Continued Petition

Thank you and good morning. I am grateful for the opportunity to come here today to discuss the independent review and answer the committee’s questions.

As people who are here will know, the review came about because of growing public concern about the use of polypropylene mesh to treat urinary incontinence and pelvic organ prolapse and as a result of the considerable efforts of those who suffered complications after surgery. You will also be aware that Lesley Wilkie, who chaired the review from the beginning through to the publication of the interim report and beyond, resigned towards the end of last year and that, at the end of last year, I was asked to take over the review and see it to its conclusion. Under Lesley’s chairmanship, the independent review published an interim report in 2015; she and the other members of the review group put a lot of work into that report, which was well received by clinicians and patients.

Before I talk about the review’s findings, it is important to touch on some of the difficulties that the review faced on the way to the publication of its final report and to acknowledge that it is deeply disappointing that one of the clinicians and two patient members felt that they had no alternative but to resign. I really tried very hard to find common ground and compromise so that we could produce a final report that all members were happy with, and I am very sorry that that did not happen. As is often the case with a review or inquiry of this type, members had many experiences and strongly held views and, in such circumstances, it proved to be difficult to reach agreement and, in particular, consensus around the interpretation of the evidence.

The review’s final report was published at the end of March, and the view of the remaining review group members was that it actually strengthened the findings of the interim report. The report included eight clear, unambiguous conclusions that I would like to have the opportunity to go through with the committee. Interruption.

Broadly speaking, the conclusions cover the very important point that decisions around treatment, particularly with regard to these conditions, must involve patient-centred care, which includes patient choice and shared decision making supported by robust clinical governance. We also concluded that support for shared decision making should take place in the context of a multidisciplinary team and that the recording and reporting of adverse events should take place in line with General Medical Council guidance. In that respect, we have concluded that the word “mandatory” should be included, and I am sure that you will have some questions about that. Moreover, the patient information in the previous consent leaflet should be reviewed and a similar leaflet should be produced for those who are considering prolapse surgery.

The expert group also wanted to highlight to the research community some of the gaps with regard to the long-term impact of mesh surgery to ensure that further questions in that respect could be addressed. There is a need for work to address the current information gaps and a need to ensure that information that is currently available is used as effectively as possible. Furthermore, we concluded that the expert group should review the training and information available to clinical teams and find ways of ensuring that patient views are incorporated into the recording of multidisciplinary treatment outcomes.

We also concluded that, in considering surgical treatment for stress urinary incontinence, women must have the opportunity to be offered all appropriate treatments, both mesh and non-mesh, as well as the necessary information to allow them to make informed choices. In the case of pelvic organ prolapse, we concluded that mesh procedures must not be offered routinely. I am happy to return to that point, because I think that that is where the final report’s conclusions move beyond those in the interim report.

In coming to those conclusions, the independent review members considered the best available evidence. One of the reasons for the gap between the interim and the final report was that new evidence became available that drew on a wide range of sources, including patient surveys as well as stories that women submitted individually to the review or separately to the Scottish Government. Other evidence included the analysis of nationally available hospital record data carried out by the Information Services Division—that is set out in chapter 4—and a number of different scientific studies, which are included in chapter 5.

As I mentioned, it is deeply disappointing that three members of the review felt that they had to resign, but I want to make clear my gratitude to all members for their efforts in bringing the report to the place that it got to. In coming to their conclusions, the remaining members of the review group took care to consider and try to reflect the views of those members who had resigned. That is, in part, why we see the inclusion of the word “mandatory”, which we knew was important to the patient members of the group.

I want to conclude by thanking those who took part and the many women who have submitted stories. I hope and firmly believe that, as the conclusions in the report are taken forward, the standard of care that is provided to women will improve. There are many important lessons to learn from the events that preceded the review and from the review itself. I hope that they will improve care in the future.

That was not the intention of the report in any way—Interruption.

I think it is important for me to say that there was no intention or any implication—Interruption.

There was no intention to imply that people were not believed. I chaired two meetings of the group and went to a lot of effort to try to make sure that we were trying to listen to all views around the table.

