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Transvaginal Mesh

– in the Scottish Parliament on 26th June 2019.

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Photo of Christine Grahame Christine Grahame Scottish National Party

The next item of business is a statement by Jeane Freeman on transvaginal mesh. The cabinet secretary will take questions at the end of her statement, so there should be no interventions or interruptions.

Photo of Jeane Freeman Jeane Freeman Scottish National Party

I am pleased to update members on the progress of our work in relation to transvaginal mesh. In doing so, I thank all those who are involved in the Scottish mesh survivors group for their tireless campaigning, and members across the chamber who have supported them.

In September 2018, I announced my decision to halt the use of transvaginal mesh in cases of pelvic organ prolapse and stress urinary incontinence. I set out that I required high vigilance from boards to ensure that my decision was implemented, and that such a halt would be lifted only if a restricted-use protocol could be developed to my satisfaction.

Our chief medical officer, Dr Catherine Calderwood, duly instructed health boards on the restriction to practice and, in compliance with my statement, established a group of board accountable officers to consider aspects of service and care that are available to women who suffer from stress urinary incontinence and pelvic organ prolapse. The group has met once, and the minutes were published on the Scottish Government website. To be as clear as possible, I see no prospect of the halt that I instigated being lifted, and I have not asked for any planning to lift the halt.

I wrote to the chief executive of the Medicines and Healthcare products Regulatory Agency on 31 October 2018, and the CMO was in contact with the director of medical devices in November and December, which was followed by a phone call later in December. In those exchanges, we raised our concerns about the approvals process, and I hope that we have been not only listened to but understood. The MHRA has set out that it takes those views extremely seriously, and it has invited NHS Scotland to join all cross-cutting initiatives, including the work on the unique device identifier and the improved communication with patients on the potential outcomes from the use of all types of medical devices. The MHRA says that it stands ready to support us and our healthcare system to ensure the safety of all patients who need treatment. I am sure that members across the chamber will join me in ensuring that we hold the MHRA to that commitment.

In March this year, following a members’ business debate, the CMO and I met a group of women from the mesh survivors group. I am grateful to them for their time and for their courage and willingness to share their experiences with me. Following that meeting, I set in train the work that I had promised the women that I would.

A mesh complications short-life group was set up to consider the physical and psychological needs of the women who experience complications; to consider what additional steps are needed to offer choice to women who are clinically suitable for and want mesh removal; and to review and identify areas of best practice, wherever it happens, and determine how such practice can be provided in Scotland.

In addition—again, in line with the commitment that I gave—I ensured that the voices of women would be heard in the short-life group’s deliberations through the membership of Dr Wael Agur, whom members of the mesh survivors group wanted to represent them, and the Health and Social Care Alliance Scotland. As members will be aware, I set out details in four Government-inspired questions, on 8 March, 6 June and 13 June, and through an update that was provided on 19 June.

A key part of the mesh complications working group’s actions is to ensure that the care and treatment that is provided for women who have been affected is as good, if not better, than that offered in any other centre here in the United Kingdom or elsewhere around the world. That requires benchmarking processes and outcomes with other centres, as well as sharing experience and techniques with clinicians.

In that context, Dr Veronikis’s offer to come to Scotland to work is very welcome, and I recognise that a number of patients are eager for him to come here. As a result, and in consultation with the service here in Scotland, I have asked that we look to bring Dr Veronikis to Scotland as soon as possible. The intention will be for him to work with the clinical service in a complementary fashion to provide treatment, expert advice and training. I want there to be a valued partnership that benefits patients now and over the long term.

In saying all that, it is important that we are all clear that such an arrangement is subject to agreement and regulatory approval. As regulation in the area is reserved, I have written to the United Kingdom Government’s health secretary and to the General Medical Council to highlight the case and to ask that, on their part, steps are taken as expeditiously as possible.

