PE01517: Polypropylene Mesh Medical Devices

Health

Petitioner: Elaine Holmes and Olive McIlroy on behalf of Scottish Mesh Survivors - "Hear Our Voice" campaign

Status:
Lodged

Date Lodged: 30 April 2014

Calling on the Scottish Parliament to urge the Scottish Government to:

1. Suspend use of polypropylene Transvaginal Mesh (TVM) procedures;
2. Initiate a Public Inquiry and/or comprehensive independent research to evaluate the safety of mesh devices using all evidence available, including that from across the world;
3. Introduce mandatory reporting of all adverse incidents by health professionals;
4. Set up a Scottish Transvaginal Mesh implant register with view to linking this up with national and international registers;
5. Introduce fully Informed Consent with uniformity throughout Scotland’s Health Boards; and
6. Write to the MHRA and ask that they reclassify TVM devices to heightened alert status to reflect ongoing concerns worldwide.

Petition History:

The petitioner has also collected 314 hard copy signatures.

Report

The Committee published its report on 21 August  2018:    

The Cabinet Secretary for Health and Sport responded to the Committee's report on 25 June 2019:

Summary

3 June 2014: The Committee took evidence from Elaine Holmes, Olive McIlroy, and Marion Scott, Sunday Mail. The Committee agreed to write to the Scottish Government, the Medicines Healthcare Products Regulatory Agency, NHS National Services Scotland, the European Commission, the Royal College of Surgeons of Edinburgh, the British Medical Association Scotland and NHS boards. The Committee also agreed to invite the Cabinet Secretary for Health and Wellbeing to give evidence at a future meeting. Link to Official Report 3 June 2014 (484KB pdf)

Below: Elaine Holmes, Olive McIlroy and Marion Scott at the meeting on 3 June 2014

17 June 2014: The Committee took evidence from Alex Neil, Cabinet Secretary for Health and Wellbeing, and Dr Frances Elliot, Deputy Chief Medical Officer, Scottish Government. The Committee agreed to invite Adam Slater, Mazie Slater Katz & Freeman, LLC, to give evidence via video link at a future meeting. The Committee also agreed to explore the possibility of meeting the European Commissioner for Health and Consumer Policy at a future date. Link to Official Report 17 June 2014 (589KB pdf)

11 November 2014: The Committee agreed to write to the Scottish Government and the Department of Health. Link to Official Report 11 November 2014

27 January 2015: The Committee agreed to reschedule the evidence session with Adam Slater. The Committee also agreed to invite the Cabinet Secretary for Health, Wellbeing and Sport, the Medicines and Healthcare Products Regulatory Agency, the Chair of the Independent Review of Transvaginal Mesh Implants and the European Commission to give evidence at a future meeting. Link to Official Report 27 January 2015

24 February 2015: The Committee took evidence from—

Dr Neil McGuire, Consultant in Intensive Care and Anaesthesia, Clinical Director Devices, and Sally Mounter, Senior Medical Device Specialist, Biosciences and Implants Devices Division, Medicines and Healthcare Products Regulatory Agency;

and then, via videoconference, from—

Adam M Slater, Mazie Slater Katz & Freeman, LLC. 

The Committee agreed to write to the Scottish Government to seek its assurance that the evidence of the Medicines and Healthcare Products Regulatory Agency and Mr Slater would be taken account of by the Independent Review of Transvaginal Mesh Implants. The Committee also agreed that the evidence sessions with the Cabinet Secretary for Health, Wellbeing and Sport, the Chair of the Independent Review and the European Commission would take place after publication of the Independent Review's findings. Link to Official Report 24 February 2015

12 May 2015: The Committee agreed to write to the European Commission's Scientific Committee on Emerging and Newly Identified Health Risks, the Royal College of Obstetricians and Gynaecologists and the British Society of Urogynaecology. Link to Official Report 12 May 2015

6 October 2015: The Committee took evidence from—

Dr Lesley Wilkie, Chair, Independent Review of Transvaginal Mesh Implants, Dr Rachael Wood, Consultant in Public Health Medicine, NHS Information Services Division and Dr Phil Mackie, Lead Consultant in Public Health, Scottish Public Health Network;

and then from—

Shona Robison, Cabinet Secretary for Health, Wellbeing and Sport, and Catherine Calderwood, Chief Medical Officer, Scottish Government.

The Committee agreed to consider the evidence heard at a future meeting. Link to Official Report 6 October 2015

26 January 2016: The Committee agreed to write to the Scottish Government. Link to Official Report 26 January 2016

8 March 2016: The Committee agreed to include the petition in its legacy paper for consideration by the Session 5 Public Petitions Committee. In doing so, the Committee agreed to write to the UK Government. Link to Official Report 8 March 2016   

29 September: The Committee agreed to defer further consideration of the petition until the final report of the Independent Review is published and to seek an update from the Scottish Government on the work of the expert group. Link to Official Report 29 September 2016

18 May 2017: The Committee agreed to invite the petitioners to provide oral evidence at a future meeting, to invite members of the Independent Review to make submissions to the Committee, to seek time for a debate on the petition and to seek clarification about powers in relation to the regulation of medical devices. Link to the Official Report 18 May 2017

26 October 2017: The Committee agreed to consider a draft report in private at a future meeting. Link to the Official Report 26 October 2017

7 June 2018: The Committee considered a draft report on petition PE1517. The Committee agreed to continue consideration of the draft report in private at future meetings. Link to Official Report 7 June 2018

21 June 2018: The Committee considered a revised report on petition PE1517. Various changes were agreed to, and the Committee agreed to consider a further draft by correspondence.

