Polypropylene Mesh Medical Devices (PE1517)
Thank you very much, convener; I also thank you for the opportunity to discuss this issue this morning. I thank the ladies behind me in the gallery, too, for bringing the matter to the attention of the committee and Parliament.
The first thing to say is that we should all be very concerned to hear how the implants have affected the lives of some women in Scotland and elsewhere. I have met women who have been adversely affected, including Mrs Holmes and Mrs McIlroy, and was deeply troubled to hear how they have suffered. They have my full sympathy and support, and we will certainly do everything that we can to improve the situation. No one should have to experience the level of suffering that those women have experienced.
I will set out the actions that the Scottish Government is taking to address the issues that have been raised.
I asked the deputy chief medical officer, Dr Elliot, to investigate and to recommend actions to address the matter. We estimate that each year in Scotland about 1,500 women who suffer from stress urinary incontinence and 350 who suffer from pelvic organ prolapse have synthetic mesh implant surgery. Those conditions result in reduced quality of life and I understand that traditional surgery techniques have a high failure rate of between 20 and 30 per cent for primary pelvic organ prolapse surgery. Based on the 2012 York report, which was a study commissioned by the Medicines and Healthcare Products Regulatory Agency—MHRA—it is estimated that about 1 to 3 per cent of women experience complications following stress urinary incontinence surgery. According to the MHRA, the percentage of women who experience complications following POP surgery is slightly higher; it is estimated to be between 2 and 6 per cent. That contrasts with the failure rate of between 20 and 30 per cent for traditional surgery for POP, which I mentioned.
That means that a majority of women—based on that estimate, the figure is about 1,450 annually—would appear to benefit from the surgery without complications. Of course, that is not to diminish the seriousness of the situation for the women who do suffer complications. However, I add that the percentage of complications is probably substantially underestimated because of underreporting and non-reporting of adverse events. I therefore regard the figures as not being entirely reliably accurate.
I asked Dr Elliot to chair a working group that includes clinicians and patient representatives to consider the issues in more detail. That group has now met twice. I thank Mrs Holmes and Mrs McIlroy for their on-going contribution to it. The group has made progress; it has produced a new patient information and consent booklet for SUI, copies of which I have with me for the committee. The booklet clearly demonstrates the risks that are associated with the procedure and the alternatives that are available before women make a decision on whether they wish to proceed. The information in it will be the absolute minimum information that is provided to patients by national health service boards.
Two patient guidance booklets that set out the pathway for the management of POP and for women who present with complications are being developed. Dr Elliot will work with NHS colleagues to develop that service as a matter of urgency.
I can confirm that, in the past year, the chief medical officer has written three times to all general practitioners, through medical directors, to alert them to the possibility that women may suffer complications following insertion of the mesh implants, and that all adverse events must be reported to the MHRA, which is the regulatory authority.
I will explain the regulatory framework. As members have already heard, mesh implants are classified as medical devices and are governed through the European Union medical device directives. The MHRA is the competent authority for the whole United Kingdom and has responsibility for removal of any device from the market for the whole UK. Obviously, evidence is required for it to take such a step.
Individual medical devices follow procedures that are set out in the EU directives by manufacturers in order that they can gain a CE mark, which is conformity marking that is awarded by notified bodies. The MHRA oversees the work of those organisations in the UK and performs regular audits. The rules for classifying medical devices are applicable across all EU member states.
I have spoken to the MHRA’s chief executive and medical director about mesh implants and agreed that a dossier that details the experiences of women in Scotland should be given to them to help them to reach a decision on use of the implants. In the discussion with the MHRA, I was reassured that it is taking the issue very seriously. The Scottish Government will continue to assist that agency to provide answers on a way forward. I have another discussion arranged with the chairman later this month.
I have also written to the European Commission, which is currently working towards formulating a scientific opinion on the safety of the devices. That work will be available in January 2015.
We are aware of the US Food and Drug Administration’s proposal to reclassify mesh for POP from a moderate-risk device to a high-risk device. Currently, of course, Europe has the device classification IIb, which is moderate to high risk.
The Scottish Government will participate in the UK working group, whose remit includes consideration of how data on complications and reporting of adverse events can be improved. The group will meet for the first time next week.