I refute that it was not fully transparent. One of the issues is about the tables of evidence, and it might be useful to explore that at this stage, because I think that it is what has led people to worry about transparency. The tables of evidence that were included in chapter 6 of the interim report were drawn up by one of the clinicians. They contain extracts from the full critical appraisal.

In discussion with the clinicians, it became clear that certain things might have been highlighted rather than others. Chapter 5 in the report is the critical appraisal of the evidence that was collected through systematic review. I wanted to make sure that there was clear visibility of all parts of those systematic reviews, which is why the tables in chapter 5 can appear to be more difficult to read. They contain every extract from the systematic reviews that have been undertaken. When it seemed difficult for some people that the tables from chapter 6 were being included in chapter 5, we included those cut down tables in front of the full tables and a link to chapter 6 of the interim report at the back.

One of the difficulties that we have when people talk about the assessment of evidence-based medicine and how evidence is assessed is about which parts of the evidence have been looked at. I wanted to make it clear that all the evidence that was taken in those systematic reviews was set out in chapter 5 and that is why it is there.

09:45

I think that women who have had adverse effects have not been believed, and I am very sorry that that is the case, because they should have been believed.

I can only apologise for that change in wording. That was not the intention. Interruption.

Yes. I have a number of letters that I would be happy to provide to the committee at a later date, if that would be helpful.

I would be happy to do that.

As I understand it, following a meeting between Mrs Holmes and Mrs McIlroy and the cabinet secretary, there was a request that she then put to me for information to be removed. I wrote to ask for clarification of which pieces of information were to be removed. Following that, there was clarification from the minutes of the meeting of the Scottish mesh survivors women with the cabinet secretary, which stated that it was the minority report that was to be removed. Interruption. I understand that some might not agree with that, but that is the information that I received.

In discussion with the review group, there was a very strong feeling among its remaining members that, after individuals have resigned, they should not be able to influence the content of the report as agreed by the review group as it stood at the end of the process. The minority report was part of an appendix and had not formed the basis of discussion within the process as the review was formulated—that is why it was removed.

I received communication that said that my letter had caused distress, for which I am sorry, but, following that, I felt that it was necessary to be clear about what had been removed, so I wrote a further letter, which was sent by post. Interruption.

I have finished trying to answer your question. If I have not answered any parts of it, could you tell me which parts I have not answered?

Of course.

That was in a discussion.

Yes, it did.

As I have outlined, that is what I wrote to Elaine Holmes and Olive McIlroy to ask them about.

Yes.

As I have explained to you, I wrote to ask about that. I took that suggestion back—

She was passing on what was discussed in their meeting—

I am afraid that you would have to take up that issue with the cabinet secretary.

I am trying my best to navigate a difficult process where people have different views. Some of those views are, understandably, incredibly strongly felt. There has been discussion about the integrity of the review, but the review group had agreed the content of the review. I take seriously my responsibility as chair. As such, I needed to go back to the standing members of the group who had not resigned about any significant changes in content. It is right to listen to requests, but that does not mean that I would necessarily accede to those requests. That is the point.

The issue was fully discussed at meetings held at the end of January and on 6 March. The changes to the review were fully discussed as part of those meetings. The agenda sets out that each chapter was discussed, chapter by chapter.

All the papers were circulated to them, including those who did not attend in person or by phone.

Let us consider the word “mandatory”. That was clearly important to the people who had suffered complications following the

use of mesh. Although the group had previously discussed the inclusion of the word “mandatory” and had not felt that that was the way in which to go, at the meeting on 6 March we added into the review the statement about the GMC’s expectation that individual practitioners would report complications. The absence of the word “mandatory” was clearly still a source of deeply felt upset to individuals. I agreed to go back to the group and check that they were all right. At the meeting, I said that I would take the chair’s prerogative, if you like, and accept that that word could be included, because it seemed to me to be unreasonable to hold out against that.

A list at the back of the report gives the dates when people left.

