Public Petitions Committee

Meeting date: Tuesday, June 3, 2014

Official Report 491KB pdf

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New Petition

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Polypropylene Mesh Medical Devices (PE1517)

Thank you very much for making that statement. I know that you found it personally very difficult. Although, technically, no applause is allowed in the gallery, on this occasion I will allow it.

We are now at summation, so we have stopped asking questions, but I ask the petitioners to stay where they are.

My personal view is that this is one of the most significant petitions that we have had in the three years over which I have convened the committee. I again thank the Sunday Mail for all the work that it has done to highlight the issue. I am sure that I speak for other committee members when I say that we clearly need to continue the petition. I, for one, certainly want to get the views of the Scottish Government, the MHRA and NHS National Services Scotland.

It is also important for us to write to the European Commission because, as I said earlier, it has a regulatory role. If the committee agrees, we have a provisional date to meet the European Parliament’s Committee on Petitions in October. That has not been confirmed yet, but if the committee is so minded, we might be able to visit one of the directorates general that have responsibility for the issue. That is my view; it is for committee members to consider the next steps.

I have set out some parameters, so we will start by hearing the views of the deputy convener, Chic Brodie, on the committee’s next steps.

11:45

Good morning, and thank you for your opening statement. We know that as a consequence of your meeting the health secretary, he has taken up certain actions with MHRA and the EU, and new consent forms will be available next month and people will be able to record complaints.

Let me focus, if I may, on general practitioners. How aware were they of the implications?

Of course, the harrowing aspect of all this is the largely irreversible nature of the introduction of mesh, because of what Marion Scott described, including the fact that tissue grows through the mesh, and the consequences of that. The Government’s hesitation—or at least people in the health service’s hesitation—is, however, due to the fact that it has been applied successfully to a number of women. I am interested to hear your response to that.

A variety of products are on the market, albeit that they are underpinned by the same principle. Has the product been at fault or has the clinical procedure been at fault? How do you react to the comments that, for some people, the treatment has proved to be successful? Why has that been?

We start by thanking Alex Neil, the Cabinet Secretary for Health and Wellbeing, for recognising the seriousness of the situation and the failures in the system. We are grateful to him for instigating a working group of mesh victims and health professionals. The group is working to produce a new patient information and consent booklet. That will include all known risks associated with polypropylene transvaginal mesh implants. That is something that we did not have but which should be available in every hospital in Scotland before a single procedure more is undertaken.

11:00

We would like to stress that none of what we are asking for will benefit any of us here today. We cannot change what happened to us, but it is not too late to make the changes that we believe will protect others from future injury, saving them and their families from pain, frustration, helplessness and possible disability.

While other countries are now taking action—the USA by reclassifying mesh for some procedures as high risk and Canada by issuing warnings to hospitals and doctors—we are failing to bring in the measures that are needed to protect the unsuspecting others sitting in hospital waiting rooms right now.

We have been told that regulation and safety are issues for the European Commission. However, given that our First Minister shows political willingness to intercede over fishing quotas, we ask that he show political willingness to intercede over something that has such a detrimental effect on human life.

The Medicines and Healthcare products Regulatory Agency has confirmed that we already have the powers that are needed to make a difference in Scotland, and too many Scottish women are being hurt on a daily basis for us to wait on the slow-moving wheels of Westminster. The rest of the United Kingdom can follow suit, but let us lead the way.

Almost two months ago, a US court found the mesh implant of choice in Scotland—Ethicon’s Gynecare TVT obturator system—to be defective. If it is defective in the USA, it would likely be found defective here if a UK court were to examine the same evidence. However, because there is no implant register here, Alex Neil, the Cabinet Secretary for Health and Wellbeing, has had to admit that there are no available records to allow health boards to write to each woman who was given the defective implant, either to warn her or to check on her health.

We were not told that as many as one in five mesh implants can go wrong. When you consider that 11,000 women in Scotland have had the procedure, one in five suddenly becomes an alarming statistic. Further, as complications often take years to develop, we fear that we may just be the tip of the iceberg.

