Thank you, Presiding Officer; I thought you were being unduly generous.
Presiding Officer, thank you for the opportunity to make a statement regarding mesh implant procedures. I was deeply troubled when I first met with some of the women adversely affected by the implants and heard of the horrendous complications that they have suffered, in some cases altering their lives for ever. They have shown considerable courage in raising the profile of the issue and discussing publicly very personal, sensitive issues, especially when we consider that they will not now personally benefit from any changes.
Mesh implants for pelvic organ prolapse and stress urinary incontinence are classified as medical devices and governed by European Union regulations. As soon as I became aware of the anguish experienced by the women involved, I asked the deputy chief medical officer for Scotland, Dr Frances Elliot, to investigate and recommend actions to address the issues. We estimate that around 1,500 women suffering from stress urinary incontinence and 350 women suffering from pelvic organ prolapse have synthetic mesh implant surgery each year in Scotland. Those conditions result in a reduced quality of life, and I understand that traditional surgery techniques have a high failure rate—for example, of 20 to 30 per cent for primary pelvic organ prolapse surgery.
The 2012 York report, a study that was commissioned by the Medicines and Healthcare products Regulatory Agency, estimated that around 1 to 3 per cent of women experience complications following stress urinary incontinence surgery. According to the MHRA, the percentage experiencing complications following pelvic organ prolapse surgery is slightly higher, at around 2 to 6 per cent. That contrasts with a failure rate of 20 to 30 per cent for traditional surgery for pelvic organ prolapse.
The research indicated that a majority of women—around 1,450 annually in Scotland—appear to benefit from mesh tape surgery for stress urinary incontinence, without complications. There is, however, growing public concern about the number of women experiencing complications linked with underreporting of adverse events and a poor understanding as to why the complications have occurred. I do not believe that we know the real incidence of adverse events in relation to the procedures, and we are not yet able to trace implants to individuals. The Scottish Government therefore considers the following actions to be necessary to address the issue.
As I outlined at the Public Petitions Committee meeting last week, I have asked the acting chief medical officer to request all national health service boards in Scotland to consider suspending routine mesh implant procedures for pelvic organ prolapse and stress urinary incontinence. I can confirm that the acting CMO has now written to all health boards. NHS Inform has provided an information page on its website and, crucially, all boards are currently contacting patients who are listed for surgery and, where necessary, putting in place alternative pathways for those women.
As members will know, the Scottish Government does not have the authority to withdraw the products, as the matter is reserved. However, I am aware that two health boards had stopped mesh implant procedures for treatment of pelvic organ prolapse prior to my announcement last week, due to changes in staff and the small numbers of procedures that were being carried out.
The changes will support the development of any new specialised pathways. The decision to request boards to suspend the routine use of synthetic mesh for the procedures does not prevent individual women and their clinicians from agreeing on the need for a particular service, which will still be available. In addition, I have endorsed the position that, for the improvement of our future evidence, if women are being considered for entry into clinical trials, use of mesh for the conditions affected can be approved for those entered into the arms of the trial, provided that the risks that are associated with the procedure are fully explained.
I have asked for an independent review to be set up urgently to report on the issues that are raised, such as complication rates and underreporting, which have become growing concerns. The review will establish the facts and will report at the beginning of 2015, after taking account of the European Commission’s study on the devices, which is due in January. The review will look at synthetic implant procedures for stress urinary incontinence and for pelvic organ prolapse. I fully understand that they are two very different procedures, and the review will take account of that.
I can announce that Dr Lesley Wilkie, a retired director of public health, will lead the independent review. It will start next month and, as I said, will report early in 2015. The key priority for the review is to establish the facts concerning the number of women experiencing complications and the issue of underreporting of adverse events. I will ask Dr Wilkie to consult the women’s group and with clinicians and NHS boards prior to finalising the specific detailed remit for her review. I gave an undertaking that the women would be consulted, and I intend to keep to that.