When members resigned, I wrote to thank them for their contribution and to express my regret that they had resigned. I would be happy for those letters to be on the website. I am also happy to reflect the comments that you have made to me today and for it to be put on the website next to the review that the report does not make clear the points of dispute over which people resigned and what elements they wanted to have removed.

Part of the difficulty of producing a report that is written by many different people and in which we are trying to build consensus is that, if people choose to leave the process because they are not happy with the conclusions, it is not possible to disaggregate the contributions that they have made in the development of the report.

Another patient representative and several other individuals remained part of the group. You are right that, if one were left as the chair of a group of two people, one would have to say that any report that it produced would not be credible to the various audiences that one would expect the report to go to. However, a significant number of members of the review group remained, and all of them were in agreement with the content of the review.

When I listened to the clinicians discussing how they wanted to frame the conclusions of the clinical part of the report—you must remember that new evidence came forward between the interim report and the final report, which was the reason for the delay—it was clear that there was a lack of consensus around the content of those tables, which were no longer agreed by the clinician members of the group. There was no longer sufficient consensus for people to feel comfortable.

It was a way of considering whether there was a different way in which to express it in order to continue to build consensus.

I absolutely refute that. It comes down to who the intended audience is. As I said, I understand that information at that level can be difficult to navigate. However, it sets out each of the outcomes that the systematic review considered rather than a selection of outcomes. For a report to be sufficiently credible to influence clinical practice, it needs to be transparent for clinicians and the broader clinical group need to be able to read through it and see all the different outcomes that might be considered.

That becomes particularly important in the case of surgery for stress incontinence, as there is no single surgical procedure that one would describe as a standard choice. It is important to take a step back and remember that a treatment might be non-surgical. However, each of the surgical options has a range of risks, potential benefits and complications, and each differs in that regard. It is important to make sure that all of that subtlety is set out.

10:00

That is not my area of technical expertise. That particular point was expressly discussed by the clinicians, and there was agreement that, in their surgical experience, that was the correct wording.

No. I think that it—Interruption. I think that what happened in the time between the interim report and the final report is that surgical experience moved on, which was why they wanted to alter the statement in the interim report about mesh used via a transobturator route not being fully removable. That was a clinician-led decision about the content of the report.

There is a recommendation that the information leaflet be reviewed.

Yes.

It is important that all information is reviewed on a regular basis as practice changes.

The word “mandatory” was included when the report was being finalised. As I have previously discussed, that followed a conversation in which the mesh survivors group expressed their view to the cabinet secretary, who then wished to meet me to make sure that I understood the depth of feeling on the matter. At the meeting on 6 March, we had a discussion around the use of the word “mandatory”, and the group thought that it could be difficult to implement mandatory reporting. However, at the time, it seemed that, if there was a strongly held view about mandatory reporting of adverse events, it would be appropriate to include the word “mandatory” in the final report. I checked that with the group and it was agreed.

Yes, I can explain that. Interruption. Sorry—I am looking at a number of notes here. I understand that the study to which you refer was circulated to the group by one of the clinicians prior to my arrival in the group. There was no discussion at any meeting that I attended of whether people wished to include that study.

The evidence that is included in chapter 5 falls into two broad groups. The safety reviews that were included were published by agencies that are charged with device safety, and Cochrane reviews were the systematic review method that was used to assess effectiveness. The Nature review does not follow the guidelines for a Cochrane systematic review report, so it was not considered. If the clinicians on the group felt that the review covered important evidence and thought that there was a gap in the report, there were at least three opportunities when it could have been discussed and included.

Any ask for it to be included was not made when I was the chair.

I disagree with that point. Chapter 6 sets out a synthesis of how the different strands of evidence might be used by a clinician. Importantly, it considers non-surgical treatment options and tries to emphasise that surgery is not the only way for the conditions to be treated. It is really a view from the clinicians on the group. My role as the group’s chair is to draw the views together in what has been set up as a multi-author review rather than to pass judgment on the technical views that are contained in the report.

