BACKGROUND AND PURPOSE:

• The VIGI-MESH registry was established to assess complications arising from stress urinary incontinence (SUI) or pelvic organ prolapse (POP) surgeries beyond RCTs
• Using VIGI-MESH data, Fritel et al. (BJOG, 2019) analyzed the short-term incidence of serious complications arising from SUI or POP surgeries

METHODS:

• Prospective longitudinal cohort study (between February 2017 and August 2018)
• Setting
  • Thirteen public hospitals in France
• Participants
  • Women undergoing SUI or POP surgical repair
• Study design
  • Surgeons reported procedures and complications
  • Verified by the hospitals information systems
• Primary outcomes
  • Serious complication: (1) Requiring discontinuation of the procedure or (2) subsequent surgical intervention
  • Life-threatening complication requiring resuscitation
  • Death

RESULTS:

• 1,873 women were included
  • Serious complication rate: 2.8%
  • Need for resuscitation: 1 patient
  • No deaths reported
  • Mean follow-up of 7 months (0-18 months)
• Removal of mesh
  • Midurethral slings (MUSs): 1.4% (11/811); 95% CI, 0.7 to 2.3%
  • Transvaginal meshes: 0.5% (2/391); 95% CI, 0.1 to 1.6%
  • Laparoscopically placed mesh implants: 0.7% (4/611); 95% CI, 0.2 to 1.5%
• Estimated incidence of serious complications 6 months after the surgical procedure
  • MUS alone: 3.5% (95% CI, 2.0 to 5.0%)
  • MUS with prolapse surgery: 7.0% (95% CI, 2.8 to 11.3%) 
  • Vaginal native tissue repair: 1.7% (95% CI, 0.0 to 3.8%)
  • Transvaginal mesh: 2.8% (95% CI, 0.9 to 4.6%) 
  • Laparoscopy with mesh: 1.0% (95% CI, 0.1 to 1.9%)
• Several MUS complications were related to sling adjustments (loosening or division)   
• Most complications were related to intraoperative bladder injuries during vaginal surgery resulting in discontinuation of the mesh or sling placement
• Early complications: Bladder voiding after MUS accounted for 50% of early complications
• Later complications: Vaginal exposure of either MUS or mesh
  • More often when placed vaginally vs via laparoscope

CONCLUSION:

• SUI or POP surgery complications are rare
• While an additional surgical procedure will be classified as a complication, the authors note that one of the benefits of MUS for SUI is the ability to adjust the sling, which is not possible with other procedures (e.g., retropubic colposuspension or traditional sling)
• Monitoring surgical outcomes including use of mesh and other materials is of value | Long-term follow up is necessary

Learn More – Primary Sources:

Complications after pelvic floor repair surgery (with and without mesh): short‐term incidence after 1873 inclusions in the French VIGI‐MESH registry

Related ObG Topics:

ACOG/AUGS Guidance Update: Diagnosis and Management of Pelvic Organ Prolapse Including Role of Mesh

Prolapse and Stress Incontinence: Burch Procedure vs Midurethral Sling

Surgery for Stress Urinary Incontinence: Which Procedures are Most Effective and Safest?

Midurethral Tape and Repeat Surgery for Stress Incontinence: Is the 2nd Time the Charm?