Parliament Workbench
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Official Report · Committee

Current Petitions

Polypropylene Mesh Medical Devices (PE1517)

Tuesday 11 November 2014 Public Petitions Committee About 12:00–12:15 Petitions 18 contributions · 6 speakers

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The record

18 contributions
David Stewart Lab The Convener · Highlands and Islands
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The next petition is PE1517, by Elaine Holmes and Olive McIlroy, on behalf of the Scottish mesh survivors hear our voice campaign, on mesh medical devices. Members have a note by the clerk and the submissions.

We all recognise that it has been a first-class petition. A number of supporters are in the public gallery; I welcome them back. I also put on record our thanks to Neil Findlay, who has carried out a strong campaign, and to the Sunday Mail for the work that it has carried out.

The suggestion is that we defer consideration of the petition until early 2015 to await the outcome of the independent review that the Scottish Government set up and the opinion that the European Commission requested from the Scientific Committee on Emerging and Newly Identified Health Risks. Before we make a final decision, I want to hear from any committee members who wish to speak.

Chic Brodie SNP South Scotland
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I will speak, despite what some people think about Government back benchers. In reference to paragraphs 12 and 13 of the clerk’s note, I do not remember when the Cabinet Secretary for Health and Wellbeing was at the committee, but the action that had to be taken was made clear. I acknowledge what Mr Findlay has done and I am more than concerned that 29 women have received mesh devices from NHS Greater Glasgow and Clyde since June 2014. I thought that the cabinet secretary’s decision was clear, so I am surprised that the Minister for Public Health said:

“there will be individual circumstances where clinicians, in consultation with the women involved, will consider all the potential risk factors”.—Official Report, 30 October 2014; c 8.

I would like to understand the basis for that.

David Stewart Lab The Convener · Highlands and Islands
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We could certainly write to the cabinet secretary about that.

12:15

Jackson Carlaw Con West Scotland
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I echo that. When we took evidence, we were largely assuaged by the cabinet secretary’s assurance that he had instructed that a moratorium be put in place. He explained the limitations on him, but I thought that the response to the question that was put in the chamber was somewhat cavalier in its generality. I think that we had expected something a little more absolute, based on the assurances that had been given to us.

We should acknowledge the public recognition that the petitioners have been given for the work that they have done. I believe that, as a consequence of what they have done, Westminster’s Department of Health has also taken an interest in the issue. As we continue to review the petition, it will be interesting to note what that department’s conclusions have been and to consider whether that might affect the position that we adopt and pursue in Scotland.

David Stewart Lab The Convener · Highlands and Islands
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We are still part of the European Union, so it would be useful to get the European Commission’s views as well.

Anne McTaggart Lab Glasgow
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Like Chic Brodie, I listened to the cabinet secretary give evidence to the committee, so I am aghast. The saying that the tail is wagging the dog springs to mind. I would like more information.

Chic Brodie SNP South Scotland
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I have another point to make—I am going to become a bore on the subject. Two weeks ago, we discussed how long one element was taking. We need to start asking those who advise ministers exactly when in early 2015 we can expect to see the outcome. In business, if I am asked to do something, I cannot say, “I’ll do it early next year.” It is incumbent on us to start asking when we will see information and outcomes and what those outcomes will be, so that we can promote the interests of those who bring petitions to us.

David Stewart Lab The Convener · Highlands and Islands
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Neil Findlay has been a champion of the issue. I invite him to address the committee.

Neil Findlay Lab Lothian
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I have with me the patient information leaflet that has been produced to accompany the on-going trials. Given the lack of information in the leaflet, the belief is that people are being, in effect, hoodwinked into taking part in trials. They are being asked to take part without knowing that they will have a mesh device fitted or that the procedures have been suspended by the Scottish Government pending a safety review. That is a concerning situation. There is no mention of mesh in the leaflet.

Since the process started, we have seen the suspension—or the alleged suspension—of the procedure in Scotland; a working group has been set up; a revised consent booklet that should include the word “mesh” is being created; US courts have twice found products to be defective; and, alongside all that, the deputy chief medical officer—one of the most senior medical officials in the country—has been encouraging women to take part in trials.

Also since then, many settlements have been reached in the US courts. The list that I have covers two pages. There was a settlement on 4 March of $16 million; on 3 April of $1.2 million; on 5 September of $3.27 million; on 8 September of $73.5 million; on 30 September of $1.6 billion; on 21 October of $21 million; and so on.

