Surgical revision for complications following incontinence or prolapse surgery in 212 women included in the VIGI-MESH observatory

Fritel X1, Campagne-Loiseau S2, Cosson M3, Saussine C4, Lucot J5, Salet-Lizee D6, Barussaud M7, Boisramé T8, Carlier-Guérin C9, Charles T7, Debodinance J10, Deffieux X11, Hummel M8, Pizzoferrato A12, Ragot S1, Fauconnier A13, de Tayrac R14

Research Type

Clinical

Abstract Category

Female Stress Urinary Incontinence (SUI)

Abstract 698
Urogynaecology 6 - Mesh / Sling Complications
Scientific Podium Short Oral Session 33
Friday 6th September 2019
16:15 - 16:22
Hall G3
Surgery Stress Urinary Incontinence Pelvic Organ Prolapse Female Grafts: Synthetic
1.Université de Poitiers, 2.CHU Estaing, Clermont-Ferrand, 3.Université de Lille, 4.Université de Strasbourg, 5.Hôpital Saint-Vincent de Paul, Lille, 6.GH Diaconesses-Croix-Saint-Simon, Paris, 7.CHU de Poitiers, 8.CHRU de Strasbourg, 9.CH de Châtellerault, 10.CH de Dunkerque, 11.APHP, Clamart, 12.CHU de Caen, 13.CHI Poissy-Saint-Germain, 14.CHU Carémeau, Nîmes
Presenter
X

Xavier Fritel

Links

Abstract

Hypothesis / aims of study
The purpose of the VIGI-MESH observatory is to collect complications after surgery for urinary incontinence and genital or rectal prolapse in women.
Study design, materials and methods
The postoperative complications selected for this analysis are surgical revisions in the operating room. Revisions for failure or recurrence of incontinence or prolapse were not included in this analysis. Complications are classified according to the initial surgical procedure: sacrocolpopexy with mesh for pelvic organ prolapse (POP), vaginal surgery with mesh for POP, vaginal repair without mesh for POP, mid-uretra sling (MUS), and other surgery; depending on the indication for surgical revision (several indications in some cases): chronic pain, pelvic abscess, visceral or vaginal exposure, voiding dysfunction, ureteral obstruction or other; depending on the delay since the intervention using the ICS-IUGA categories, between 0 and 2 days, after 2 days and before 2 months, between 2 and 12 months, and after 12 months; and depending on the type of surgical revision: sling loosening, sling division, partial or complete excision of mesh (by a vaginal or abdominal route), vaginal trimming (burial), procedure on the upper urinary tract (JJ probe or nephrostomy).
In case of multiple complications, we have taken into account the first complication occurred.
Results
Between February 2017 and December 2018, 212 women were reoperated one or more times because of complications and are the subject of our analysis. The median time to complication treatment was 29 months, 39.6% (84/212) was resumed more than 60 months after the initial surgery.
MUS approach was retropubic in 45 cases, transobturator in 55 cases, and with a single incision in 8 cases (13 missing data); sacrocolpopexy approach was by laparoscopy or robot in 25 cases and by laparotomy in 4 cases (3 missing data).
The main indication for surgical revision (Table) was mesh exposure, vaginal (89 cases), visceral (26 cases including 15 urethral exposures, 13 bladder exposures, and 1 rectal exposure), or cutaneous (1 case). Six cases of exposure on non-absorbable stiches were also reported. The median delay to surgical revision was 65 months (from 1 day to 228 months). The exposure was accompanied by pain in one third of cases (40/112) and by vaginal discharge in 17% (19/112).
The second indication for surgical revision was pain related to BSU (39 cases), vaginal surgery with wick (18 cases), sacrocolpopexy (17 cases), or vaginal surgery without mesh (5 cases). Pain included dyspareunia in 29 cases. The median delay to surgical revision was 50 months (0 to 260 months).
In 58 cases, the surgical revision indication was voiding dysfunction (Table), the vast majority after BSU (51 cases). The average delay to surgical revision was 31 months. Urinary tract infections were reported in 7 cases. The sling was released in 17 cases (median delay 3 days), divided in 11 cases (median delay 9 months) and excised in 21 cases (median delay 65 months). 
Deep infections were an indication for surgical revision in 18 cases, the majority after sacrocolpopexy (14 cases). Vaginal discharge was associated in 5 cases and pain in 9 cases. The median delay to surgical revision 56 months (2 days to 204 months).
Eleven women returned to operative room due to hematoma or postoperative bleeding, with a median delay of 12 days. Seven women required surgical revision due to ureteral obstruction with a median dealy of 17 days. Other indications for surgical revision were anorectal disorders (2 cases), or hernia (1 case). Twenty-six women (12%) were repeatedly operated for complications.
Interpretation of results
The most common complication of mesh surgery is exposure, regardless of the surgical procedure (MUS, vaginal surgery with mesh, sacrocolpopexy with mesh). The second in terms of frequency is chronic pain that can occur with or without wick and regardless of the surgical procedure. MUS expose to a risk of surgical revision for voiding dysfunction. Many complications can occur late.
Concluding message
Clinicians should be warned that incontinence or pelvic organ prolapse surgery with mesh exposes to late complications.
Figure 1 Table. Main complications and surgical management according to the initial surgical procedure; three women combined complications related to several surgical procedures
Disclosures
Funding ANSM (Agence Nationale de Sécurité du Médicament) Clinical Trial No Subjects Human Ethics Committee CPP (Comité de Protection des Personnes) Ouest III Helsinki Yes Informed Consent Yes