Having said that, I am convinced that more needs to be done by us in Scotland. Therefore, in addition to what I have already outlined, I am announcing today that an independent review will be set up urgently to report on all the issues that have been raised, including complication rates and underreporting of adverse events. That review will report in 2015 and will take account of the European Commission’s study on the devices which, as I said, is due to be published in January 2015. I hope to announce the specific remit and the chair of the review before the summer recess.
In addition, I have asked the acting chief medical officer this week to write to all health boards to request them to suspend immediately the POP and transvaginal tape procedures until further evidence becomes available from the two reports next year—the EU report and the report of the independent review that I have set up. I believe that that is the right thing to do and that we should base any future decisions on the evidence as presented by those two reports.
Someone who is sitting in my chair must weigh up a number of things. As I have pointed out, the evidence that was available to me and the advice that I got at that time suggested that there was a fairly low rate of adverse events.
I am now satisfied from information available from the MHRA and others that the rate of underreporting is much higher than was originally thought. I was convinced that, in taking the decision, we had to balance the interests of women who are at risk and those who have experienced complications with the interests of women whose operations have been successful. Despite the percentage who have had complications, a fairly high percentage of women have—as far as we know—had what they regard as successful operations. Of course, we have not heard from those who have not had complications, and it might well be that some of the women who wanted this procedure still want it and are not happy that, for the time being, they cannot get it.
There is a balance to be struck. I have now come to the clear view that, because of the scale of the underreporting of adverse incidents, our new approach is the right thing to do, until we get the evidence from the independent review as well as from the European report, which is due in January.
I am afraid that we are out of time. We have extended the question-and-answer session by 20 minutes because of the petition’s importance. We have now reached the summation; the committee will discuss its next steps and no further questions will be asked.
My view is that we need to continue this important petition. We need to wait for certain information that we requested two weeks ago, and additional points have come up. The minister mentioned the important role of Europe. I suggest that, when the committee visits Brussels in October, we seek a meeting with the European Commissioner for Health and Consumer Policy—Tonio Borg, who is from Malta—to discuss the issues around the CE mark that the cabinet secretary raised. Adam Slater, a lawyer from America who has given us written evidence, also wishes to provide oral evidence, and it might be possible, if the committee agrees, to enable that to happen through a videoconference.
There are three issues. First, I believe that the committee needs to wait until it has further information before it makes a final decision. Secondly, I want to hear the committee’s view on whether we meet the European commissioner when we visit Brussels. Thirdly, do members wish to take part in a videoconference with the American lawyer who is an expert in this area?
I was lucky enough to visit Brussels and meet commissioners a number of years ago. Even though other places might not want to hear the views of this place, I know that commissioners are keen to hear about the work that is being carried out by committees of this Parliament. The opportunity to speak to the commissioner on this issue and possibly on other issues of concern and to put across our views about what is happening would clearly be of great advantage to this committee and to the people of Scotland.
First, I should say that there is an obligation to report adverse events under the General Medical Council’s code of conduct. As I said in my introductory statement, we have issued clear instructions to remind everybody that they are obligated to report every adverse incident to the MHRA. The problem of underreporting is not just a Scottish one; it goes right across the UK. The MHRA and the Scottish Government need to make sure that every adverse event is reported. Obviously, if we are suspending use of the devices now, there should not, by definition, be any new adverse events.
With regard to measurement of historical adverse events, I am setting up the independent review to address that. I do not want to prejudice how the review group will undertake its work, but a clear part of its remit will be to establish the real percentage of adverse events.
One issue that has been highlighted by the ladies who have spoken to me concerns the number of women who have come forward and spoken to them. That indicates that the percentages that have been officially reported by the MHRA represent significant underreporting of the number of adverse events. However, I do not have the information that would allow me to say whether the real figure is 10, 15 or 20 per cent. I would like the independent review to at least have a stab at getting a percentage that is of the right order of magnitude for the number of adverse events.
The traditional surgery has a failure rate of between 20 and 30 per cent. There is clear evidence that the failure rate, the complication rate and the adverse-event ratio in the procedures that we are discussing are significantly higher than what is officially reported. Frances Elliot will give some supplementary information.
We have been involved in the discussions with the Department of Health and the MHRA on the work that they are doing with the two UK professional bodies—one of them is the British Society of Urogynaecology but, off the top of my head, I cannot remember the name of the other—together with the Royal College of Obstetricians and Gynaecologists. We have been involved in the debate about using the societies’ databases to create a single database for all the procedures and the complications that arise from them.
