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

Xavier Fritel 1, 2, 3, * Sandrine Campagne-Loiseau 4 Michel Cosson 5 Philippe Ferry 6 Christian Saussine 7 Jean-Philippe Lucot 8 Delphine Salet-Lizee 9 Marie-Line Barussaud 10 Thomas Boisramé 11 Caroline Carlier-Guérin 12 Thomas Charles 13 Philippe Debodinance 14 Xavier Deffieux 15 Anne-Cécile Pizzoferrato 16 Sandra Curinier 4 Stéphanie Ragot 1 Virginie Ringa 2 Renaud de Tayrac 17 Arnaud Fauconnier 18 
Abstract : 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.
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Submitted on : Thursday, October 10, 2019 - 7:57:07 AM
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Xavier Fritel, Sandrine Campagne-Loiseau, Michel Cosson, Philippe Ferry, Christian Saussine, et al.. Complications after pelvic floor repair surgery (with and without mesh): short-term incidence after 1873 inclusions in the French VIGI-MESH registry.. BJOG: An International Journal of Obstetrics and Gynaecology, Wiley, 2019, ⟨10.1111/1471-0528.15956⟩. ⟨inserm-02310221⟩



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