Surgical Mesh and Fixation Devices

– in the Scottish Parliament on 17th January 2023.

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Photo of Liam McArthur Liam McArthur Liberal Democrat

The next item of business is a committee debate on motion S6M-07487, in the name of Jackson Carlaw, on petition PE1865, which is on suspending all surgical mesh and fixation devices. I invite Jackson Carlaw to speak to and move the motion on behalf of the Citizen Participation and Public Petitions Committee.

Photo of Jackson Carlaw Jackson Carlaw Conservative

Colleagues across the chamber will not be surprised to hear me speak on the subject of mesh in the 10th anniversary year of that issue first being raised in a public petition to the Parliament by Elaine Holmes and Olive McIlroy. However, I do so today on behalf of fresh petitioners. Roseanna Clarkin and Lauren McDougall have lodged a petition for the Parliament’s attention on behalf of all those affected by the issues raised. Members will recognise the similarities between the issues raised in that petition and those raised in our previous debates in the chamber on the subject of transvaginal mesh. I hope that they will appreciate, and be patient with, the need for plain and uncomfortable discussion of the facts.

Our previous discussions focused on the experience of tension-free vaginal tape and women’s health. Roseanna Clarkin and Lauren McDougall have highlighted significant additional concerns about the wider use of mesh, and they have made it clear in their petition that our attention should also be focused on the use of mesh in other surgical procedures—for example, hernia repair—and the effects that that has had, is currently having and will continue to have if the use of mesh continues for men, women and children throughout Scotland.

In raising the issue, Roseanna Clarkin and Lauren McDougall have urged us to be cautious about the use of surgical mesh until more information is gathered and we have a better understanding of the complications and adverse outcomes resulting from those procedures. In their view, that should include investigation of the concerns about potential cancer risks associated with the use of titanium staples to secure the mesh.

In considering the issues raised by the petition, the

Citizen Participation and Public Petitions Committee heard from individual members of the public, including members of the Sling the Mesh campaign. We have been able to explore the experience that they have shared by gathering further information from the Scottish Government and from clinical specialists who are familiar with the alternative options for hernia repair. I will say more about that shortly.

The committee is also grateful to colleagues who joined us at various points in our consideration to offer contributions on behalf of their constituents. I see several of them in the chamber this afternoon and look forward to hearing further from them.

We also heard from the Minister for Public Health, Women’s Health and Sport, who, in the Government’s initial response to the petition, said that she did not believe that there was evidence to justify a pause in the use of relevant devices. She stated that

“using mesh resulted in lower rates of recurrence, lower rates of serious adverse events and similar or lower risk of chronic pain.”

It struck me, at our first consideration of the petition, back in September 2021, that that was almost exactly the same as the testimony that we had heard in relation to the previous petition, on transvaginal mesh. In that case, people had been dealing with their issues individually; information on their experiences and outcomes was not centrally gathered, held or reviewed; and, until people knew that there was a wider issue to speak out about, there was not much information available in the public domain.

Since then, the committee has received more than 85 written submissions. The majority of them are personal testimony from individuals detailing the life-changing effects that mesh complications have had on them.

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

Jackson Carlaw mentions the symmetry between the committee’s considerations on the use of mesh that we are considering today and the previous use of it for transvaginal therapies. Does he also agree that there is symmetry in the fact that knowledge of the risks was not imparted to patients in advance of those procedures being undertaken and, similarly, there was a stigma around their experience of pain because they sometimes were just not believed?

Photo of Jackson Carlaw Jackson Carlaw Conservative

Yes, that is a fair summary of the position. It is redolent of the experience of those who suffered because of transvaginal mesh, who were told that it was a psychological condition and not a real expression of pain and discomfort.

Figures from Public Health Scotland and the Scottish Health Technologies Group suggest that around 10,500 hernia repairs are carried out in Scotland each year—for all I know, there may be some people with them in the chamber—with mesh being used in approximately 62 per cent of those procedures. Official statistics also suggest that there are, on average, 32 procedures to remove mesh from previous hernia repairs each year. What is not yet available is data on the reasons why the mesh has been removed. In comparison with the number of hernia repairs that are being carried out, those numbers may appear small, but we must keep in mind the fact that individual patients are behind each of those statistics.

The committee also heard from the chief medical officer that the complex mesh surgical service deals only with TVM removal and that there is no similar service for the removal of other types of mesh. We heard of difficulties in getting mesh removal surgery on the national health service, which were attributed to a lack of knowledge about the issue in primary care and the complex mesh surgical service accepting only gynaecological referrals. Some individuals resorted to going private to get their mesh removed and some travelled abroad to have that done. We heard that there is no clear pathway for patients and that general practitioners are not aware of where to send them.

The testimony that we have received details the pain that many individuals who had mesh implanted during hernia or rectal prolapse repair surgery have experienced. The people behind those statistics have told us that their symptoms occurred very quickly after surgery and have worsened over time. They have been left in constant pain—I apologise here—and have nerve damage, sexual pain, issues with their bladder and incontinence. One patient described the pain as feeling like

“a cheese grater rubbing against my groin.”

Another patient told us that the pain feels like they are

“wearing a tampon dipped in acid.”

Some people told the committee that they had been told that the hernia or rectal prolapse mesh had eroded into their vagina wall, bowel and bladder or had adhered to their bladder, ovary, fallopian tube or bone. The committee heard that complications had led to mobility issues and had significantly reduced people’s mental health and quality of life. Some people reported improvements after mesh removal surgery, but others were told that the mesh was too enmeshed in their body to be removed without causing serious ramifications, such as the loss of their rectum or testicles.

A Scottish Government-commissioned review on hernia mesh stated that most common adverse events following mesh-based hernia repair are pain, infection, hernia recurrence, scar tissue forming between separate surfaces of the body and blockage of the bowel. The complications that people are being forced to live with mean that they have had to give up working, their relationships have broken down and even something as simple as going out for a meal with their family has become impossible due to the pain that they experience.

They have told us of their concerns about informed consent—the point that Mr Cole-Hamilton raised—and the challenges they faced in having their pain taken seriously. In one case, we heard that a patient was not given any other choice of treatment, was not informed that the surgery would involve mesh and, despite reporting pain in their hips, legs and pelvic area, was met with a dismissive response from the surgeon.

Similar stories have emerged throughout the submissions. Over and over, people have told us either that they were not informed that mesh would be used or, if they were informed, that they were told that the only risk was that the mesh could be too tight, which could be resolved by snipping it. Unfortunately, the testimony that we have heard clearly and, at times, graphically demonstrates that that has not been the case. People have told us about having developed autoimmune diseases, which they believe was linked to having mesh inserted into their bodies.

Those are all themes that we have explored with the Minister for Public Health, Women’s Health and Sport during two separate evidence sessions.

It was encouraging to hear from the minister and the chief medical officer about the progress that is being made on embedding shared decision making as part of the patient journey. The CMO indicated that a

“shared decision-making approach has ... been whole-heartedly embraced by the profession”—[

Official Report, Citizen Participation and Public Petitions Committee

, 8 June 2022, c 5.]

and is supported by education delivered by the NHS. He told us that part of that approach includes sending letters to out-patients, encouraging them to engage with the clinical team and to ask questions about the benefits, risks and alternatives, as well as about what happens if no action is taken.

Photo of Daniel Johnson Daniel Johnson Labour

I am very grateful to the member for giving way, especially as I will not be able to speak in the debate.

Jackson Carlaw has clearly outlined that the issue goes much wider than transvaginal mesh, and the motion refers to the use of polyester and other materials. Like other members, I have been contacted by women who have had Essure devices fitted and have had similar complications. Do the reassurances that the member has been hearing from ministers and medical officials extend to broader categories of devices?

Photo of Jackson Carlaw Jackson Carlaw Conservative

Mr Johnson raises a valid point. The evidence that we have taken has related more directly to the issues that have been raised by the petition, but he raises an important consideration. I would be interested to hear the Cabinet Secretary for Health and Social Care address that point.

The committee heard that surgical mesh has become the preferred method for hernia repair worldwide, with evidence suggesting that using mesh in hernia repair reduces recurrence. Nonetheless, a small minority of surgeons prefer to use natural tissue repair and will use mesh only as a last resort.

During our deliberations, we heard from experts at Shouldice hospital, in Canada. For those who may not be familiar with that unique hospital, I highlight that it is the only licensed hospital in the world that is dedicated to hernia repairs. We are particularly grateful to Dr Fernando Spencer Netto, who is a surgeon at Shouldice, for taking the time to meet the committee during a virtual evidence session last May.

Anyone who views the evidence that we heard from Shouldice hospital cannot fail to be impressed by its results. Dr Spencer Netto told us that the hospital carries out 6,000 to 6,500 procedures each year, around 99 per cent of which do not use mesh. The specialist focus on natural tissue repair has resulted in Shouldice having one of the lowest rates of hernia recurrence. Indeed, its recurrence rate is around three times lower than that of the hospital with the second-lowest rate of recurrence.

Presiding Officer, I see that I am very close to the time by which I must finish. I will conclude with the words of one of the petitioners. Roseanna Clarkin told us:

“We feel the Scottish Government have completely ignored us over the past 8 years.”

That is how the petitioners feel. She continued:

“We have campaigned alongside the transvaginal mesh women ... We always knew we would have to fight for better healthcare together ... This petition is our last chance to get what we feel should have already been in place.”

I am pleased that the Citizen Participation and Public Petitions Committee can play a part in ensuring that Roseanna, Lauren and all those who continue to campaign with them will have their voices heard.

I move,

That the Parliament notes public petition PE1865 on suspending the use of all surgical mesh and fixation devices while a review of all surgical procedures which use polyester, polypropylene or titanium is carried out, and guidelines for the surgical use of mesh are established.

Photo of Humza Yousaf Humza Yousaf Scottish National Party

I thank

Jackson Carlaw and members of the Citizen Participation and Public Petitions Committee for their work on the petition, and, most important, I thank Roseanna, Lauren and the other petitioners for their involvement in the petition.

I am grateful for the opportunity to speak on behalf of the Government in the debate. I know that most members of this Parliament are familiar with issues that are associated with surgical procedures involving the use of transvaginal mesh, whether that is from our constituents, the press or the Sling the Mesh campaign, which has been running for 10 years, as Jackson Carlaw mentioned.

We have heard about many distressing situations that those with complications have experienced. Those have caused us all great concern and I am genuinely grateful to all who have taken the time to speak openly about their experiences, which is not at all easy, given the deeply personal nature of what they have faced. We have heard some of that in the personal testimonies that Jackson Carlaw read out.

As I said, many of us in the Parliament first heard about mesh and surgery involving its use through the campaigning of those who had transvaginal mesh implants. I remain grateful to that group of patients for making their voices heard, and I continue to engage with them. The Government has taken a wide range of actions to assist the women who have been affected, and I hope that they have seen some progress, particularly over the past 12 to 18 months.

In my remarks today, I propose to focus on people with experiences of other types of mesh. It goes without saying, but I will say it nonetheless: I am always very sorry to hear of instances of complications and adverse side effects, and the impact that they have had on individuals as well as their wider families.