My concern is primarily for the women who are affected and those who might be affected if they take part in a trial and are injured by the product. However, I have another concern. Those lawsuits are massive. We know the number of people who have been affected in Scotland, and the consequences for our national health service if the situation develops in the way that it has in the US and is likely to in Australia are eye watering.

David Stewart Lab The Convener · Highlands and Islands
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It would help if you could leave the information that you have quoted with our officials, for the Official Report.

I put on record the fact that the committee is due to visit Brussels soon. We made attempts to contact the office of the European Commissioner for Health to raise the issue. Although we will not be able to meet him when we go to Brussels, we are assured that we will meet his officials at some stage. That is important. We want to put the issue to bed, because it is crucial across Europe and America, as Neil Findlay has stated. We will give people further information about that when we have had the meeting.

John Wilson Ind Central Scotland
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On the back of Neil Findlay’s comments, one of the problems, which the petitioners highlight in their updated submission, is the lack of certainty in the reporting mechanisms from health boards around Scotland. The petitioners have highlighted that some of the evidence that health boards provided—I welcome that evidence—clearly indicates that they do not keep or might not be keeping accurate records of incidents when patients have reported concerns about the devices that have been fitted. Concern has been raised about that.

The petitioners have asked whether the records include referrals to specialist services and general practitioner referrals. The British Medical Association’s response states:

“The BMA recognises that many women have suffered complications following the insertion of a polypropylene mesh medical device”.

However, the difficulty is that we do not have an accurate number of the women involved, because of the reporting mechanisms and the issue of who patients speak to after an operation. Do they raise concerns only with their GPs or are they referred back to the consultants who carried out the operations?

We must try to impress it on the Scottish Government that we need to find ways of accurately measuring the number of operations that have resulted in complications in later years or immediately after they were carried out. It would be useful to get some clarification because, if health boards are not clear about the reporting mechanisms, we certainly cannot be clear about the number of incidents that have taken place in Scotland.

David Stewart Lab The Convener · Highlands and Islands
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Neil Findlay raised a specific point about the future liability of the Scottish Government to court actions. Do members agree that we refer to that in our letter to the Cabinet Secretary for Health and Wellbeing?

Members indicated agreement.

Neil Findlay Lab Lothian
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Another issue is the information leaflet that is provided to those who might be considering—or might be being considered for—trials. A major concern is that people are being approached about clinical trials without having the full evidence. I do not want to tell the committee what to do, but it might be appropriate to write to the Scottish Government and the other agencies involved about the issue.

David Stewart Lab The Convener · Highlands and Islands
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When the minister was before us, we discussed the wider issue of informed consent. I think that you are raising the question whether consent is informed.

Chic Brodie SNP South Scotland
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Like Jackson Carlaw, I understood that there was to be a moratorium. The letter from the chief executive of NHS Grampian, who I think is no longer with us, suggests that

“medical recommendations should be based on medical literature, high quality medical research focused on patient-reported outcomes and clinical expertise.”

The penultimate sentence of the letter states:

“We must avoid basing any recommendations on the basis of media or political pressure.”

I believe and will personally ensure that anything that comes out of the committee is properly directed political pressure. The political pressure comes from those who come here with petitions and, if the balance of probability results in a cabinet secretary announcing a moratorium, the people who run the various health services should understand that that is properly directed political pressure.

David Stewart Lab The Convener · Highlands and Islands
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The wider point, which Mr Brodie rightly makes, is that our consideration of several previous petitions has shown that a clear and well-accepted Scottish Government policy might not be fully implemented by health boards. That is a common theme that we have raised time and again.

I am conscious of the time. If members have no further points, do we agree that we write to the Cabinet Secretary for Health and Wellbeing about liability costs and informed consent and that we defer consideration of the petition until 2015 to await the opinion of the Scientific Committee on Emerging and Newly Identified Health Risks, which the European Commission requested?

Members indicated agreement.

John Wilson Ind Central Scotland
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I add to the list that you have read out the issue of the records of incidents that health boards are keeping. It is important that there is an accurate record and that the patients who are suffering can be assured that their issues are being heard and reported appropriately.

David Stewart Lab The Convener · Highlands and Islands
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Thank you for that point. We will add that to our list of objectives. I thank Neil Findlay for giving evidence and all the supporters in the gallery who have come along again. We are with you on the petition. Thank you for all the work that you are doing.

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