The work that the cabinet secretary referred to is the work that we are doing to identify a unique device identifier in Scotland, which is part of the work that we are doing to address the issues that have been raised in relation to cosmetic surgery and to the mesh, breast and hip implant problems that have been identified in the recent past by ensuring that any device or implant can be tracked, irrespective of what type it is and what procedure is used to implant it.
We are involved at high level with our UK counterparts in the discussions. I will be participating in the meeting on 16 July with the UK group that has been set up to progress that work.
On the second part of your question, we have already written to every GP in Scotland three times on how to handle the situation that you have described. Every GP in Scotland has already had three letters about that.
As for the suspension itself, the acting chief medical officer will, in her letter to health boards, make absolutely clear the advice that clinicians should give on handling the suspension and dealing with women who are in distress because of the condition—either urinary incontinence or prolapse—that the procedure is meant to rectify. The acting chief medical officer will include that in her letter and ensure that appropriate guidance is provided at board level as well as in the acute and primary sectors.
The cabinet secretary mentioned that the FDA has raised the risk level to high risk. What contact—if any—have we had with the FDA? Have we had access to the information that prompted that change in guidance?
10:15
Thank you very much, cabinet secretary. I, for one, certainly welcome your independent review of the issues around suspension.
In your normal way, you have probably predicted one of my questions. You will know that NHS Dumfries and Galloway has suspended use of mesh devices. My question was going to be about the wider issues relating to suspension across Scotland. Perhaps you can comment first on the Dumfries and Galloway suspension as far as you are aware of it.
09:45
At the very least, there is certainly a presentational problem, but I have made it clear to officials that the person who leads the independent review in Scotland must not only have no such connection and be totally independent of any manufacturer or other vested interest but be seen to be independent. It is important that the review carries the confidence of the ladies behind me in the public gallery, the community of women who have been badly affected by the procedures going wrong and the wider public. I have made that absolutely clear.
Before I finalise the remit of the independent review, I will consult the patient representatives from the women’s group to ensure that they are happy that the remit is satisfactory and robust enough.
I appreciate that and recognise the work that you are doing in pushing back up the chain. I understand that the European directive is why the MHRA is not doing the same further up the chain. As far as I can recall, this is not the first time that the MHRA has been in such a situation. You have said that the European Commission is looking at the issue.
I have one other question about the relationship with the MHRA. Our briefing indicates that the MHRA has an overarching role in the process but that, in Scotland, adverse events are handled by Health Facilities Scotland. What is the relationship between the two bodies? How often do they meet?
Thank you—I am sure that the campaigners appreciate those comments.
It is not technically a suspension. The medical director issued an order last year that meshes were not to be used in any POP operations. As the committee will know, the medical director in Dumfries and Galloway also called for an urgent review of use of tapes.
At least two other health boards, NHS Highland and NHS Forth Valley, have also put a stop on use of meshes. By rolling out the suspension throughout Scotland, we can ensure that every health board takes exactly the same position.
Good morning. I add my support for the proposed action. I have known the cabinet secretary for many years, so the speed at which he is taking action does not surprise me.
I have a question about the MHRA. We have been talking about the database and the process, but this is not the first time that an issue has come up with products or devices. Addressing such issues is a bit like shutting the door after the horse has bolted. In relation to the discussions that you have had and that you will have with the MHRA, what guarantees can we get that such a situation will not occur again? It is all very well producing products for the marketplace, but it seems highly surprising that we do not have the process or the outcome measurements to go with that.
I know that you cannot give such a guarantee, because you do not have control over the MHRA’s functions—yet—but what questions have been raised with the MHRA as a consequence of what has happened to ensure that it gets its processes and management into proper perspective?
The clerks would like me to stress for the sake of accuracy that we have not yet confirmed the date of the visit, which would be subject to the agreement of the Conveners Group and organisational issues. Perhaps I should rephrase my question and ask whether—if we can get a time that suits the parliamentary committees, the clerks and ourselves—the committee agrees in principle to meet the commissioner. I am enthusiastic about the idea. Does the committee agree?
Members indicated agreement.
It is important that, when we set out the terms of reference for the independent review, we ask the group to identify the barriers to reporting. As the cabinet secretary mentioned, the General Medical Council’s “Duties of a doctor” guidance indicates clearly that professionals are required to report adverse incidents and events to the appropriate bodies. Something must be getting in the way of that happening on a routine basis, so we need to establish what it is more accurately than we have previously been able to do.
