Submission on PE1517 on Polypropylene Mesh Medical Devices
Made by Dr Peter J Gordon
Date of submission: 17th May 2017
Submission made in a personal capacity.
The Agenda for the Public Petitions Committee meeting of the 18th May 2017 includes a most helpful summary “Note by the Clerk” on PE1517: Polypropylene Mesh Medical Devices (Document PPC/S5/17/10/1). Having read this carefully, and in accordance with the first suggested “Action” (point 45, page 8), I would like to offer evidence. Before doing so I have listed below the most relevant sections of PPC/S5/17/10/1 in relation to the points of evidence that I wish to make.
In Annexe B of PPC/S5/17/10/1 the Interim and Final Conclusions of the Independent Review are listed side-by-side.
Conclusion 1, both Interim and Final, was that “Robust clinical governance must surround treatment”
Conclusion 3, both Interim and Final, was that “Informed consent is a fundamental principle underlying all healthcare”
In Annexe C: Parliamentary Action (page 21 of PPC/S5/17/10/1) the Cabinet Minister for Health, Shona Robison answered question S5W-07749 by Neil Findlay, MSP on the 17 March 2017, by stating:
“Informed consent and shared decision making are expected prior to any procedure being carried out. The Chief Medical Officer goes into this in more detail in her Realistic Medicine report.”
The Clerk, in point 7, (page 2 of PPC/S5/17/10/1) confirms that:
“The Scottish Government does not have the power to regulate what medical devices are licensed for use in the UK. The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medical devices in the UK”
The Clerk, in point 12 (page 3 of PPC/S5/17/10/1) includes quotations from the Preface of the Review’s Independent Report:
“We found some concerning features about how new techniques are introduced into routine practice” and that
“We are aware that some of our conclusions have wider implications and see the need to embed this in patient Safety and Clinical Governance strands of the NHS”
Points of Evidence by Dr Peter J Gordon (GMC number 3468861)
• HDL62: the Scottish Government has acknowledged that this
Guidance is not being followed by NHS Boards
• There have been media reports that NHS professionals working in
Scotland, who are involved in educating NHS staff about Mesh
procedures, have been paid by commercial sectors who have
financial interest in Mesh products.
• PE1493, A Sunshine Act for Scotland, was closed in February 2016
• A Public Consultation on PE1493 was undertaken by the Scottish
Health Council. The Scottish public, in majority, were of the view
that it should be mandatory for all financial payments made to
healthcare workers and academics to be declared in a publically
accessible form
• No meaningful update has been provided by the Scottish Government
since this Public Consultation was published more than a year ago.
• I fully support the Chief Medical Officer’s “Realistic Medicine”
initiative and I have suggested that Sunshine legislation should be
considered an essential part of this development
• I agree with the Independent Review that “robust clinical
governance must surround treatment”. I am concerned that if the
current situation continues, where “education” of health
professionals may be significantly based on marketing, further
examples of iatrogenic harm may occur in NHS Scotland.
• The Independent Review concluded that “informed consent is a
fundamental principle underlying all healthcare”. If the advice
given to patients is based on marketing, either partially or wholly,
then informed consent may be denied patients. Further examples of
Iatrogenic harm may then unfortunately occur and healthcare
in Scotland may risk being considered as unrealistic
rather than “realistic”.
Update, 22 May 2017:
Public Petitions Committee – Scottish Parliament: 18 May 2017 (click on image below to watch the full meeting)
The official report of the Public Petitions Committee of 18 May 2017
Sunday Post, 21 May 2017: ‘Probe to examine possible conflicts of interest in troubled mesh implant inquiry’
