Meeting of the Parliament

Meeting date: Wednesday, September 12, 2018

Official Report 1235KB pdf

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Transvaginal Mesh

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.

14:11  

I am grateful for the opportunity to make a short statement today on transvaginal mesh in NHS Scotland. I was appointed Cabinet Secretary for Health and Sport less than 80 days ago. Since then, this issue is among those to which I have given my highest attention.

I expect that most members of this Parliament have received letters from or met women who have suffered significant and life-changing complications following vaginal mesh surgery. I think that we would all want to acknowledge the bravery of the women who have come forward to tell their story—doing so would be by no means easy for them, given their pain, the impact on their lives and the very sensitive nature of the problem.

As members will be aware, regulatory power over medical devices is reserved to the Medicines and Healthcare products Regulatory Agency and the United Kingdom Government. However, within the limits of the powers that are available in Scotland, progress in restricting the use of mesh and improving surgical consent procedures has been made under the guidance of my predecessors Alex Neil and Shona Robison.

In 2014, in response to concerns about safety, the then acting chief medical officer requested that health boards suspend the use of vaginal mesh. That led to a substantial reduction in mesh implant surgeries. An independent review of the use of vaginal mesh was established, and a final report was published last year.

As a result of the recommendations made by the review, which are similar to those that have been made in other reviews across the UK and further afield, a number of actions are being taken. The development of clinical pathways is being progressed by individual health boards and through work at regional level. Management of patients throughout the care pathway has been considered, including care for women who experience complications from treatment.

It has been stressed that the care for each and every patient must be considered by a multidisciplinary team, and that that must occur in all cases. In addition, the need to restrict the number of surgeons who undertake procedures has been highlighted to medical directors, and application of existing National Institute for Health and Care Excellence guidance on a minimum number of procedures to ensure sufficient experience has been advised.

Healthcare Improvement Scotland has established an oversight group, which is reviewing evidence and trends in procedures and reported adverse events. The group’s work will influence the nature of clinical pathways and provide high-level external review.

The chief medical officer, Dr Catherine Calderwood, has been clear that all patients must be provided with information to help them to make informed decisions about their treatment. Scottish Government officials are working in partnership with colleagues from the Department of Health and Social Care in England and the devolved nations to establish a mesh registry, which will collect information on all procedures.

The CMO has continued to keep the issue under review. She and I have listened to the voices of the women who have been affected, and we have discussed what steps would be necessary that would satisfy me that every action has been taken to ensure that the national health service treatment options that are available are as safe as possible, irrespective of the views of the MHRA.

As a result, I have today asked the chief medical officer to instruct health boards immediately to halt the use of transvaginal mesh altogether in cases of both pelvic organ prolapse and stress urinary incontinence, pending the implementation of a new restricted use protocol that will ensure that procedures are carried out only in the most exceptional circumstances and subject to a robust process of approval and fully informed consent. Such a halt in use will not affect other uses of mesh—for example, transabdominal and in hernia repair—but we will continue to keep those areas under review.

The instruction to halt is, I believe, a proportionate measure while a rigorous, high-vigilance restricted use protocol for any future practice is developed and put in place. The lifting of the halt in use can be considered only once there is confidence that there is sufficient evidence that the protocol will be triggered in only the most limited of circumstances, informed by any new evidence and the forthcoming NICE guidance on the management of pelvic organ prolapse and stress urinary incontinence that is expected in the spring of next year.

There is one exception to this effective ban. A very small number of women are presently waiting for a mesh procedure under the treatment time guarantee. Such operations will be allowed to go ahead, provided that that is the women’s express wish and that their clear, informed consent is demonstrated.

The chief medical officer will write to health boards today to set out the high-vigilance restricted use protocol to be implemented, many elements of which are already occurring as a result of the recommendations of the independent review. The purpose of the protocol is effectively to ensure that transvaginal mesh is not used in Scotland’s NHS save in the most exceptional circumstances, when there is absolutely no clinical alternative and it is the fully informed and consented wish of the woman concerned.

Subject to the evidence, should the halt be lifted, transvaginal mesh would be available in the NHS in Scotland only under the restricted use protocol, which would require the health board’s medical director—who would become the accountable officer—to consider and agree each case individually, taking account of the clinical evidence, and would be subject to evidenced, informed and voluntary consent being obtained from the woman. The medical director will therefore be responsible for signing off the use of transvaginal mesh on an individual named patient basis, and no such mesh will be able to be used or procured by a surgeon except under those circumstances.

