Following a recommendation by the Independent Medicines and Medical Devices Safety Review, the government and NHS have introduced a “high vigilance restriction” on the use of vaginally inserted surgical mesh for stress urinary incontinence (SUI) and pelvic organ prolapse.
Vaginally inserted meshes will now only be used when there is no alternative and after “close and comprehensive consultation between patient and clinician, with rigorous oversight and governance at all times.”
The restrictions will remain in place until the National Institute for Health and Care Excellence (NICE) guidelines on the use of mesh for SUI are published, and specialist centres for mesh procedures are identified and accredited. Under the new conditions, every procedure must be reported to a national database. A register of operations will be maintained to ensure every procedure is notified and the patient identified. Reporting of complications is being linked to the register.
In cases where mesh procedures may be the only viable treatment, strict adherence to the recently published NICE Interventional Procedure Guidance is required. There must be multidisciplinary team assurance at trust level to support the necessity of the procedure without delay and the decision must be fully supported by the patient, with sign off in advance. Evidence of the competence of the surgeon performing the procedure will be required.
A Clinical Advisory Group has been established, which includes members from specialised commissioning teams and clinical expertise from the British Society of Urogynaecologists and the British Association of Urological Surgeons. The group will define the scope for the high vigilance restriction and advise on appropriate processes to ensure appropriateness of any intended procedures and the competence of the surgeon.
