Methods
Participation in the VIGI-MESH registry began after its approval by the Comité de Protection des Personnes Ouest III (Institutional Review Board) in February 2017 (IDRBC 2017-A000308-45), and the posting of the study on Clinicaltrial.gov (NCT03052985). The Agence Nationale de Sécurité du Médicament et des produits de santé (national medicines agency) provided funding for the VIGI-MESH registry, but played no role in data collection or analysis, assessment of the complications, or interpretation of the results. The study had no support or involvement by any manufacturer of mesh.
Participation was offered to all women undergoing surgery for anterior, apical (uterine or vaginal vault) or posterior vaginal prolapse. Each participating woman received information about the VIGI-MESH registry and consented. Surgeons described each operation on a specific case report form. We checked the data collection by reviewing mesh deliveries from the hospital pharmacies and the surgical codes of eligible surgeries recorded by each hospital’s medical data department.9
This analysis considered three surgical groups: vaginal repair procedure involving native tissue and no mesh (hereafter, vaginal repair), transvaginal placement of mesh (hereafter, transvaginal mesh), and laparoscopic sacropexy, which included colposacropexies (in cases of previous or associated hysterectomy) or colpohysterosacropexies (when the uterus was left in place) that placed mesh by laparoscopy. These procedures are those most frequently used in high-resource countries.11Haya N, Baessler K, Christmann-Schmid C, de Tayrac R, Dietz V, Guldberg R, Mascarenhas T, Nusller E, Ballard E, Ankardal M, Boudemaghe T, Wu JM, Maher CF. Prolapse and continence surgery in countries of the Organization for Economic Cooperation and Development in 2012. Am J Obstet Gynecol 2015;212:755.e1-27 The other, rarer surgical procedures (sacropexy by laparotomy, laparoscopy without mesh, and lateral suspensions) were not included in this analysis as they were rare in our registry.9 The planned surgical group was used for the intention-to-treat analysis; for example, a laparoscopic sacropexy converted to a transvaginal mesh procedure was analysed as laparoscopic sacropexy.