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

• Published in: BJOG : an international journal of obstetrics and gynaecology 2019-09
• Main Authors: Fritel, Xavier, Campagne-Loiseau, Sandrine, Cosson, Michel, Ferry, Philippe, Saussine, Christian, Lucot, Jean-Philippe, Salet-Lizee, Delphine, Barussaud, Marie-Line, Boisramé, Thomas, Carlier-Guérin, Caroline, Charles, Thomas, Debodinance, Philippe, Deffieux, Xavier, Pizzoferrato, Anne-Cécile, Curinier, Sandra, Ragot, Stéphanie, Ringa, Virginie, de Tayrac, Renaud, Fauconnier, Arnaud
• Format: Article
• Language: English
• Subjects: Gynecology and obstetrics; Human health and pathology; Life Sciences
• ISSN: 1470-0328; 1471-0528
• DOI: 10.1111/1471-0528.15956

OBJECTIVE:Assess the short-term incidence of serious complications of surgery for urinary incontinence or pelvic organ prolapse.DESIGN:Prospective longitudinal cohort study by using a surgical registry.SETTING:13 public hospitals in France.POPULATION OR SAMPLE:1873 women undergoing surgery between February 2017 and August 2018.METHODS:Preliminary analysis of serious complications after a mean 7-month follow-up (0-18), 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:52 women (2.8%, 95% CI 2.1-3.6) experienced a serious complication during either the surgery, requiring discontinuation of the procedure, or the first months of follow-up, necessitating a subsequent reoperation; one case also required resuscitation; no women died. Of 811 midurethral slings (MUS), 11 were removed in part or totally (1.4%, 0.7-2.3), as were 2 of 391 transvaginal meshes (0.5%, 0.1-1.6), and 4 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 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 enlarged to assess the long-term risk associated with mesh use and identify its risk factors.