We have other mechanisms that we can use, including meetings with clinical leaders in Scotland. Together with the acting chief medical officer, we will take those opportunities to inform them of the advice that has been sent out. You are absolutely correct. We need to follow through the processes to ensure that women who are already on waiting lists in health boards get the opportunity to have further discussions with clinicians if they so wish.
The cabinet secretary has announced today that an expert group will consider the issue, and it is expected to report in January. As for the question whether we take evidence from a lawyer in the United States in a videoconference, I simply point out that a number of legal firms in Scotland are involved in legal action against NHS boards and others in relation to this matter.
I suggest that we defer future consideration of the petition until we get the written evidence that we called for two weeks ago and the report of the expert group in January. That will enable us to consider the reports in more detail and to consider further how we take the issue forward.
First, to be fair to the MHRA, it operates in a European Union dimension—the medical devices directives are the part of European law that is relevant to the MHRA’s remit. In effect, it is the EU’s agent in the UK when it comes to enforcing EU regulation. I suspect that some of the regulation needs to be strengthened not just at UK level, but at EU level. We will be able to establish that from the report that is due in January 2015.
By undertaking the work that Dr Elliot outlined, we will be less reliant on after-the-fact regulation. I am very keen to prevent any further harm coming to any patient, no matter what the device or the procedure is. That must be our objective.
From the discussions that I had last week with the medical director and the chief executive, I was certainly reassured that the MHRA intends to take a very robust approach in this area, but it feels as though it is part of the EU regime.
I will ask Frances to give you some specific examples of the work that is being done.
The only information that we have is that which is in the public domain. We have not had specific contact with the FDA, principally because the MHRA’s classification is already moderate to high risk. That should be the flag for clinicians to understand and take into account the fact that the devices have a potential risk.
I am glad that you have taken the issue so seriously. You obviously followed very closely the committee’s deliberations two weeks ago. All members of the committee were, quite frankly, shocked at what we learned from the excellent petition and the evidence from Elaine Holmes and Olive McIlroy.
In my time as convener of the committee, I have not seen such emotion and tears in the gallery during consideration of any other petition, and we have dealt with many very good petitions in the past three years. I am sure that you accept the strength of feeling among the women, given the fact that one in five mesh implants can go wrong and cause horrific physical injuries.
I place on the record my thanks to the Sunday Mail for raising awareness, as it has done with issue after issue. I am sure that you are aware of how shocked all the committee members were, and that you realise that decisive action is extremely necessary.
The MHRA is the regulatory body, as I have already explained. All adverse incidents that are reported within the national health service in Scotland are fed through Health Facilities Scotland. For example, in the past year, NHS Grampian and now other boards have started to treat every complaint that they receive, irrespective of its nature or seriousness, as an adverse event. They regard a complaint as an adverse event.
The bulk of those adverse events will not involve the MHRA at all, because they have nothing to do with regulation. They might relate to a procedure that has gone wrong or whatever, rather than raising a regulatory issue. We have to be clear that “adverse events” has a wide definition and that it is widening. A percentage of those events will come under the regulatory remit of the MHRA, but the number of adverse events exceeds anything that the MHRA would be involved in with the NHS in Scotland.
I very much welcome the cabinet secretary’s statement and course of action. I seek clarity on where we are now and what will happen moving forward. I want to compile some of the information that has been given. Will the new patient information and consent booklet that the working group has produced be available as of today? Will it be online?
The cabinet secretary said that the problem may be complications with the procedure rather than with the devices. Will your expert group, in breaking down the figures, seek to identify which incidents were caused by devices and which were caused by complications from the operation?
One of the joys of sitting at this end of the table is that I can see the reaction of the people in the public gallery. When you said that GPs had been written to three times and that information was available, their reaction made it clear that that information is not being imparted to the women who have been speaking to their GPs. Would you consider seeking the views of the women concerned? Can you find a mechanism that will allow them to feed into the working group so that you can hear some of these women’s real experiences about how they have been dealt with by their GPs when they have tried to report these incidents and so that we have other information that we can reflect on?
I often hear that guidance has been given to GPs and others, but sometimes it does not filter down to the patients. We need to ensure that the views and experience of patients in those circumstances are reflected in any future policies that are developed by the Scottish Government or the medical profession.
That is a sensible approach.
