On 10 July 2018 NHS Improvement and NHS England wrote to all acute trust CEOs and medical directors in England advising of the immediate implementation of a high vigilance restriction period regarding vaginal mesh.
This followed the announcement by the Government of a ‘pause’ in the use of surgical mesh/tape to treat stress urinary incontinence (SUI) and vaginal prolapse where the mesh is inserted through the vaginal wall.
The ‘pause’ will take the form of a high vigilance restriction, which will remain in place until the following conditions are met:
- Surgeons should only undertake operations for SUI if they are appropriately trained, and only if they undertake operations regularly
- Surgeons report every procedure to a national database
- A register of operations is maintained to ensure every procedure is notified and the woman identified who has undergone the surgery
- Reporting of complications via MHRA is linked to the register
- Identification and accreditation of specialist centres for SUI mesh procedures, for removal procedures and other aspects of care for those adversely affected by surgical mesh
- NICE guidelines on the use of mesh for SUI are published
These restrictions also apply in Wales and Northern Ireland.
On 12 September 2018, the Scottish government instructed all Health Boards to completely stop all transvaginal mesh procedures until a new ‘restricted use protocol’ has been developed and implemented to ensure the procedures can only be carried out in the most limited circumstances, subject to rigorous process.
The Minister for Health in the Republic of Ireland has also confirmed a pause in the use of all procedures involving mesh for SUI and prolapse.
Guidance for clinical care
For the majority of patients, mesh surgery should not be performed during this period of high vigilance restriction.
For some patients, mesh procedures may be the only viable treatment option. This includes cases where clinicians judge there is clinical urgency to carry out the procedure and no suitable alternative exists, and/or where delay would risk harm to the patient. However, this treatment should only be used in carefully selected patients who understand the risks and have given fully informed consent. For this group of patients, the period of high vigilance restriction will include:
- strict adherence to the recently published IPGs (Interventional Procedure Guidance) published by NICE for these procedures
- multidisciplinary team assurance at trust levels to support the necessity of the procedure without delay
- fully supported patient choice and sign off in advance of that process
- evidence of the competence of the surgeon
NHS Improvement and NHS England set up a Clinical Advisory Group to:
- define procedures and scope for the high vigilance restriction
- advise on appropriate confirmation process to ensure appropriateness of any mesh procedures intended
- recommend a process for provider trust Medical Director sign off of the surgeon’s competence for those mesh procedures required and any alternate operations
- advise on best options to ensure patient information and consenting processes are in place in a trust
NHS Improvement and NHS England communicated the recommendations of the Clinical Advisory Group to trusts on 20 July 2018 - see links below for further details.
Last updated 13 September 2018