Independent Medicines and Medical Devices Safety Review Update

Tuesday 10th July 2018 Written Statements

[The Parliamentary Under-Secretary of State for Health and Social Care (Jackie Doyle-Price)]

In February, the Government announced the establishment of the Independent Medicines and Medical Devices Safety Review. Baroness Cumberlege is in the process of conducting the review into 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, and to make recommendations on what should happen in future.

Baroness Cumberlege has reported to the Department of Health and Social Care an early finding of her review relating to surgical mesh. Following a number of engagement meetings with patients, she has concluded that there should be a pause without delay in the use of surgical mesh for stress urinary incontinence (SUI).

In letters to the Secretary of State, Parliamentary Under-Secretary of State for Mental Health and Inequalities, Parliamentary Under-Secretary of State for Health (Lords) and chief medical officer, Baroness Cumberlege has set out a number of conditions that should be met ahead of the resumption of mesh procedures used to treat SUI:

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; and

NICE guidelines on the use of mesh for SUI are published.

Ministers in the Department of Health and Social Care have taken advice from the chief medical officer and the senior clinicians in our health system on Baroness Cumberlege’s recommendation.

Having reviewed Baroness Cumberlege’s recommendation and having considered the NHS’s progress in implementing the relevant NICE guidelines across the system, the chief medical officer and senior clinicians have concluded that we should institute a pause in the use of vaginally inserted mesh to treat prolapse and the use of tape or slings to treat stress urinary incontinence. They have concluded that this should be done through implementation of a high vigilance programme of restricted practice. They have advised that this approach will allow the NHS to put in place a consistent, high-quality service that adequately meets the conditions set out by Baroness Cumberlege. Both the chief medical officer and Baroness Cumberlege agree that we should not introduce a blanket ban of the relevant procedures, and that there will need to be some exceptions within the pause, within a high vigilance programme of restricted practice. The Department has accepted Baroness Cumberlege’s recommendation, and the advice from the chief medical officer and senior clinicians.

NHS England is now working with other agencies in the system to implement the pause quickly and safely. A clinical advisory group is being established to ensure that appropriate measures are put in place to give effect to the high vigilance programme. NHSE will be writing to providers imminently.

NHS England and NHS Improvement will ensure that provider medical directors and nurse directors are equipped with timely advice and guidance to ensure that clinicians can support patients to make clear decisions about their treatment.

The Department will work with Baroness Cumberlege and senior clinicians in the NHS to act with pace on this decision. The Department is very grateful to Baroness Cumberlege and her review team for listening to the voice of patients and for intervening on their behalf; and to the chief medical officer and senior clinicians for their further advice and commitment to putting in place safe and effective changes for patients.

[HCWS841]