I am pleased that the GMC has responded quickly and positively with an assurance that it will do all that it can to ensure that the important regulatory process is completed quickly and smoothly. With appropriate agreement and sponsorship by the service, I hope that Dr Veronikis can visit by the autumn. I await a response from the UK Government.

The mesh complications working group has been working to establish a national complex case review unit in NHS Scotland. The work to finalise the details and the important connections between the unit and the relevant health board is being taken forward through our service design processes, with the intention that the unit be established by mid-2020.

The working group has also taken forward a number of other measures, which are designed to ensure that patients have choice, and all the information that they need to exercise that choice. That includes the establishment of clear care pathways—through primary care as well as in acute services—that are consistent throughout Scotland.

I repeat my thanks to the Scottish mesh survivors group. The group’s initial work and campaigning was intended to ensure that in the future no other women would suffer the pain and life-changing effects of mesh use that they had suffered and still suffer. The halt that I instructed last September was a direct response.

The women then, rightly, sought the attention and care that they themselves are due. From all the correspondence that I have received, from the representations that members have made to me and, most important, from the women themselves, I understood clearly the areas where the care and attention—and choice—that is being offered could be improved. The update that I have provided today directly responds to that.

Our health service is there to provide safe, effective and person-centred care. In this area, and for the women who suffer complications from mesh, my intention is that what I have set out today should take us ever closer to providing that focused, safe and person-centred care.

I commend this update to the Parliament and I am happy to take questions.

The Deputy Presiding Officer:

The cabinet secretary will now take questions on her statement, as she said. We will have about 20 minutes for questions before we move on to the next item of business. I ask members—apart from those on the two front benches—to be crisp in their questions, as far as possible, so that I can get everyone in.

Photo of Miles Briggs Miles Briggs Conservative

I thank the cabinet secretary for advance sight of her statement.

Like the Scottish mesh survivors group, I think that there is cross-party support for the development of a clinical service to provide treatment, expert advice and training opportunities in our country. The cabinet secretary will have the support of Conservative members in taking that work forward.

What training budgets will be made available, in relation to the training time and capacity that Dr Veronikis will need to take forward the new techniques and technology that will provide for full mesh removal for women here in Scotland?

Photo of Jeane Freeman Jeane Freeman Scottish National Party

I am grateful to Mr Briggs for the support of Conservative members for the work that is being undertaken. I am also grateful to Mr Carlaw, who has been prominent in pursuing the mesh survivors’ case.

On training budgets, we are in discussion with Dr Veronikis. Part of what is being done is that, sensibly, the right group of our clinicians will shortly go to the United States to speak to him, to see what he uses by way of equipment and so on, and to discuss with him how they will work together and what their training needs are. I hope that then, with due regulatory process completed—and the GMC’s support is helpful in that regard—Dr Veronikis will arrange to come to Scotland. There are limits to the length of time for which an external expert can practise in our country, but all that will be resolved and we will agree the arrangements with him.

I will understand better what is needed by way of training for our clinicians and Dr Veronikis’s time—and therefore what additional funding might be made available—when we visit him in the States and when he comes here. At this point, for all those reasons, I cannot give Mr Briggs the figure that he asked for. However, I can give him my absolute commitment to ensure that what is needed is provided and that our clinicians, where appropriate, learn from and exchange good practice with Dr Veronikis.

Photo of Monica Lennon Monica Lennon Labour

I thank the cabinet secretary for advance sight of her statement.

The mesh-injured women of Scotland continue to live with the life-changing consequences of this medical scandal.

The cabinet secretary says that she hopes that Dr Veronikis can visit by the autumn, but Dr Veronikis offered to come to Scotland in November 2018. A flurry of correspondence now to make that happen is disappointing. Autumn is no use to women such as Claire Daisley, a mother of three from Greenock, who is set to lose her bowel and bladder next month. Claire’s body is swelling up because of her mesh injuries and she is trapped in her home.

Can the Cabinet Secretary for Health and Sport tell Claire Daisley and other women in her position whether they will have surgery from Dr Veronikis before it is too late? Will the Scottish Government fund Claire to have her surgery in America, where Dr Veronikis is based, if that is what it takes?