In Alex Cole-Hamilton’s intervention a moment ago, he made the point that one striking common theme that has come out of engagement with women who have been affected by transvaginal mesh is that they simply were not believed. We have heard testimonies from those who have been affected by hernia mesh or other uses of mesh, who have spoken powerfully about the pain that it has caused them. I do not want them to think for one second that the Government does not believe them or does not believe that their pain is real. If they have ever felt that a clinician has not believed them, that is not the trauma-informed and compassionate NHS that I believe in.

Photo of Jackson Carlaw Jackson Carlaw Conservative

I think that politicians across the chamber, including those in the Government, accept that patients who have suffered in this way need to be believed. Rona Mackay, who is the convener of the cross-party group on chronic pain, has, along with me and others, heard repeatedly from individuals that, unfortunately, that is not always their experience when speaking to clinicians.

Photo of Humza Yousaf Humza Yousaf Scottish National Party

Yes, of course, and I have heard that, too, when I have engaged with those who suffer from chronic pain or other conditions. That is why some of the trauma-informed and compassionate leadership work that we are doing is so important. If there are particular services where that approach is not being taken, I am always open to MSPs or members of the public writing to me or communicating that to me directly, and I will ensure, for the Government, that that particular health board or service is investigated. I reiterate on behalf of the Government that, regardless of how mesh is used and the procedure that it is used for, individuals who suffer from side effects, pain or complication should get the care and treatment that they need.

As has been referenced, after hearing the concerns of patients, the Government commissioned the Scottish Health Technologies Group to look into the use of mesh in hernia repair. That led to the publication of not one but two reports on the subject. Those reports are based on information from peer-reviewed published evidence, much of which is from comparative trial data. Both reports support the continued use of mesh in most abdominal wall and groin hernias.

We have discussed those findings with professional bodies such as the relevant royal colleges and the British Hernia Society, and we will continue to work with them on this important issue. It is fair to say that they support much of what is in the reports from the Scottish Health Technologies Group on the continued use of mesh.

Work is also on-going with regard to establishing registries and encouraging better data collection, which was a theme in Jackson Carlaw’s contribution. That will provide important surveillance and outcome information in years to come.

I realise that the petitioners would like an independent review of all surgical mesh and fixation devices to be undertaken, which is entirely understandable in light of their experiences. However, given the conclusions of the Scottish Health Technologies Group reports as well as the action that we are taking in response to those reports—I will touch on that in more detail in a moment—and the various reviews that have been carried out in relation to transvaginal mesh, I do not believe that a further review is warranted. We will, though, remain focused on available evidence, including new information as it emerges—including from the data collection that I spoke about a moment ago—and we are of course committed to acting on it.

Photo of Daniel Johnson Daniel Johnson Labour

I note what the cabinet secretary says about the efficacy of a further review, but there is a growing sense globally that there is a broader issue surrounding medical devices. Will he comment on whether we need a revision of the approach that is taken to medical devices that use polyester or other materials, as cited in the motion, or more broadly, given the global concern about such devices, and not just particularly about mesh?

Photo of Humza Yousaf Humza Yousaf Scottish National Party

The Scottish Health Technologies Group looks at the global evidence that is available. There is a lot of value in working on some of these issues on a four-nations basis, which is why making progress on Baroness Cumberlege’s report is important. We have the Scottish Health Technologies Group to review any global evidence that emerges on the various devices and the potential complications associated with them. I am happy to take away the specific issue that Daniel Johnson has raised and to see whether we can do anything further in that regard.

I am not making as much progress in my speech as I would like, but I will reiterate a couple of points for emphasis. I understand the reasons for the suspension of the use of mesh that have been given by people, particularly the petitioners. However, some 100,000 hernia repairs are carried out each year in the United Kingdom, and approximately 11,000 such repairs were carried out in Scotland in the year before the pandemic. That number includes elective procedures as well as those presenting as emergencies. Surgery must be available for all, and establishing a specialist centre, which is one of the petition’s suggestions, might not be conducive to that, as it could pull resources into one health board area and mean that patients have to travel.

There will, of course, be hernia repairs that are more complex, and it is for that reason that the chief medical officer has asked medical directors to consider the development of local clinical groups and broader clinical networks for the management of more complex cases. We will continue to work with clinical colleagues on that. In the interim, however, it is a patient’s right to request a second opinion if they are in any doubt about the treatment that is being offered to them.

I will now address the continued use of mesh in other areas. In comparison with the use of mesh in hernia repairs, such procedures, including those involving the use of mesh in reconstructive surgery and its continued use in gynaecology, are not performed frequently. In those cases, it is recognised that there are currently very few—if any, frankly—viable alternatives, so to suspend the use of mesh in the very wide way that is anticipated by the petitioners would, unfortunately, leave quite a large cohort of people with limited or, indeed, no treatment options, which I am sure is not what the petitioners want.

I will end on one of the points that Jackson Carlaw made. In the Scottish Health Technologies Group’s reports and reviews, it made a number of recommendations about ensuring that any procedure is done in conjunction with, and in collaboration with, the patient involved, that the patient is fully apprised of the potential risks that there might be to any surgery, particularly surgery that involves mesh, and that alternatives are explored if they are clinically safe and viable. Potential alternatives to mesh, particularly for hernia cases, are being explored.

The Parliament has, quite rightly, called on the Government to take steps to help those who have been harmed, most notably in relation to transvaginal mesh. The Government has responded positively to that, but I have concluded that a further suspension—in the wide sense that is sought by the petitioners—or review is not warranted. In saying that, I completely understand the disappointment that some people will feel, but I hope that the actions that I have set out, which I will expand on in my closing remarks, give some reassurance that we are listening, that we are making progress and that we are absolutely committed to ensuring that people get the care that they need in the best way.

Photo of Sandesh Gulhane Sandesh Gulhane Conservative

Petitions from members of the public have brought about changes in the law and in Government policy, have helped to revise guidelines on issues and have even changed decisions. Even just raising awareness of an issue in the Parliament can be a success. We recognise the hard work of petitioners, of the people who are called to give evidence and of the members of the Citizen Participation and Public Petitions Committee.

Although we often chide the Scottish Government for its lack of transparency or its avoidance of scrutiny, because transparency and scrutiny are essential to the functioning of our parliamentary system, we are also well aware that the petitions process is important for our democracy.

Petitioners Roseanna Clarkin and Lauren McDougall have called on the Parliament

“to suspend the use of all surgical mesh and fixation devices while” a full

“review of all surgical procedures which use polyester, polypropylene or titanium is carried out; and guidelines for the surgical use of mesh are established.”

The petition is not about transvaginal tape—TVT—or pelvic mesh implants. We spoke about mesh implants in the Health, Social Care and Sport Committee today, and the cabinet secretary intimated that he might be able to give us a bit of an update. If it is possible, it would be great if he could do that in his closing remarks.

However, the petition is about mesh and other devices and fixations that are used in surgery elsewhere in the body—in particular, in hernia repair. The petition raised awareness of complications that have arisen from use of synthetic mesh in surgical repairs. The petitioners also drew attention to concerns that are associated with titanium ProTacks that are used with hernia mesh, because they carry a cancer warning.

Between May 2021 and June 2022, the committee heard evidence and received written submissions from a lot of people, including the chief surgeon of Canada’s Shouldice hospital, which is the only hospital in the world that is dedicated to hernia repair, and performs up to 6,500 surgeries annually. We heard Jackson Carlaw talk about the complications rate, but it is very important to say that the more one does one type of thing, the better one gets at it and the less likely one is to have complications.

I cannot help but wonder how long patients have to wait to be seen at the Shouldice hospital. I am assuming that it is less than they wait in NHS Grampian, where the longest recorded wait for a diagnostic test in 2022 was 258 weeks.

As for surgery, while Shouldice hospital is performing over 6,000 surgeries annually, in our country’s largest health board, NHS Greater Glasgow and Clyde, all non-urgent surgery is now paused—likewise, NHS Ayrshire and Arran and NHS Borders, and we understand that NHS Fife is also reducing its elective surgical capacity.

As a former registrar in a busy surgical department, I can say that surgery involves risk, and that the risk increases if the patient’s health is compromised, which includes their being overweight or obese. Therefore, it is important to examine the data from the outcome of many surgeries that used a particular technique in order to evaluate any potential risk.

Let us take the example of hernia repair. A hernia occurs when an internal part of the body pushes through a weakness in the muscle or surrounding wall. Hernias usually develop between a person’s chest and hips. An inguinal hernia repair can be carried out either as open surgery, which is essentially just a big cut, or laparoscopic, or keyhole, surgery. Once the anaesthetic has taken effect, the surgeon makes a single cut over the hernia. The incision is about 6cm to 8cm long. The surgeon then places the lump of fatty tissue or loop of bowel back into the abdomen and mesh is stapled or glued into the weakened area of the abdominal wall, where the hernia came through, to give it temporary strength while the body heals.

There have been reports of issues associated with the mesh that is used in hernia repair. They include infection, pain and adhesion. However, the Scottish Health Technologies Group reports that men who were operated on with mesh were less likely to have their hernia return than were those who had surgical stitches. Also, use of mesh meant that the men were less likely to suffer urinary retention or injury to nerves, blood vessels or internal organs. They were more likely, however, to develop a build-up of fluid or a swelling soon after surgery, which is common. There was no difference between stitches or mesh being used in respect of their developing chronic pain.

Only a tiny percentage of people who have had hernia repairs involving mesh have had to have their mesh removed. Between 2013 and 2018, there were about 70 operations in Scotland to remove surgical mesh after hernia repair. That represents 0.3 per cent of the 25,188 patients on whom mesh was used.

In January 2020, the Scottish Health Technologies Group recommended that NHS Scotland use mesh when repairing hernias in adult men. It also stressed the importance of robust data collection and the importance of data on long-term outcomes from hernia repair in Scotland being recorded at national level to inform future decision-making.

Photo of Emma Harper Emma Harper Scottish National Party

We are talking about mesh. There is so much choice of mesh that is implanted. Does Sandesh Gulhane agree that the data that we would get from that might—based on the properties of the mesh that is used, such as the type of filament, the tensile strength and the porosity—help us to determine which mesh leads to specific complications such as pain?

Photo of Sandesh Gulhane Sandesh Gulhane Conservative

It is almost as though Emma Harper has read the rest of my speech. Yes—I agree.

The National Institute for Health and Care Excellence, which we all know as NICE, has found that post-operative complications from mesh surgery are rare. In my experience in hospitals, mesh complications were rare, and I am probably the only member to have actually implanted mesh into hernias.

Photo of Sandesh Gulhane Sandesh Gulhane Conservative

Emma Harper has put them in, as well.

From a systematic review of the literature, covering 37 randomised controlled trials with a total of 5,560 participants—which is quite a lot—10 per cent or less experienced persistent pain from either procedure and 23 per cent or less experienced persistent numbness.

Photo of Jackson Carlaw Jackson Carlaw Conservative

I have now heard Dr Gulhane say that he has inserted mesh into other people. Were he to be diagnosed with a hernia and told that it must be repaired, would his preference be to have mesh inserted into him or to have a natural tissue repair?

