Government announces strict rules for the use of vaginal mesh
The government and NHS have accepted the recommendation from the Independent Medicines and Medical Devices Safety Review to pause the use of vaginally inserted surgical mesh.
The use of vaginally inserted surgical mesh for stress urinary incontinence will be paused until a set of conditions to reduce the risk of injury are met.
Vaginally inserted meshes will 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 Independent Medicines and Medical Devices Safety Review made the interim recommendation following a programme of engagement with patients and patient groups.
The independent review was set up in February and is being chaired by Baroness Julia Cumberlege. Its aim is to review what happened in each of the cases of primodos, sodium valproate and surgical mesh, including whether the processes pursued to date have been sufficient and satisfactory.
It also recommended that the pause should be extended to include vaginally inserted mesh to treat pelvic organ prolapse, and that the pause should be implemented through a high vigilance regime of restricted practice.
In taking this decision, ministers sought advice from the Chief Medical Officer and senior clinicians in the health system.
NHS England is now working with other health agencies to pause procedures quickly and safely. A clinical advisory group has been established to ensure that appropriate measures are put in place to give effect to the high vigilance programme.
NHS England and NHS Improvement have written to providers to ensure that provider medical directors and nurse directors are equipped with advice and guidance to ensure that clinicians can support patients to make clear decisions about their treatment.
Health Minister Lord O’Shaughnessy said:
The department’s top priority is patient safety, and we have therefore immediately accepted Baroness Cumberlege’s recommendation.
Our new approach, with a high vigilance programme of restricted practice, will radically reduce the number of women have vaginal meshes inserted, and ensure that when it does happen, it is only after close consultation with their clinician and with extremely thorough clinical oversight and governance.
Mental Health and Inequalities Minister Jackie Doyle-Price said:
We need to put in place a consistent, high quality service that meets the conditions set out by Baroness Cumberlege.
Only then can women be confident when they are considering an operation to treat pelvic organ prolapse or stress urinary incontinence – conditions that cause not just physical discomfort but long lasting psychological effects.