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Written Question
Surgical Mesh Implants: Compensation
Monday 18th March 2024

Asked by: Rosie Duffield (Labour - Canterbury)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what her planned timetable is for making a decision on redress for people affected by mesh implants following the publication of The Hughes Report on 7 February 2024.

Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

The Government commissioned the Patient Safety Commissioner (PSC) to produce a report on redress for those affected by sodium valproate and pelvic mesh. We are grateful to the PSC and her team for completing this report, and our sympathies remain with those affected by sodium valproate and pelvic mesh. The Government is now carefully considering the PSC’s recommendations, and will respond substantively in due course.


Non-Departmental Publication (Transparency)
Medicines and Healthcare products Regulatory Agency

Mar. 14 2024

Source Page: Freedom of Information responses from the MHRA - week commencing 4 December 2023
Document: FOI 23/916 (PDF)

Found: Dear FOI 23/916 - Request for information: Adverse incidents reported to the MHRA relating to mesh


Non-Departmental Publication (Transparency)
Medicines and Healthcare products Regulatory Agency

Mar. 14 2024

Source Page: Freedom of Information responses from the MHRA - week commencing 25 December 2023
Document: FOI 23/806 - attachment 14 (PDF)

Found: Model 560 IColumn: 182.9 cm x 2 mm 1.d. glass column packed with 5% Oexsil 300 on Chromosorb W 80/100 mesh


Written Question
Sodium Valproate and Surgical Mesh Implants
Thursday 14th March 2024

Asked by: Dan Carden (Labour - Liverpool, Walton)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what her Department's planned timescale is for responding to the Patient Safety Commissioner's report entitled The Hughes Report: Options for redress for those harmed by valproate and pelvic mesh, published on 7 February 2024.

Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

The Government commissioned the Patient Safety Commissioner (PSC) to produce a report on redress for those affected by sodium valproate and pelvic mesh. We are grateful to the PSC and her team for completing this report, and our sympathies remain with those affected by sodium valproate and pelvic mesh. The Government is now carefully considering the PSC’s recommendations, and will respond substantively in due course.


Scottish Parliament Written Question
S6W-25893
Wednesday 13th March 2024

Asked by: Carlaw, Jackson (Scottish Conservative and Unionist Party - Eastwood)

Question

To ask the Scottish Government what its position is on whether the 21 recommendations set out in the Transvaginal Mesh Case Record Review by Professor Alison Britton are now fully embedded within healthcare services in Scotland.

Answered by Minto, Jenni - Minister for Public Health and Women's Health

The report of the Transvaginal Mesh Case Record Review underlined what was already an important agenda for the Scottish Government: to improve care and services for women who are experiencing complications as a result of a transvaginal mesh; and, to ensure that the NHS continually reinforces good practice in confirming and recording patient consent and the treatment offered to patients. Progress continues in a range of connected activities relevant to Professor Brittons’ recommendations.

The recommendations made align with the practice that is embedded in the operation of the Complex Mesh Surgical Service, and through NHS Scotland more generally. We continue to work with NHS colleagues to ensure that women can access the care that they need, are fully supported by their GP and other clinicians, and have access to information they need to make informed decisions about their care.

The Chief Medical Officer wrote to Health Board Medical Directors on 10 October to draw their attention to the report of the Review and to the failings it identified, and to require them to seek assurance through local clinical governance committees that measures are in place locally to prevent a recurrence of the failings identified, and to assure the quality of processes connected to patient consent and record keeping. With regards to more recent patient records she reviewed, Professor Britton herself noted she was encouraged by the improvement in practice, with increasingly robust consent processes in place.

Work continues in other areas including enhancing information available to patients, credentialing of clinicians in mesh removal and improved data gathering.

The Scottish Government therefore considers that it is taking appropriate action to embed the report’s recommendations with regards to healthcare services in Scotland.


Scottish Parliament Written Question
S6W-25892
Wednesday 13th March 2024

Asked by: Carlaw, Jackson (Scottish Conservative and Unionist Party - Eastwood)

Question

To ask the Scottish Government how many mesh removal procedures in total have been carried out in Glasgow through referral to the National Complex Mesh Surgical Service since the centre was established, and how many of these procedures are considered to have been (a) successful and (b) unsuccessful.

Answered by Minto, Jenni - Minister for Public Health and Women's Health

The National Complex Mesh Surgical Service assesses patient needs and, where appropriate and subject to shared decision making and informed consent, performs mesh removal surgery. To date, 135 mesh removal procedures have been undertaken by the Service. Many women make the choice following assessment and discussion with the specialist team to follow a conservative pathway of care and do not undergo surgery.