I thank the cabinet secretary and Dr Elliot for coming along. It has been helpful to see progress on another health issue. I also thank Neil Findlay, who has shown great interest in the matter. Finally, I thank everyone in the gallery who has come along specifically for this discussion. You have shown a lot of courage. You are welcome to stay to hear our discussions of other petitions, but I understand it if you do not wish to do so.
I suspend the meeting for two minutes to allow our witnesses to leave.
10:26 Meeting suspended.
Good morning, ladies and gentlemen. I welcome you all to today’s meeting of the Public Petitions Committee. As always, I ask everyone to turn off their mobile phones and other electronic equipment, because such devices interfere with our sound systems. No apologies have been received to date.
Agenda item 1 is consideration of a current petition. The first item of business is consideration of 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 a letter that was received on Friday from NHS Dumfries and Galloway. John Scott, who has a big interest in the issue, unfortunately has another committee meeting and gives his apologies. Neil Findlay, who has been at the committee when the issue has been discussed previously, is attending the meeting. I ask members to note that we have an extra paper from NHS Grampian.
Members will recall that we heard from the petitioners two weeks ago and agreed to invite the Cabinet Secretary for Health and Wellbeing to give evidence on this important issue. I am very grateful to him for making himself available so quickly for the committee. I welcome the cabinet secretary, Alex Neil, and Dr Frances Elliot. I also welcome all our visitors to the gallery. This is obviously a very important and quite emotive issue. I particularly welcome all our visitors who are coming to Parliament today for the first time. The only very minor thing to flag up is that parliamentary rules do not allow any applause in the gallery.
I invite the cabinet secretary to make a short opening statement, which will be followed by questions from me and my colleagues.
The European Commission is conducting a review of the regulation of medical devices. That will not report for some time to come, but it is really important that, when the amendments are consulted on, we have an opportunity to explain some of the challenges that we face with the implants that have caused problems in Scotland and that we make those points robustly.
10:00
I made it clear from day 1 that I am very much on the side of the women on this issue. The regulatory regime is not straightforward. In Scotland the health boards make the decisions, which is why I am writing to request that they suspend use of meshes. I am sure that they will. The MHRA is the statutory regulatory body, and it operates under EU directives. I should also explain that the MHRA’s responsibility relates primarily to the products—the devices themselves—and the EU directives deal very much with that element.
From our discussion with the MHRA last week, it seems that the evidence that it has assembled so far indicates that many of the problems that women have had were related to complications with the procedure and not always to the product.
I want to be sure that we include in the remit for the independent review in Scotland the need to get a much better handle on the level of underreporting of adverse events in relation to such procedures. The review also needs to ask why things have gone wrong in certain cases. Is it the product or the procedure, or are there unavoidable complications in some cases? We need to have a far better understanding of those points if we are to ensure patient safety in the procedures.
The review remit will also cover the work in Europe and the US to ensure that we in Scotland adopt the best possible policy—as I am determined we will—once we have conducted that research.
I have constituents who have been victims, and I know that in one case the mesh implant worked for 12 years before complications set in, so I am keen that we look at the issue over a fairly long period. The better our understanding of the problems is, the better will be our handle on what needs to be sorted to ensure that no woman has to go through the hell that many of the women who are sitting behind me have had to go through.
I have made it clear from the outset that the more evidence that we get from the women about things that are not working in the way that they should be, the better. When we write, through the boards, to every GP, we expect every GP to read that letter from the chief medical officer and then to implement what it recommends. If that is not happening, we need that evidence. We will then work with GPs, through their boards, to ensure that those problems are addressed.
Generally, I agree. No one in the room today does not understand or appreciate the decisions that have been taken. However, I suggest that we have the videoconference with Adam Slater, as we can never have too much information on this subject.
It will be part of the review’s remit to try to gain a far better understanding of why things have gone wrong. Is it because of the products or because of the procedures, or is it because of complications and other problems that some of the women may have? I suspect that the answer is a combination of those factors, but we do not know which are more important.
It is important that we get a much better understanding of what has gone wrong. We cannot sort out the problem until we know what is going wrong. The real purpose of the review is to find out what is causing the problem. I do not want any woman to have to go through the hell that these women have experienced.
Regular liaison takes place between Health Facilities Scotland and the MHRA, as it does between ourselves and the MHRA. We have had regular contact on those issues.
I will let Frances Elliot answer that.
