The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has published its final Opinion on the safety of surgical meshes used in urogynaecological surgery.
A key conclusion is that in assessing the risk associated with mesh application, it is important to consider the overall surface area of material used, the product design and the properties of the material used. In addition, the available evidence suggests a higher morbidity in treating female pelvic organ prolapse (POP) than Stress Urinary Incontinence (SUI), as the former uses a much larger amount of mesh.
SCENIHR’s recommendations include:
- Material properties, product design, overall mesh size, route of implantation, patient characteristics, associated procedures (e.g. hysterectomy) and surgeon’s experience should be considered when choosing appropriate therapy.
- The implantation of any mesh for the treatment of POP via the vaginal route should be only considered in complex cases in particular after failed primary repair surgery.
- For all procedures, the amount of mesh should be limited where possible.
- A certification system for surgeons should be introduced based on existing international guidelines and established in cooperation with the relevant European Surgical Associations.
To read the full opinion on the ec.europa.eu website