Women are still being told that their pain is not mesh-related because they have tape, not mesh. They are still being reassured the mesh that is inside them is safe and that it is different from the problematic mesh that is reported in the media. However, both claims are untrue. Our implants are all made from the same plastic polypropylene mesh. All transvaginal mesh is high risk and must be reclassified.

Using polypropylene mesh for a transvaginal procedure is a contraindication. Ethicon’s own website states:

“As with all foreign substances, GYNECARE INTERCEED should not be placed in a contaminated surgical site.”

Surgeons consider the vagina to be a clean-contaminated surgical site, and polypropylene mesh is a foreign substance.

Until each and every woman who is injured through mesh implants has been properly diagnosed and treated, and all complications have been judiciously recorded, we do not believe that the MHRA or NHS Scotland can continue to state that the procedures are safe or that the benefits outweigh the risks.

The present system has failed because it is voluntary. Although official figures show that 328 women endured multiple surgeries—with some having as many as 12 operations to repair damage that was caused by mesh—only 12 doctor-reported incidents have been received from Scotland by the MHRA. Why did those doctors not report the complications in 328 women? Because they did not have to.

I personally know of three women who have died following mesh surgery, but just one had reference to the procedure on her death certificate. Why?

There is confusion over numbers, missing data and underreporting and we ask that you hear our voice and support us in suspending these procedures, pending an independent and thorough investigation. This is an emerging global scandal that affects hundreds of thousands of women.

We might not be able to answer all your questions and we do not know how much the changes will cost in monetary terms but, in human terms, please, just look at all the women behind us.

We will leave our dossier with you for further information.

No, not at all. I have spoken to hundreds of women and the vast majority of them were never properly told exactly what the device would do. They were just given a pat on the head and told, “This will sort you out.” They were not told what the side effects could be or about alternative operations, which is shameful. The sad fact is that for every alternative operation, six mesh operations can be done. That is why they have been done.

11:15

They were not aware of them.

As I said, we are over time, but I decided that we should extend the time, because this is important.

Do members who have not contributed wish to say anything at this stage?

Thank you for the opportunity to speak. I thank Elaine Holmes for her moving presentation.

I identify absolutely with what Mr Findlay and the petitioner said. I will make a few specific points. I am particularly concerned about the scale of the problem. If 11,000 women in Scotland have had the procedure and one in five of them is affected by the issue, that is a large number of women who are affected, and there might be more. That leads to my next point, which is that there is concern about underreporting. Regrettably, some women who have the problem might not even be aware of it.

I am concerned about the treatment pathway for women who are identified as having the problem. It is far from clear what that pathway should be. I am concerned about the lack of standard guidelines. To the best of my knowledge, there are no standard guidelines across our health boards. Finally, I am concerned about the risk to future pregnancies of affected women. That is perhaps the greatest concern.

I thank the committee for the opportunity to say those few words.

Thanks for allowing me to contribute to the committee’s consideration of this petition, which was presented so well by Elaine Holmes.

The women who are before the committee today are here as representatives of hundreds of Scottish women—and, indeed, hundreds of thousands of women across the world—who have received a polypropylene mesh implant. They either have experienced serious complications or have concerns that they might do so in future.

I became aware of this issue shortly after being appointed to the shadow Cabinet. It was then that I met the petitioners who are here today, and other mesh victims. Like today, on the day they met me, many of them did not walk into the room where we had our meeting. Some limped or shuffled. Some had to be helped into the room. Some had walking sticks or crutches and others had wheelchairs. They all believe that they have sustained injuries because of the medical procedure that they underwent. They described to me the horrific consequences for their health of the mesh implant that they believed, and had been told, was a cure for their condition.

Since then, the more I have looked into the issue, the more anxious I have become. We must be clear that this is not just a Scottish problem but a growing international healthcare issue and, potentially, a massive global scandal. That international context and the weight of evidence worry me greatly.

The day I first met Olive McIlroy and Elaine Holmes, I went with them to a meeting with the cabinet secretary and Government officials. At that meeting, they were reassured about concerns over informed consent and were told that a new process would be put in place. They were told that an information leaflet would be provided and that women would be made aware of alternatives when they were assessed, and that there would be action to address the underreporting of adverse incidents.