In addition, the deputy CMO is chairing a working group that includes clinicians and patient representatives and which is considering the issues in more detail. The group has now met twice. I thank the patient representatives and clinicians for their on-going contribution. The group has produced a new patient information and consent booklet for stress urinary incontinence, which was published yesterday on the Scottish Government website. The booklet clearly demonstrates to women, before they make a decision on whether to proceed, the risks that are associated with the procedure and the available alternatives. The information in the booklet will be the absolute minimum information that is provided to patients in future by NHS boards.
Two patient guidance booklets are being developed that set out the pathway for the management of pelvic organ prolapse and for women who present with complications. The deputy CMO will work with NHS colleagues and the women to develop the service as a matter of urgency.
I can confirm that, in the past year, the CMO has written three times to all general practitioners, through medical directors, alerting them to the possibility that women may suffer complications following insertion of the mesh implants, and that all adverse events should be reported to the MHRA. I recently received correspondence from the Scottish pelvic floor network proposing that MHRA reporting of complications should be made mandatory, and I have responded to say that I agree with that proposal.
As members have heard, mesh implants are classified as medical devices and are governed through the EU medical device directives. The MHRA is the competent authority in the UK and has responsibility for the removal of any device from the market for the whole of the UK. Evidence is required for the MHRA to take such a step, which is why the research that we are supporting is so important.
Individual medical devices are subject to procedures that are set out in the EU directives and followed by manufacturers to gain a CE conformity marking, which is awarded by notified bodies. The MHRA oversees the work of those organisations and performs regular audits. The rules for classifying medical devices apply in all EU member states.
I have previously spoken to the MHRA’s chief executive and medical director, and yesterday I met the chairman, Sir Gordon Duff, and the medical director. I was reassured in discussions that they are taking the issue very seriously, and they have confirmed that they are happy to participate in the Scottish review in addition to the work that they are undertaking.
I have also written to the European Commission, which is currently working towards formulating a scientific opinion on the safety of the devices—as I said, that work will be available in January. The chairman of the relevant scientific committee has assured me that they are taking the issue very seriously, and I have requested that, if they can take further action before the research is available, they should do so.
We are aware of the US Food and Drug Administration’s proposal to reclassify the mesh device for pelvic organ prolapse from moderate risk to high risk. Currently, Europe has given a IIb classification, which represents moderate to high risk.
The Scottish Government will participate in the UK working group, whose remit includes determining the means of ensuring the clinical quality of procedures involving tapes and meshes for the treatment of stress urinary incontinence and pelvic organ prolapse. The group will meet for the first time next month.
In conclusion, I reassure members that we are taking every possible action to address the issues with mesh implants and to improve the situation. I am happy to take questions.
The member asked intelligent questions, which, as usual, were fairly put.
On the latter point, there is barcoding for some products but there is no database of the mesh that has been used in a particular woman at a particular time in a particular hospital. Therefore, we and the MHRA are—and have been since the women brought the issue to our attention—engaged in an exercise to create a database for future use, so that we will always know not only how many procedures took place but which mesh was used in which procedures, in which women, and in which hospitals, so that if anything goes wrong we can trace back and establish the type of product that was used.
Unfortunately, to date there has been no such database, which is one of the reasons why the information that is available to us is so sporadic and, to be frank, unreliable in the context of measuring adverse events.
On guidance to women who have had implants, the chief medical officer has instructed that guidance be issued to all women. Our immediate priority is women who are due to have a procedure in the immediate future, who are all being contacted as we speak to invite them to a consultation with the relevant consultant, so that he or she can map out a pathway for them, given that they will obviously need help during the period ahead. Secondly, we will issue advice to people who have already had implants, about how they can find out whether they are likely to have problems in the future.
I know of a case in my constituency in which the mesh implant only caused a problem 12 years after it had been implanted. That is another reason why we need much more in-depth study; there has been no longitudinal study of the impact of mesh implants or longitudinal analysis of the incidence of adverse events. Without such analysis, it will be much more difficult to reach an evidence-based, scientific and objective conclusion about what is going wrong in many cases and why.
