Complications after pelvic floor repair surgery (with and without mesh): short-term incidence after 1873 inclusions in the French VIGI-MESH registry.
Adult
Aged
Aged, 80 and over
Analysis of Variance
Colposcopy
/ adverse effects
Female
France
/ epidemiology
Humans
Incidence
Intraoperative Complications
/ etiology
Middle Aged
Pelvic Floor
/ surgery
Pelvic Organ Prolapse
/ mortality
Postoperative Complications
/ etiology
Prospective Studies
Registries
Suburethral Slings
/ adverse effects
Surgical Mesh
/ adverse effects
Surgicenters
/ statistics & numerical data
Young Adult
Longitudinal study
mesh
pelvic organ prolapse
short-term major complication
stress urinary incontinence
surgery
Journal
BJOG : an international journal of obstetrics and gynaecology
ISSN: 1471-0528
Titre abrégé: BJOG
Pays: England
ID NLM: 100935741
Informations de publication
Date de publication:
01 2020
01 2020
Historique:
accepted:
09
09
2019
pubmed:
24
9
2019
medline:
24
12
2019
entrez:
24
9
2019
Statut:
ppublish
Résumé
To assess the short-term incidence of serious complications of surgery for urinary incontinence or pelvic organ prolapse. Prospective longitudinal cohort study using a surgical registry. Thirteen public hospitals in France. A cohort of 1873 women undergoing surgery between February 2017 and August 2018. 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. Serious complication requiring discontinuation of the procedure or subsequent surgical intervention, life-threatening complication requiring resuscitation, or death. 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. 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. Short-term serious complications are rare after surgery for urinary incontinence or pelvic organ prolapse, even with mesh.
Identifiants
pubmed: 31544327
doi: 10.1111/1471-0528.15956
doi:
Types de publication
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
88-97Subventions
Organisme : Agence Nationale de Sécurité du Médicament et des Produits de Santé
Pays : International
Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2019 Royal College of Obstetricians and Gynaecologists.
Références
Fritel X, Panjo H, Varnoux N, Ringa V. The individual determinants of care-seeking among middle-aged women reporting urinary incontinence: Analysis of a 2273-woman cohort. Neurourol Urodyn 2014;33:1116-22.
Fritel X, Varnoux N, Zins M, Bréart G, Ringa V. Symptomatic pelvic organ prolapse at midlife, quality of life, and risk factors. Obstet Gynecol 2009;113:609-16.
Baessler K, Christmann-Schmid C, Maher C, Haya N, Crawford TJ, Brown J. Surgery for women with pelvic organ prolapse with or without stress urinary incontinence. Cochrane Database Syst Rev 2018;8:CD013108.
Lucot JP, Cosson M, Bader G, Debodinance P, Akladios C, Salet-Lizée D, et al. Safety of vaginal mesh surgery versus laparoscopic mesh sacropexy for cystocele repair: results of the Prosthetic Pelvic Floor Repair randomized controlled trial. Eur Urol 2018;74:167-76.
Le Normand L, Cosson M, Cour F, Deffieux X, Donon L, Ferry P, et al. Clinical Practice Guidelines: Synthesis of the guidelines for the surgical treatment of primary pelvic organ prolapse in women by the AFU, CNGOF, SIFUD-PP, SNFCP, and SCGP. J Gynecol Obstet Hum Reprod 2017;46:387-91.
Afssaps. Bandelettes posées par voie vaginale, Rapport d’enquête. 2005. Available from: http://ansm.sante.fr/var/ansm_site/storage/original/application/5c67f2cb300d639de8df75f696e848ea.pdf.
Sarreau M, Bon D, Estrade V, Villemonteix P, Fritel X. Sexualité après cure d’incontinence urinaire par bandelette sous-urétrale transobturatrice et satisfaction des patientes. [Sexual function after transobturator tape procedure for stress urinary incontinence and overall patients’ satisfaction] Prog Urol 2016;26:24-33.
MRHA. A summary of the evidence on the benefits and risks of vaginal mesh implants. 2014. Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/402162/Summary_of_the_evidence_on_the_benefits_and_risks_of_vaginal_mesh_implants.pdf.
Khanuengkitkong S, Lo TS, Dass AK. Delayed vaginal and urethral mesh exposure: 10 years after TVT surgery. Int Urogynecol J 2013;24:519-21.
Roth TM, Reight I. Laparoscopic mesh explantation and drainage of sacral abscess remote from transvaginal excision of exposed sacral colpopexy mesh. Int Urogynecol J 2012;23:953-5.
NHS Recommendations of the Mesh Pause Clinical Advisory Group to Medical Directors and Surgical Teams. Available from: https://www.baus.org.uk/_userfiles/pages/files/Patients/CAGmesh%20FINAL.pdf.
Utilisation des données d’un registre de chirurgie de l’incontinence et du prolapsus pour suivre les dispositifs médicaux concernés faisant partie du programme 2016 de surveillance renforcée des Dispositifs médicaux. Available from: https://ansm.sante.fr/var/ansm_site/storage/original/application/17ae0787d2339be6aba55cba02353ece.pdf.
Dindo D, Demartines N, Clavien PA. Classification of surgical complications. Ann Surg 2004;240:205-13.
Haylen BT, Freeman RM, Swift SE, Cosson M, Davila GW, Deprest J, et al. An international urogynecological association (IUGA)/international continence society (ICS) joint terminology and classification of the complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery. Neurourol Urodyn 2011;30:2-12.
Haylen BT, Freeman RM, Lee J, Swift SE, Cosson M, Deprest J, et al. International Urogynecological Association (IUGA)/International Continence Society (ICS) joint terminology and classification of the complications related to native tissue female pelvic floor surgery. Neurourol Urodyn 2012;31:406-14.
Fritel X, Campagne-Loiseau S, de Tayrac R, Ferry P, Saussine C, Garbin O et al.French observatory of pelvic floor repair surgery (with or without mesh), VIGI-MESH, first results after more than 1000 inclusions. IUGA 2018, Vienna. Available from: https://iugameeting.org/2018-meeting/program/?where_person=44.
Wang C, Christie AL, Zimmern PE. Synthetic mid-urethral sling complications: Evolution of presenting symptoms over time. Neurourol Urodyn 2018;37:1937-42.
Gurol-Urganci I, Geary RS, Mamza JB, Duckett J, El-Hamamsy D, Dolan L, et al. Long-term rate of mesh sling removal following midurethral mesh sling insertion among women with stress urinary incontinence. JAMA 2018;320:1659-69.
Tunitsky E, Abbott S, Barber MD. Interrater reliability of the Inter-national Continence Society and International Urogynecological Association (ICS/IUGA) classification system for mesh-related complications. Am J Obstet Gynecol 2012;206(442):e1-6.
Jacquetin B, Hinoul P, Gauld J, Fatton B, Rosenthal C, Clavé H, et al. Total transvaginal mesh (TVM) technique for treatment of pelvic organ prolapse: a 5-year prospective follow-up study. Int Urogynecol J 2013;24:1679-86.
Desseauve D, Pierre F, Fritel X. Urinary incontinence in women: study of surgical practice in France. Prog Urol 2013;23:249-55.
Cundiff GW, Quinlan DJ, van Rensburg JA, Slack M. Foundation for an evidence-informed algorithm for treating pelvic floor mesh complications: a review. BJOG 2018;125:1026-37.