I understand that, but the FDA is pretty close to the manufacturer and must have some contact with it in looking at its processes. A great decision has been taken, but I would have thought that having substantive information on why the FDA made its decision would strongly support the decision that the cabinet secretary and you have—rightly—taken.
We are waiting for the final version. It will be available online and a covering letter will go to all the health boards in Scotland. We hoped that we would have it for today, but it will be available this week.
A campaigner recently emailed me to say:
“I’m advised that it’s not the role of MHRA to carry out initial investigations when adverse incidents occur.”
According to the email, the MHRA says that it has
“no independent test facility”
and that manufacturers are
“best placed to investigate.”
My question to the cabinet secretary is: who is guarding the guards here?
Thank you for that. Before I bring in John Wilson, I should just say that if Dr Elliot wishes to speak at any time she should catch my eye.
Cabinet secretary, you have written to all the health boards to ask that they suspend—
We can easily seek that information.
I am happy to go along with that course of action.
That highlights why we need a much more robust regime in Europe in relation to all of this. Clearly that is not a satisfactory situation, but I make it clear that we are aware of it. All of us—the committee, the Government and the women themselves—should submit evidence to the European Commission for the review of devices to which Frances Elliot referred. That is a point that we should all make.
Before we go to the summation, I ask Neil Findlay to comment briefly. I am sorry to press him, but we are overrunning.
You mentioned the alternatives that are listed in the information and consent booklet. Do you have any concerns about the women who are presenting today for treatment or about the alternative treatments or waiting lists?
I agree.
I, too, welcome the cabinet secretary’s announcement today that he will ask for use of the mesh devices to be suspended until the issue is resolved.
It seems from the cabinet secretary’s opening remarks that one difficulty is the accuracy of the information that is provided to the MHRA, and the information that is collated by GPs and others who are involved in treating patients who have received such operations.
What can you do to find out about historic gross underreporting of incidents among patients? We have figures of between 1 and 3 per cent, and we can bandy those around, but they cover only the reported incidents, and not the unreported ones.
The Scottish Parliament information centre briefing that we received for today’s meeting indicates that people are not obliged to report incidents. As part of the deliberations on the issue, can we get some historic data to ensure that we are dealing with accurate information, rather than information that has been provided only if and when a GP or a consultant has decided to do so?
No; the acting chief medical officer writes to all the health boards.
Frances Elliott will answer that, as it is primarily a clinical question but, before she does so, I point out that, when you see the booklet, you will find that it goes through all the risks in a great deal of detail. The text has been agreed by the working group, which includes two representatives of the patient group that represents the women. It is critically important that we look at the issue from a patient perspective because, although we might think that we are giving all the right information, if it is not absolutely clear to the patient, it will not have served its purpose. We have involved the representatives of the women who are on the group. We are determined to look at the issue from a patient point of view and not just from a national health service point of view.
I am happy to defer consideration, but I am keen to hear from the American lawyer, if he has some pertinent information to give us.
Of course. How do you think that those boards will implement the CMO’s recommendations?
I warmly welcome the cabinet secretary’s announcement but, given the statement in NHS Dumfries and Galloway’s letter that it suspended the use of such devices last year, he had no other option. I pay tribute to the magnificent campaign group that is represented in the seats behind the cabinet secretary. They should be proud today; they forced the issue and made this happen.
When we met some of the affected women last year, why did you advise me and them that you did not have the power to suspend use and that you would not suspend it because you feared litigation? At that meeting, Dr Elliot said that she would not have such a device fitted because of the concerns. According to the figures that have been given today, that delay has meant that 1,850 more women are at risk of being injured. Were you given bad advice last year? Why could you not take the decision then?
Until we are clear about the reaction to the new booklet and information, we will not be able to identify whether it will cause major issues for waiting times, although I do not think that it will. Our challenge is with the two pathways that we are developing for women who already have the implants and who have had complications or adverse effects. Providing specialist surgery or other treatment for them will be a challenge, which is why I am involved in discussions with our national planning forum, on which all the health boards are represented through their strategic planners, to consider ways in which we can introduce the pathways as quickly as possible to ensure that waiting lists do not build up for the women.
I apologise for missing the earlier part of the meeting, convener.
If the health boards receive a letter from the acting chief medical officer with the backing of the Cabinet Secretary for Health and Wellbeing, it would be highly unlikely—and highly unacceptable—if they did not agree to the request.