As for conversations with the Department of Health, I have to say that our main conversations have been with the MHRA. That said, all the UK departments of health are involved in this issue through the MHRA and they are all represented on the MHRA working party. Furthermore, because the matter is very much guided by EU directives, we are through the MHRA in touch with all the health departments in Europe, and the MHRA itself is now working closely with the Food and Drugs Administration in the United States.
This is very much a global problem. Last week, I had an email from a lady in New Zealand who has had problems similar to those that were outlined by the ladies who presented to the Public Petitions Committee. It is a world-wide phenomenon and, as the MHRA has pointed out to me, Scotland is actually the most advanced in trying to get to the bottom of why these adverse events are taking place.
I think that in evidence to the Public Petitions Committee, the medical director of NHS Dumfries and Galloway said—it was certainly reported in the press—that Dumfries and Galloway had suspended the procedures. In fact, NHS Dumfries and Galloway has stopped the procedures; it did not suspend them, because it has no intention of reinstituting them.
The fact is that we are looking at creating centres of excellence for the procedures, because one of the problems in NHS Dumfries and Galloway was that the throughput of patients was inadequate for keeping up the required quality. In the end, the health board decided to stop the procedures, and the expert that it had employed no longer works there. However, because of the way in which that was reported in the press, it appeared that NHS Dumfries and Galloway had suspended the procedures, which suggests that it might reintroduce them. That is not currently its intention.
In terms of potential conflict of interests, I spelled out to the Public Petitions Committee last week that I will ensure that whoever is appointed to lead the review will have no potential conflict of interests and, in particular, no previous or current contractual relationship with the manufacturers. I can confirm that Dr Wilkie fits the bill: she has no such previous or current contractual relationship.
As for the review itself, as I said in my statement I am asking Dr Wilkie—as her first step—to sit down with the women and agree the remit for the review in detail because I want to be absolutely sure that we satisfy them. We owe it to them to ensure that the review is comprehensive enough to cover all aspects of their concerns. Obviously, Dr Wilkie will also consult the clinicians and NHS boards. I will confirm the detailed remit to the chamber at the appropriate time.
On advice, there is clear direction from the CMO about the need to offer all women a clear pathway in relation to their treatment—especially women who were due to have procedures in the immediate future, as I said earlier. There are a number of ways in which they can be supported—weight loss is one of them—and that support will happen. We will ensure that all the women who are on the waiting list are contacted and offered a special session to get advice on the way forward and to work out a pathway in co-production with clinicians.
First, on discussions with the manufacturers, clearly the whole purpose of the work that is going on in Europe, in the UK and in Scotland is to find out exactly what we need to do to guarantee the future safety of any of the procedures and the use of particular products.
There will be a strong interface with manufacturers as part of the work that is being done because we want to be absolutely sure that we identify whether, in most cases or in any cases, the actual products—and there are varied products—have been the problem, whether the procedure has been the problem, or whether it is the procedure and the products that have been the problem. That is clearly one issue that we need to focus on to get to the bottom of why the implants have gone wrong in so many cases.
As for women who have had an adverse event and a bad experience and whose health has been damaged as a result of the procedures, I have said from the beginning that we will ensure that any medical assistance, including any further procedures, that those women require and which they agree with their clinician will be provided on the national health service. We will ensure that that happens.
Order. Mr Findlay.
I welcome the statement today and the announcement that the cabinet secretary made last week at the Public Petitions Committee. I also welcome the announcement about the booklet outlining the associated risks of the procedure. Does the booklet contain information on the possibility that, following the procedure, women may not be able to have children? Also, how can patients feed back concerns about the lack of information that would allow them to make informed choices prior to the operation?
I intend to allow the statement to run on for a bit more time, because a number of members still wish to ask questions. The issue is important and sensitive. The consequence is that decision time is not likely to take place until quarter to 5. We will sort out the procedural bits later.
