Between February 2017 and August 2018, we included prospectively 1873 women. Index surgery (at baseline) was MUS only in 658 women, prolapse surgery in 1062 (including 888 with at least one mesh), and incontinence associated with prolapse surgery in 153 women (all with at least one mesh); associated hysterectomies (total or subtotal) were not counted as a prolapse correction procedure (Table).
Mean age was 62 (29 to 93), 75.9% were postmenopausal; 45.9% were sexually active; mean BMI was 26 kg/m² (16 to 61); 9.2% were smoker, 6.8% were diabetic, 17.5% has already undergone an hysterectomy, and 20.4% a surgery for SUI or POP; the physical status (ASA score) was rated 1 for 628 women (33.5%), 2 for 950 (50.6%), 3 for 143 (7.6%), and 4 for 2 (0.1%). Mean length of follow-up was 7.3 months (0 to 18).
Among the 1873 women included in this analysis, 52 (2.78%) experimented a serious complication during the surgery or the first months of follow-up. The incidence of serious complication 6 months after the surgical procedure was estimated around 0.99% [0.12-1.86] after laparoscopy with mesh (blue curve), 3,54% [95% CI: 2.03-5.04] after MUS alone (red curve), 7.03% [2.79-11.28] after MUS associated with POP surgery (green curve), 1.73% [0-3.77] for vaginal repair without mesh (purple curve), and 2.80% [0.86-4.65] after vaginal repair with mesh (orange curve; Figure). Most were Grade IIIb complications (surgical revision under general anaesthesia), one case need resuscitation, and no death occurred. The most frequent complication was obstructive micturition (18 cases all related to MUS, 2.22%) and the second one mesh exposure (9 cases related to MUS, 1.11%; 5 to vaginal mesh, 1.28%; and 2 to laparoscopic mesh, 0.33%).
Thirteen complications occurred within the first 48 hours, all related to vaginal surgery: bladder (eight cases) or urethral (two cases) wounds, bleeding or thrombus (four cases), and complete urinary retention. The vaginal placement of the mesh was discontinued eight times because of the complication. Three hemorrhages required a return to the operating room for secondary hemostasis. The mesh was removed on day 1 vaginally in one case because of bladder exposure. One MUS was vaginally loosened on day 1 due to bladder retention in another case.
Twenty-four complications were treated between 2 days and 2 months after index surgery. It was necessary to loosen the MUS in twelve cases, and to cut it in two cases. In three cases (one sacrocolpopexy by laparoscopy and two vaginal surgery with mesh) it was necessary to manage a painful ureteral obstruction. In three cases it was necessary to evacuate a hematoma or resume hemostasis in the operating room. In two cases it was necessary to partially remove the MUS because of early vaginal exposure. In two cases the mesh was removed by laparoscopy due to pelvic infection (one sacrocolpopexy and one rectopexy).
Fifteen complications were treated between 2 and 12 months postoperatively due to late bladder retention on MUS (one case), vaginal exposure (six MUS, four vaginal repair with mesh, and two sacrocolpopexy), urethral exposure of MUS (two cases), and painful subcutaneous swelling on a retropubic MUS (one case). Complications requiring a division of the MUS (one case), a partial resection of the MUS (seven cases) or mesh (one vaginal mesh, and two related to sacrocolpopexy), and in the four other vaginal trimming.
Taking into account all revisions for complication, 11 MUS out of 811 were partially or totally removed (1.36%), as well as 2 mesh among 391 vaginal repair (0.51%), and 4 mesh among 611 laparoscopic prrocedures (0.65%). We observed 29 surgical revisions (1.55%) for urinary incontinence (24 cases) or prolapse (5 cases); the most frequent wass the placement of a MUS after sacrocolpopexy by laparoscopy (14 cases or 3.59%). Finally, 69 women (3.68%) were reoperated at least once for complication, urinary incontinence or prolapse.