Evidence

Evidence received by the Review can be accessed from this page. All evidence has been subject to legal review in the interests of those who submitted it and the Review itself. Where necessary redactions have been made but these are not intended to compromise the substance of the evidence received and have been kept to a minimum.

WARNING: Please be aware some evidence contains descriptions, pictures and audio of the harm suffered by individuals. Some may find this distressing.

Written evidence

Written evidence is grouped as follows:

Patient Groups - Hormone Pregnancy Tests

Patient Groups - Pelvic Mesh

Patient Groups -Sodium Valproate

Patient groups – Campaigning Activities

Clinicians, academics and other individuals – Hormone Pregnancy Tests

Clinicians, academics and other individuals - Pelvic Mesh

Clinicians, academics and other individuals -Sodium Valproate

Clinicians, academics and other individuals -Others

Professional and Trade Bodies

Other Organisations

Regulators

Public Bodies

Manufacturers of Hormone Pregnancy Tests

Manufacturers of Pelvic Mesh

Manufacturers of Sodium Valproate

Evidence submitted to the Review following its Oral Hearings

Evidence submitted to the Review following its Oral Hearings - October 2019 update

Evidence submitted to the Review following its Oral Hearings - April 2020 update

Evidence submitted to the Review following its Oral Hearings - July 2020 update

Properties of Mesh

Mesh products (please note this file is 160MB in size)

Epilim and Depakote SmPCs and PILs

Oral evidence

Videos of oral hearings are grouped by date:

20th November 2018

• Session 1: FACSaware
• Session 2: Young People Affected by Sodium Valproate
• Session 3: Organisation for Anti Convulsant Syndrome (OACS) & Organisation for Anti Convulsant Syndrome (OACS) Ireland

21st November 2018

• Session 1: Mashed Up By Mesh
• Session 2: Mesh UK Charitable Trust
• Session 3: Meshies United Group UK
• Session 4: Welsh Mesh Survivors Support Group
• Session 5: Scottish Mesh Survivors

26th November 2018

• Session 1: Association for Children Damaged by Hormone Pregnancy Tests (ACDHPT)
• Session 2: Jason Farrell
• Session 3: Dr Jesse Olszynko-Gryn
• Session 4: Fetal Anti Convulsant Syndrome Association (FACSA) and Independent Fetal Anti Convulsation Trust (INFACT)
• Session 5: Professor Peter Turnpenny, Dr Rebecca Bromley, Professor Jill Clayton-Smith

27th November 2018

• Session 1: Sling The Mesh
• Session 2: Ms Sohier (Suzy) Elneil
• Session 3: Myra Robson
• Session 4: Dr Wael Agur
• Session 5: Professor Carl Heneghan
• Session 6: Professor John Abraham
• Session 7: Professor Neil Vargesson

10th January 2019

• Session 1: Dr Frances Elmslie
• Session 2: Action against Medical Accidents (AvMA), Private Healthcare Information Network (PHIN), NHS Resolution
• Session 3: Medicines and Healthcare products Regulation Agency (MHRA), Drug Safety Research Unit (DSRU)
• Session 4: General Medical Council (GMC), General Pharmaceutical Council (GPhC)
• Session 5: Professional Standards Authority (PSA)

18th January 2019

• Session 1: Sanofi

23rd January

• Session 1: Dr Vincent Argent
• Session 2: Royal College of General Practitioners (RCGP)
• Session 3: FEG Textiltechnik
• Session 4: Dr Mark Slack

28th January

• Session 1: Expert Working Group on Hormonal Pregnancy Tests
• Session 2: Association of British Neurologists (ABN) & Royal College Psychiatrists (RCPsych)
  
• Session 3: Royal Pharmaceutical Society (RPS)
• Session 4: Professor Shakila Thangaratinam

7th February

• Session 1: British Pain Society
• Session 2: Chartered Society of Physiotherapy
  
• Session 3: British Association of Urological Surgeons (BAUS), British Society of Urogynaecology (BSUG), Pelvic Floor Society (PFS)
• Session 4: Royal College of Surgeons (RCS)
• Session 5: Royal College of Obstetricians and Gynaecologists (RCOG)

14th February

• Session 1: Association for Children Damaged by Hormone Pregnancy Tests (ACDHPT)
  ↳ Right to reply MHRA - Right of reply.pdf
  ↳ Right to reply EWG HPT- Right of reply.pdf
• Session 2: National Institute for Health and Care Excellence (NICE)
  
• Session 3: NHS England

27th February

• Session1: Medicines and Healthcare products Regulation Agency (MHRA)
• Session2: Medicines and Healthcare products Regulation Agency (MHRA)

