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

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 (19kg/m): 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 analysed. Eligible patients had POP vaginal repair (recurrent or not) planned with anterior Restorelle® Direct FixTM 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 didn't have per operative complications. We observed one fail of procedure. Early complications mainly included urinary retention (8.7%) urinary tract infections (5.5%) and hematoma (2.7%). One hematoma required surgical treatment and another, embolization. 80.7% of the patient didn't have complications during hospitalisation and 80.3% didn't have complication at the follow up visit. None of the analysed 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 FixTM 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 FixTM mesh performances and to appraise patient satisfaction feedback.