Medicines and Medical Devices Safety Review

Department of Health and Social Care written question – answered on 16th July 2018.

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Photo of Owen Smith Owen Smith Labour, Pontypridd

To ask the Secretary of State for Health and Social Care, pursuant to the Written Statement of 10 July 2018 on Update on the Independent Medicines and Medical Devices Safety Review, HCWS841, what the (a) names and (b) objectives are of the clinicians on the clinical advisory group for surgical mesh.

Photo of Jackie Doyle-Price Jackie Doyle-Price The Parliamentary Under-Secretary for Health and Social Care

The name of the clinicians on the clinical advisory group for surgical mesh are:

Professor Keith Willett – National Medical Director for Acute Care and Emergency Preparedness, NHS England

Professor Jonathan Duckett – Chair – British Society of Urogynaecology (BSUG)

Mr Chris Harding - Chairman – British Association of Urological Surgeons (BAUS) subsection of female, neurological and urodynamic urology

Mr Roland Morley – President, Urology section of The Royal Society of Medicine; Chairman, Specialist Advisory Committee on Urology (United Kingdom)

Mr Nigel Acheson – Regional Medical Director, NHS England

Mr Alfred Cutner – NHS England Specialised Commissioning Clinical Reference Group

Dr Heather Payne – Senior Medical Officer for Maternal and Child Health (Wales)

The objectives of the Clinical Advisory Group, with subject matter expert members representing NHS England, BSUG and BAUS, are to:

  1. Recommend the mesh/tape procedures included in the high vigilance restriction.
  2. Recommend and justify any mesh/tape procedures that should be excluded from the restriction, with or without increased vigilance.
  3. Recommend any alternative non-mesh procedures that should be subject to increased vigilance, given the change in practice caused by the pause on mesh/tape use.
  4. Advise on high vigilance processes which must be followed by NHS and private hospitals for any mesh/tape surgery defined in (A) deemed clinically essential during the pause, and for the unrestricted procedures defined in (B) and (C). This includes:

- Ensuring the appropriateness of the procedure and exclusion of alternatives.

- Ensuring that all appropriate surgical options have been offered, including where secondary referral would be required. Local unit capability should not restrict treatment options;

- Ensuring that appropriate information and consenting processes are in place in all cases;

- A process for provider trust Medical Director’s sign-off of the surgeon’s competence; and

- A process for documenting and registering the procedures.

5.Recommend how trusts and general practitioners should support patients with advice, including patients newly referred or diagnosed, patients on the waiting list, and patients who have had previous mesh surgery who may have concerns.

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