As a member of the Health and Sport Committee I welcome today’s statement and I compliment the cabinet secretary on his action. The cabinet secretary said that alternative care pathways would be developed for women who have suffered complications and women who decide to go ahead with a mesh procedure. Can the cabinet secretary offer any guidance on how quickly those pathways could be in place?
I have the “Synthetic Vaginal Mesh Mid-urethral Tape Procedure for the Surgical Treatment of Stress Urinary Incontinence in Women” booklet in front of me. For the sake of ensuring that I cover this properly, I will list what it covers in its 18 pages. It includes an explanation of terms, a definition of stress urinary incontinence, alternative treatment options, what the synthetic vaginal mesh tape procedure is, possible risks of the procedure, useful resources, questions that women should ask their surgeon, what their expectations should be from surgery, and the consent form. It is a detailed booklet and I am happy to ensure that a copy is placed in the Scottish Parliament information centre so that all members can see exactly what issues are covered in it.
The scale of underreporting suggests that the rate of adverse events is far higher than anyone has officially estimated it to be.
Let me give the figures that underlie my concerns, just on SUI tape procedures. It is estimated, based on the York report, that in Scotland up to 45 women per year experience complications after such a procedure. However, although in one year the total number of cases reported to the MHRA by healthcare professionals was four, the total number reported to the MHRA by the public was 110. There is clearly a problem.
In my job I must base my decisions on evidence. It is the evidence that led me to take the decision to make a request to health boards. I do not have the power to tell health boards to suspend operations willy-nilly. Nor do I have power over the product itself, because, as I explained in detail in my statement, that power is reserved and lies with the MHRA, which works within the overall EU directive.
I, too, thank the cabinet secretary for an advance copy of his statement. Sadly, we are where we are. What will be the care pathways—apart from weight loss—for adversely affected women? Will a specialist centre be set up to deal with and perhaps develop removal techniques to address the problems? Perhaps that could be in Glasgow; there may already be a de facto centre. If so, has a budget been allocated or will one be allocated?
The chief medical officer has already contacted all the health boards to make sure that the clinicians get in touch with the women affected to offer and arrange early appointments with them. Each woman will go through with her clinician what the most appropriate pathway is for her. It is extremely important that, first, we do that for every woman who could be affected, which is everybody on the waiting list; secondly, that we do that quickly; and thirdly, that we do it in terms of the advice that is on offer. There is already fairly extensive advice on a range of issues relating to this from the National Institute for Health and Care Excellence and other sources, all of which is already in the hands of the health boards and clinicians. The chief medical officer will be keeping a very close eye on the issue of guidance on the different pathways available to the women.
We are already working on the latter issue. Before the suspension was requested, most health boards provided one or both of the procedures. I stress that they are two different procedures—there is commonality on the problems, but we need to address both procedures separately. There is undoubtedly some division in the clinical community about the safety of tapes versus the safety of meshes. Clinicians do not all agree with each other about that.
We are looking at the future delivery of all services that relate to the procedures. That includes dealing with the complications and the consequences of complications.
It is clear that we need areas of expertise rather than necessarily to have procedures widely available across the country. In some places, as in Dumfries and Galloway, the throughput of women did not really meet the new standards on patient safety more generally. For some procedures, it is important to have a high throughput so that clinicians can maintain their high standards and upgrade their skills continually to meet changes in technology.
The work is under way. I expect it to be concluded at the turn of the year, when we will allocate budgets to health boards if they are to host any centres of excellence in relation to the procedures.
As I have said, the chief medical officer will issue details on the pathways that can be offered to women, which include weight loss and—in theory—a traditional operation, although the failure rate of operations is such that we and boards would not recommend them. Another option is to wait for the results of the reports. If women can suffer their problems long enough to take that option, they can see what is and is not safe, which will put them in a better position to make their own judgment about the procedure that they want to have.
I thank the cabinet secretary for advance sight of his statement. I pay tribute to my constituent Elaine Holmes, who together with others I helped to support when she presented her petition to the Public Petitions Committee. Her evidence was highly emotional, compelling and brave. The cabinet secretary’s response is brave, too.