Photo of Jeane Freeman Jeane Freeman Scottish National Party

I am grateful to Ms Lennon for her question but I am disappointed at the parsimonious nature of that.

Photo of Monica Lennon Monica Lennon Labour

You are not the one who is losing their bladder, cabinet secretary.

Photo of Jeane Freeman Jeane Freeman Scottish National Party

I will answer the question. Mr Findlay, there is no need to shout at me. If you want to ask me a question, I suggest that you press your button and get up on your pins.

Photo of Kenneth Macintosh Kenneth Macintosh Labour

Order, please. Let the cabinet secretary speak.

Photo of Jeane Freeman Jeane Freeman Scottish National Party

If members understood how a health service works, they would understand the important steps that we have to go through: to have those discussions with clinicians to understand what their needs are; to have the further conversations; and to have due diligence done on any external expert whom we wish to come here. That is why we are now—fortunately—in the situation that we are in.

As members might know, the CMO has had a conversation with Ms Daisley about her situation. Whether a person is suitable for full mesh removal is a clinical decision. I will not discuss an individual case in the chamber. It will be for the board and Ms Daisley to take that further. I will look at any other matters that arise from that.

The important point here is that, from the meeting that I had in March with the women representing the mesh survivors group, I have now done everything that I undertook to do.

Photo of Alex Neil Alex Neil Scottish National Party

I welcome the statement by the cabinet secretary and I congratulate her on the work that she is doing to rectify a long-lasting injustice to those women.

Is the mesh complications working group yet in a position to estimate the number of women who could benefit from the establishment of the complex case review unit? Given that it will probably take until the middle of next year to fully establish such a unit, what are the interim arrangements for women with complications who require urgent treatment?

Photo of Jeane Freeman Jeane Freeman Scottish National Party

I am grateful to Mr Neil for the question.

On estimating the number of women who are experiencing mesh complications, the detail planning for the development of the complex case review unit will be able to take forward more rigorous estimation of demand. At the moment, the work that is going on is that of estimating the figures from our current knowledge and using estimates from NHS England. Once the planning process is finalised, we will put all that together.

As Mr Neil knows, part of the difficulty was with the work that I referred to. That is now being taken forward, thanks to our intervention with the MHRA, to have the unique device identifier and to develop the registry in Scotland and across the UK, which I announced in September; that will give us much better data in that regard. The work is under way, but we are not yet in a position to be completely confident that our estimate of the numbers is as accurate as we wish it to be.

On Mr Neil’s point about the situation in anticipation of the complex case review unit being established, when people have been in touch with me about individual cases, I have set out exactly what the process is in relation to choice and how they can exercise that choice. In addition, the short-life group that we set up to consider those matters following my meeting with the women at the beginning of March is establishing a pathway with each relevant health board, so that boards can respond quickly to requests for second opinions and requests about choice with regard to where mesh removal might be undertaken.

Photo of Jackson Carlaw Jackson Carlaw Conservative

Whatever differences there might be between us on the overall shape of healthcare, I congratulate the cabinet secretary on the series of actions that she has taken in her year as health secretary, which stands in contrast to the years of frustration that mesh sufferers experienced previously. I have met women in tears who have campaigned to stop mesh as a future condition, and who now have a real expectation that something can be done for them. As a consequence, expectations are sky high.

How confident is the cabinet secretary that the discussions that are under way with Dr Veronikis will lead to a successful conclusion? What, if anything, can Scottish Conservatives do to assist with regard to any support that is required to achieve objectives with the UK Government?

Photo of Jeane Freeman Jeane Freeman Scottish National Party

I thank Jackson Carlaw for his kind comments and for his support. As I said earlier, I also thank him for the work that he and others have undertaken to raise the issue consistently.