Even in those circumstances, and with those requirements, NHS procedures will then be permitted only in a very small number of designated centres of expertise, and only where the woman concerned has made the choice, with full information, to have such a procedure by using transvaginal mesh. Health board medical directors will be responsible for ensuring that the appropriate high-vigilance process is followed in each individual woman’s case. Clinicians will be asked to document and retain confirmation of the information provided to patients, the agreement and consent of the patient, and the discussions of the multidisciplinary team assigned to the case. They will ensure that every patient is given documentation that details their procedure, the product used and the name of the surgeon. They will document all procedures in a local or national registry, report all complications to Health Facilities Scotland’s incident reporting and investigation centre, and give patients information on how to report any complications. The chief medical officer will also make it clear that this high-vigilance procedure must apply to all treatments for pelvic organ prolapse and stress urinary incontinence—not only when the treatment option is mesh.

Finally, the chief medical officer has announced a prospective audit of all procedures carried out in Scotland in future, which will run until such time as a UK-wide registry, which I touched on earlier, is developed.

In addition to the measures that are being taken directly by the CMO, the further NICE guidance that I have already mentioned is expected to be available for consultation in October and November of this year. We will, of course, consider any additional recommendations that are given in the guidance when it is published and take those into account when treating women in Scotland, regardless of the treatment chosen.

As the power over the approval of medical devices is a reserved one, the instruction to halt that we are instigating cannot extend beyond the bounds of NHS Scotland.

The measures that I have set out are intended to underline the clear message and my determination that our care is as safe as possible and that patients are listened to, are heard and, when confronted with decisions on their care, have the full facts available so that they can make informed decisions.

I thank the women who have campaigned tirelessly on the issue. I hope that all we have done, including the additional measures that I have announced today, gives them confidence that we have heard what they have said, taken their concerns seriously and, within the limits of our powers, acted.

I welcome the cabinet secretary to her post. As one of those who has been associated with the issue for a long time, I will want to reflect and consider with care the statement that she has just given.

However, I welcome the statement. It seems to me, and I hope to many others, to be a decisive step on a pathway to a different approach to the whole question of mesh. I hope that Elaine Holmes, Olive McIlroy and all the women who I hope are watching this afternoon can at least give one qualified cheer for the progress that it represents while recognising and paying tribute to Eileen Baxter and Michele McDougall, the women who have died—one directly and the other indirectly—as a result of this medical process.

It is an unhappy coincidence that the process has been available since 2007, but I consider that a Government of any stripe would have embraced it. It is only in recent times that many have felt that, in the face of evidence, we have not been pursuing the path that is clear and singularly appropriate. There is still an opportunity for the Government and this Parliament to apologise to all the women across Scotland whose lives have been so irredeemably and irreversibly compromised by the mesh scandal.

The cabinet secretary mentioned the MHRA. This is not an issue of whether the power on medical devices is devolved or reserved; it is not an issue of party politics. I repeat the offer that I have made here before. I am happy—as are others in this chamber—to join the Scottish Government in making the strongest representation to the UK Government that the MHRA has proven to be a hopelessly ineffective vehicle for considering the appropriateness of the mesh transplant implant process.

Is the high-vigilance restricted use protocol a completely new procedure, or is it a new protocol? I ask in order to know only whether it is a process that has been available to the Government and it chose not to implement it, or whether the cabinet secretary has identified a different way forward.

Alex Neil previously wrote to health boards with guidance. Although I know that such matters fall within the domain of medical directors, the advice was set aside and not always followed in the way that the Scottish Government had intended it to be. What enforcement is available to the Scottish Government to ensure that the new protocol is absolutely and rigorously applied?

Finally—at least for today—I say well done, cabinet secretary.

I thank Jackson Carlaw for his comments. I commend him on the wisdom of wanting time to reflect on what I have said—he had only limited sight of my statement, albeit that he got it before I stood up to speak—because this issue deserves mature reflection and continued consideration.

I am happy to take up Jackson Carlaw’s offer to join us in making representations to the MHRA. My predecessor, Ms Robison, wrote to the MHRA, and we have raised the matter with it. However, I am happy to look at the issue again and discuss it further with him.

