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Public Health (12-06-2015)

Public consultation on the Preliminary Opinion on the safety of surgical meshes used in urogynaecological surgery

Surgical meshes are used for urogynaecological surgical procedures such as stress urinary incontinence (SUI) and female pelvic organ prolapse (POP). The use of surgical meshes has been associated with various adverse effects such as infection, tissue erosion, pain and sexual dysfunction. The European Commission therefore requested that the independent Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) asses the risks of surgical meshes used in urogynecological surgery.

SCENIHR’s Preliminary opinion, published today for public consultation, looks at the rationale for and risks associated with the use of surgical meshes for various conditions, how to identify high risk patient groups and further assessment needs. Interested parties are invited to submit comments on the scientific evidence online before 19 July.

Based on the available scientific evidence, SCENIHR recommends that:

  • Aspects such as material properties, product design, overall mesh size, route of implantation, patient characteristics, associated procedures (e.g. hysterectomy) and surgeon’s experience should be taken into consideration when choosing appropriate therapy.
  • In assessing the risk associated with mesh application, consideration should be given to the overall surface area of material used, the product design and the properties of the material used. The available evidence suggests a higher morbidity in treating POP, which uses a much larger amount of mesh compared to SUI. 
  • When assessing synthetic mesh risks there is a need to clearly separate the smaller risks associated with SUI sling surgery from those of POP mesh surgery. 
  • 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. 
  • Synthetic sling SUI surgery should only be carried out by appropriately trained surgeons after thoroughly counselling patients on the associated risk/benefits.
  • Use of synthetic mesh for POP repair via a trans-vaginal route, should only be used when other surgical procedures have already failed or are expected to fail. 
  • The amount of mesh should be limited for all procedures 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.

For more information on the work of the Commission's independent scientific committees: http://ec.europa.eu/health/scientific_committees/policy/index_en.htm