Synthetic Surgical Mesh for the repair of stress urinary incontinence, pelvic organ prolapse and inguinal hernia

Health Technology Assessment Committee Recommendations

Based on the below findings, HTAC recommends:

1. The evidence currently available does not warrant removing the option of synthetic surgical mesh for the surgical repair of stress urinary incontinence or inguinal hernia.
    
2. The use of synthetic surgical mesh for the surgical repair of pelvic organ prolapse should only be used in patients for whom alternative surgical treatments are not appropriate.
    
3. Given the limited evidence available, especially for long-term outcomes, BC should work with Health Canada through the Medical Device Action Plan to improve performance monitoring of the use of synthetic mesh.

Health Technology Assessment Committee Findings

1. Many countries, including Canada have issued different levels of advisories for various uses of surgical mesh. Some countries have banned very specific uses of mesh, particularly for certain uses of mesh in POP. On July 25, 2019 Health Canada indicated that based on a safety review they will be working with manufacturers to remove synthetic surgical mesh devices indicated for the transvaginal repair of posterior compartment POP from the Canadian market.¹
    
2. Clinicians and key informants expressed mixed views on the use of mesh, with most expressing concern for the appropriate use of mesh for pelvic organ prolapse. Stakeholders expressed concern for completely limiting the use of mesh and indicated that appropriate patient selection and informed patient consent are important considerations.
    
3. Patient experiences for surgical mesh were mixed. While many patients experienced increased quality of life with few or no complications, other patients report severely diminished quality of life with complications such as mesh exposure and/or erosion, pain, dyspareunia, bleeding, organ perforation, urinary problems, vaginal scarring or shrinkage, neuromuscular problems, recurrent prolapse and infection. Some patients with complications reported the difficulty or near impossibility in resolving the complications, with limited options (if any) to surgically remove mesh and address other complications.
    
4. For stress urinary incontinence HTAC compared synthetic mesh to sutures and porcine mesh.
   
   Overall, much uncertainty remains regarding the effectiveness and safety of synthetic surgical mesh for SUI. While the existing literature suggests that synthetic surgical mesh may be similar to autologous fascial sling (AFS), native tissue suspension, and porcine mesh, there is considerable variability across studies with respect to cure definition, follow-up duration, and availability of QoL data. With consideration of these limitations, HTAC found that:
   • In the short-term synthetic mesh is associated with higher odds of intraoperative bladder injury and lower odds of wound infection;
   • In the long-term (> 3 years) there were no comparative data available.
      
5. For pelvic organ prolapse HTAC compared synthetic mesh to sutures.
   
   Overall, much uncertainty remains regarding the efficacy and safety of synthetic surgical mesh for POP. While meta-analyses of the existing literature suggest that synthetic surgical mesh may result in better cure rates than porcine mesh and native tissue suspension, this must be interpreted with caution due to heterogeneity of the effect. Meta-analyses suggest synthetic mesh is significantly associated with more bladder injury, intraoperative blood loss, and urinary retention than native tissue suspension. However, the literature on the efficacy and safety of synthetic mesh vs. other comparators is scarce and limited conclusions can be made. With consideration to these limitations, HTAC found that:
   • Synthetic mesh is associated with higher odds of intraoperative bladder injury, blood loss, urinary retention, and pain at 1-3 months.
   • Synthetic mesh has similar odds of dyspareunia (pain during sex), de novo urinary infection, pain at 1 year, UTI, fever and the need for blood transfusion during surgery.
      
6. For inguinal hernia HTAC compared synthetic mesh to sutures and porcine mesh.
   
   While relatively robust meta-analysis comparisons could be made for the synthetic mesh vs. suture repair groups at the 1-2 year follow-up point, there were few studies for the remainder of the time-points for the suture repair comparison, as well as the comparison with porcine mesh. Furthermore, evidence on patient-reported QoL using validated measures was scarce. With consideration to these limitations, HTAC found that:
   • In the short-term synthetic mesh has similar efficacy and risks of complications.
   • In the long-term there were no comparative data available.

Health Technology Assessment Committee recommendations on synthetic surgical mesh were accepted by a committee of senior health authority and ministry executives in November 2019. Please note health authorities determine how health technologies are implemented within their programs and services. Other relevant scientific findings may have been reported since the completion of the reference documents used to form the basis of the committee's recommendations.