Photo of Sandesh Gulhane Sandesh Gulhane Conservative

My preference would be to have what the surgeon deemed to be most appropriate for me. [

Interruption

.] No—if that involved the surgeon saying that he or she thought that mesh would be the correct procedure, I would whole-heartedly go forward with that. It would depend on the hernia that I had. I would not have a problem with having mesh implanted into me or my family.

NICE guidelines recommend future research into chronic pain and numbness, as well as the setting up of a registry to monitor adverse events and recurrence rates.

As for the petitioners’ cancer concerns, the US Food and Drug Administration reviewed early epidemiologic studies on implant-related haematopoietic cancers and found conflicting evidence, with only two studies suggesting that there was an increased risk of lymphoma or leukaemia.

This is important to note: no medical or surgical intervention is without its side effects.

Having considered the evidence that has been taken by the Citizen Participation and Public Petitions Committee, we do not support the petition. I will explain why through another example. Earlier today, Andy Murray won in the first round of the Australian open, which is, quite frankly, amazing, given that he has a metal hip. However, he does not have a total hip replacement; he has had hip resurfacing. When I was working in London under Professor Haddad, there was a scandal around hip resurfacing, with calls for the procedure to be banned completely. However, we have discovered that it is a fantastic piece of kit if it is inserted by the right surgeon on the right patient. Andy Murray shows us the value of the procedure when it is done right.

What I am saying is that not all kinds of mesh are the same, that not all patient indications are the same, and that most evidence points towards hernia mesh being much safer than transvaginal mesh. However, we support calls from the Scottish Health Technologies Group—the Presiding Officer will tell me to wrap up, at this point—to strengthen data collection on hernia outcomes and from NICE to monitor adverse events.

I declare an interest as a practising GP.

Photo of Jackie Baillie Jackie Baillie Labour

I apologise to members in advance because, with your permission, Presiding Officer, I need to leave the chamber briefly during the debate to give an interview. I will return and ensure that I catch up on my colleagues’ contributions.

I thank the Citizen Participation and Public Petitions Committee for its work on the petition, and I commend Roseanna Clarkin and Lauren McDougall for lodging the petition with the Scottish Parliament.

The petition is about suspending the use of mesh, other devices and fixings that are used in surgery and, in particular, in hernia repairs. Some 11,000 hernia procedures were carried out in a recent four-year period, which is five times as many as were carried out for pelvic or transvaginal mesh. Problems that have been reported include infection, pain and adhesion to other parts of the body. There are clear similarities between the experiences of people who have had hernia operations and those of women who have had transvaginal mesh implanted.

There are lessons that the Scottish Government must learn from the 2014 campaign to suspend the use of transvaginal mesh and from the unacceptably long time that campaigners have been forced to wait for treatment and solutions. People who have experienced problems with mesh are often left in crippling pain; they have suffered from multiple organ trauma and extensive nerve damage, despite being told that the mesh that caused them the pain was safe. We know that their pain went ignored by some health professionals because they have told us so; it was dismissed as being all in their minds.

Many of the circumstances, and much of the language, from the fight against transvaginal mesh are replicated now in discussions about the use of all surgical mesh and fixation devices.

People with lived experience have spoken about the excruciating pain that they are forced to endure and about how that has led to depression and sometimes to suicidal thoughts. They tell of how they have been ignored and shrugged off by doctors when reporting their symptoms or attributing pain to their mesh implants. That pain impacts on their ability to work or to enjoy any quality of life. In the evidence that they gave to the Citizen Participation and Public Petitions Committee, patients detailed how the prolapse mesh that they have been fitted with has eroded into the walls of their body, or even adhered to their organs.

In line with the experience of women who were fitted with transvaginal mesh, there are currently few processes in place for addressing and removing defective surgical mesh. There is also a lack of process for tracing the product, which makes it hard to retrieve faulty mesh that has been fitted. Although I welcome the establishment of a medical device information system, it is concerning that such a system is still not in place almost 10 years after transvaginal mesh survivors brought those issues to the fore. The Scottish Government must work to rectify that as a matter of urgency.

I give a cautious welcome to the two Scottish Health Technologies Group reports that make recommendations about the conditions for the continued use of mesh, but I believe that patients must be able to make choices about their treatment and note that some countries, such as Canada, where mesh has been banned since 2019, no longer use mesh at all. What do they know that we do not?

I also agree with the petitioners that there must be a specialist mesh removal service. The complex mesh surgical service deals only with the removal of transvaginal mesh. The waiting time to be seen is currently 42 weeks and patients must wait for treatment after that. I have a constituent, Maureen, who faced months of cancelled appointments before finally being scanned at the Glasgow clinic in November 2021. She had been told that there were no issues with her mesh, yet a private scan, which she organised for peace of mind, confirmed that it was twisted and was the cause of her pain. Maureen lost her job due to the complications from her mesh surgery. She has been failed multiple times by the Government.

The minister cannot tell us how many people have been referred to specialists in England or the US, or how long that will take. I understand that Dr Veronikis has treated only 10 women and that his contract runs out this summer. There appears to be a reluctance to refer women for their preferred choice of operation.

I previously raised the case of Anne, who has been to America for treatment with Dr Veronikis. Ministers said that there was no cap on the amount that could be claimed from the reimbursement scheme, but Anne’s experience was entirely different. Despite the minister saying that there was no cap, Anne is still fighting to be compensated for the full cost of her flights. The service established to address the serious problems faced by transvaginal mesh survivors is welcome, but it is not adequately resourced. If we are to include other types of surgical mesh removal, its operation must be urgently reviewed and its scope expanded. We have a duty to get this right for all those who have experienced negative side effects because of surgical mesh

The experiences and stories that the committee heard are not isolated—they are widespread and real. The Government must learn from that testimony and must prevent history from repeating itself.

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

It gives me pleasure to rise for my party in support of the committee’s motion.

I have raised this subject several times in debates about the use of transvaginal mesh implants and have said that we need to expand our debate and discussion to include the use of mesh in other parts of the body. I am very gratified by the work that the petitioners, Roseanna Clarkin and Lauren McDougall, have done to get us to this point—it has been a long time coming.

Last year, I shared the story of my constituent Cathy, whose account echoed those of hundreds of other women who were referred to GPs and physiotherapists to receive mesh implants. Cathy was given very little information, other than being told that the procedure would alleviate the mild incontinence that she was suffering. What followed was five years of crippling pain. Her mobility, mental health and intimacy with her partner all suffered. To put it simply, her quality of life was devastated.

My party and I were proud to back the legislation that the Parliament passed almost a year ago to reimburse the victims of transvaginal mesh implants for the surgery that they would have to undergo to have it removed privately. Although nothing can take away from the trauma that they have had to endure, at least they did not have to bear the hefty financial cost of having implants removed, and at least their plight and their injuries were recognised by this place. However, that legislation was far from a panacea and it was incomplete. The reimbursement scheme did not include the victims of other mesh implants—for instance, those who have suffered complications with hernia mesh. We have heard some graphic descriptions of those cases. That is why I was one of the first to raise hernia mesh in the chamber, along with a number of other MSPs. We have probably all met constituents to whom that has applied. One of my constituents was in effect left crippled by her hernia mesh.

There are harrowing accounts of the impact of hernia mesh implants, including a patient being left with a gaping wound in the side of her stomach that cannot be healed properly and which prevents her from going out and travelling to visit her children, who live far away. Despite such accounts, however, hernia mesh implants are still widely used. The petition that we have before us today seeks to address that and looks towards the suspension of the use of surgical mesh and fixation devices while a review is conducted of the use of all surgical procedures that implant any form of polyester, polypropylene or titanium products.

Photo of Sandesh Gulhane Sandesh Gulhane Conservative

As the member well knows, lots of people are waiting for hernia treatment. Their cases are not emergencies, but they need treatment. What would we do for them?

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

An anxiety that I have about the approach of the medical profession in some cases is that it involves rushing into a decision and bouncing patients into treatment without fully informing them of the risks and possible side effects of the intervention. If mesh is not a safe intervention, it is not a solution to the problems that Dr Gulhane outlines.

I have met many survivors of both transvaginal and, now, hernia mesh, and having heard so many tragic and life-changing stories, I have an immediate and visceral problem with that or similar material being implanted into anyone’s body. Personally, I would like to see compelling evidence of the safety of any mesh implant before I would ever be comfortable recommending it to someone that I knew or receiving it myself.

I am aware of the reports of the Scottish Health Technologies Group that support the continued use of mesh in abdominal wall and hernia situations provided that there is shared decision making and an informed consent process with an awareness of the risk being imparted to the patient, but I am not persuaded that that is happening. I intervened on Jackson Carlaw to say—and he agreed with me—that that does not always happen. Informed consent, with patients being given agency and provided with the facts and the risks, is not always happening. Were it to happen, I think that several people might take different decisions and we would see a shift in the balance away from the use of mesh.

I am mindful of the concern that suspending the use of hernia mesh could leave some people with no or very limited treatment options. We have to be cognisant of that and it needs to be taken into account, as is reflected in the petition. I give credit to the petitioners for the elegant way in which they have put it to us. There are of course some life-or-death cases where the use of mesh or some surgical implant is essential.

What many cases involving the use of transvaginal mesh had in common was the failure of those who provided treatment to make the patients fully aware of the risks that were involved in using those implants. Informed consent is one of the key principles or pillars of our health service, or at least it should be, and it is right for every patient to be given all the information about what their treatment involves. That is realistic medicine. That is treating people as grown-ups. That information must include the potential risks as well as the benefits, and patients must always be offered reasonable alternative treatments wherever possible.

In this case, it is also important that we ensure that health boards are provided with all that they need to ensure the availability of non-mesh surgery and that any skills gaps that impact the treatment of complex cases are addressed.

I also agree with Jackie Baillie, who made an excellent point about the urgent and pressing need for mesh removal care pathways in the Scottish NHS. We need to build in the capacity and expertise to make that happen here in Scotland.

I am not a clinician—that is clear—and it is of course right that scrutiny is provided and decisions are taken by specialists. The first step in that process is to hear the lived experience of those who have suffered from complications.

We must remember that many survivors of vaginal mesh implants describe not being taken seriously and even being told that they were imagining their pain. That theme has echoed throughout the debate. In fact, Roseanna, one of the people who brought forward the petition, has a similar story, sadly. She even had to deal with her GP’s suggestion that the pain that she was experiencing was all in her head. It is only by listening to people such as her that we will do the necessary due diligence on the long-term effects of those materials on the body and get a full picture to ensure that nobody else is harmed.

The Deputy Presiding Officer:

We move to the open debate.

Photo of Rona Mackay Rona Mackay Scottish National Party

The issue that we are debating has been highlighted in the chamber many times over the years—we have been debating it for 10 years, as Jackson Carlaw said—and I have taken a keen interest in it.

Now, thankfully, there is a ban on the use of transvaginal mesh implants, which was brought in by former health secretary Jeane Freeman and warmly welcomed by campaigners and their families.

Jackson Carlaw, whose motion we are debating, and former MSPs Neil Findlay and Alex Neil were at the forefront of the fight for justice for women, and they spearheaded the campaign for women victims of mesh.

