Complication, revision and perceived health after pelvic organ prolapse surgery. Prospective medium-term results for 2,340 women participating in the VIGI-MESH register

Fritel X1, de Tayrac R2, Campagne-Loiseau S3, Ferry P4, Hummel M5, Deffieux X6, Lucot J7, Wagner L2, Debodinance P8, Saussine C5, Pizzoferrato A9, Carlier C10, Thubert T11, Panel L12, Bosset P13, Nkounkou E14, Ramanah R15, Charles T1, Boisramé T5, Bressler L16, Ragot S1, Cosson M17, Fauconnier A18

Research Type


Abstract Category

Pelvic Organ Prolapse

Abstract 63
Scientific Podium Short Oral Session 6
Grafts: Synthetic Pelvic Organ Prolapse Prospective Study Surgery Questionnaire
1. Université de Poitiers, 2. CHU Nîmes, 3. CHU Estaing, 4. CH La Rochelle, 5. CHRU Strasbourg, 6. CH Béclère, 7. GH Institut Catholique Lille, 8. CH Dunkerque, 9. CHU Caen, 10. CH Châtellerault, 11. CHU Nantes, 12. Languedoc Mutualité, 13. Hôpital Foch Suresnes, 14. CH Béthune, 15. CHU Besançon, 16. CHU Nancy, 17. CHRU Lille, 18. CHI Poissy-St-Germain