We left that meeting with optimism, thinking that things would be moved on quickly. However, here we are, nine months later, with little or limited progress. Indeed, five years after a complaint was upheld by the Scottish Public Services Ombudsman about a patient not being given information about the risks that are attached to the procedure, we are still not in a position to systematically provide women with the opportunity to give informed consent to the procedure. That is of grave concern to those involved, obviously, but also to our NHS more broadly, which I believe might have left itself wide open, in a legal sense, on this issue.

At that meeting with the cabinet secretary, he suggested that evidence relating to adverse incidents was weak, with only six adverse incidents being reported. To that, the six women around the table said, “Well, that must be us six.” However, since then, through parliamentary questions, I have been advised that around 100 women have had mesh fully or partially removed. Then, through freedom of information requests to the NHS boards, we established that more than 300 people have had complications. That statistical inconsistency rings alarm bells for me. I think that the reality is that no one knows how many women are affected by this issue, and we might just be scratching the surface.

That is mainly explained by the fact that doctors are not compelled to report adverse incidents. I believe that they should be so compelled and that the petition is right in calling for that. The Government needs to take action on that immediately, and on the need to set up the register.

Something has been done.

On paper, the benefits may appear to outweigh the risks, given that only 12 reports have been given to the MHRA from Scotland and 11,000 women have had the operation. However, there is no database and there is no mandatory reporting, and hundreds of us—almost 400—are litigating, and that is just the tip of the iceberg. Many of us have had multiple procedures and each one of those procedures is an adverse incident that should be reported. If they were reported, we would be looking at a very different scenario. The benefits would not outweigh the risks.

I am sorry; I cannot remember the second part of your question.

Mr Findlay, we are a bit short of time. Are you near the end of your statement?

I thank the petitioners for their presentation. The committee does not make final decisions; it recommends further action.

On a personal level, I have no doubt that the evidence that you have given supports the action that you are asking be taken. To that end, I suggest that we write to the Scottish Government, continue the petition and invite the cabinet secretary to come to the committee to explain the Government’s actions. Regrettably, the power is not yet in our hands—we have to discuss the issue with the EU—but I am once again disappointed that products in which we can have no or little confidence seem to be entering the marketplace. That point might be for another day, but we should invite the cabinet secretary to come and discuss the petition with us.

I thank Neil Findlay and John Scott for coming along.

I will start the questions, after which I will bring in my colleagues. Elaine Holmes mentioned the Medicines and Healthcare products Regulatory Agency. How effective is it as a watchdog?

There was no channelling of information to GPs.

I appreciate that. Again, we have to talk in generalities; we cannot talk about specific situations. I am trying to determine whether there is a preponderance of advice that the product is the answer, as opposed to any other possible devices. Is there a preponderance of advice that the treatment is the solution to the medical problem?

I am not saying that nothing has been done about it, but surely not enough has been done. We are asking for the procedure to be stopped and for the issue to be fully investigated. I am not sure why we are not doing that.

Thank you for making that statement. I know that this is a sensitive and difficult area for you, but your statement was helpful to the committee. I also thank your supporters in the gallery for coming along today.

I invite Neil Findlay to make a short statement.

I just have one supplementary. I deliberately left it to the end, because I thought that it was important to hear the factual evidence first.

These are very personal stories. Would the two petitioners share with the committee how their lives have changed?

I will be very quick.

We have a product that continues to be used in hospitals and continues to damage Scottish women, as more and more receive the treatment. The evidence from abroad is compelling, and I believe that we should suspend the use of the product, pending an inquiry into the scale of the problem and the safety of the product. We should also introduce the rest of the changes that the women propose.

If there is no Government inquiry, this committee or the Health and Sport Committee should conduct one immediately.

I urge you to support the aims of the petition. I thank the campaigners, and I thank the Sunday Mail for its support.

Today, you have seen determined women who have been willing to talk about a personal matter that has had a devastating impact on their lives. Some of the women have been left in wheelchairs, and some have lost organs. Many have lost their jobs, and some have lost their marriages. This Parliament is here to represent the issues that concern communities and our people, and I trust that the committee will take the petition seriously.

That is right. Even the two communications that were put out by Sir Harry Burns and those that have been put out latterly by—I believe—the deputy chief medical officer, were directed to health boards. We need direct communication specifically to GPs, because they are often the first port of call.