Last year, the Scottish Government passed legislation to establish a £1 million fund to support women who were affected by mesh complications, who had received implants on the NHS but had to travel abroad to have them removed by an experienced clinician. Now, thankfully, we have a facility in Glasgow, with specially trained surgeons, where mesh removal can be carried out.

The scandal of women in Scotland—and, indeed, globally—whose lives have been ruined by transvaginal mesh will go down in history as one of the worst medical injustices for decades. However, in all honesty, the debate surrounding petition PE1865 has left me a bit confused. I am sympathetic to the petition, but I probably feel more confused, having listened to Jackson Carlaw and Sandesh Gulhane, who, it is clear, do not agree on it. However, good points have been made in the speeches of everyone who has spoken so far.

Essentially, the petition calls on the Scottish Parliament

“to urge the Scottish Government to suspend the use of all surgical mesh and fixation devices while— a review of all surgical procedures which use polyester, polypropylene or titanium is carried out; and guidelines for the surgical use of mesh are established.”

It acknowledges that

“mesh must be used in life or death situations” but adds the caveats that

“mesh is only used when essential; patients have alternatives to mesh; and mesh is only used with the fully informed consent of the patient.”

The petitioners want the use of mesh devices and stitches

“to be suspended while a review of all surgical procedures which implant any form of” the materials that I have just mentioned—

“for example hernia mesh, rectomesh, mesh used in hysterectomies—is carried out and guidelines for the use of surgical mesh are established.”

They call for the suspension of the use of titanium ProTack devices, which, they claim, carry a cancer warning.

Crucially, however, the petition also recognises and supports

“women with TVT or pelvic mesh implants” and acknowledges that

“the mesh that we are talking about is not the same.”

I am not a clinician, nor are the majority of MSPs—with notable exceptions. My opposition to women receiving mesh implants was based on hundreds of testimonies from women who had suffered life-changing injuries. However, as I have said, even the petitioners acknowledge that the type of mesh that is the subject of the petition is different from TVT. The fact is that many people have successfully had mesh inserted for hernia, and I do not know the data for those who have reported ill effects. Data is absolutely key to the issue, and I hope to learn more about that.

The obvious statement is that a review would cause delay for patients in getting treatment, at a time when, as we all know, delays are prevalent due to the intense and unprecedented pressure on the NHS. A review would take time to set up and to come to a conclusion. That would surely leave medics and patients in limbo.

The petitioners ask that

“mesh is only used when essential”,

but surely a surgeon would not use it unless he deemed it essential. They ask that

“patients have alternatives to mesh”.

I am unclear—how many of us know?—what options are available to surgeons to treat hernias and other conditions.

The petitioners also ask that mesh is

“only used with the fully informed consent of the patient.”

One of the stipulations since the scandal of TVT mesh is that patients have fully informed choice. That should be the norm for any surgical procedure that is undertaken. However, I take on board what Alex Cole-Hamilton has said.

The petitioners also acknowledge that

“mesh must be used in life or death situations”.

I suggest that only clinicians know the severity of any situation, and that they would make the correct choice to keep their patient alive.

The mesh scandal has been a long and difficult journey for the many hundreds of women in Scotland, and many more throughout the world, who have been affected by the devastating and life-changing symptoms and side-effects. We have come a long way in 10 years—although admittedly at a much slower pace than should have been the case—to stop women being affected in this way, and that has been acknowledged by the medical profession.

My issue with the petition is that, although it is undoubtedly well intentioned and heartfelt, I simply do not know whether there is justification for it. I am not sure whether the majority of us do. I am simply saying that there is uncertainty and that there could be unintended consequences. I agree with previous speakers. We must listen to the petitioners on what they have experienced, but my concern is that many patients would face delayed or less effective treatment if the petition were to be upheld.

Photo of Meghan Gallacher Meghan Gallacher Conservative

I begin by recognising the many women and men who have come forward to discuss deeply personal accounts of the life-changing and lifelong consequences that mesh surgery can cause. Reliving that trauma must be difficult, but it gives MSPs the opportunity to pause, reflect and review treatments that are offered to people across Scotland. I also recognise those who have campaigned vigorously to ensure that any procedure involving mesh is low risk and appropriate.

In all our considerations of the use of such devices, people’s health, safety and wellbeing must be our first concern.

The petition that we are debating, if approved by this Parliament, would suspend the use of all surgical mesh and fixation devices.

I have some sympathy towards those who submitted the petition to the petitions committee, given the serious implications that the use of transvaginal mesh has had for many women globally.

Mesh was previously used to treat stress urinary incontinence and pelvic organ prolapse in women. However, in 2014, a petition was submitted on behalf of the Scottish Mesh Survivors’ hear our voice campaign. We have all heard from women who have bravely told their harrowing stories about how they were told that they were just experiencing “women’s problems” and that there was nothing seriously wrong. Taking the time to read some of their accounts helped me to understand the distrust that women felt towards the Government and our NHS for not being believed.

It was right that the 2017 Scottish independent review of transvaginal mesh implants recommended stopping the surgery after concerns were raised by women who suffered debilitating, severe and painful consequences. Thankfully, there are now specialised services in Scotland for women who have experienced complications from mesh implant surgery, and the Scottish Government officially signed a contract that allows women to have painful mesh implants removed by a specialist surgeon in the United States free of charge. The deal allows NHS patients in Scotland to travel to Dr Veronikis’s clinic in Missouri for transvaginal mesh removal surgery. Earlier this year, a contract was also agreed with Spire Healthcare, where Professor Hashim Hashim operates, which gave women the option to go to Bristol for the surgery.

However, the points that Jackie Baillie raised in her speech were concerning, and

I will not be the only MSP in the chamber today who wishes that the Government had acted sooner and more efficiently to support women who have had such surgery.

One takeaway from the whole debacle was that MSPs from across the chamber rallied together to ensure that mesh survivors not only had a clear route to treatment but were compensated if they had spent thousands of pounds of their own money to have their implants removed.

As my colleague Dr Sandesh Gulhane and others have articulated, there is more than one type of surgical mesh. With other kinds of mesh, such as that used for hernia, there appears to be evidence of issues arising that are similar to those that arose in relation to the use of transvaginal mesh. Potential complications include chronic pain, bowel obstruction, hernia recurrence and infection.

Given that those concerns have been raised, the need for data and evidence is essential when investigating the link between cause and treatment.

For example, only a tiny percentage of hernia repairs involving mesh has resulted in mesh having to be removed.

The National Institute for Health and Care Excellence found that post-operative complications from mesh were rare, so we need to be careful when looking at the use of mesh and any side-effects of having such surgery.

Photo of Emma Harper Emma Harper Scottish National Party

Does Meghan Gallacher agree that anyone who is experiencing complications of inguinal hernia repair or any mesh implant should be looked after by a caring, compassionate, kind and competent multidisciplinary team? We need to consider that issue and move forward on it.

Photo of Meghan Gallacher Meghan Gallacher Conservative

Anyone experiencing any kind of pain should be treated with the utmost care, respect and dignity. Any patient who approaches any service in the NHS should expect that. I agree with Emma Harper that we should always look at those scenarios and make sure that we are moving in a positive and forward-thinking direction.

Moving on to the petition, the foundation behind the campaign is that the petitioners believe that the use of surgical mesh can lead to cancer. The petition also calls for mesh to be used only in life-and-death circumstances and for a full review of how surgical mesh is used. That is why I and other members have outlined the importance of evidence-based arguments. My colleague Sandesh Gulhane mentioned that earlier. Official sources such as the US Food and Drug Administration have said that they are sceptical of mesh leading to cancer. More evidence is needed, therefore, before we consider the petition further.

Having said that, I will not speak against any individual’s personal experience of mesh complications. However, I believe that all avenues must be investigated, should someone experience any of the issues that have been identified by transvaginal and hernia mesh victims.

I want to mention hospital waiting lists, because they will undoubtedly impact people who are experiencing any symptoms that could come with mesh surgery. At present, many people cannot see a GP, be seen at accident and emergency within four hours or get through to NHS 24 on the phone. That, combined with budget cuts and NHS staff shortages, is deepening the crisis that has emerged in our healthcare service. If the Government does not get to grips with hospital waiting times, people will continue to suffer unnecessarily due to the pressures on our NHS and the lack of action from the Government.

Conservative members will continue to hold the Scottish National Party-Green Government to account to ensure that improvements are made to our healthcare service.

Photo of Emma Harper Emma Harper Scottish National Party

I am speaking in the debate because there are two points that I want to make. I also have some additional information that I want to share after hearing other members’ contributions.

First, as a former operating room nurse in Scotland, England and California, I have experience of inguinal hernia repairs and other hernia surgery using surgical mesh, and I have seen the amazing results achieved with repair of anatomical defects using mesh. Surgical mesh is a crucial tool in surgery.

Secondly, and notwithstanding that, I completely understand the chronic, serious and total distress that some women experience as a result of transvaginal mesh. I was a member of the Health and Sport Committee in the previous session, when the mesh legislation was being taken forward. The testimony from women who had had complications was extremely powerful, as were the campaigning efforts of mesh survivors. Again, I put my thanks to them on the record. Anyone experiencing mesh complications must be listened to with kindness, compassion and care, and they need a great team of health professionals. It distresses me to hear that some folk have had their pain ignored.

I welcome the steps that the Scottish Government has put in place to allow women to take whichever course of action is most suitable to them for their mesh complications, so that they can be rectified. I look forward to updates from the cabinet secretary on how the complex mesh surgical service is progressing.

Recent studies, including from the Royal College of Surgeons, suggest that the risk of chronic pain following an inguinal hernia repair is similar, regardless of whether mesh is used. Prior to the use of mesh in hernia surgery, recurrence rates of herniorrhaphy were extremely high—10 to 20 per cent in some studies—and there is little doubt that mesh use has dramatically improved statistics and outcomes for patients. According to the Royal College of Surgeons, most of the negative coverage of surgical mesh has focused on post-operative pain issues. The RCS says that there is a danger that the coverage of the issue may be taken out of context.

The original reports of mesh complications featured gynaecological surgery, which is entirely different from patients having a groin or other abdominal hernia repair. In a report published by the Scottish Health Technologies Group, there are a number of recommendations for NHS Scotland, which are underpinned by evidence.

The clinical evidence supports the continued use of surgical mesh as an option for elective repair of primary ventral, incisional and primary inguinal hernias in adults in Scotland. Although patient preference might be for a non-mesh or suture-only hernia repair, access to alternative hernia management options should be available. Those will depend on the patient, the size of the defect—or even the size of the patient—the assessment, the diagnosis and the specific surgical or non-surgical recommendations that need to be made.

The report makes it clear that all elective hernia repairs should be preceded by detailed discussion between the patient and the surgeon as part of an informed consent process. I agree with Alex Cole-Hamilton on that. It is important to ensure that such discussions include the benefits and risks of surgical and non-surgical approaches to hernia management, including the fact that neither mesh nor non-mesh repairs such as the suture method are risk-free procedures. It is also necessary to ensure that the risk of developing chronic pain following hernia repair, especially for patients with pain as their main presenting symptom, is put to patients. Such communication is absolutely crucial in enabling them to make informed consent decisions on their treatment options. The decision to use laparoscopic or open mesh repair should be based on the patient’s medical history, the characteristics of their hernia and the level of the surgeon’s expertise.

