Introduction
Pelvic organ prolapse is a frequent disability that leads to surgical repair for around one fifth of women.11Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime Risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol 2010;116:1096-100. About 1.1 woman per 1000 undergoes surgery for this condition in France, and around 3.6-3.8 per 1000 aged 60-79 years in U.S.22Subramanian D, Szwarcensztein K, Mauskopf JA, Slack MC. Rate, type, and cost of pelvic organ prolapse surgery in Germany, France, and England. Eur J Obstet Gynecol Reprod Biol 2009;144:177-81.,33Wu JM, MD, Matthews CA, Conover MM, Pate V, Funk MJ. Lifetime Risk of Stress Incontinence or Pelvic Organ Prolapse Surgery. Obstet Gynecol 2014;123:1201-6. Information about the risks of adverse effects is essential for choosing the procedure most appropriate to the woman’s clinical situation and expectations. To promote shared decision-making, this information must include the frequent or serious complications.44Barber MD. Mesh use in surgery for pelvic organ prolapse, Despite many advances, outcomes after surgery remain far from perfect. BMJ 2015;350:h2910
The information that surgeons provide before the intervention comes from their own experience and their knowledge of the clinical studies. The limited number of patients likely to be covered by both experience and knowledge prevents any exhaustive collection of rare events. Surgical trials often include selected and small samples. Subjects included in trials are often younger and at lower risk than their target population.55Hofmann R, James SK, Jernberg T, Lindahl B, Erlinge D, Witt N, Arefalk G, Frick M, Alfredsson J, Nilsson L, Ravn-Fischer A, Omerovic E, Kellerth T, Sparv D, Ekelund U, Linder R, Ekström M, Lauermann J, Haaga U, Pernow J, Östlund O, Herlitz J, Svensson L; DETO2X–SWEDEHEART Investigators. Oxygen Therapy in Suspected Acute Myocardial Infarction. N Engl J Med 2017;377:1240-9.,66Lindsay WA, Murphy MM, Almghairbi DS, Moppett IK. Age, sex, race and ethnicity representativeness of randomised controlled trials in peri-operative medicine. Anaesthesia 2020;75:809-15. This situation should encourage efforts to verify the results of trials in current clinical practice with prospective registries.77Rimmer A. Vaginal mesh procedures need compulsory register, says royal college. BMJ 2018;360:k586.,88Fritel X. Evidence about surgical revision for MUS complications will come from large retrospective cohorts and prospective registers. BJOG 2020;127:1034.
The VIGI-MESH registry enables an exhaustive collection of the operations performed in current clinical practice to treat pelvic organ prolapse and the follow-up of both serious complications and reoperations for recurrence.99Fritel X, Campagne-Loiseau S, Cosson M, Ferry P, Saussine C, Lucot JP, Salet-Lizee D, Barussaud ML, Boisramé T, Carlier-Guérin C, Charles T, Debodinance P, Deffieux X, Pizzoferrato AC, Curinier S, Ragot S, Ringa V, de Tayrac R, Fauconnier A. Complications after pelvic floor repair surgery (with and without mesh): short-term incidence after 1873 inclusions in the French VIGI-MESH registry. BJOG 2020;127:88-97. Now that the registry has been in operation for three years, we report here its medium-term results. We anticipate that the incidence of serious complications and of reoperations for recurrence might differ by the type of surgical repair planned (native tissue vaginal repair, transvaginal mesh placement, or laparoscopic sacropexy with mesh). The objective of our analysis was to assess the risk ratios of the different surgical options used in real-world practice for prolapse repair.