Has the cabinet secretary had conversations with the Department of Health since his announcement? Have health departments from other countries been in touch with him?
A tremendous number of women who believe that they have had a successful implant might now be reading that late complications can arise. What reassurance or guidance will the minister make available to women who have had a mesh implant and who might now have a concern that they did not have a week ago, before the announcement?
Given that a number of health issues arise from implants more generally, will the Scottish Government consider leading a campaign to ensure that all implants are barcoded in future, so that when issues arise, perhaps some years after the event, we are able to establish who has had an implant and might therefore need to be consulted or reassured?
Will the cabinet secretary consider requests for a funded support service for those affected and will he ensure patient involvement in any such group, which he acknowledged is vital? These women deserve our support.
I anticipate that that will be one of the bits of work that the review will address, and work is already going on regarding what support is required in addition to the medical support. Medical support is the immediate priority and I have made it absolutely clear that whatever medical support these women need, they will get. Any additional support would need to be identified systematically, and then we would look at what has to be provided, where it has to be provided, how much it would cost and how it would be funded.
Thank you for extending the statement to allow me to ask my question, Presiding Officer.
Mesh implants have created great misery for some—misery for one being misery for one too many. What assurances can the cabinet secretary give that the MHRA and the relevant European authorities that issue product directives will be asked to review their practices, processes and legal responsibilities, to avoid similar events in future, and to carry out that review quickly? What positive involvement and direct role does he see for Scotland in that process?
As I said in my statement, I have already written to the European Commission, and although the MHRA is a statutory body for the United Kingdom, clearly we want to have direct dialogue with the European Commission to satisfy ourselves that everything is being done objectively to address all the issues.
Mr Brodie’s points are the subject of the discussions that we are having with the MHRA and that we want to have with the European Commission, particularly in terms of its current review, which is due to report in January 2015.
On a point of order, Presiding Officer. In his answer to my question the cabinet secretary suggested that I was quoting from press reports. I quoted from a letter from NHS Dumfries and Galloway to the Public Petitions Committee, which is available on the Parliament’s website. Can you advise how the cabinet secretary can amend his statement to give the accurate position of NHS Dumfries and Galloway?
I was not saying that Rhoda Grant was quoting from the press report. I was quoting from the press report.
Thank you, cabinet secretary. That ends the statement and questions.
The next item of business is a statement by the Cabinet Secretary for Health and Wellbeing, Alex Neil, on an update on polypropylene mesh devices. The cabinet secretary will take questions at the end of the statement, and there should therefore be no interventions or interruptions. It would be helpful if members who wish to ask a question of the cabinet secretary pressed their request-to-speak button now. Cabinet secretary, you have around 20 minutes or so—no, you have 10 minutes; it is 20 minutes for questions, which makes half an hour.
15:01
All surgical procedures in the NHS must be based on the latest clinical evidence, backed by robust data and open and transparent record keeping, but does the cabinet secretary agree that the most important factors must always be the patient experience and patient safety? Will he commit to ensuring that the voice of patients through the Scottish mesh survivors group and the hear our voice campaign continues to be heard during the independent review process and at all decision-making levels?
Absolutely. I stress that it is important to involve the patients. The working group that is operating under Dr Frances Elliot’s leadership already contains two representatives from the women’s group. Such representation is extremely important at every level. Nobody knows better the consequences—particularly of the adverse events—than the affected women.
I thank the cabinet secretary for early sight of his statement, and I welcome the action that he has belatedly taken to suspend the use of polypropylene mesh.
However, the cabinet secretary’s statement and his year of dithering throw up many more questions than they answer. Almost a year ago, in rejecting the call for the suspension of the use of mesh, the cabinet secretary claimed, first, that he had no power to act and, secondly, that he could not act because he feared litigation by the manufacturers. He also claimed at that time that the number of women who had experienced problems with mesh was very low.