In addition, it is crucial that we monitor the effectiveness of surgical mesh data. Data on long-term outcomes from hernia repair in Scotland must be recorded at national level to inform future decision making. It must be aligned with the UK medical device information system—MDIS—and should include collection of patient-reported outcomes. I would welcome an update from the cabinet secretary on whether such data will be collected and, if so, how it will be reported.

It is also worth noting that the NICE guidelines recommend laparoscopic surgery as one of the treatment options for the repair of inguinal hernia. I underline that the choice between unilateral and bilateral methods involves assessment and diagnosis of the patient. Section 1.2 of the NICE guidelines states that to enable patients to choose between open and laparoscopic surgery by either the transabdominal preperitoneal or the totally extraperitoneal procedure—the latter is my favourite, by the way—patients should be fully informed of all of the risks. The international guidelines for groin hernia management, which have been developed by the HerniaSurge Group, show that it conducted a thorough review of hernia repairs, leading to 136 statements and 88 recommendations on best practice for hernia repair. It is worth exploring its evidence and guidelines.

Last Thursday, I spoke to Mr David Sanders, consultant upper gastrointestinal surgeon at North Devon district hospital in Barnstaple, who is also president of the British Hernia Society. He gave me lots of information to take away. When the deputy convener closes the debate, I will be interested to hear whether the committee will go on to seek the input of the society, one of whose members is right here on our doorstep in Edinburgh.

I thank the petitioners for bringing the issue to the Parliament. I underline that any decision that we might take in future must be based on the best available clinical data and evidence.

Photo of Baroness Katy Clark Baroness Katy Clark Labour

I thank the petitioners: Roseanna Clarkin, a mesh-injured woman who has suffered chronic debilitating pain and life-altering injury after a procedure for a hernia; and Lauren McDougall, whose mother Michele McDougall suffered 18 years of pain as the result of a surgical mesh procedure before dying of a rare cancer. Neither Roseanna nor Michele had given their assent to mesh being used. Having met both Roseanna and Lauren, I know the pain and damage that mesh has caused in their lives and why they now seek the support from the Scottish Government that they deserve. Roseanna and Lauren have met a number of politicians, but they have not yet met the cabinet secretary. I ask that he consider meeting them to hear of their experiences at first hand. I asked Roseanna Clarkin what her top ask from the debate would be. She said that it was for patient pathways to be provided for all those who have been injured by mesh, rather than each individual having to fight for medical support.

The petition that they lodged in the Scottish Parliament is backed by powerful testimonies from more than 70 mesh patients and their families. It is clear what action they are asking from the Scottish Government. We need to accept that people are still having mesh implanted in Scotland. The Scottish Government must suspend the use of all surgical mesh and fixation devices while an independent review takes place.

Mesh is a cheaper option, but there are other options—the petitioners believed that pig skin should have been used in their procedures. The Scottish Government must provide greater healthcare support for patients who are mesh injured. It must increase access to specialist care, including mesh removal surgery and alternative treatments.

Photo of Emma Harper Emma Harper Scottish National Party

I am busy on my feet this afternoon, Presiding Officer—it is a really interesting subject for me.

Does Katy Clark agree that it might be worth exploring what they are doing with the one-stop-shop clinic in Barnstaple, Devon, which has a whole pathway sorted for the management of chronic pain from mesh repairs?

Photo of Baroness Katy Clark Baroness Katy Clark Labour

I thank the member for that helpful intervention. Yes, we should look at what is happening there and around the world. Jackie Baillie already mentioned the decision in Canada to suspend the use of mesh.

The Scottish Government must apologise for its failure to date to act on the concerns of mesh patients and should establish a compensation scheme to support those individuals as they attempt to overcome the pain and damage that mesh has caused them. Many of the campaigners on the issue now live with life-changing conditions that are directly linked to the mesh procedures that they underwent.

Although transvaginal mesh and its complications affected the lives of so many women, as we have heard, the use of other products to treat conditions such as hernias affect women, men and sometimes children, too. However, despite the testimonies that the Citizen Participation and Public Petitions Committee received from patients affected by the use of mesh, the true extent of the damage caused by those products remains unclear. Indeed, there have already been several calls in this debate for more data and for evidence to be obtained.

In her evidence to the Citizen Participation and Public Petitions Committee back in June, the Minister for Public Health, Women’s Health and Sport admitted that it was not easy to trace what products had been used in all procedures and which were causing harm. However, despite the lack of regulation on its use, NHS Scotland continues to use mesh in surgical procedures. From 2016 to 2020, 62 per cent of all hernia repairs carried out by NHS Scotland used mesh. That is why I join campaigners in their call for an independent review of mesh and fixation devices.

We cannot establish the true scale of the damage that those mesh products have caused to the lives of so many patients across Scotland until we get the data and the evidence. Until that review is completed, the Scottish Government must order health boards to suspend the use of surgical mesh and fixation devices and to use other procedures instead.

We need to put protections for patients in place. There needs to be clear guidance governing the surgical use of mesh. I believe that we need to suspend the use of mesh, but there may well be situations where its use is essential and no other alternatives are available. That must happen only when patients have given their informed consent to its use. It is disturbing that so many of the patients who contacted the Citizen Participation and Public Petitions Committee did not give their consent.

I am very grateful to the Citizen Participation and Public Petitions Committee for giving us the time to explore the issues today. I hope that the cabinet secretary will agree to meet the petitioners to take forward the issues that have been raised in the debate.

Photo of Siobhian Brown Siobhian Brown Scottish National Party

I have mentioned in the chamber numerous times the experience of a constituent of mine who received a transvaginal mesh implant. She shared with me her story, which she described as a “12-year nightmare” of excruciating pain. Her continual pain had a knock-on effect on all aspects of her life, including her career and her family.

I note that the petition that we are considering today is not explicitly about transvaginal mesh but is about mesh used in surgery elsewhere in the body. The reason that I mention the experience of my constituent is that the story of Roseanna Clarkin, one of the petitioners, echoes what my constituent went through. That all-encompassing pain can have a devastating effect on a person’s life.

I thank Roseanna and Lauren McDougall for bringing the petition to Parliament, because it gives us a chance to speak about this very important issue and hear other people’s stories. It is clear that the Minister for Public Health, Women’s Health and Sport and the Cabinet Secretary for Health and Social Care are taking the issue seriously and are listening to concerns as well as to the evidence.

Given the statements that the Scottish Government has issued and the scientific research that is available, it would not be wise to call for a suspension of the use of surgical mesh in other parts of the body. As we have heard, mesh is routinely used in hernia surgery, and, in Scotland, around five times as many hernia mesh procedures have been carried out as pelvic mesh or TVT implants. Furthermore, hernia repairs are among the most common surgeries carried out globally.

As with any surgery, it carries risks and can have side effects. The Scottish Government commissioned research into the use of mesh in a commonly performed hernia repair, which resulted in the publication of the Scottish Health Technologies Group’s report on the use of mesh in primary hernia repair in adult males. The report concluded that, compared to non-mesh procedures, using mesh resulted in lower rates of recurrence, fewer serious adverse events and a similar or lower risk of chronic pain. A further report by the group found that evidence supports the continuation of using surgical mesh in hernia repair as an option. As the minister has previously stated, the use of mesh in operations is long established, and in many situations there are few—if any—viable alternatives. Therefore, the suspension of mesh treatments would leave people with no option.

Informed consent is a very important point that has been raised by the petitioners, the Government and research bodies. It has been reported in the media that Roseanna was not told that her operation would involve the use of mesh and that she did not find out until much later that mesh had been used. I obviously cannot comment on the specifics of the case, but it is unthinkable that something like that could happen.

I agree with the minister and healthcare professionals that, with the exception of emergency procedures, the use of mesh should be carried out only with the fully informed consent of a patient who understands the potential risks and the other options that are available to them. I know that the then chief medical officer wrote to health board medical directors in 2018 to highlight the importance of informed consent. I ask the cabinet secretary, in his closing speech, to confirm that the need for informed consent in relation to mesh surgery is still being highlighted across health boards.

I will draw my remarks to a close. I completely understand that some members of the public who signed the petition will be disappointed that mesh surgeries are still going ahead. I trust that communications from the Scottish Government and healthcare professionals will give reassurance on the reasons behind that.

Fundamentally, it is crucial that we listen to those people who are suffering from mesh surgery complications. My constituent was not listened to, and Roseanna Clarkin was dismissed at first and told that her pain was “in her head”. I am sure that many others will have had similar experiences. Only by continuing to listen to people with lived experience can we start the important process of supporting anybody who needs this type of surgery and ensuring that the best possible care is in place for the future.

Photo of Brian Whittle Brian Whittle Conservative

I welcome the opportunity to speak in the debate. The mesh issue has been on the agenda of petitions committees since my arrival in the Parliament, and it is fair to say that it has delivered some of the most harrowing evidence sessions that I have been involved with in my time here. It has certainly focused my mind on the fact that what we do in the Parliament, amid all the other white noise of political discourse, has a profound effect on the lives of people in Scotland. In the case of today’s debate, the topic has had a far wider reach and far wider implications than just within our borders.

In a particular evidence session, the sight of the cabinet secretary and the chief medical officer being cross-examined in committee room 1 by committee members and former members, with many women affected by the procedure sitting behind them—many of them were in wheelchairs—was a vivid one. I remember that picture every time that I step into committee room 1. The fact that the then committee was joined by Jackson Carlaw, who is now the convener of the Citizen Participation and Public Petitions Committee, Alex Neil and Neil Findlay highlights the cross-party support for the campaign. I put on record that the undaunted pursuit of the issue by my colleague Jackson Carlaw and my previous colleagues Alex Neil and Neil Findlay was very important in arriving at a solution for a petition on such a harrowing issue. Without their determination and effort, it is unlikely that we would have got to where we are now.

We should consider the time that it took to get here. It should be remembered that I have been involved for nearly seven years, which is way short of the time for which my colleagues have been involved. It seems ridiculous to me that it took so long to make the Government move on such an acute issue and accept that there was a major problem. Yet, here we are again, discussing similar issues and trying to ensure that similar required outcomes are realised. Having said that, and given the recent political discourse, it restores a bit of my faith in the Parliament that we can effect change for the good of the country if we come together across the chamber.

Again, I express my sincere gratitude to Scottish Mesh Survivors for its hear our voice campaign, for its unrelenting and resolute campaigning to ensure that what mesh survivors have had to endure was spoken about in a public forum, and for its desire that no one else need have their life devastated by potential repercussions of the use of mesh. That campaign highlights the national and international impacts that a public campaign can have through the vehicle of the Citizen Participation and Public Petitions Committee.

Back then, there were questions to be answered. How could a former health secretary—Alex Neil—take the robust action of imposing a moratorium on the use of transvaginal mesh only for certain health boards to continue to use the procedure to treat stress urinary incontinence? I think that some 400 women have undergone that procedure since that moratorium. Who was ensuring that the moratorium was adhered to? Who was responsible? Rules cannot be set if there is no system of enforcement. It was news to me and, apparently, many other MSPs as well as the campaigners that a moratorium called for by the Government is not binding. That has to be an area of concern, and it is something that the Parliament still has to address. If that moratorium had held, I do not think that we would be in the position that we have found ourselves in.