I can walk from my front door to the driveway—that is as far as I can walk. I now rely on a wheelchair. I have had severe left-side nerve damage. My life is not what I envisaged for myself, my husband or my family. We have learned to live with it. We have good days and bad days. As Olive McIlroy said, we have gained support from one another.

All three witnesses will be aware that the European Union has a very important role here through the CE mark—the European conformity mark. As you will know, given all the research that the Sunday Mail has done on the issue over the years, medical products must comply with the CE mark. If there is a complaint from a devolved authority or, in our case, the UK authority, about a medical product, the CE mark can be withdrawn. Have you looked at that course of action in its generality?

In essence, your argument is that if the procedure is allowed to carry on indefinitely, around the world a huge cohort of people who have had an adverse reaction will emerge, if the problem were properly reported. Therefore, it may be not the procedure but the product: it is the principle that underpins the treatment that is at fault.

The agency is not an effective watchdog. It does not take our concerns seriously. We have written to it a number of times and telephoned it, but we get standard copy-and-paste replies. The agency does not listen to us.

The agency says that it can take complaints only if someone has their full device details; otherwise, people are put on a trending database. As most of us do not know what is implanted inside us, it is impossible to give the details. More often than not, the device details are not recorded in people’s medical notes; sometimes, they are in theatre notes, but sometimes, your guess is as good as mine. Even the agency does not know the full scale of the problem, because few of us have our full device details.

As I have said, GPs cannot really give advice if they do not in the first place know the information that they need in order to give advice. They are still totally in the dark, even after getting letters from the deputy chief medical officer. There is still a lot of confusion about mesh medical implants.

Obviously, after this the committee will talk about next steps. I am sure that we will want to write to the Scottish Government, for example. Do you have any further questions for the witnesses, Ms McTaggart?

Mr Brodie’s recommendation is that we continue the petition and write to a variety of organisations.

Once of the devices, TVTO, is the preferred device in Scotland, but a US court of law recently found it to be defective.

Any mesh product is defective. The MHRA thinks that the benefits outweigh the risks, but the benefits do not outweigh the risks when people are becoming disabled. It is not a negligible thing.

As you have pointed out, there is no post-recording of situations.

No—not just now.

I agree with Elaine Holmes. The agency’s work is subject to European Union medical directives and most of it depends on the evaluation of reported incidents. As reporting is not mandatory, the incidents are not getting to where they have to be to be evaluated. The agency is not getting reports because nothing is mandatory—it is all voluntary. The devices were not even tested on humans from the start.

That should be looked at, and it is perhaps something that we could take further. However, I know that a licence is needed to use the mesh product. I have here in my hand a polypropylene mesh that is used to tie up newspapers, but it is the same substance as the mesh that is put inside women. The only difference is that the medical mesh holes are bigger so that the body tissue grows through them. You can therefore imagine the damage that is done when trying to remove the mesh.

Licences are given to use mesh in one part of the body, but it is not necessary to ask for a new licence to use mesh in another part of the body. However, mesh that is okay for one part of the body is not necessarily okay for use in another part. Members know of the damage that has been caused to women’s bodies by mesh.

So, as far as you are concerned there has been no feedback to Government, to the MHRA and the EU.

Basically, the life that I had was a healthy, active, employed life. I do not have that life any more, now that I am disabled. I have chronic pain. In the morning, I get up, I brush my teeth and I feel pain. When it comes to sitting and walking, I am like Elaine. I am determined not to be in a wheelchair, but it would make my life so much easier if I was. I have constant symptoms. There is no off switch for the symptoms. It is the same for all the girls we speak to.

Agenda item 2 is consideration of a new petition, PE1517, by Elaine Holmes and Olive McIlroy, on behalf of the Scottish mesh survivors hear our voice campaign, on mesh medical devices. Members have a note from the clerk, the Scottish Parliament information centre briefing, the petition and the related submissions. Neil Findlay MSP and John Scott MSP, who both have an interest in the issue, are in attendance. I welcome both members to the meeting.