Jackson Carlaw asked whether this is a new procedure or a new protocol. It is not a procedure. It is a protocol that is designed to put in place further steps that will restrict the use of the procedure and of mesh in these instances. It does so in a way that allows for clinical judgment and gives assurance that women are fully informed and have given voluntary consent on the basis that they know all the options that may be available to them and the consequences of those options as best as they can be anticipated, but which makes the medical director of a health board the accountable officer for ensuring that every step in the high-vigilance protocol has been taken. If all those steps have been taken, that triggers the use of mesh in those very limited circumstances, provided—as I said and keep repeating—that the woman has given her fully informed and voluntary consent, and that that is evidenced, as I read out.

When it comes to ensuring that health boards are compliant, the chief medical officer has today instructed health boards to halt the use of transvaginal mesh in the two procedures that I identified. We have a number of steps that we can take to ensure that boards are compliant with the measures that I have read out today and what my predecessors put in place. That includes the engagement between the CMO and medical directors, the involvement of Health Improvement Scotland in looking at how boards perform and what they do on such matters and ministers’ annual review of health boards, as well as the work that is undertaken on a regular basis by officials in the health directorate and boards to ensure that all the necessary steps are taken.

We will give thought to whether there is more that we can do on that, but we should take the time to hear and consider the views of the medical directors and the clinicians involved, as well as other voices. There is a degree of potential further work that we might do to ensure compliance that we should take a bit of time to reflect on.

The cabinet secretary has made an appeal for mature reflection, but it is sometimes difficult to engage in mature reflection when looking into the eyes of people whose lives have been ruined.

I thank the cabinet secretary for providing early sight of her statement, and I warmly welcome today’s decision to halt the use of mesh in Scotland, which I and the Scottish mesh survivors have been calling for for the past six years. If the Scottish Government had acted at the time, thousands of women would have been spared the enduring anxiety and misery of lost mobility, constant pain, ruined lives and even the possibility of death, which we know exists because of what happened last week.

We know that the MHRA is not fit for purpose—I agree with Jackson Carlaw on that—but successive Government ministers have hidden behind the MHRA. They have used it as a shield and have claimed that medical devices being a reserved matter has prevented the Scottish Government from acting. Today, that claim has been exposed as the bogus smokescreen that we all knew it was. All the steps that have been announced today have been suggested by the mesh survivors for years.

Will the cabinet secretary confirm that the procedures that she has put in place today bring Scotland into line with what is already happening in the rest of the United Kingdom? Will she confirm that the claims that were made in the media last month by the chief medical officer about Scotland having a more robust system were wholly misleading?

Does the cabinet secretary accept that the independent review of use of mesh was, indeed, a whitewash? When will the review of the review be published? Does she have it on her desk?

Does she accept that the campaigners’ demands have been right all along? Will she now—in very clear and unambiguous terms, and without ducking the question—accept that the evidence that was available in 2014 was stark and more than enough to have allowed consecutive cabinet secretaries to take the action that she has taken today in order to have prevented many more women from being horribly injured or leading lives of anxiety and uncertainty?

Finally, how will today’s decision and its implications be communicated to all past and present mesh patients?

I thank Mr Findlay for those comments.

I want to make a point about what I mean by “mature reflection”. I do not expect anybody in the chamber, other than those who have held the post of cabinet secretary for health, to feel sorry for me in doing the job that I have to do: it is a brilliant job. However, it always involves careful balancing of evidence from more than one source. It is, of course, entirely the right and the responsibility of Opposition members to argue their case hard, but mature reflection requires that while we acknowledge that it is absolutely the case that very many women have been damaged by the procedure, we also acknowledge that it has helped some women. Mr Findlay will have received the email that I received only last week from a woman who pointed out that no procedure had helped her but this one. It is not possible to be so binary on some such matters.

What I have said today is that I will listen to the voices of the women who have campaigned on the matter, look again at the evidence and decide whether there is more that we can do. What I will not do is agree with Mr Findlay that what our chief medical officer said was “wholly misleading”, because it was not. Nor will I agree that what I have set out brings us

“into line with ... the rest of the United Kingdom”.

In fact, it takes us ahead of the rest of the UK. We have taken steps beyond what the rest of the UK has done, and we have done so because I consider that to be proportionate and justifiable.

The review of the review is independent, and I do not know when it will be published. It is certainly not on my desk at this point in time. I expect that we will all know at the same time, broadly speaking, when it is published and we will then be able to look at the matter.