The involvement of the Medicines and Healthcare products Regulatory Agency was absolutely shocking. A body in which we place a great deal of trust and responsibility has been exposed as inadequate and incapable of applying any degree of logic or care. In fact, it claimed that the sufferers’ pain could by psychosomatic. There was no duty of care or candour. It was also painful to watch the chair of the review squirming in her chair under questioning during the evidence session. Her answers caused gasps from the women who were seated behind her. A lack of empathy and understanding was all too evident.

Given the language that was used at the time by certain clinicians around “It’s all in your head”, as was highlighted by Jackson Carlaw on behalf of the committee, and the way in which such language slowed up the process of getting to the moratorium in the first place and the subsequent positive results for the transvaginal mesh petitioners, it is a worry to hear that such language is creeping back into similar concerns about men who have had or are considering mesh implants for hernia repair. As we know, men are not as good at talking about health issues, and they are certainly more reticent about organising themselves in the way that women mesh survivors did and pushing for justice in the way that they did. We all want to avoid a similar situation further down the line, in which we take evidence from a group of men suffering from the misuse of a similar procedure.

For me, a key element that came out of the initial petition was the lack of discussion about available options for treatment and the possible repercussions. Furthermore, the subsequent way in which the international community has communicated and delivered better medical solutions must be applauded, and further cognisance must be given to co-operative working continuing as we develop the right solutions.

I listened with interest to what my colleague Sandesh Gulhane said. Obviously, he has massively more experience than I have. He talked about the right procedures being conducted by the right surgeon, which brings us to the crux of the matter. As the committee considers a pause, I ask that the pathway of treatment reflect the desire to have the best treatment by the best surgeon.

I once again thank the petitioners for their courage and persistence. I assure them that they will be heard through the committee. I also ask the cabinet secretary to learn from the mistakes that were made in dealing with transvaginal mesh. It is entirely reasonable to note that the Citizen Participation and Public Petitions Committee is considering the use of surgical mesh and the potential for a moratorium until such time as a full review of all the relevant surgical procedures is carried out and more comprehensive information detailing all treatments is available. We must avoid at all costs having another committee session when it is too late to prevent such painful complications.

I look forward to further deliberations by the Citizen Participation and Public Petitions Committee.

Photo of Emma Roddick Emma Roddick Scottish National Party

I enjoyed hearing from Jackson Carlaw earlier about the history of campaigning in the Parliament on the use of mesh. I was interested to read up on his committee’s work on the matter over the past few years. My reliable source of pre-2021 parliamentary gossip has had to pop out for a moment, but Christine Grahame tells me that he has been a stalwart in this very cross-party issue.

I, like many, am pleased with the progress that was made last year on transvaginal mesh, which ensures that mesh-injured women can access treatment in Scotland or elsewhere with an independent provider if that is what they want to do. I will repeat something that I said back then and encourage any of my constituents in the Highlands and Islands who would like a referral to any of those services to make their wishes known to their clinical team. They should be able to access the best possible treatment for them as quickly as possible.

One strong theme during that debate last year, which is reflected in what I just said, was the importance of choice for patients—the choice to see the specialist they want and not have a particular pathway prescribed by the Scottish Government in exchange for supporting the necessary removal of mesh. That is my concern—probably my only concern—about the petition.

There has to be choice for patients. It must be informed choice and I am certain that, despite the steps forward in realistic medicine in Scotland, there is work to be done in making sure that patients feel empowered to understand their treatment, ask questions and request alternatives, even through what is undoubtedly a power imbalance between them and their doctors. We have all heard of people being laughed off for consulting Dr Google, but patients should be encouraged to find out more about their own needs and treatment.

Mesh is still considered suitable in some situations and it would not be reasonable to remove that choice from patients here and now when the medical guidance is still that it can be the most effective treatment. That would be particularly concerning where there is no obvious alternative and, certainly, no risk-free alternative.

I understand that the Minister for Public Health, Women’s Health and Sport told the committee last year that the chief medical officer had written to health boards to encourage them to consider the availability of non-mesh alternatives and address any skill gaps. That certainly needs to happen alongside, if not before, efforts to cease the use of mesh altogether.

If the Medicines and Healthcare products Regulatory Agency were to come out and say that mesh is not suitable, the petition’s ask would absolutely be the right move. At the moment, the guidance is that it is still suitable in some situations. We have heard that echoed by other members with medical backgrounds. In the meantime, it is right that the NHS be particularly vigilant with procedures in which mesh is still used. I understand that protocols are in place to ensure that. We all have a responsibility in Parliament to ensure that lived experience is heard and that mesh is not being used inappropriately or carelessly.

I am glad that the issue is still being given deserved attention. It is right that the Scottish Government keeps an eye on on-going work and forthcoming research, as well as any emerging patterns in complaints from patients who have experience of mesh. I am sure that many members across the chamber will ensure that eyes are not taken off the ball on that.

I also thank those who lodged the petition and contributed to the debate surrounding it. I share their concerns and I completely sympathise with their position. I have read submissions to the committee. It is always devastating to hear of people—usually women—feeling dismissed by doctors when they experience complications or symptoms. There is no doubt that mesh was used when it should not have been and that women have not been listened to when they should have been. As a young woman with a chronic illness, I completely understand that feeling and I am all too aware of the possibility that seeking medical help can mean facing condescension or even being ignored and then suffering further harm as a result.

My heartfelt empathy goes out to all those who are brave and passionate enough to use their stories to influence us and to help others. I hope that, regardless of how long or whether mesh is used, the petitioners know that they have made a strong contribution to the discourse around mesh, the need for specialist mesh removal services and the wider issue of informed consent.

We have heard some considered contributions today. I hope that the impact that the petitioners have had on all of us is clear to them. It would be very helpful to hear from the Scottish Government how the use of mesh will be monitored.

Photo of Annabelle Ewing Annabelle Ewing Scottish National Party

Before we move to closing speeches, I express disappointment that we seem to have two members who have not shown the courtesy—[

Interruption

.] Oh! We now have only one member who has not shown the courtesy of being here for closing speeches. Presumably that message can be communicated and an apology to the Presiding Officer given.

I call Paul Sweeney to wind up on behalf of Scottish Labour.

Photo of Paul Sweeney Paul Sweeney Labour

I am grateful for the opportunity to speak in this afternoon’s debate on the suspension of the use of surgical mesh, both as a member who is representing survivors of mesh repair and as a member of the Citizen Participation and Public Petitions Committee. That committee and its predecessor committee have considered this extremely important matter in various forms over 10 years. The member for Eastwood has ably convened discussions about the petition in the current committee with great diligence, and with great sympathy for and empathy with those who have been affected.

Dealing with the petition has shown Parliament at its best. As a new member to this institution, I have been impressed to see how accessible and effective it is at addressing serious concerns of marginalised groups in society and I commend the committee for its work.

Like Katy Clark, I extend my gratitude to Roseanna Clarkin and Lauren McDougall in particular for their tireless work in keeping the issue on the parliamentary agenda by sharing their harrowing experiences of mesh repair, as Mr Carlaw described in stark detail earlier, with parliamentarians and the public alike. Constantly reliving and sharing that trauma is not easy. It is not easy to listen to and it must be even harder to talk about. I commend their courage in sharing their stories to the committee and for serving the public interest so well. I hope that the cabinet secretary has heard those remarks today and that he will consider the reasonable request that he meet the women so that they can describe that to him in detail and can seek redress not merely through the committee but through the machinery of Government

Transvaginal mesh is an issue that has been raised in Parliament on a number of occasions, but this petition focuses on the use of surgical mesh and fixation devices elsewhere in the body—that is a crucial distinction—particularly in relation to hernia repair, which has continued to cause pain and discomfort for survivors.

The petitioners have rightly raised the complex problems that mesh can cause, including infection, pain and adhesion. A lack of specialist services for survivors to explore treatment and removal is an issue that we have seen with transvaginal mesh and, unfortunately, the lack of treatment options is a key issue for survivors of hernia mesh repair, too.

Mesh specialists are scattered throughout Scotland, but their number is scarcely enough and many survivors’ referrals to those professionals are rejected, especially if their mesh repair was used for hernia treatment and was not transvaginal.

Medical professionals are trying their best to be of support to mesh survivors, but the simple reality that we have heard in evidence to the committee is that there is not a clear pathway for referral and treatment for their patients who are left feeling alone, isolated and reliant on emotional support from other survivors and their families in the absence of specialist medical treatment.

It is not sustainable or acceptable to deprive mesh hernia repair survivors of options to treat or remove mesh, forcing them to live in chronic pain. Therefore, I am dismayed that the Conservative spokesperson for health and social care said that his party will oppose the petition today. That is deeply harmful to those people, most of whom are women, who have said that they have suffered acute pain.

Photo of Sandesh Gulhane Sandesh Gulhane Conservative

It is the suspension that we would be against but, as you heard in my speech, I am very much in favour of data gathering and further investigation.

The Deputy Presiding Officer:

I remind members to speak through the chair.

Photo of Paul Sweeney Paul Sweeney Labour

I thank the Conservative spokesperson for that clarification. Suspension in this instance is about addressing real harms that have been experienced, and that should be considered. The Conservative shadow minister makes a point about evidence gathering, and he described the low rate of defects and low requirement for repairs, but how can the evidence be valid or reliable when so many women are denied agency in the healthcare system? That is the issue that the petition seeks to address.

We have a kind of circular logic here. We are short-circuiting the issue and we are not addressing the reality of the evidence and picking up on the lived experience of the individuals involved. That is the issue for which the committee is seeking to provide a remedy. I hope that the Conservative shadow minister and the cabinet secretary might consider that, although there is a need to gather more evidence, those witnesses’ voices have not been heard thus far, which is simply not acceptable. What are the Parliament and the Government going to do to address that?

Canada provides a stand-out example of what can be done with national specialist centres for surgical repair for mesh and fixation devices, and survivors have expressed their desire for that to be delivered in Scotland. The Shouldice hospital is specifically devoted to hernia repair and holds the largest single database of hernia patients in the world. Each surgeon performs 600 to 700 hernia surgeries per year. The Shouldice repair technique has the lowest rate of recurrence, as Mr Carlaw described. Although in the short term we should enhance services that already exist in Scotland to better treat and remove mesh, the long-term goal should be to establish a similar national specialist treatment centre where survivors can access the support and treatment that they need from specialist medical professionals.

Photo of Paul Sweeney Paul Sweeney Labour

Do I have time in hand, Presiding Officer?

The Deputy Presiding Officer:

Yes—if we have a brief intervention and a brief response.

Photo of Paul Sweeney Paul Sweeney Labour

Thank you for your generosity, Presiding Officer. I will give way.

Photo of Emma Harper Emma Harper Scottish National Party

The Shouldice clinic has caveats around issues such as weight loss and stopping smoking and alcohol—it is very selective about the patients that it takes for its non-mesh repair. Do you not agree that it is kind of difficult to compare that with the patient population in Scotland?

The Deputy Presiding Officer:

I again point out that members should speak through the chair.