The committee is aware that a number of cases have been lodged at the Court of Session. The committee cannot become involved in individual cases, so no reference should be made to named clinicians and no statements should be made that would identify any individual clinician or national health service staff member. In accordance with the Parliament’s rules, I will be forced to stop any member or witness who brings such details into the arena.

I thank the petitioners and the Sunday Mail for all their work on the petition. I am sure that all members have followed this very sensitive case, particularly through the pages of the Sunday Mail. It is another good example of how a petition is formatted, submitted and addressed by this committee.

I welcome the petitioners, Elaine Holmes and Olive McIlroy, as well as Marion Scott, from the Sunday Mail. I invite Ms Holmes to make a short presentation of around five minutes to set the context of the petition. I will then ask Neil Findlay and John Scott to make very brief statements, after which I will kick off the questions and other committee members will follow.

I have a few more recommendations to make. I suggest that we write to the Royal College of Surgeons and the British Medical Association to seek their views on the procedures. I also suggest that we write to four health boards in Scotland—I have randomly chosen NHS Lothian, NHS Greater Glasgow and Clyde, NHS Ayrshire and Arran and NHS Fife—to ask for their views on the issues that the petition has raised and the evidence that we have heard today.

When we write to the Scottish Government, we should ask what advice is being provided to general practitioners on the issues that have been raised by the petition. The first point of call for many women after the operation is their GP, because they do not get a direct referral back to the consultant. Based on the evidence that we have heard, GPs need to be made aware of the issues that are being raised and the complications that come about. Women should not feel that they are being left on their own to deal with their situation.

We could also ask the Scottish Government what procedures will be put in place to ensure that there is appropriate recording of complications, either at GP level or at hospital surgeon level.

Last but not least, we should reinforce the call for the suspension of all such procedures until such time as we have assurances and other measures in place that mean that people can give informed consent for such procedures, in the light of the issues that the petitioners have raised.

I have a final point before bringing in my colleagues, who I am sure will have lots of questions. Neil Findlay referred to international comparisons, and I read the other day that in the US the mesh implant is seen as a high-risk procedure. What are your thoughts on that?

In almost 40 years in front-line journalism, I can honestly say that I have never come across such a horrendous scandal. These women’s lives have been decimated by what has happened to them. The effects are felt not just by the women but by their families. To see young women stuck in wheelchairs following what they were told was a simple operation is beyond belief. These women are struggling, but they have bravely come forward to tell their stories.

I am saddened that many of the women were told that they were the only ones who were suffering, when that was not the case. Often, the same doctors told each woman that she was the only one. It is a great sadness that many of the women feel very let down by the people who were supposed to help them. Why the doctors did not report what was happening is a great mystery.

No. There are no registers. Everything is voluntary; there are no mandatory regulations.

That is right.

I thank the witnesses for their evidence today and for the written evidence that we have received, including the weighty document from the Sunday Mail that we received as we sat down to consider the petition.

You have raised a number of concerns. You indicated that you have had meetings with the Cabinet Secretary for Health and Wellbeing and health officials. What assurances, if any, did you receive from the cabinet secretary and officials about the request to suspend use of the operation until the matter is fully investigated?

Thank you, Mr Wilson. That is a very comprehensive list of additional recommendations. I certainly endorse it.

I understand. I am just trying to get the issues on our record.

I understand that your clear desire is that the product and this form of treatment no longer be used, and that alternatives be found. However, you have actively engaged with the Government and Cabinet Secretary for Health and Wellbeing with a view—short of that desire becoming a reality—to having proper advice made available to women, so that they understand exactly what risks they might be taking. Where are you in those discussions? At what point will you be satisfied that the knowledge is being communicated?

Thank you.

I think that America has done exactly the right thing. It is something that Scotland can do today that is very much needed. Scotland needs to lead the way. America has done exactly the right thing and we should be doing it today before another unsuspecting woman ends up like all the ladies who are here today and all those who are too ill to come—there are many of them.

Guidance has been mentioned. Are you aware of any recent change in the guidance or in the recommendations of the MHRA or the European Commission?

Do you know whether that applies to recording internationally, as well?

You make some good points. The evidence from Professor Joyce talks about the precautionary principle. He argues that patients need to give informed consent before they have the operation. Has that been the case in medical practice?