5 September 2019: The Committee agreed to write to the Scottish Government. It also agreed to write to Dr Dionysios Veronikis,Obstetrician-gynaecologist based in Missouri, USA. Official Report of Meeting 5 September 2019

3 September 2020: The Committee agreed to write to the Cabinet Secretary for Heath and Sport. Official Report of Meeting 3 September 2020

22 October 2020: The Committee agreed to write to the Cabinet Secretary for Health and Sport. It also agreed to write to the petitioners, Dr Wael Agur, the Chief Medical Officer and other relevant professional bodies. Official Report of Meeting 22 October 2020

10 February 2021: The Committee agreed to write to the Cabinet Secretary for Health and Sport. The Committee also agreed to write to the Health and Sport Committee. Official Report of Meeting 10 February 2021

24 March 2021: The Committee agreed to continue this petition and include it in its legacy paper for its successor Committee, along with a suggestion to refer the petition to the Health and Sport Committee. Official Report of Meeting 24 March 2021

Written Submissions

Suspension of mesh procedures must be immediate, until such times as we really understand the risks from this procedure. We also believe that compelling doctors to report adverse incidents related to mesh implants must be introduced. Transvaginal Mesh devices are having a devastating impact on tens of thousands of women across the world and hundreds in Scotland. We believe that fully informed consent must be provided as well as stringent monitoring, assessment and registration of this procedure. We believe the Scottish Government should register all medical devices, this would not stifle innovation, it would help with patient safety. Please sign our petition to support a suspension of polypropylene Transvaginal Mesh devices.

THANK YOU TO EVERYONE WHO HAS SIGNED OUR PETITION AND SUPPORTED US.

Elaine Holmes

0:12 on 01 May 2014

I have been suffering immense pain as a result of a mesh implant. I had no idea I had a permanent medical mesh implant inside me and that this was not designed to come out once placed. I did not consent to mesh being used. I have a very young family and am the main provider for them. Many people have made a significant amount of money from mesh products, many people now stand to lose a lot of money as a result of the impending litigation. People are scared. However the only people that really matter in all of this are the women who are affected by the mesh and all the family and friends who are trying so hard to support them through immense physical and psychological pain. I want to see and enjoy my children growing up and provide for them. I live every day trying to do this now, however in pain, trying to hide this from them and all the time with the immense worry of whether I will be able to continue to do this. We need organised and trusted specialist care from whoever in the world has the best experience in this highly specialised area of healthcare. We need understanding, counselling and ongoing support as patients and also for our families who are significantly traumatised. We need respect and where necessary financial support for our families. We do not need to be punished further by being caught in the cross fire of acceptance that mistakes have been made in using these mesh devices in UK women. We deserve humanity and compassion.

Lisa Anderson

21:56 on 30 Apr 2014

Mesh hurts men and women. It ruins marriages and destroys our bodies. If polypropolene leaching into our water from plastic bottles is a major concern then why isn't it a major concern when they put it in our bodies!

Venita Reich

21:13 on 30 Apr 2014

This must be dealt with.

Caroline Mcallister

18:48 on 30 Apr 2014

This needs to stop

Dawn Rennie

16:57 on 30 Apr 2014

The past 10yrs of my life have been denied me because of this procedure, i have been left mentally and physically scared and life for me is in bed, the pain I endure as soon as I am on my feet is excruciating and my tummy swells where you would think I was having triplets and have great difficulty passing urine. I could go on and on telling you how bad it has been but know after reading other comments we're all dealing with the same pain and betrayal. Please put a stop to this now and don't let another woman endure this suffering

Ann Campbell

13:05 on 30 Apr 2014

My mother in law has suffered terribly because of this procedure, 10 yrs down the line with absolutely no hope of reversal and still going through agonizing pain daily. This should never have been allowed to happen in this day and age and disgusts me that Alex Neil continues to support such an attrocitie shame shame shame on him

Sharon Campbell

12:36 on 30 Apr 2014

I've had a TVT for 10 years and thankfully had no problems with it so far, but if women are suffering then this has to be sorted !! Keep strong and keep fighting !!!

Lesley

11:45 on 30 Apr 2014

The sooner this is looked at the better

shona mcleish

9:43 on 30 Apr 2014

It will not take away my mesh and my pain, the mesh ruined my life, i'm 100% unable to do a job, live just half the day :( "Plastic" in a women her body ? we can even get allergy and cancer from it ... But this law can save other women!!!

Janneke Wijchers

8:54 on 30 Apr 2014

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