As I tried to say in my opening statement, the review contains different types of evidence. Some of the evidence is quantitative results from research trials that have selected a narrow group of the population and randomised participants between different treatments. Those trials are then put together, like different layers, in a Cochrane review in order to see, by looking at the weight of evidence from those randomised trials with their narrow perspective, whether a particular benefit or risk profile is related to a particular treatment.

There is also the type of evidence that comes from the study that ISD produced, which is routinely collected hospital in-patient day case activity data. That shows the outcomes over a much broader population, so it is a much more pragmatic way in which to look at what the outcomes are.

The review also contains qualitative evidence, which is based on people’s experience. Interruption.

I have come in at the end of—

You asked me here to answer questions, and it is important that I am allowed to comment.

I have come in at the end of a process that was set up in a particular way. If I had started the process, I might not, as the chair, have chosen to approach it in the same way. That is not to imply any criticism of the previous chair; it is simply the case that the review has been running for a considerable length of time.

If matters come forward that do not necessarily fit neatly into one of the chapters that have been set out, I understand why people might think, “Why did the review not consider that?” There have been opportunities for any individual member of the group, and any of the people who are far more steeped in the current evidence in this particular area of practice, to contribute to the process if they feel that it is important for their view to be included.

I do not have a clear view on that. I would not want to comment on the technical validity of the way in which the study was done.

I am rather unclear about the validity of such a personal question about my own health in this setting—

Sorry—in thinking about the second point, I have slightly lost track of the first point. Could you repeat it, please?

The Medicines and Healthcare products Regulatory Agency is the regulatory body for devices in the United Kingdom. It was part of the group, and it attended meetings. The specific points that you raise were expressly discussed on 6 March, and that input has gone into the final review. The regulatory body in the UK has been part of the group and has been responsible for the content; that is clearly set out. The FDA is not the regulatory body in the UK.

On the second question, it is important to highlight as a difficulty the fact that we are at the forefront of a necessary and important change in surgical practice, from a more professionally led view of what the right procedure for somebody might be to a much more participatory and equal relationship between professional and patient. That is a difficult change to navigate, but it is very important that we make it.

The professional’s role then becomes not to say what they think should be done for an individual but to find out enough about what is important to that individual and to provide them with information that allows them to navigate the information and come to a shared decision about whether to have a surgical procedure. That type of practice requires many more skills from professionals than we currently provide them with if they are to feel comfortable about asking some of those questions and about not providing the normal professional response.

10:15

In answer to your question, if that was me, I would want to ensure that the professional I was dealing with was able to give me an explanation of the risks and benefits of the different options, and to ensure that they would find out from me the things that would be important to me and come to a joint decision with me. I have considered that question for myself, but I do not think that it is appropriate for me to give you the answer.

We have tried very hard, in conclusions 7 and 8 in particular, to set out that none of the surgical options for stress urinary incontinence is, if you like, a clear option to choose. Each has different risks, benefits and complications, and it is not possible to look at the evidence and say, “Choose this one,” or, “Choose that one.” That is what makes it complicated to understand.

I realise that this did not go down well when I said it at the beginning, but we think that the thing that the final report has strengthened is around the use of mesh in prolapse. Interruption. There is now clear evidence of no benefit from the use of mesh in prolapse. That is the thing that has changed between the interim report and the final report. It is based on the evidence that the final report was waiting for. All the available evidence points in the same direction.

I point out an important and subtle difference: “evidence of no benefit” is stronger and clearer than “no evidence of benefit”. That is the thing that we have tried to move forward in the final conclusion.

Those are important questions, but the review’s purpose is not to provide an implementation mechanism. We have highlighted that, as it moves to becoming an oversight group, what was the expert group must be clear about how it wishes recording to happen and it must ensure that systems are there to support that.

I completely agree that it is not possible to understand the incidence of adverse events if denominator information is not clear.

Yes.

I cannot give you an absolute number. Given the difficulties, we were quite careful to ensure that every member of the review group who remained at the end signed off the report. Each of the members who are listed in the appendix signed off the report.