Photo of Paul Sweeney Paul Sweeney Labour

I thank the member for that reasonable intervention. We heard that point in evidence, and it is certainly an important clarification that is, for sure, useful to have on the record. Those are important caveats but, nonetheless, it was explicit and clearly expressed in evidence that having that concentration of medical professionalism and skill is critical to achieving low recurrence rates and that doing high volumes in a focused national centre is absolutely important.

The Conservative shadow minister mentioned the need for evidence. Let us look at the structure of the medical service provision and the treatment pathways. We heard compelling evidence about that concentration in a national centre.

As the Labour shadow minister in this area has said, and as has been put to the committee—indeed, as a minister has put to the committee—it is important that that model is supported, and we should consider delivering it. The Government does not think that it is workable, but I think that it merits further investigation. If the issue of people living in chronic pain and illness due to mesh repair anywhere in the body is to be tackled, we need ambition, not abdication. These people deserve much better.

Photo of Alexander Stewart Alexander Stewart Conservative

I am grateful for the opportunity to close the debate on behalf of the Scottish Conservatives. I strongly welcome the opportunity for Parliament to have the debate. As a member of the Citizen Participation and Public Petitions Committee, I commend our committee convener, Jackson Carlaw, and my fellow committee members for the way that they have conducted themselves throughout the process. Today’s committee debate is an excellent example of what can be achieved.

I really hope that the petitioners have seen the debate and have taken from it many of the views that have been expressed. A common theme throughout scrutiny of the petition has been that campaigners feel that their views are not being heard and that they have not been listened to. Following the many passionate contributions that we have heard this afternoon, I hope that one of the things to come out of the debate will be that campaigners feel that the issue is being looked at and addressed by the Parliament.

The issues relating to use of transvaginal mesh have been documented extremely well. Many members have talked about the opportunities and flexibility in that regard. However, wider use of mesh and fixation devices has received much less scrutiny than has use of transvaginal mesh, so I thank the petitioners for their courage in lodging the petition and giving us the opportunity to debate it today.

Many of the themes and concerns that have been encountered will be widely recognised, given the long-running debate around transvaginal mesh. Many members talked about the work of Jackson Carlaw, Alex Neil and Neil Findlay in the previous parliamentary session on ensuring that concerns were listened to. Once again, that shows how the Parliament can, when we work together, achieve great things for the people whom we represent.

We have heard distressing accounts from individuals who have had their lives turned upside down due to mesh-related complications. Some people wrote of how they undertook having the procedure in good faith; they were not necessarily aware of many of the risks. It is to their credit that, through the pain following their procedure, they decided to talk publicly about the process. It is widely recognised that many individuals suffered in extreme ways, and continue to suffer. We have a role to play in ensuring that that is recognised in the Parliament. We should be their voice, and today has shown how that can be achieved.

What many members have said about the process is vital. We have heard that the Scottish Health Technologies Group continues to support use of mesh in hernia procedures, but there have been many mesh-related complications. Many members spoke about that in relation to constituents with whom they have had personal contact.

We have the opportunity to ensure that there is greater clarity when it comes to certain types of devices that are used in procedures. That said, our experience of dealing with transvaginal mesh and the technology associated with it shows that many people have experienced problems. Members have talked about that.

It is important to consider pathways of alternative treatment to mesh. Those have been discussed today. Dr Fernando Spencer Netto, from the Shouldice hospital in Canada, gave evidence to the committee and made suggestions; it has been useful to hear from other members about what has been happening at that hospital. When it comes to managing treatment, Scotland’s healthcare system is, of course, different from Canada’s, and it has different population demographics. Nevertheless, the Government should seriously consider the lessons that can be learned from what is happening in Canada.

As expected, a number of important and passionate contributions have been made in today’s debate; I would like to dwell on them for a moment or two. Our convener, Jackson Carlaw, talked about the life-changing effects of the procedures. He said that the Scottish Health Technologies Group suggests that 10,500 hernia repairs take place in Scotland each year. Of those procedures, 62 per cent use mesh, and there are 32 procedures to remove mesh each year. However, there is not enough data to find out the reasons for that.

In his opening speech, the cabinet secretary acknowledged the distress that is caused to patients and the adverse effects that they have suffered. That is vital. He talked about issues regarding data collection and said that there should be local clinical groups rather than a national centre, as the petitioners have suggested.

My colleague Dr Sandesh Gulhane, who has expert knowledge and experience in relation to the matter, talked about the need for such petitions so that we have the opportunity to debate and discuss issues. He spoke about what is happening in Canada and the risks and complications relating to patient size, infections, chronic pain and numbness. It is vital that we consider all that in order that we give the best treatment to everyone.

Jackie Baillie gave a very strong and passionate speech, as she always does on health topics, and I enjoyed it greatly. She talked about how the Scottish Government must learn lessons, which is important. She also talked about people’s lived experience and said that pathways are needed, which is vitally important, and she talked about how there were 10 years when nothing happened. I hope that the cabinet secretary will take on board all the comments that she made.

Alex Cole-Hamilton spoke about the risks, the side-effects and the tragic stories that we have all had to deal with. That is the crux of the matter; we have all heard about and seen the lived experiences of constituents.

Meghan Gallacher, too, spoke about data and the evidence-based approach. She also talked about the waiting times that everyone is experiencing at present and about how the knock-on effects could have a real impact on the way forward.

Emma Harper, who is a nurse, spoke about how mesh is a crucial tool. She also said that people should be treated with kindness, compassion and respect. We hope that that would be the case for all individuals, but we have seen and heard that many people have found it not to be the case.

Brian Whittle spoke about how affected he was and what he saw during the transvaginal mesh situation.

Today, we have had a real opportunity to hear about mesh at first hand. I hope that the cloud of all our warning signals ensures that we do not see the same mistakes as were made in the past being made. We owe it to everyone who has suffered due to mesh in the past, and those who risk it still in the future, to do all that we can to ensure that they are listened to, understood and respected as a result of the report.

I commend the petitioners for what they have done so far.

The Deputy Presiding Officer:

I call Humza Yousaf to wind up for the Scottish Government, for around eight minutes.

Photo of Humza Yousaf Humza Yousaf Scottish National Party

I thank all members from across the chamber for their contributions. It has been a very good debate. Common themes have been raised throughout, again from members across the chamber. There have also been diverging opinions on what the next steps should be. That has not detracted at all from the debate. Sometimes, we can assume that only consensual debates are the best debates, but that is not always the case.

However, there is consensus on a number of points, and perhaps I should start at that place. There is absolute consensus that we are all grateful that the petitioners who are raising the issues have shared their stories and the stories of their loved ones, and there is consensus that the pain that they are describing, be it on their own behalf or on behalf of a loved one, is very real. Nobody here doubts that and, as I said already, I would be greatly upset and, frankly, angry and annoyed, if stories are brought to my attention involving issues around pain and chronic pain being dismissed by clinicians. I do not think that that is the experience of a majority of people, but I accept, from some of the testimonies that we have heard, that that has been the experience of some people. As I say, I am very open to members of the public—or, indeed, members of the chamber—writing to me directly in relation to some of those concerns.

Where else do we have consensus? I think that we have consensus on the fact that the Government—mainly—should be learning from the journey that we went on in relation to the women who were affected by transvaginal mesh issues. I do not take away from what was said by critics when they argued that perhaps—well, definitely—it should not have taken 10 years to get to where we eventually ended up. That is fair, and it is imperative that the Government learns from that. I am absolutely committed to doing that.

The points of difference really centre on what happens next. Some members are arguing very passionately for a complete suspension of the use of mesh and hernia mesh; others are saying that that would not be the right approach. I think that I would be right to say that the majority of contributions said that that is probably not the right approach, at this stage, but it is one to be kept under continual review. All that being said, I hope that, although they will be disappointed, those who have called for a suspension of the use of mesh will, at least in part, be reassured by the fact that we are aiming to improve data collection, which was another common theme.

What will that look like? Some work has already been undertaken by the British Hernia Society, of which a number of members will be very aware. In our work on data collection, the aim is that the NHS Scotland scan for safety programme will improve patient safety in acute care; it will provide electronic traceability, linking patients to implantable devices so that we can get real-time data electronically in relation to any issues that might crop up. As I said, that work comes in addition to the work that is being done by the British Hernia Society, which has made progress in establishing its own registry that it will begin piloting shortly. We will watch that closely, and we will work closely with the society, where appropriate.

I want to address some of the other issues that have been raised by members from across the chamber. I thought that Sandesh Gulhane’s speech and, more so—if he does not mind me saying—his exchange with Jackson Carlaw was very interesting to watch. Dr Gulhane made it clear in his response to Jackson Carlaw that the clinical advice that is provided should be listened to, although we all agree that there should be discussion between patient and clinician. He also said that he would have no issue with a mesh implant in himself or a family member. From his clinical perspective, we can see that there continues to be a high level of confidence in mesh, and what Dr Gulhane expressed has been expressed by many clinicians right across and up and down the country. We have seen that from the Scottish Health Technologies Group, too. There is a high degree of clinical confidence in the continued use of mesh.

Where alternatives can be explored, they should be, if that is what the patient wishes, and, as for any surgery, the potential complications and risks that are inherent in the use of mesh should be made very clear.

Informed consent was raised by many members, and Siobhian Brown asked specific questions on it. I give her and other members an absolute guarantee that I take informed consent seriously; I have discussed it with the chief medical officer, and he takes it very seriously, too. I am encouraged to hear from patient groups that informed consent processes have improved quite significantly, and shared decision making and informed consent are the centrepieces of realistic medicine. Government ministers often talk about realistic medicine, but it is also close to the heart of the CMO.

We want people to be fully involved in decisions about their care. That is why we encourage people to ask their healthcare professionals questions to help them to make informed choices. Equally, we encourage clinicians to ask questions when they are in discussions with their patients.

Photo of Humza Yousaf Humza Yousaf Scottish National Party

I will, shortly.

The questions that we expect clinicians and patients to ask one another are, “What are the benefits, risks and alternatives?” and, “What if I do nothing?”.

Photo of Jackson Carlaw Jackson Carlaw Conservative

Does the cabinet secretary agree that, although this would have been impossible 10 years ago and unlikely five years ago, we have had a substantive informed debate on the subject of mesh this afternoon, with contributions from all across the chamber? Is that not the perfect tribute to all the campaigners who, over the past 10 years, have worked so hard to ensure that members of this Parliament understand the issues that underpin mesh as well as they now do?

Photo of Humza Yousaf Humza Yousaf Scottish National Party

Not for the first time in the debate, I agree whole-heartedly with Jackson Carlaw. I am beginning to doubt myself, thanks to the number of times that I have agreed with him this afternoon. I say that in jest only, because, as he knows, he has my admiration, as well as that of the Government, for the excellent work that he has done on mesh—both transvaginal mesh and wider mesh issues. I have been in front of the Citizen Participation and Public Petitions Committee, which he convenes, and I know how seriously he and other committee members take the issues.

I hope that the testimonies and stories of the women who have been affected by transvaginal mesh and the bravery that they have shown give confidence to other people to speak about complications in relation to their own health, whether due to mesh or other matters. That should be seen as a good thing. There might be disagreements between members on the way forward, but it is important that people speak openly about their health and raise issues about complications or the harmful impacts of a procedure, because it is important that the Government and the health service know about that.

