Directorate-General for Health and Food Safety
A public consultation on this opinion was opened on the website of the Scientific Committees from 12 June to 19 July 2015. Information about the public consultation was broadly communicated to national authorities, international organisations and other stakeholders.
52 organisations and individuals (providing in total 178 comments) participated in the public consultation providing input to different chapters and subchapters of the Opinion. Among the organisations participating in the consultation, there were universities, professional associations, institutes of public health, industry representatives and NGOs.
Comments received during this time have been considered carefully by the SCENIHR. Where appropriate, the text of the relevant sections of the opinion has been modified or explanations have been added to take account of relevant comments. The literature has been accordingly updated with relevant publications. The scientific rationale and the opinion section were clarified and strengthened. In the cases where the SCENIHR, after consideration and discussion of the comments, has decided to maintain its initial views, the opinion (or the section concerned) has remained unchanged.
Content of the opinion
The SCENIHR considers three factors as being important when assessing the risks associated with mesh application: 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.
The body of evidence suggests that, when assessing the health risks of synthetic meshes, there is a need to clearly separate the smaller risks associated with stress urinary incontinence sling surgery from those of pelvic organ prolapse mesh surgery.
Based on the currently marketed products, assessment of the risks reported indicates that polypropylene type 1 meshes are the most appropriate synthetic meshes for vaginal use and polypropylene type 1 and polyester type 3 for insertion via the abdominal route. However, there is a need for further improvement in the composition and design of synthetic meshes, in particular for female pelvic organ prolapse surgery.
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 are aspects influencing the clinical outcome following mesh implantation. Such aspects are to be considered when choosing appropriate therapy.
- For all procedures, the amount of mesh should be limited where possible.
- 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.
- A certification system for surgeons should be introduced based on existing international guidelines and established in cooperation with the relevant European Surgical Associations.