites were included in the study arm and 485 patients underwent native tissue repair. Propensity score stratification was applied to achieve balance between treatment groups. Study outcomes were compared in per protocol and intent-to-treat analysis. RESULTS: The primary outcome, treatment success at 36 months, was 83.6% (191/228) for transvaginal graft and 80.5% (390/485) native tissue repair (0.2%, 90% confidence interval [-5.6% to 5.9%]), demonstrating noninferiority at a preset margin of -12%. The overall rate of severe adverse events was 5.3% (12/228) in transvaginal graft vs 2.7% (13/485) in native tissue repair groups. The study group demonstrated noninferiority in serious adverse events at the preset margin of 11.6% (2.0%, 90% confidence interval [-0.8% to 4.7%]). There were no reports of graft erosion, and graft exposure rates were low (0.9% [2/228]). CONCLUSIONS: Transvaginal repair of anterior and/or apical prolapse with a biological graft is noninferior to traditional native tissue repair in effectiveness and safety at 36 months.

Permanent Compared With Absorbable Suture for Vaginal Mesh Fixation During Total Hysterectomy and Sacrocolpopexy: A Randomized Controlled Trial.

OBJECTIVE: To compare mesh and permanent suture exposure rates in the first year after minimally invasive total hysterectomy and sacrocolpopexy with a light-weight polypropylene mesh using permanent or delayed absorbable sutures. METHODS: Across five centers in the United States, women were randomized to permanent or delayed absorbable suture for vaginal attachment of a Y-mesh during hysterectomy and sacrocolpopexy for stage II prolapse and worse. The primary outcome was mesh or permanent suture exposure in the first year after surgery. The secondary outcome was to compare a composite measure for success defined as leading edge of prolapse not beyond the hymen and apex not descended more than one third vaginal length, and no subjective bulge and no prolapse retreatment. Patients completed a pelvic examination including the pelvic organ prolapse quantification system and questionnaires at baseline, 6 weeks and 1 year postsurgery. A sample size of 80 per group was planned to compare the rate of mesh or permanent suture exposure in the permanent compared with delayed absorbable groups. RESULTS: From April 2015 to May 2019, 204 patients (n=102 permanent; n=102 delayed absorbable) were randomized. One hundred ninety-eight women had follow-up data, with 182 (93%) completing 1-year follow-up: 95 of 99 (96%) permanent, 87 of 101 (86%) delayed absorbable. The total rate of mesh or permanent suture exposure was 12 of 198 (6.1%): 5.1% for permanent compared with 7.0% for delayed absorbable (risk ratio 0.73, 95% CI 0.24-2.22). The majority (9/12) were asymptomatic. Composite success was 93% for permanent compared with 95% for delayed absorbable suture, P=.43). Six (3.0%) women had a serious adverse event. CONCLUSION: Suture type used for vaginal graft attachment did not influence mesh or permanent suture exposure rates. FUNDING SOURCE: Boston Scientific Corporation. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02277925.