Complications after pelvic floor repair surgery (with and without mesh): short-term incidence after 1873 inclusions in the French VIGI-MESH registry

Abstract

Objective: To assess the short-term incidence of serious complications of surgery for urinary incontinence or pelvic organ prolapse.

Design: Prospective longitudinal cohort study using a surgical registry.

Setting: Thirteen public hospitals in France.

Population: A cohort of 1873 women undergoing surgery between February 2017 and August 2018.

Methods: Preliminary analysis of serious complications after a mean follow-up of 7 months (0-18 months), according to type of surgery. Surgeons reported procedures and complications, which were verified by the hospitals' information systems.

Main outcome measures: Serious complication requiring discontinuation of the procedure or subsequent surgical intervention, life-threatening complication requiring resuscitation, or death.

Results: Fifty-two women (2.8%, 95% CI 2.1-3.6%) experienced a serious complication either during surgery, requiring the discontinuation of the procedure, or during the first months of follow-up, necessitating a subsequent reoperation. One woman also required resuscitation; no women died. Of 811 midurethral slings (MUSs), 11 were removed in part or totally (1.4%, 0.7-2.3%), as were two of 391 transvaginal meshes (0.5%, 0.1-1.6%), and four of 611 laparoscopically placed mesh implants (0.7%, 0.2-1.5%). The incidence of serious complications 6 months after the surgical procedure was estimated to be around 3.5% (2.0-5.0%) after MUS alone, 7.0% (2.8-11.3%) after MUS with prolapse surgery, 1.7% (0.0-3.8%) after vaginal native tissue repair, 2.8% (0.9-4.6%) after transvaginal mesh, and 1.0% (0.1-1.9%) after laparoscopy with mesh.

Conclusions: Early serious complications are relatively rare. Monitoring must be continued and expanded to assess the long-term risk associated with mesh use and to identify its risk factors.

Tweetable abstract: Short-term serious complications are rare after surgery for urinary incontinence or pelvic organ prolapse, even with mesh.

Keywords: Longitudinal study; mesh; pelvic organ prolapse; short-term major complication; stress urinary incontinence; surgery.