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.