Thank you very much for that and thank you again for providing such sensitive, personal information, which will serve to advise the committee when it looks forward to the next steps.

Do any other committee members have any final points?

Mr Findlay has a final point to make. I ask you to keep it brief, as we are very short of time.

We are working towards a new patient information booklet for stress urinary incontinence. Our aim is to make sure that women realise that they are having mesh applied. Often it is referred to as a tape, but the product is made from polypropylene mesh—that has to be clear in the information that women are given. They have to be told that it is a permanent device, they have to be made aware of all known risks, and they have to be made aware that if complications occur, multiple surgeries may be necessary to solve the problem. Women have to be made aware.

With this petition, I feel that there is a weight of responsibility on the committee. Some petitions that we receive are not time critical, but this one could be time critical because, although it might deal with an issue that the Health and Sport Committee might have been expected to consider, that committee has its own busy and detailed agenda. We have heard evidence and, in a way, I feel that we are compelled to act on that evidence.

Therefore, to pick up on a point that Chic Brodie made and to give the process a bit more urgency, although we are to seek the views of others, I would like us to flag up with the cabinet secretary that we would like to discuss the issues with him at the earliest opportunity. Although, in some cases, that might happen at the end of the process, in this instance it might be only an interim step in the process of action that the committee might want to recommend.

None.

America is proposing to reclassify mesh for pelvic organ prolapse but not mesh for transvaginal stress urinary incontinence, although the exact same material is implanted through the exact same clean-contaminated surgical field. In addition, the mesh used for stress urinary incontinence is heavier, which makes its use more problematic, so that mesh should also be included in any measures.

I do not really understand your question.

I am not sure. I would guess that there is nothing mandatory internationally.

Thank you, Mr Carlaw. My thoughts were that the committee would invite Mr Matheson and Mr Neil to attend our meeting two weeks from today, which will be our final meeting before the recess. Alternatively, we have a meeting scheduled in August. The clerk will certainly make that clear to the ministers’ offices. In fairness, the ministers have always been reasonable about turning up when we have made such a request, so I am not expecting any problems.

When will that advice be at a point at which it could be communicated?

Yes, I will keep it very short.

I have a general question for committee members. Would any of you have this operation, knowing what you now know, or—given that it is a very male-dominated committee—would you allow your wife, your partner, your daughter or any female relative to have it? If the answer is no, members know what the committee has to do. It must act on behalf of these women, who have been so brave today.

In fact, the cabinet secretary has refused to suspend use of the operation.

We hope that we are not too far from having the document in use throughout Scotland, but there are a few points that we have not yet agreed on.

I am conscious of the time, but we will try to keep this debate going for as long as possible because it is a very important one. Can you describe to the committee in a straightforward manner what the alternatives to mesh are?

Michael Matheson, the Minister for Public Health, said that

“if there is any change to the guidance or a recommendation is made by the MHRA or the European Commission,”—[Official Report, 13 May 2014; c 30815.]

regarding the devices, the Scottish Government would act accordingly. Given your comments about the international implications, are you aware of any change to the guidance or recommendations?

The cabinet secretary said that there is a fear of being sued by the mesh manufactures.

Does Marion Scott know about that from her investigations?

I agree with the recommendations, but I also want the committee to have some background information on the use of the procedures elsewhere in the UK. We could ask the Scottish Parliament information centre for that.

Thank you very much, Mr Findlay.

As you have probably gathered from the previous petition, we are now at the summation stage, so we have stopped asking questions.

So the cabinet secretary and officials have refused to suspend, even though we do not have any proper procedures or an advice booklet available for women for whom the operation has been recommended.

Can I make a short concluding statement?

We will certainly speak to SPICe. I thank Anne McTaggart for that point.

Are there any final points?

I think that some countries are busy looking at the whole issue. Irrespective of doctors not recognising things, I know from speaking to many women here and many women who cannot be here that many of them were dismissed and told that they must be imagining things and that it was all in their heads. Some of them were even sent to psychologists and psychiatrists when they were suffering horrific physical pain.