As I said, what I am doing today is recognising the evidence that is before me, recognising the importance of clinical decision making, and recognising that I, as a politician, like everyone else in the chamber, am not a clinician, and will therefore try to make the best decisions for safety and care in our health service—in particular, for those who come to it for care and support.

I believe that what I have set out in the statement takes us in that direction. I am not closing the door to further issues that may arise—we will always be happy to look at them—but today we are able to say that we have heard what the women have said, and that we have put in place steps that will ensure that any woman who comes forward can be confident that she will be given all the information that she needs, and the opportunity to make a fully informed and voluntary choice about what happens to her body.

I, too, welcome the cabinet secretary’s announcement, and I thank all those whose work has got us here—although I also think that it is fair to say that the halt is overdue.

The cabinet secretary said in her statement that the procedure will be permitted only when a woman makes the choice with “full information”. Will a woman who chooses to go ahead with a transvaginal mesh implant be informed of the decision that the Government has taken today, and will she have an opportunity to meet people whose experience informed that decision? The women whom I met in Parliament said that their lives had been limited because of incontinence, but not to the extent that they are limited now, by having to use crutches and wheelchairs. Their relationships have also been severely impacted. I just want to understand what “full information” means.

We have today put in place a halt to the procedure, with the exception of the very small number of cases that we have identified of women who currently have a treatment time guarantee in place. They, too, will be given the opportunity, in the light of what I have set out today, to determine whether they wish to go ahead with the treatment.

The halt will be lifted only when we have absolute confidence that all the steps that I have outlined are in place, including the high-vigilance protocol. At this point, there is a halt, with the exception of the cases of women who currently hold a treatment-time guarantee and who still, in the light of all the circumstances and what I have set out—of which they will be advised—wish their procedure to be carried out.

There will be no other procedures using mesh, as I have described, until we are certain and confident that all the steps that I have outlined are in place. That will involve making sure that we can evidence the situation as fully as possible so that any woman who, in the future, is presented with that treatment option has full information on what the option entails, on previous complications, on clinical advice and on alternatives, so that she can take time to discuss the matter with her family before she makes a decision about what might be best for her to do.

In devising what the full information might be and how fully informed consent would be evidenced, I am, of course, open to propositions being made to me by members, as well as by groups around the country.

I am grateful for advance sight of the cabinet secretary’s statement and for its contents.

I have a constituent who has a hernia mesh problem. She has to go to London to have it removed. Will the cabinet secretary cover what the touchstones of the hernia mesh review will be and when that will be revisited? What provision will the NHS in Scotland make for surgery to remove mesh implants where it is appropriate to do so? What consideration is the cabinet secretary’s Government giving to compensation for survivors of mesh implants?

On the use of mesh for conditions other than the two that I have mentioned, the halt that I have advised members of does not apply to those other procedures, because we have no evidence at this point that would justify that. However, we will keep the situation under review. By that, I mean that we will constantly review whether evidence is coming forward from our boards and internationally or otherwise that suggests that we should look to take different steps in those circumstances.

Mr Cole-Hamilton asked about arrangements for removing meshes. I cannot give an answer to that question in detail today, but I would be happy to get back to him on it.

With respect to compensation, there is a procedure in place—I am sure that women are informed of it, but if they are not, we will certainly ensure that they will be—that women can use to have their case considered and to determine whether they are due financial compensation for a procedure that the health service has carried out.

I am conscious that at least 11 more members wish to ask a question. The issue is very sensitive and emotional for many. All the front benchers have had a chance to make a point. I ask all members to keep their questions succinct and the minister to be succinct in her answers.

I, too, very much welcome the cabinet secretary’s statement, which laid out a clear direction of travel. At long last, her foot is on the accelerator.

Is the cabinet secretary satisfied with the enforcement procedures in the national health service to ensure that, this time, her instructions will be carried out in full, unlike what happened when I issued the suspension request four years ago?

I suggest that the three or four health ministers in the UK—there are currently three—get together and agree a programme of action to deal with the MHRA. All parties agree that it is totally unfit for purpose. Any regulator that is funded by those whom it regulates is not fit for purpose, and any organisation that does not test devices before it authorises their use in the national health service is completely failing in its duty. The issue is not the only one in respect of which the MHRA has failed patients across the UK, and dealing with it is an urgent requirement if we are going to put an end to such incidents and examples of devices being misused, as has happened in the case of mesh.