I am confident that the current discussions will lead to a successful conclusion. I am clear that I want Dr Veronikis to come here to give expert advice and to support the treatment of patients and the training of clinicians, so that any skills and techniques that he has and which it would be useful for our clinicians to acquire are passed on. I want to consider long-term training for our clinicians, and not just the immediate situation.

I am grateful for the Scottish Conservatives’ offer to do what they can to assist us. I await a reply from the Secretary of State for Health and Social Care. I am not trying to make anything other than a statement of fact in noting that I understand that other things are happening for the UK Government at the moment. If I think that the reply is taking a wee bit too long, I will certainly call on Mr Carlaw and others to give the nudge in the appropriate direction. At this point, perhaps they could simply raise with the secretary of state that we have had a very speedy reply from the GMC and that it would be good to get a positive reply from the UK Government.

Photo of Neil Findlay Neil Findlay Labour

I remind the chamber that we are having this statement only because Labour demanded it.

Nonetheless, I very warmly welcome the progress that has been made on bringing Dr Veronikis to Scotland. It appears that campaigning and pressure work, which is a good thing.

However, something does not stack up. On 20 June, I asked the cabinet secretary whether there were any plans to bring back mesh. In her answer, she said:

“I have not instructed any planning to consider the lifting of that halt and the Scottish Government has undertaken no work to that effect”.—[

Official Report,

20 June 2019; c 74.]

However, the minutes of the transvaginal mesh accountable officers group of 22 February state:

“With the likely publication of key guidance later in the year, it will be helpful to look at how reintroduction of the surgical service will work in practice”.

The minutes go on to state:

“Primary mesh operations could be performed in Individual Boards”.

The cabinet secretary has either lied to the women in Scotland and lied to this Parliament—

The Presiding Officer:

Mr Findlay—

Photo of Neil Findlay Neil Findlay Labour

—or she does not have a clue what the chief medical officer is doing on her behalf. Which one is it?

The Presiding Officer:

You can use a certain amount of language in the chamber, Mr Findlay, but “lying” is not a term that we allow. I therefore ask that you withdraw your remark and ask your question of the cabinet secretary in a polite way without using that term.

Photo of Neil Findlay Neil Findlay Labour

I would have thought that the person who is exposing the mistruths and lies that have been told would be protected—

The Presiding Officer:

Mr Findlay, I just asked you—

Photo of Neil Findlay Neil Findlay Labour

—and that the person who told them would be thrown out.

The Presiding Officer:

That word is not acceptable in the chamber, Mr Findlay. You cannot make personal accusations like that across the chamber.

I will let Mr

Findlay think about that. In the meantime, we will move on to the next question.

Photo of Rona Mackay Rona Mackay Scottish National Party

Will the cabinet secretary expand on how the voices of mesh survivors have been heard during the process of establishing the complex case review unit? Will she reassure them that they will remain involved in the process?

Photo of Jeane Freeman Jeane Freeman Scottish National Party

As I said in the statement, after the meeting with the women on 5 March,

I set up the short-life working group, which is what I said I would do. I asked the Scottish mesh survivors who they would wish to represent them on that group and whether they wished to be represented directly or through a third party. Their response was that they wished Dr Agur to represent them, so he is a member. I have also involved the Scottish care alliance to ensure that there is a wider patient perspective, so both those aspects are involved. The women’s voices have been heard in the work that the group has developed, including the complex case review unit, which will be established as quickly as possibly. They will continue to be involved to ensure that we deliver on the work that we have said that we will deliver as timeously as possible.

Photo of Alison Johnstone Alison Johnstone Green

I appreciate the cabinet secretary’s assurances that there are no plans to lift the halt on the use of transvaginal mesh. However, I am concerned by her statement that

“such a halt would be lifted only if a restricted-use protocol could be developed”.

In March 2017, the Scottish independent review of the use of transvaginal mesh reported:

“In the surgical treatment of POP, current evidence does not indicate any additional benefit from the use of transvaginal implants ... over native tissue repair”.

Knowing what we know now, why are we even considering a reintroduction of mesh operations?