It was between 12 and 15—a number of that order.

Yes.

I am aware that some people, particularly those who are in the room now, have strongly held views, which are based on very real experience. There are many other people whose voices are less audible, and the report tries to acknowledge that. I wanted to make sure that the review made it into the light of day because there are many women who are unsure about what they should do and, prior to the review being published, many clinicians were not clear about what was the right thing to do. In terms of the totality of people for whom this is important, it seemed to me that the right thing to do was try to bring the review to publication.

I am sorry if I phrased that incorrectly, because that is not at all what I meant to imply. I absolutely understand that it is about their experience.

I am sorry if that is felt not to be the case. I think that that also reflects the group’s view in not wanting pieces of the review removed at the final stage because people had resigned. It was almost mission impossible from the beginning. One should always reflect on whether one could have done things differently, but I think that we have produced a report that has tried to look at all the available evidence and assimilate it. The respected clinicians from Scotland and elsewhere who participated and the professional bodies that participated have signed off a report that they feel is balanced and reflects the current state of the evidence. Interruption.

Sorry, that is a personal view. As you said correctly, it was clear that there were different strongly held views at the point that I came in. One could say more fool me for agreeing to chair the review. It was not something that most people would have—“welcomed” would be the wrong word, but it was clearly going to be a difficult task.

Personally, having reflected on it, I feel disappointed that I have not achieved what I set out to do, which was to achieve consensus. I hear the voices from behind me and I feel very sorry—Interruption. I feel sorry that I have not achieved the bringing together of something that people felt able to stay part of to the end. I am personally sorry that that has not happened. If that is due to any fault of mine, I would want to acknowledge that. However, the reason why I accepted what I might describe as mission impossible—that is my personal view—is that I thought that it was important for the totality of women who might face this problem to try to bring the final report to a conclusion, so that there could be the necessary improvements in information and clinical governance, and discussions around treatment options.

The final meeting was held on 6 March. In between other agreements on wording, that was not raised and discussed. However, I again point out that we obtained individual sign-off from each constituent member about whether they were happy with the content of the report. It was not raised as something that we could have amended.

It is a reason of omission rather than commission. It was not deliberate in any way.

I can clarify that. It is the statement that references the obligations on a professional to report adverse events to the necessary regulatory body, which would be the MHRA in this case. If you wait, I will find it. Interruption. It is in chapter 8. It is on page 91 and is under the heading “Summary”. It says:

“The reporting of adverse events is therefore mandatory”.

That is the part that was added in later. As we have already discussed several times, that word was added in.

The part that was added after 6 March following the discussion was:

“The reporting of adverse events is therefore mandatory, in line with The General Medical Council’s Good Medical Practice which states that, to help keep patients safe, clinicians must:

‘report adverse incidents involving medical devices that put or have the potential to put the safety of a patient, or another person, at risk.’”

It gives a link to that part in “Good medical practice” and sets out that the MHRA is the organisation that should be informed.

In terms of how it would change practice, reclassification would not have any other implications for the way in which the mesh is currently used.

That point was specifically discussed at previous meetings with the MHRA. I can provide you with an extract of the minutes that outline that discussion.

10:30

I understand that point of view. I would be happy to come back to you with a written view on that and I can provide you with the extract of the minutes.

That is a fair point.

No.

When I came in as the chair, the position was that the review was pretty much concluded and we had to move it on. It was not to start unpicking other opportunities to explore—

My understanding of what the review was set up to do is that it did not include that question.

I do not think that that is a question for me as chair of the review.

Taking the opportunity to make a recommendation to the Scottish Government about exercising through regulation powers on not undertaking procedures was not my understanding of what the review had been set up to do.

I can only apologise that that message—Interruption. That was not the brief that I received.

Before you arrived, I spoke about the previous chair, who obviously undertook a lot of hard work and set up the review in a particular way. I do not know her; I have not spoken to her. Interruption.