The needs of patients and their goals may differ and therefore their definition of success will vary too. The removal of mesh is often only part of the treatment journey, with further reconstructive surgery depending on clinical need taking place at a later date. Patients may also have other needs which require to be addressed by other members of the clinical team.

The service is required to comply with normal clinical governance mechanisms in place within NHSGGC to provide an assurance that the service being delivered is safe and of an appropriate quality.


Written Question
Surgical Mesh Implants: Compensation
Tuesday 12th March 2024

Asked by: Taiwo Owatemi (Labour - Coventry North West)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, for what reason the compensation scheme for people suffering from the effects of vaginal mesh operations does not cover all those impacted by the use of the same materials in rectopexy procedures.

Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

The Government commissioned the Patient Safety Commissioner (PSC) to produce a report on redress for those affected by sodium valproate and pelvic mesh. We are grateful to the PSC and her team for completing this report, and our sympathies remain with those affected by sodium valproate and pelvic mesh.

While the PSC does not include rectopexy mesh within her proposed definition of directly harmed patients for the purposes of her redress recommendations, we note that the PSC has said in her report that the Government needs to consider how to investigate issues related to harm caused by other uses of mesh going forward. The Government is now carefully considering the PSC’s recommendations, and will respond substantively in due course.


Scottish Parliament Written Question
S6W-25634
Tuesday 5th March 2024

Asked by: Mundell, Oliver (Scottish Conservative and Unionist Party - Dumfriesshire)

Question

To ask the Scottish Government, in light of it approaching four years since the report of the Independent Medicines and Medical Devices Safety Review, First Do No Harm, was published, and that three years have nearly passed since the Scottish Government published its plan for delivering on its commitment to implement, in full, the recommendations of the review, whether it will (a) provide an update on its delivery plan and (b) confirm when it expects to implement the remaining recommendations of the review to improve the lives of those impacted by sodium valproate, Primados and mesh implants.

Answered by Minto, Jenni - Minister for Public Health and Women's Health

There has been progress in implementing the Scottish Government’s delivery plan:

  • the Patient Safety Commissioner for Scotland Act 2023 established a Parliamentary Commissioner on patient safety
  • the Glasgow Complex Mesh Surgical Service offers mesh removal surgery, and women can also choose an NHS England surgeon or an independent provider
  • 25 women have had the costs of previously arranged private mesh removal surgery reimbursed
  • the NHS Scotland Scan for Safety Programme for implantable medical devices is planned to roll out across territorial boards by the end of March 2026
  • on valproate, the Medicines and Healthcare products Regulatory Agency introduced regulatory measures for the prescribing of valproate and we are working closely with the agency to support their implementation

The Scottish Government considers, further to the undertaking offered in 2021, that it is taking appropriate action to pursue the outcomes sought by all of the recommendations of the 2020 report insofar as they relate to devolved matters.


Written Question
Surgical Mesh Implants
Monday 4th March 2024

Asked by: Emma Hardy (Labour - Kingston upon Hull West and Hessle)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to his correspondence of 28 February 2024 to Kath Sansom and Ruth MacLeod of the Sling the Mesh Group, if he will publish (a) the patient groups that contributed to, (b) the distribution lists used to inform (i) patient groups and (ii) stakeholders about and (c) a summary of the contributions of patient groups to the consultation.

Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)

The Government is in the process of drafting the response to the consultation on Disclosure of industry payments to the healthcare sector, which will be published in due course. As the consultation response is in policy development, the information requested is not available.


Scottish Parliament Written Question
S6W-25467
Thursday 29th February 2024

Asked by: Carlaw, Jackson (Scottish Conservative and Unionist Party - Eastwood)

Question

To ask the Scottish Government how much public money has been spent to reimburse the costs associated with mesh injured women experiencing private mesh removal surgery in the period since the Transvaginal Mesh Removal Reimbursement Scheme opened for applications.

Answered by Minto, Jenni - Minister for Public Health and Women's Health

As at 15 February 2024, £481,423.63 had been paid to applicants. Administration costs to the same date are approximately £120,000.

The original scheme closure date was specified in the Scheme documentation and announced at the time of the Scheme’s opening as 6 December 2023. This date was then extended to 31 March 2024. The Government therefore urges any woman who wishes to apply, but has not yet done so, to ensure that an application is sent prior to this date.

The closure of the Reimbursement Scheme to applications has no effect on the arrangements that NHS National Services Scotland has entered into with both Spire Hospital, Bristol, and Dr Veronikis in the USA. In any situation where it is determined that removal surgery is clinically appropriate, the patient will remain able to choose, via the official NHS referral process, to have that surgery carried out in the Complex Mesh Surgical Service in Glasgow, in an NHS England centre, or by one of the two contracted independent providers.