Photo of Jeane Freeman Jeane Freeman Scottish National Party

Ms Johnstone will recall that what I said about that in the statement today is exactly what I said in September when I announced my decision to halt the use of mesh in these procedures. She will also recall that the reason why I wrote to the MHRA is that it is responsible for determining whether any device that is used is safe. I wanted to question the degree to which it undertakes that process with rigour and with any evidence base. I am simply being consistent with what I said in September.

To be clear, what I have said again and again—I think that I have now said this three times in the chamber as well as in answers to Opposition members and to Government-inspired questions—is that I can foresee no circumstance in which I will approve the reintroduction of the use of mesh.

Photo of Neil Findlay Neil Findlay Labour

Why are you planning it then?

The Presiding Officer:

Before I call Mr Cole-Hamilton, I note that I am waiting a second for Mr Findlay to calm down and to regain some measure of control over his emotions. I understand how emotive the subject is and how strongly members feel, but I cannot tolerate people shouting accusations across the chamber. I will return to Mr Findlay in a second to ask him to withdraw the remark. In the meantime, Mr Findlay, please do not barrack the cabinet secretary in the middle of other members’ questions.

Photo of Alex Cole-Hamilton Alex Cole-Hamilton Liberal Democrat

I welcome today’s statement and the hope that it offers to all the mesh survivors who are known to us in this chamber.

The cabinet secretary will recall the case of my constituent who is suffering not from transvaginal mesh complications but hernia mesh complications, which I raised with her at a previous statement on the issue. Will the considerations in today’s statement be extended to sufferers who have experienced complications as a result of mesh in other parts of the body?

Photo of Jeane Freeman Jeane Freeman Scottish National Party

I am grateful to Mr Cole-Hamilton for his support and for his question. With regard to the example that he gave, the complex case review unit will certainly consider complex cases arising from complications where mesh has been used, and that goes wider than the particular group of women and procedures that we are talking about at this point. The starting point for follow-up treatment for an individual in those circumstances will, of course, be with their own clinician and that clinician’s decision as to whether these procedures are clinically suitable for them.

I anticipate that the training, learning and benefit that we gain from the experience of Dr Veronikis and from elsewhere in Europe, where our clinicians are currently looking—as I have asked them to do—will assist NHS Scotland in dealing with complications in that regard in the future.

Photo of Stuart McMillan Stuart McMillan Scottish National Party

I welcome the statement. Will the cabinet secretary outline how the accountable officers will work with the primary care services to ensure that the individual cases of mesh survivors are addressed?

Photo of Jeane Freeman Jeane Freeman Scottish National Party

A primary care health professional has become a member of the short-life working group and will canvass opinions and views from professionals in primary care. They will work together on the self-evaluation tool that is being completed by health boards for Healthcare Improvement Scotland’s transvaginal mesh oversight group to provide information on any additional needs, in order to strengthen the primary care services and pathways. As I said in my statement, it is about making sure that the pathway for individuals in such circumstances is clear to them and to all the clinicians who might be involved at various stages, and that the pathways are consistent across Scotland, so that, no matter where a person lives, they can expect the same response from healthcare professionals in their area.

Photo of Annie Wells Annie Wells Conservative

I also thank the Scottish mesh survivors group for its hard work campaigning on the issue and I thank the cabinet secretary for her update.

I am pleased to see that there is scope for Dr Veronikis to come to Scotland.

What reflections has the cabinet secretary had on the lessons that have been learned?

Photo of Jeane Freeman Jeane Freeman Scottish National Party

That is an important question, and there are two main reflections. One is that we need to pursue the work that we are undertaking with the MHRA on the rigour with which devices are approved for use in our healthcare system. That work involves devices across the piece, whether they are mesh or a hip joint or something else, and is to ensure that we have a rigour in that area that is comparable to the rigour for drug trials and approved drug use in our health service.