Photo of Brian Whittle Brian Whittle Conservative

Would the cabinet secretary agree that it is really important that people who are encouraged to speak up are listened to and that, as happened previously with cases involving transvaginal mesh, we are keen to hear what people have to say?

Photo of Humza Yousaf Humza Yousaf Scottish National Party

I agree whole-heartedly. That was a common theme in the cases of the women who were affected by transvaginal mesh.

I will try to make progress on some of the other issues that members raised.

A couple of members have asked whether I will meet with the petitioners. I do not know if I have had a request to meet them; I will double check that. I will, of course, give that my absolute and full consideration. I am not necessarily convinced that that will change my opinion, given the reviews and reports by the Scottish Health Technologies Group, but there is nothing to be lost by meeting with petitioners and members of the public about their experiences and those of their families, so I will consider that when a letter or any other correspondence to that effect comes to me.

Jackie Baillie and a couple of other members mentioned Canada and other international examples that we should look to. It is fair to say that we should look to other jurisdictions and countries. I may have the wrong information, but I am not sure that Canada has entirely suspended or halted the use of mesh. I think that Canada has done so for transvaginal mesh, but I am not entirely sure whether that has been done for all mesh procedures. I will double check that and, if that is the case, we should link in with our health colleagues in Canada.

The Deputy Presiding Officer:

I can allow a brief intervention and a brief response.

Photo of Paul Sweeney Paul Sweeney Labour

The issue of the structure of the specialist surgical centre was a key aspect of the evidence from Canada. Would the minister consider replicating that in Scotland?

Photo of Humza Yousaf Humza Yousaf Scottish National Party

We have considered that. The points made by Maree Todd when she was asked about that by the committee still remain. We are talking about two very different health systems. I said in my opening comment that having a specialist centre for hernia operations might involve people having to travel to one particular centre when they could be seen closer to home. However, let us not dismiss issues concerning pathways and special centres.

I know that I am already running vastly over time. Allow me to reflect. I recall a debate when we were taking forward the Transvaginal Mesh Removal (Cost Reimbursement) (Scotland) Act 2022. I commented that our work on mesh had shown this Parliament at its very best. I end on the point made by Jackson Carlaw in his intervention, which is that I hope we can continue to work in that spirit when considering what more can be done for patients. Although they may be disappointed that the Government is not suspending the use of mesh in hernia operations, I am listening. We are listening and we are committed to ensuring that people get the care that they need.

The Deputy Presiding Officer:

I call David Torrance to wind up the debate on behalf of the Citizen Participation and Public Petitions Committee.

Photo of David Torrance David Torrance Scottish National Party

I am pleased to close this extremely important debate on behalf of the Citizen Participation and Public Petitions Committee. I thank my fellow committee members and the committee clerks, whose support, hard work and guidance for elected members is vital and is very much appreciated by the committee. I also thank colleagues who have contributed to today’s debate.

After what the convener, the cabinet secretary, Alex Cole-Hamilton and many of my colleagues have said throughout the debate, we can be left in little doubt about the devastating impact that surgical mesh has had on patients from across Scotland or about their fight to be believed about their condition. In our consideration of the petition, the Citizen Participation and Public Petitions Committee gathered a wide range of evidence to assist our understanding of the use and impact of surgical mesh. I place on record my thanks to the petitioners,

Roseanna Clarkin and Lauren McDougall, and to all those who have shared their experiences of the issue with the committee in the past 20 months.

This is not the first time that we have debated the effects of mesh treatment; Parliament has been speaking about the use of surgical mesh in one way or another for almost 10 years. Jackson Carlaw and I were members of the petitions committee when the issue of transvaginal mesh was introduced. I am honoured to stand here today as deputy convener of the committee, with Jackson Carlaw its convener, as we debate this petition.

Although we recognise the progress that has been made for those suffering complications caused by the use of transvaginal mesh, the issues that are raised by Roseanna and Lauren’s petition are still to be resolved. It is for that reason that I will focus my remarks on finding solutions to the concerns that have been raised.

Since the petition was submitted to Parliament for consideration, the Scottish Health Technologies Group has published two reports on the use of mesh in hernia repair. The first report provided an assessment of the use of surgical mesh for hernia repair in male patients. Dr Gulhane mentioned the findings of that report, one of which was that the use of mesh meant that men were less likely to have their hernia return. The report said that the use of mesh meant that men were less likely to suffer urinary retention and injury to nerves, blood vessels or internal organs, but it said that patients were more likely to develop a build-up of fluid or swelling soon after surgery.

The SHTG has recommended that all elective inguinal hernia repair should be preceded by detailed discussion with patients to help to manage their post-surgery expectations. We heard from patients that it is vital that those discussions take place ahead of any surgery to ensure that they can reach a fully informed decision about their health.

As we have heard, the recommendations were further developed in the second SHTG report, which explored the use of surgical mesh in repairs of abdominal and groin hernias in all adults and not just male patients.

Although both reports conclude that evidence appears to support the continued use of surgical mesh in hernia repair, I highlight the recommendation that patients should be able to express a preference for a non-mesh repair and access to alternative hernia management options. The report mentions that patients should be provided with detailed information on hernia repair in a variety of accessible formats.

Anyone who has been to a hospital appointment to discuss treatment options will know how challenging it is for a patient to absorb all the relevant information and feel confident that they are making a fully informed decision, so the provision of that information in other formats, both written and verbal, would certainly be a positive development.

The committee heard that the chief medical officer wrote to all health boards in December 2021 highlighting the SHTG report and asking them to consider the availability of non-mesh surgery. In an evidence session in June 2022, one of the Scottish Government’s senior medical advisers, Terry O’Kelly, stated:

“it is critical that, when appropriate, patients have access to non-mesh surgery, which might be provided by their health board or by another health board somewhere else in Scotland.”—[

Official Report, Citizen Participation and Public Petitions Committee

, 8 June 2022; c 18.]

As Paul Sweeney said this afternoon, the committee heard from patients that it is critical to ensure that there are patient pathways for those who, having been made aware of the risks, want to pursue the option of non-mesh treatment.

Photo of Emma Harper Emma Harper Scottish National Party

We have talked about mesh this afternoon, but we havnae really talked about titanium fixation devices, which are also part of

Roseanna Clarkin and Lauren McDougall’s petition. Does David Torrance agree that further discussion might be necessary and further evidence might need to be taken on that? We now have biodegradable fixation devices, which are being used more often.

Photo of David Torrance David Torrance Scottish National Party

The committee is still taking evidence on what is raised in the petition, so I think that there is scope for us to look at what Emma Harper has suggested.

A key aspect of ensuring that patients have access to those alternatives will be to identify any skills or training gaps. As the committee convener mentioned, we look forward to seeing the findings of the Scottish Association of Medical Directors report on the availability of non-mesh surgery in health boards across Scotland.

It may feel as if they have been a long time coming, but we welcome the steps to support patients in making informed decisions before any surgery takes place. It is important to get things right at the beginning of the patient’s journey. We heard a lot during the committee’s deliberations—and indeed we have heard a lot this afternoon—about the complications that arise when mesh does not work as patients and clinicians had hoped.

There is a small minority of surgeons who prefer to use natural tissue repair and who use mesh only as a last resort. The committee was interested to hear more about that approach and, as the convener touched on at the beginning of the debate, and as Alexander Stewart and several other members mentioned, we took evidence from the Shouldice hernia hospital in Canada. It is the only licensed hospital in the world that is dedicated to hernia repairs and it has been a steadfast supporter of natural tissue hernia repair for over 76 years, performing more than 400,000 abdominal wall hernia repairs. To date, it has used mesh in less than 2 per cent of cases—I note that mesh is still used in Canada—and its surgical outcomes remain the gold standard in abdominal wall hernia repair.

The committee held a virtual evidence session with Dr Fernando Spencer Netto, the chief surgeon at Shouldice hospital, to discuss its work. Given his views on the use of mesh, we asked him,

“Would a ban of the use of mesh in hernia repairs be a good thing?”

His response was:

“In some situations, there is no possibility other than to close the opening with mesh. Sometimes, the hernias improve, and surgeons’ knowledge of how to treat hernias also improves. The stats from today are probably very different from the stats on patients who were operated on five to 10 years ago. In relation to hernia repairs, it is not possible for there to be a ban, because, in some situations, using mesh is the only way to do a good repair.”

Given the success of the Shouldice hospital with natural tissue repair, which has resulted in a low recurrence of hernias, it was extremely helpful to speak with as experienced a surgeon as Dr Netto. Nonetheless, although, undoubtedly, much can be learned about the skill, training and techniques that are used in the Shouldice hospital, it is important that its successes and achievements are taken in the context of our own healthcare system and culture.

The pre-operative preparation and post-operative care for hernia repair surgery in Scotland differs greatly from the treatment of patients at Shouldice, when it comes to the application of strict criteria for selection. Shouldice hospital applies selection criteria such as weight loss before admitting patients. In addition, it does not take patients who might have more complex medical needs, such as back-up from cardiology or intensive care units.

Dr Netto told us:

“if the patient in question is too obese and wants to undergo weight loss, that is okay. Sometimes there are patients who need to lose, say, 50 pounds; indeed, there have been patients who had to lose 100 pounds or more to have the operation. Sometimes we also change the estimated ideal weight a little bit.

One of the suitability criteria is the patient’s medical condition. If they have a chronic condition, it needs to be stable before they can have the operation. With obesity, though, it is questionable whether we can do tissue repair, because the operation is a lot more difficult: the incision has to be bigger, the wound can get more infected, there can be more hematomas and, frequently, one complication will lead to another. That is why we always try to get patients to the correct weight. Unless some very specific things happen, most of them reach the correct weight—or at least get very close to it—and they have the operation. I am 100 per cent sure that that makes a difference to the final result for individual patients.”—[

Official Report, Citizen Participation and Public Petitions Committee,

12 May 2022; c 9, 6.]

That raises an important question about restricting access to treatment because of personal criteria, and about whether such criteria could be brought into play here and would be acceptable to members of the public.

For some patients, the use of surgical mesh may be the most appropriate option available. It is important to note that the petitioners have called not for a permanent ban on the use of mesh but for the suspension of its use until we understand the complications better and ensure the establishment of robust guidelines.

The evidence that our committee has gathered indicates that work is still to be done to track the outcomes of the use of surgical mesh. As the minister has mentioned in evidence, there are challenges in tracing what products have been used and which of those are causing harm. Although we recognise that the regulation of medical devices is a reserved matter, the committee has also noted cross-party support in this Parliament for the Scottish Government’s efforts to make progress on the regulation of such devices.

Our committee has had powerful testimony from individuals who are living in constant pain following the use of mesh; we have heard from the experts on the alternatives that could be used; and we have heard about the need to improve patient pathways and embed a culture of informed consent. What has been clear, as we heard all that evidence, is that we cannot wait for another 10 years for solutions to be developed and implemented.

Photo of Alison Johnstone Alison Johnstone Green

That concludes the debate on petition PE1865, on suspending all surgical mesh and fixation devices.