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 > 1year 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 (19g/m2) Restorelle®DirectFix™ 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® mesh has good safety and efficiency in the medium term. Long-term data and comparative studies are needed.

Transvaginal treatment of anterior and apical genital prolapses using an Ultra lightweight mesh: Restorelle® Direct Fix™. A retrospective study on feasibility and morbidity.

BACKGROUND: Vaginal mesh safety information is limited, especially concerning single incision techniques using ultra lightweight meshes for the treatment of anterior pelvic organ prolapse (POP). OBJECTIVE: To determine the intraoperative and postoperative complication rates after anterior POP repair involving an ultralight mesh (19g/m2): Restorelle® Direct Fix™. METHODS: A case series of 218 consecutive patients, operated on between January 2013 and December 2016 in ten tertiary and secondary care centres, was retrospectively analyzed. Eligible patients had POP vaginal repair (recurrent or not) planned with anterior Restorelle® Direct Fix™ mesh (with or without posterior mesh). Surgical complications were graded using the Clavien-Dindo classification. RESULTS: Intraoperative complications were bladder wound (0.5%), rectal wound (0.5%), ureteral injuries (0.9%). 98.2% of the patient did not have per operative complications. We observed one fail of procedure. Early complications mainly included urinary retention (8.7%) urinary tract infections (5.5%) and haematoma (2.7%). One haematoma required surgical treatment and another, embolization. 80.7% of the patient did not have complications during hospitalization and 80.3% did not have complication at the follow up visit. None of the analyzed factors (age, body mass index, surgical history, grade of prolapse or concomitant procedure) was significantly associated with the risk of perioperative complications. A total of 2.8% patients had grade III complications according Clavien Dindo. None had grade IV or V. CONCLUSIONS: This multicentre case-series on the early experience of the use of anterior Restorelle® Direct Fix™ mesh showed a satisfactory technical feasibility and a low rate of grade III complications according Clavien Dindo. Long term studies are necessary to assess anterior Restorelle® Direct Fix™ mesh performances and to appraise patient satisfaction feedback.