How many women have had complications following mesh surgery for stress urinary incontinence or pelvic prolapse, and how many have had to have the device removed? What advice have those women been given since the cabinet secretary’s announcement?
Given the limited number of consultants available in Scotland to deal with mesh complications, and the fact that some patients are waiting five months for a review appointment, will the cabinet secretary agree to fund health boards to allow patients to be seen elsewhere in the UK? It is my understanding that, at present, some health boards have advised mesh victims that they will not fund out-of-area consultations.
Why, a year ago, did the cabinet secretary claim that he had no powers to act when clearly he did? Who gave him that advice, and will he publish it? When did the cabinet secretary become aware of the fact that NHS Dumfries and Galloway had acted last year to suspend the use of mesh despite his protestations that he did not have the powers to act?
How many more women have been treated with mesh during the cabinet secretary’s year of dithering? Why did he fear litigation by the manufacturers a year ago when he apparently does not fear it now?
Finally, I pay tribute to each and every one of the mesh victims. They were doubted by some in the medical profession and let down by the cabinet secretary. They deserved better, and they deserve answers now.
It is a great pity that the Opposition spokesman for the Labour Party can never rise to the occasion. I would have hoped that members in the chamber would be united on the matter.
I will give the facts, because I know that Mr Findlay sometimes confuses facts with arguments. In the latest full year for which figures are available, which is 2011-12, there were 313 POP mesh procedures and 1,436 SUI tape procedures. In that same year, the York health economics consortium report showed that the estimated complication rates for POP procedures were between 2 and 6 per cent, and for SUI tape procedures between 1 and 3 per cent. That was the evidence that was available to me last year.
I should point out that it is a very serious matter to suspend any procedure, particularly when a total of 1,700 to 1,800 people are going through those procedures and the official figures show that for 95 per cent of them the procedure is successful. What has convinced me is that after discussion with the MHRA it became clear to me that the scale of underreporting of adverse events was far higher—[Interruption.] I will get it from the scientists, Mr Findlay, not from you. [Interruption.]
Will the cabinet secretary advise campaigners who are here today what support will now be offered to mesh patients who have already undergone a traumatic experience and are now left with health complications? Will he also advise what discussions he will have with the European Commission on the regulatory regime, given that manufacturers are the ones who are apparently policing the devices when adverse incidents are reported, and will he note that the MHRA, by its own admission, has no independent test facility?
I, too, welcome all the actions that the cabinet secretary has taken to address the very serious concerns that have been raised about mesh implants. Professor Don Berwick commented that thanks to the Scottish patient safety programme, Scotland is
“the safest nation on earth from the viewpoint of healthcare”.
How has the collaborative approach that has been taken in the patient safety programme informed the Government’s approach to mesh devices?
The main motivation for asking the health boards to suspend the treatments is patient safety; after all, the issue is not just the adverse events themselves but the horrific impact on women when things go wrong. It really ruins lives, which is why patient safety and quality must be absolutely at the top of the healthcare agenda. Indeed, that is why, according to Professor Don Berwick, who is, of course, an adviser to Prime Minister Cameron as well as to President Obama, Scotland has the safest health service in the world.
The approach fits very well with the patient safety programme’s overall governing philosophy, which is that patient safety, alongside the quality of care that we provide, must be the number 1 priority. Because of that approach, a recent Canadian study rated the Scottish and, indeed, the UK health services as the top health services in the world.
I must notify members that I am going to struggle to call everyone who wishes to speak or ask the cabinet secretary a question. Nevertheless, I will do my best and press on.
I wonder whether the cabinet secretary will clarify a statement that seems to run contrary to a comment by NHS Dumfries and Galloway, which has said:
“Following the concerns that have been raised nationally and internationally we have taken a local decision to suspend the use of meshes and this has been in place since last year.”
As for the review, what will be its remit and terms of reference? How will the cabinet secretary ensure that there is no conflict of interests, and that the concerns and experiences of the women who have been affected will be at the very heart of the review? Finally, what alternative treatments will be available to women who are suffering from the conditions?