It would be a great tragedy if people tried to turn this into a party-political issue. We should all unite in getting a solution to the problem instead of engaging in party-political point scoring. I have acted with total faith throughout. It has been clear that the issue has required serious consideration. I have outlined the regulatory regime. Regulation of the products is the statutory responsibility of the MHRA, operating within the EU medical devices directives. Health boards have the power to suspend use. The chief medical officer will write to ask all boards to suspend use because of the evidence that we now have, particularly about adverse events and the underreporting of them. I have explained why that is the right decision.
I am sure that they will.
Will that information be discussed in the independent review and the working group? Will it be reported back?
I ask Neil Findlay to be brief, as we are very short of time.
Not at all.
The MHRA advised me yesterday that NHS Scotland could advise its institutions and clinicians not to use a particular device. They will take great heed of what the cabinet secretary says.
This is not a party-political issue. The question is why, when we knew what was going on last year and when your advisers said that they would not have the device fitted, you waited a year to make the announcement. The announcement is welcome, but it is a year on.
I agree with the proposal. Mr Slater’s evidence might well be of value publicly and to any group that is considering the matter.
It will all be made available to the independent review. We will share with it the work that we have done to date and will provide the various information booklets and leaflets, as well as the minutes and documents from our various meetings.
Thank you, Mr Brodie.
I am conscious of time, so I have a very quick question for Dr Elliot. At the evidence session a couple of weeks ago, the women who gave evidence said that it was sometimes difficult to complain about the mesh implants because, when they complained to the MHRA, they were asked for the unique identifier at the time that the problem occurred and, of course, many of the women involved did not know that. Can you confirm that that information will now appear on the GP medical notes for each such patient in Scotland?
The unique identifier database will hold that information. It should be in the hospital record and should be notified to the GP. As we introduce the new database for that, we will make sure that processes are in place to inform the clinicians who need to have that information.
To be clear, when would you be happy to take that evidence?
Naturally, we do not want women not to come forward because the treatment has changed or because the alternatives are not as readily available as they could be. Thank you.
Do you accept that that was not possible in the past, which meant that patients were in a catch-22 situation? It was impossible for patients to complain about the mesh implants, because they did not have the unique identifier.
I would be happy to have the videoconference this year, but I suggest that we defer consideration of our next steps until all the evidence has been gathered.
As the clear majority view is that we take evidence from the lawyer in the United States, I agree with that course of action.
Yes, and that is very unsatisfactory from the clinical perspective in terms of a record of what was undertaken, and for the women themselves.
We had already planned to go to Brussels in October, subject to the agreement of the Conveners Group. Assuming that we are going, do we agree to seek a meeting with the commissioner, Tonio Borg?
I whole-heartedly welcome the independent review in Scotland and the calls for the suspension of the use of such products.
On the European review, according to last weekend’s Sunday Mail, the European Commission investigation into safety issues has appointed a Dutch urogynaecologist who previously had a consultancy agreement with Ethicon, the Johnson & Johnson company that produces mesh implants. It is clearly advantageous to have experts on any review or independent panel, but do you share the campaigners’ concerns that those who have previous vested interests in the industry are involved in the European Commission’s investigation, which is completely independent of and separate from the Scottish one?
I have a follow-up question for the cabinet secretary and Dr Elliot. The cabinet secretary is going to ask the acting chief medical officer to write to all health boards, requesting them to suspend future operations. What advice will be issued to GPs and others on advising patients why the suspension has taken place? After all, while the procedures are suspended, women who had been informed that they would be going through the procedure will now be told that they are not going to go through it. How will we manage that situation in relation to the individuals involved? How do we get GPs to get the message over to those women who have been through the procedure and who have had an adverse reaction, and to women who are concerned?
Cabinet secretary, you also mentioned that some had experienced an adverse reaction a number of years after the procedure. Will specific information be provided to GPs and others so that they can advise their patients, first, on the need for the suspension and, secondly, on how women should report and speak to their GPs about any adverse reaction or worries about such a reaction?
Good morning. The UK Department of Health has been working to create a register for mesh implants. What discussions has the Scottish Government had with the department on that work?
We are establishing a database of the women who have gone through these procedures, as it is clear that the lack of a systematic database is one of the reasons why we do not have the full understanding that we need to have of why things have gone wrong. We are doing that in consultation with the women’s group as part of the work that Frances Elliot and her working group are progressing, so I will ask Frances to update you on where we are with the database.
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