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Written Question
Surgical Mesh Implants
Wednesday 5th June 2019

Asked by: Owen Smith (Labour - Pontypridd)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to the Provisional Monthly Hospital Episode Statistics for Admitted Patient Care, Outpatient and Accident and Emergency data April 2018 - March 2019 (M12), what estimate he has made of the number of procedures for stress urinary incontinence and prolapse using mesh carried out during the period of high vigilance restriction which paused such surgery.

Answered by Jackie Doyle-Price

NHS Digital publishes data on finished consultant episodes where a procedure for treatment of urogynaecological prolapse or stress urinary incontinence (insertion) is recorded.

In year commencing April 2018, data is available up to March 2019. The March 2019 data is provisional.

The most recent provisional Hospital Episodes Statistics data demonstrates that the number of procedures for insertion from April 2018 is 8,931 in total for all procedures, vaginally inserted mesh or otherwise.

For vaginally inserted mesh, to which the period of high vigilance restriction relates, there have been approximately 31 total procedures up to March 2019 for the introduction of:

- tension-free vaginal tape;

- transobturator tape;

- vaginal tape NEC;

- the repair of vault of vagina with mesh using vaginal approach;

This figure excludes data for the month of July, as guidance on the Pause was issued on 20 July to Regional Directors and Trust Medical Directors. For July, the total figure for insertions is 70, though this includes a period before the Pause came into effect.


Written Question
Pensions: Consumer Information
Thursday 1st November 2018

Asked by: Owen Smith (Labour - Pontypridd)

Question to the Department for Work and Pensions:

To ask the Secretary of State for Work and Pensions, what steps she is taking to ensure that private pensions are accessible through the pensions dashboard.

Answered by Guy Opperman - Parliamentary Under-Secretary (Department for Transport)

Private Pensions information will be available through dashboards. Delivery of these will be led by industry and facilitated by government. We will set out and consult on our proposed approach to delivery, including how to maximise private pension schemes participation in the dashboard in our feasibility report, which will be published shortly.

People can already access the online ‘Check your State Pension’ service through GOV.UK to get a forecast of their State Pension. This includes information about how they may be able to improve the amount of State Pension they are entitled to, as well as providing a view of their National Insurance contribution record. Check Your State Pension service has provided more than ten million online estimates since its introduction in 2016.


Written Question
Pensions: Consumer Information
Thursday 1st November 2018

Asked by: Owen Smith (Labour - Pontypridd)

Question to the Department for Work and Pensions:

To ask the Secretary of State for Work and Pensions, if she will take steps to ensure that State Pension information is accessible through the pensions dashboard to enable (a) pensioners and (b) people approaching retirement age to make informed decisions.

Answered by Guy Opperman - Parliamentary Under-Secretary (Department for Transport)

Private Pensions information will be available through dashboards. Delivery of these will be led by industry and facilitated by government. We will set out and consult on our proposed approach to delivery, including how to maximise private pension schemes participation in the dashboard in our feasibility report, which will be published shortly.

People can already access the online ‘Check your State Pension’ service through GOV.UK to get a forecast of their State Pension. This includes information about how they may be able to improve the amount of State Pension they are entitled to, as well as providing a view of their National Insurance contribution record. Check Your State Pension service has provided more than ten million online estimates since its introduction in 2016.


Written Question
Medicines and Medical Devices Safety Review
Monday 16th July 2018

Asked by: Owen Smith (Labour - Pontypridd)

Question to the Department of Health and Social Care:

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 estimate he has made of the number of potential exceptions there will be to the pause in the use of mesh for stress urinary incontinence; and how exceptions to the suspension will be determined.

Answered by Jackie Doyle-Price

The pause in the use of vaginally inserted mesh to treat prolapse and tape/sling used to treat stress urinary incontinence will be implemented through a high vigilance programme of restricted practice. This is not a blanket ban as for some patients this can be a last treatment option for a debilitating condition.

These operations will therefore be available for carefully selected patients based on a multidisciplinary team decision, where the patient understands the risks involved and has provided informed consent. It is therefore not possible at this stage to quantify the number of exceptions that will take place.

This is similar to the position in Scotland, where mesh used to treat stress urinary incontinence and pelvic organ prolapse has been temporarily suspended, but is allowed in certain tightly controlled circumstances.


Written Question
Medicines and Medical Devices Safety Review
Monday 16th July 2018

Asked by: Owen Smith (Labour - Pontypridd)

Question to the Department of Health and Social Care:

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, if he will publish in detail the Government’s plan for a high vigilance programme of restricted practice for the use of surgical mesh to treat stress urinary incontinence.