Xavier Fritel



Hypothesis / aims of study
Pelvic organ prolapse is a frequent situation which leads in 19% of cases to surgical treatment [1]. Information about the risk of complications and recurrence is essential to help women and surgeons in choosing the best surgical procedure. This information comes from the surgeon's experience and clinical studies. However, clinical studies (or the surgeon's experience) may be limited in the number of patients observed, which does not allow rare events to be collected.
The VIGI-MESH registry aims are to collect the surgical activity for the treatment of pelvic organ prolapse (POP) in several surgical centers and to monitor complications, surgical revisions and women perceived health [2]. 
Here we report the first medium-term results of our registry.
Study design, materials and methods
Eligible POP surgical procedures included were vaginal repair (with native tissue), transvaginal mesh placement, and abdominal or laparoscopic repair. All surgeons described each operation performed on a specific case report form. We checked the data collection by reviewing deliveries from the hospital pharmacies and surgical procedure codes recorded by each hospital's medical data department. 
We defined serious complications using Clavien-Dindo classification: mesh use canceled due to peroperative injury (Grade III), subsequent surgical intervention related to a complication (Grade III), life-threatening complication (Grade IV), woman's death (Grade V). We collected also surgical revisions for POP relapse. We used several sources to identify complications and revisions: the monitoring of surgical procedures by the data departments, surgeons' spontaneous reports, and a questionnaire sent to the women a year later. These annual follow-up questionnaires collected also information about perceived health and improvement (WHO, EQ5D, and PGI-I).
Between February 2017 and November 2019, 2,375 women underwent a POP surgical repair in 19 centers and agree to participate. In two cases the laparoscopic surgery was abandoned due to surgical difficulties, in eleven cases the sacropexy was planned by laparotomy, in seven cases the  procedure planned was a laparoscopy without mesh insertion, and in fifteen cases it was a lateral fixation with mesh by laparoscopy; these 35 women were not included in the analysis. 
The analysis include 2340 women whose planned surgery was a sacropexy by laparoscopy with mesh (hysteropexy, colpopexy or rectopexy, N = 1142), a transvaginal mesh procedure (N = 694) or a vaginal repair without mesh (N = 504). Sacropexy by laparoscopy was converted ten times (0.9%) to another surgical procedure: five in sacropexy by laparotomy, two in lateral fixation by laparoscopy, two in transvaginal mesh, and one in vaginal repair. 
The women characteristics differs according to the type of intervention with younger and healthier patients in the sacropexy group, and more frequent surgical history in patients operated by the vaginal route. Surgeons preferred mesh surgery more often in case of anterior or apical prolapse. 
Median follow-up was 15 months. We observed complications grade III or higher in 48 women (2.05%).
Complications grade III or IV occurred during surgery or in the first 48 hours in 12 women: one had a cardiac infarct, seven an intraoperative injury, and four a postoperative haemorrhage or haematoma. Placement of the mesh were cancelled six times; three women returned to OR for haemostasis; three women needed intensive care.
Grade III complications required a surgical treatment from two days to two months after the index surgical procedure in 15 women: one peritonitis related to ileal injury after sacropexy, one appendicitis after sacropexy, one bladder retentions related to transvaginal mesh, five hemorrhages or hematomas, four ureteral obstructions, four pelvic abscess, one severe pain related to vaginal repair with sacrospinofixation, and two vaginal mesh exposure related to sacropexy. Two laparoscopy were performed to treat appendicitis and peritonitis; ureteral obstructions were treated by double J stents, by hematoma drainage, or by nephrostomy; pelvic abscess or/and mesh exposures were treated by mesh removal in four cases and drainage in one case; a bladder retention was treated by removal of the stitches between the mesh and the uteri cervix; a severe pain after sacrospinousfixation was treated by fixation removal; and the two last returned to OR for haemostasis or hematoma drainage.
Between 2 and 12 postoperative months, 19 women required surgical treatment for grade III complications: ten vaginal mesh exposure, one bladder exposure after sacropexy, 6 severe or chronic pain, 2 ureteral obstructions after transvaginal mesh, one scar hernia after sacropexy, three vaginal granuloma. Eleven women need a surgery for mesh removal because of mesh exposure, ureteral obstruction, or pain; six for vaginal scar revision without mesh removal because of vaginal mesh exposure or granuloma; one for scar hernia treatment; and one for pudendal infiltration.
Two women returned to OR more than a year after sacropexy, one for  scar hernia, and one for bladder toxin injection.
The complication-free survival curve showed a significant difference between the types of surgery (Figure 1 in months, logrank test p=0.005). The incidence of serious complications at 12 months was estimated at 1.28 in case of vaginal repair [95 % CI 0.25-2.30], 1.44 in case of sacropexy [0.71-2.17], and 3.72% in case of transvaginal mesh [2.29-5.15]. An history of hysterectomy (RR 2.11 [1.11-4.10]), and transvaginal mesh versus vaginal repair (RR 2.98 [1.22-7.26], Figure 1) were associated with an higher risk of complications. 
Twenty-nine women (1.24%) benefited from surgical revision due to failure or recurrence of the prolapse: 11 after sacropexy (0.96%), 6 after transvaginal mesh (0.86%), and 12 after vaginal repair (2.38%). Compared to native vaginal repair, the risk of surgical revision for recurrent prolapse is three times lower in case of sacropexy with mesh (RR 0.34 [0.15-0.77]) or in case of transvaginal mesh (RR = 0.29 [0.11 -0.76]; Figure 2). We did not identify any other risk factor for prolapse recurrence. 
Among the 1,598 women operated between February 2017 and December 2018 contacted by mail, we received 931 responses to the health questionnaire sent a year or more after their surgery (58.3%). To the question "What do you think of your current state of health compared to what it was before your surgery for incontinence or prolapse?”, they were 90.3% (787/872) who consider themselves better (much better, better, or a little better; PGI-I). 96.4% (823/854) rated their general health as good (very good, good, or fairly good). We did not find any difference depending on the surgical group. Compared to the French population of the same age, women operated for POP declared a better perceived  health .
Interpretation of results
Sacropexy by laparoscopy was the most performed intervention in the registry, but was not always possible with a risk of conversion of approximately 1%. At mid-term, serious complications were uncommon (2%) especially after sacropexy by laparoscopy. Recurrences requiring surgical revision were infrequent (1%), especially after sacropexy by laparoscopy.
Women were more than 90% improved after surgery and their perceived health was better than in the general population.
Concluding message
In our registry, compared to vaginal repair and transvaginal mesh, laparoscopic sacropexy with mesh presented the best benefit-risk profile. Native vaginal repair exposed to a low risk of complications, but the risk of recurrence was 3 times greater than transvaginal mesh. Transvaginal mesh exposed to a low risk of recurrence but the risk of serious complication was 3 times greater than vaginal repair.
Figure 1 Figure 1. Survival without grade III or more complication depending on the time (months) and the surgical group (2340 women)
Figure 2 Figure 2. Survival without surgical revision for POP relapse depending on time (months) and surgical group (2340 women)
  1. Smith et al. Lifetime Risk of Undergoing Surgery for Pelvic Organ Prolapse. Obstet Gynecol 2010.
  2. Fritel 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 2020.
Funding National medicines agency (Agence Nationale de Sécurité du Médicament et des produits de santé, ANSM) Clinical Trial No Subjects Human Ethics Committee The Comité de Protection des Personnes Ouest III approved the protocol 9 February 2017 (IDRBC 2017-A000308-45) Helsinki Yes Informed Consent Yes
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