On the question of whether I am satisfied that the instructions that have been issued and the requirements that I have set out will be followed, I have already set out what the procedures are, but I am interested in considering whether we need to do more in to ensure that the halt is adhered to. The halt is a halt, and it will not be lifted until I am satisfied that all the steps that I have put in place are understood and will be enacted. I hope that that gives some assurance. We will certainly consider whether there is more that we can do.

The point about health ministers elsewhere in the UK is interesting, as I have been discussing inviting them to Scotland to discuss matters of common interest. We are likely to pursue that approach and, should they accept the invitation, I am happy to include the MHRA in that discussion.

I sincerely hope that today is a step in the right direction and will help to regain the confidence of men and women across Scotland. Given the restriction of use announced in the past and the instruction to halt today, what guidance has the cabinet secretary issued to health boards about additional costs associated with more complex treatments and procedures, and the need for that not to form part of any consideration? It is clear that, since the announcement of restriction of use was made, some health boards have carried on with the use of the method, most notably NHS Greater Glasgow and Clyde, whereas other boards, such as NHS Grampian, NHS Ayrshire and Arran and NHS Tayside have completely stopped using it.

As I said earlier, the instruction that the chief medical officer issued today advised people of the halt of this procedure in relation to everyone apart from those women who have the treatment time guarantee. I have also outlined the situation with regard to the procedure being brought back in any respect.

On the issue of instructions to health boards about cost, I have made it clear to health boards that they should not be removing capacity in any respect on the ground of cost. That is not my expectation of how they should be delivering services in the name of the national health service in Scotland.

I will reflect on what Mr Briggs has said and will consider the evidence for myself. If I think that such considerations might be a factor in a health board’s decision about how it enacts what we have set out, I will make it clear to it that cost should not be a factor in its decisions about alternative treatments.

I understand that NICE is currently carrying out a further review of the mesh. Can the cabinet secretary confirm that the halt will remain in place at least until the new guidance is completed? Can she advise how members of the public can provide their views to this further review?

The halt will certainly remain in place until I am satisfied that all the steps that I have outlined are in place and will be followed. That includes the high vigilance protocol in terms of use.

The NICE guidelines, which we expect to be consulted on soon, will be part of that, but they will not in themselves be the trigger for the lifting of any halt that we have put in place today. They will inform that decision, but they will not be the trigger.

With regard to how members of the public might be involved in the consultation exercise, we will ensure that the Scottish Government website has the necessary link for people to follow so that they can provide their views, and I urge members to make that available via their own channels to their constituents.

In her statement, the cabinet secretary set out an exception to the ban, which involves women who are currently waiting for a mesh procedure and the treatment time guarantee. Effectively, that means that, even though the minister has announced a halt today, a woman could undergo a mesh procedure tomorrow. Following on from the answer that was given to Alison Johnstone, and given the serious nature of the statement, will the cabinet secretary instruct the chief medical officer not only to write to health boards to set out the new protocol, but to write directly to all the women who are currently awaiting a mesh procedure so that they are fully aware of the new protocol that has been issued and have full knowledge of the situation, which will, in essence, give them the ability to give renewed and fully informed consent?

As I think that Mr Sarwar knows, we do not hold the data on the women who have the treatment time guarantee, for very obvious reasons. Each of the boards holds that data. However, I am happy to ask all of the boards to contact any such women that they might have in their area in order to ensure that they are aware of what I have set out today and have all the information that they should have in order to make a decision about whether they want to go ahead with the treatment.

I fully welcome the cabinet secretary’s statement. Will the effective ban extend to the use of pelvic organ prolapse devices by private healthcare providers, or is the power to do that reserved to the MHRA and the UK Government?

As well as writing to health boards as I have described, the CMO has written to the chief executives and medical directors of private healthcare providers, advising them of the decisions that we have taken and of the halt that we have put in place for the NHS. However, our halt applies to the NHS and we cannot halt procedures in private healthcare. That is something that the MHRA would do, should it determine at some point that the procedure or the use of those devices is not acceptable, but it is not something that I can do as the cabinet secretary.

I thank the minister and members for their contributions. I am sorry to have to cut this session off here, but we are already six minutes over the time allocated. It is a subject of particular sensitivity and interest, but so is the following debate on suicide.