5th March

• Session 1:NHS Digital, Healthcare Quality Improvement Partnership (HQIP), Private Healthcare Information Network (PHIN), Professor Justin Keen
• Session 2: The National Congenital Anomaly and Rare Disease Registration Service (NCARDRS), National Joint Registry (NJR)
• Session 3: Association of British HealthTec Industries (ABHI)
• Session 4: NHS Resolution

14th March

• Session 1: General Medical Council (GMC)
• Session 2: UK Epilepsy and Pregnancy Register
  ↳Right to reply MHRA - Jim Morrow Right of reply.pdf
• Session 3: vCJD Trust

19th March

• Session 1: Thalidomide Trust
• Session 2: Mesh Ireland

26th March

• Session 1: Care Quality Commission (CQC)
• Session 2: NHS Improvement
• Session 3: Independent Healthcare Providers Network (IHPN)

16th April

• Session 1: Pelvic Floor Society, British Society of Urogynaecology (BSUG)
  
• Session 2: MESH SPECIALIST CENTRES:South Tees Hospitals NHSFT, Central Manchester University Hospitals NHSFT
• Session 3: Epilepsy Society, Epilepsy Action
  ↳Right to reply MHRA - Right of reply.pdf

23rd April

• MESH SPECIALIST CENTRES:King’s College Hospital NHSFT, Oxford University Hospitals NHSFT, Epsom and St Helier University Hospitals NHS Trust

2nd May

• Department of Health and Social Care - part 1
• Department of Health and Social Care - part 2
  

14th May

• Session 1: APPG on Surgical Mesh Implants - Took place on 28th May
• Session 2: Hormone Pregnancy Tests APPG
  ↳Right to reply MHRA - Right of reply.pdf
  ↳Right to reply EWG - Right of reply.pdf
  ↳Right to reply CHM- Right of reply.pdf
  ↳Right to reply Bayer - Right of reply.pdf
  ↳Evidence Minutes of General Medical Services meeting (dated 13 March 1964).pdf
  ↳Evidence Letter of Sir Derrick Dunlop (4 May 1964).pdf

• Session 3: Valproate and Other Anti-Epileptic Drugs in Pregnancy APPG
  ↳Right to reply MHRA - Right of reply.pdf
  ↳Right to reply MHRA - Right of reply.pdf

20th May

• Session 1: Welsh Mesh Survivors
• Session 2: Mesh Ireland
• Session 3: Association of Children Damaged by Hormone Pregnancy Tests (ACDHPT)
  ↳Right to reply EWG - Right of reply.pdf
  ↳Right to reply MHRA - Right of reply.pdf
  ↳Right to reply CHM - Right of reply.pdf
  ↳Right to reply EMA - Right of reply.pdf
  ↳Right to reply CMO - Right of reply.pdf
  ↳Right to reply Bayer - Right of reply.pdf

• Session 4: Scottish Mesh Survivors

21st May

• Session 1: The Voices Today on Messed up Mesh (TVT MUM)
• Session 2: Mashed Up By Mesh - Unable to attend
• Session 3: Meshies United Group UK - Unable to attend
• Session 4: Sling the Mesh
  ↳Right to reply MHRA - Right of reply.pdf
  ↳Right to reply GMC - Right of reply.pdf
  ↳Feedback from our meeting with UCLH

• Session 5: Mesh UK Charitable Trust
  ↳Right to reply MHRA - Right of reply.pdf

22nd May

• Session 1: INFACT
• Session 2: Young People Affected by Valproate
• Session 3: FACSaware
• Session 4: OACS, OACS Ireland
  ↳Right to reply MHRA - Right of reply.pdf
  ↳Right to reply Sanofi - Right of reply.pdf
• Session 5: Valproate Victims

Click here for information on the order of witnesses for each date.
Some evidence received during the oral hearings is not yet available pending clarification of its provenance

Personal testimonies

• Nicky Gubbins - Personal Testimony
• Daniel Mason - Personal Testimony
• Warren Matthews - Personal Testimony
• Carol Lapidge - Personal Testimony
• Linda Kelly - Personal Testimony
• The Bagley family - Personal Testimony
• Lynne Sharman - Personal Testimony
• Anne Cook and Stuart Cook- Personal Testimony
• Christine Feltham - Personal Testimony
• Val Curtis - Personal Testimony
• Janis Nicholson - Personal Testimony

Disclaimer
The statements made and the opinions expressed in response to the Independent Medicines and Medical Devices Safety Review’s  (‘IMMDSR)   Call for Evidence and in the video recording of the IMMDSR’s oral hearings are those of the authors. They do not purport to reflect the opinions, views or conclusions of the IMMDSR or its members. The statements and opinions made do not imply the expression of any opinion whatsoever on the part of the IMMSDR concerning the truthfulness, veracity, accuracy or legal status of any statements or opinions made and published on the IMMDSR website. Nor does the IMMSDR  accept any legal liability arising from any statements or opinions so expressed and published