The reasons for the previous chair’s resignation are not known to me. I need to respect that situation. I took on the review from the point that it had reached at the end of November 2016. Alex Neil established the review, so he knows what he had in mind, but the questions would probably be more reasonably addressed to the previous chair than they are to me, if he wanted those issues to be explored at the beginning of the review.

That is correct.

I can only reiterate what I have said. I have done my best, from the place where I started the work, to include the views as I heard them and to make sure that we considered the evidence, as we had been asked to do, and produced a credible report that set out as much of the evidence as possible.

That is correct.

It is important to remember that another individual who had experience remained in the group.

In answer to your first question, I would very much welcome the opportunity to speak to someone who is reviewing the process of this review, so that future processes are improved.

Tracey Gillies was previously medical director in NHS Forth Valley, which has not done any procedures using mesh since June 2014. On 1 February, she took up a new position as medical director in NHS Lothian. She was therefore in a health board that was not performing mesh procedures at the time she was appointed as chair of the review group.

One of the reasons for the delay between the interim review and the final publication was that we were waiting for several very large pieces of evidence, including a European study that was looking at the safety of the use of mesh, and the prolapse surgery: pragmatic evaluation and randomised controlled trials—PROSPECT trials—which are a long-term follow-up on the use of mesh in prolapse.

It was the evidence from the PROSPECT trials that has led to the conclusion about the use of mesh in vaginal prolapse. The full text in the chapter says that it

“must not be offered routinely”

and that it may be used only in complex situations and then only with the agreement of the full multidisciplinary team. That evidence, which was well worth waiting for, has led the clinical community to completely change the way in which we talk to women about using mesh for vaginal prolapse. We will not discuss the use of mesh, except in very complicated examples of prolapse, and we will use only native tissue to repair prolapse when women come forward with symptoms.

As for stress urinary incontinence, we have waited to collate as much evidence as possible. We knew that trials were going to be published—we had publication dates—and it was well worth waiting for them because we now have a much broader body of evidence and complication rates can be discussed with women based on the most up-to-date evidence.

I have asked that our current information for patients is completely reviewed. We have a standard leaflet for stress urinary incontinence, but it now needs to be updated. There is an instruction to medical directors that mesh is not to be used for vaginal prolapse. We expect the oversight group to keep reviewing the evidence that comes forward and to review the data that ISD is collecting for us. We have new codes because, after the women brought the petition forward, we made changes as we realised that our coding for the procedures was not adequate. It did not reflect the complications and—as the women will affirm—it did not talk properly about removal or the number of procedures that women were having. Those codes have now been revised and will be used in ISD to collect all our data going forward. I expect the oversight group to look at the data for the use of mesh and procedures that do not use mesh across Scotland.

11:15

Absolutely not. I have been meeting women since this process started and I have listened to their stories. You can hear those stories from the women themselves, but they are clearly documented. We know that there are women who have had mesh inserted into them who should not have had it because they were not properly consented. They did not have a full description of what might happen to them in the worst-case scenario. For that, I have already apologised. No clinician intends to harm patients or to harm women.

We have moved from that situation to needing to find out more about exactly what this mesh was doing to women. When some women had the procedure, the full evidence was not available. The clinicians were working on the evidence that they had, but some of it was very short term. Mesh has been used only for around 10 to 15 years. The evidence that we now have has come partly from the brave efforts of women in flagging it up. There is a need for more research and for long-term complications to be followed up.

We have changed the way in which we talk to women who come forward with it. We must remember that around 50 per cent of women will have incontinence at some stage in their lives, so this is an extremely common condition. In some cases, it is very life limiting. It restricts people so they come—Interruption.

As I say, the condition is common, so a lot of women come forward. Those who have particularly severe symptoms will be referred up to hospital to a gynaecologist or a urologist to discuss their symptoms. In some cases, the woman will have such severe symptoms that they want to have something done. What we read in the review is that all options must be offered.

Some women will have no treatment at all, and that will be their decision or a shared decision between them and their clinician. However, we want the other women to have all the options laid out with all the complications and risks and the things that these women were not fully aware of because, at the time, they did not have what we now see as fully informed consent.