Answered by Jackie Doyle-Price

On 10 July, alongside the Government’s announcement of a pause in the use of sling/tape to treat stress urinary incontinence and vaginally inserted mesh to treat prolapse, NHS England and NHS Improvement wrote to provider Chief Executives and Medical Directors, advising on implementation of the pause through a high vigilance programme of restriction. It was advised that, for the majority of patients, a delay until the high vigilance programme ceased would be the preferred option. This information is in the public domain and available on the NHS Improvement website at the following link:

https://i.emlfiles4.com/cmpdoc/9/7/2/8/1/1/files/47633_mesh-letter-to-acute-ceos-and-mds.pdf

A Clinical Advisory Group has been formed, with subject matter expert members representing NHS England, British Society of Urogynaecology and British Association of Urological Surgeons. The Clinical Advisory Group is developing clinical recommendations for implementation following the initial advice given to providers. NHS England will ensure that these clinical recommendations are communicated to providers once they are agreed.


Written Question
Medicines and Medical Devices Safety Review
Monday 16th July 2018

Asked by: Owen Smith (Labour - Pontypridd)

Question to the Department of Health and Social Care:

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.

Answered by Jackie Doyle-Price

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.


Written Question
Medicines and Medical Devices Safety Independent Review
Monday 16th July 2018

Asked by: Owen Smith (Labour - Pontypridd)

Question to the Department of Health and Social Care:

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 estimate he has made of the number of potential exceptions there will be to the pause in the use of mesh for stress urinary incontinence; and how exceptions to the suspension will be determined.

Answered by Jackie Doyle-Price

The pause in the use of vaginally inserted mesh to treat prolapse and tape/sling used to treat stress urinary incontinence will be implemented through a high vigilance programme of restricted practice. This is not a blanket ban as for some patients this can be a last treatment option for a debilitating condition.

These operations will therefore be available for carefully selected patients based on a multidisciplinary team decision, where the patient understands the risks involved and has provided informed consent. It is therefore not possible at this stage to quantify the number of exceptions that will take place.

This is similar to the position in Scotland, where mesh used to treat stress urinary incontinence and pelvic organ prolapse has been temporarily suspended, but is allowed in certain tightly controlled circumstances.


Written Question
Medicines and Medical Devices Safety Independent Review
Monday 16th July 2018

Asked by: Owen Smith (Labour - Pontypridd)

Question to the Department of Health and Social Care:

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, if he will publish in detail the Government’s plan for a high vigilance programme of restricted practice for the use of surgical mesh to treat stress urinary incontinence.

Answered by Jackie Doyle-Price

On 10 July, alongside the Government’s announcement of a pause in the use of sling/tape to treat stress urinary incontinence and vaginally inserted mesh to treat prolapse, NHS England and NHS Improvement wrote to provider Chief Executives and Medical Directors, advising on implementation of the pause through a high vigilance programme of restriction. It was advised that, for the majority of patients, a delay until the high vigilance programme ceased would be the preferred option. This information is in the public domain and available on the NHS Improvement website at the following link:

https://i.emlfiles4.com/cmpdoc/9/7/2/8/1/1/files/47633_mesh-letter-to-acute-ceos-and-mds.pdf

A Clinical Advisory Group has been formed, with subject matter expert members representing NHS England, British Society of Urogynaecology and British Association of Urological Surgeons. The Clinical Advisory Group is developing clinical recommendations for implementation following the initial advice given to providers. NHS England will ensure that these clinical recommendations are communicated to providers once they are agreed.


Written Question
Medicines and Medical Devices Safety Independent Review: Surgical Mesh Implants
Monday 16th July 2018

Asked by: Owen Smith (Labour - Pontypridd)

Question to the Department of Health and Social Care:

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.

Answered by Jackie Doyle-Price

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.


Written Question
Surgical Mesh Implants
Monday 4th June 2018

Asked by: Owen Smith (Labour - Pontypridd)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether he will make an assessment of the potential merits of extending the three-year limit in medical negligence cases for mesh-injured patients.

Answered by Jackie Doyle-Price

There is no plan to extend the three-year limit in medical negligence cases specifically for mesh-injured patients.

Under section 11 of the Limitation Act 1980 a patient is able to bring a claim for damages for clinical negligence against a trust or any other healthcare provider within three years from the date of injury. However, this can be longer if the patient is a child, when the three year period only begins on his/her eighteenth birthday the patient has a mental disorder within the meaning of the Mental Health Act 1983 so as to be incapable of managing his/ her own affairs, when the three year period is suspended or there was an interval before the patient realised or could reasonably have found out that he/she had suffered a significant injury possibly related to his/her treatment.

The ‘date of knowledge’ of an injury could be a number of years after the treatment. In recognition that there may be some cases where the prescribed period is inadequate, the Limitation Act 1980 also gives the court discretion to disapply the limitation period in respect of claims for personal injuries when it considers it just and equitable to do so.