Transvaginal treatment of anterior and apical genital prolapse using Restorelle® direct fix™: An observational study of medium-term complications and outcomes

Introduction: The purpose of the study was to assess the frequency of late postoperative complications, surgical revisions and anatomical and functional outcomes > 1 year after the insertion of an ultra-light vaginal mesh for the treatment of genital prolapse. Material and methods: In our multicenter retrospective series, patients who had a previous ultra-light transobturator mesh (19 g/m2) Restorelleg DirectFix (TM) mesh placed, either reviewed in post-operative consultation or interviewed by phone with a minimum of twelve months' follow-up were included. Results: 172 patients were included in the analysis. Among them, 8/141 (5.7%) had chronic pain, 7/141 (5.0%) recurrent urinary tract infections, 1/70 (1.4%) resolving granulomas, 2/70 (2.9%) painful retractions, 2/70 (2.9%) colpectomy for vaginal erosion, 1/141 (0.7%) ureteral reimplantation, 1/141 (0.7%) a reoperation for colonic occlusion on mesh and 1/141 (0.7%) self urinary catheterization, 9% of patients with at least one minor complication (without major complication) and 3% of patients with a major +/- minor complication. Nine patients out of 142 (6.3%) had a surgical revision for recurrence of prolapse and 2/70 (2.9%) for vaginal mesh exposure. The anatomical success rate of cystocele repair was 72%. 20% of patients had symptomatic recurrence. The rate of de novo dyspareunia was 13%. Functional success was noted in 82% of patients. Conclusion: The Restorelle (R) mesh has good safety and efficiency in the medium term. Long-term data and comparative studies are needed. (C) 2019 Published by Elsevier Masson SAS.