The other reflection is the importance of a consistent pathway and making sure that our patients, whatever the circumstances and whatever their condition, have the maximum amount of information in order to make an informed decision and choice. That was reflected by the work of the citizens panel that the chief medical officer ran. I am sure that members have seen its report about the importance of genuinely shared decision making and making sure that an individual patient has all the information that they need and is given the opportunity to ask questions and to return to those questions.

Those are the two main reflections, which apply widely across our health service, rather than simply to this issue.

Photo of Emma Harper Emma Harper Scottish National Party

Will the cabinet secretary further clarify whether it is her intention that clinicians in Scotland will learn from Dr Veronikis and that the sharing of that learning will be supported and monitored, such as by using a peer-reviewed approach?

Photo of Jeane Freeman Jeane Freeman Scottish National Party

Yes, I will. As Emma Harper says, and as I am sure she well knows given her background, the whole approach of peer review, consistent learning and exchange of experience, skills and ideas is central to our health service and it is taken across the board. From conversations with Dr Veronikis, I understand that that is his expectation, too. Therefore, I think that it will be a fruitful partnership.

Photo of David Stewart David Stewart Labour

I, too, praise the work of the mesh survivors group. Will the cabinet secretary outline what work has been done to assess the number of women who would need specialist mesh removal operations? Can a clinical case can be made for mesh-damaged patients to have removal carried out by Dr Veronikis in the United States and for it to be funded by the Scottish Government or NHS boards?

Photo of Jeane Freeman Jeane Freeman Scottish National Party

I have already mentioned the work that is under way to estimate the numbers that we might be dealing with. Our data is not as good as we want it to be, primarily because such a level of data on procedures is not routinely gathered, and we do not yet have the individual product identifier on which we are working with the MHRA. The credit for the fact that the MHRA is working on that should largely go to us for pursuing issues in relation to the way in which it approaches its work.

In relation to whether an individual can benefit from the treatment that Dr Veronikis offers here in Scotland or elsewhere, the discussions that will take place in advance of his coming to Scotland—as I said, I hope that he will be here by the autumn—will be about how he will undertake the clinical assessments, how he will access patient records and so on. We need the regulatory process to be put in place to ensure that he is properly registered to carry out that work and to access that information.

We have not discussed with Dr Veronikis the possibility of patients travelling to the US, but my answer to a previous question remains the same: that is a matter for individual clinical decisions but, should clinicians think that it was required within the timeframe and in advance, we would certainly look at that. I am sure that David Stewart understands that I will not discuss individual cases in the chamber.

Photo of David Torrance David Torrance Scottish National Party

Will the cabinet secretary provide further details of the activities that Dr Veronikis will undertake while he is here, and of the activities of Scottish surgeons when they travel to the USA?

Photo of Jeane Freeman Jeane Freeman Scottish National Party

I am grateful to Mr Torrance for that question. I have already indicated, in part, the areas of work in my statement. They include jointly delivered treatment, expert advice and training. The details will be further developed through the discussions that my officials and clinicians are having with Dr Veronikis. I am happy to ensure that members are updated once the conclusions are reached. For me, the key point relates to not only treatment but training, because we want to build something for the current patient cohort, as well as for any patients in the future.

The Presiding Officer:

Thank you very much, cabinet secretary.

Before we move on, I say that I appreciate that Mr Findlay feels very passionately about this subject, but his outburst earlier was not acceptable. I have given him a few minutes to calm down and to reflect. I ask him to withdraw the remarks and accusations that he made.

Photo of Neil Findlay Neil Findlay Labour

Presiding Officer, you know that I have great respect for you and the office that you hold. I also have great respect for the women who have been injured by mesh. Two weeks ago, they made a similar statement in the media to the one that I made. The cabinet secretary has to be held to account for her actions. I apologise to you, Presiding Officer—I am very sorry—but I cannot withdraw the comment.

The Presiding Officer:

I am sorry, Mr Findlay, but that is not acceptable. I am afraid that I will have to ask you to leave the chamber.