When the mesh cuts through organs, it cuts like cheesewire. Members can imagine the physical pain that the women have been through. Because of the long delay before the GP says that maybe the mesh implant is causing the problem, the tissue will already have grown through the mesh, so trying to get it out is really problematic. Only a couple of doctors in Scotland are used to taking it out. That is completely and utterly inadequate in the light of the scale of the problem.

There are lots of alternatives. First, if your situation is not seriously problematic, you can choose to do nothing. However, if you have stress urinary incontinence, you could consider pelvic-floor exercises, physiotherapy or incontinence pads. There are all sorts of things that you could do. The non-mesh surgical options are Burch culposuspension or fascial sling, whereby your own tissue is used. That was how procedures were carried out for years before the revelation that mesh was came into play. Those operations have a similar success rate to mesh operations, but when a Burch culposuspension stops working after a number of years, you are back to square 1 and have a leaky bladder. If you have mesh and it stops working—well, we are the proof of what can happen. It can erode through your organs or your urethra. You have that information in front of you.

No. There has been no change. The Cabinet Secretary for Health and Wellbeing has written to the European Commission and to the MHRA asking them urgently to reconsider the issue and to look into what is happening in America.

I declare an interest in that I am dealing with constituency casework on the issue.

I thank the women for their presentation, the women who are here to support, and Marion Scott for the hard work that she has done in bringing the issue to the front of people’s minds.

We have gone round the issue of adverse incidents not being registered. How far back does use of the procedure go?

I think that the European Commission has recognised that there are serious problems with medical implants. I have read some information on that and its plan is that, in the future, every patient with an implant will have a bar code or an implant card, so that problems with implants will be recorded. Everything is currently voluntary. Nothing is mandatory.

The problem is the classification of the devices and the fact that, if an adverse incident happens but the authorities do not know about it, they do not know that there is a problem. They eventually find out only when hundreds or thousands of patients come forward with complications. By that time, the horse has bolted from the stable and we are in a situation such as we are in now.

Yes.

As usual, Mr Wilson made comprehensive recommendations. I differ, however, on the idea of approaching four health boards. We should not be selective about it; we should approach all the health boards so that all are involved in what should be a timeous exercise. We need to get someone here before recess so that we can make a clear action plan.

If you make it very short.

They have refused to suspend the procedure until such a document is produced and until clear guidelines are issued to all practitioners in relation to advising patients of the options and the dangers—or, I should say, the potential side-effects.

I agree with Mr Brodie on that. There is one further meeting and it is my view that the ministers should appear before the committee in two weeks’ time. We will certainly keep the witnesses from whom we have heard today up to date.

As the petitioners have heard, we think that their petition is very important, and we have taken it very seriously. We have tried to cover every single option that we can. If Mr Neil or Mr Matheson is at the meeting in two weeks’ time, you are free to come to the gallery on that occasion.

I thank everyone for coming along—our witnesses and all the supporters in the public gallery. The petition deals with a sensitive issue. The committee feels that it is an extremely serious one and we will do everything that we can to pursue the aims of the petition.

11:51 Meeting suspended.

11:56 On resuming—

I think that use of the procedure started in the late 1990s. I think that the tension-free vaginal tape procedure, which is for stress urinary incontinence, started in 1998 and that TVTO started in 2003. Treatment for pelvic organ prolapse started somewhere in between, although I am not quite sure when.

On behalf of everyone at Scottish mesh survivors, I thank you all for listening to us and for considering our petition.

I thank our families, all those who signed our petition and politicians from all parties for their support. I pay special thanks to Marion Scott and the Sunday Mail for the hear our voice campaign. I thank the mesh-injured girls and all those who made it along today to support us. Special thoughts go to the girls who are not well enough to attend.

The eyes of mesh-injured women across the world are watching what is happening here today in the Scottish Parliament. They are all relying on Scotland to take the initiative and lead the way to prevent even more victims from being harmed by mesh implants.

What we are asking for is so very little when we compare it to the human cost as well as the financial burden of doing nothing at all. Our suggestions will ensure that proper early-warning systems are put in place, and we believe that those simple measures can easily be adapted to protect anyone who undergoes any implant procedure.

Please make the changes to prevent scandals such as the one that we have told you about from happening in the future, so that no more lives will be needlessly destroyed. Please study our dossier—the evidence is overwhelming. Please hear our voice. Thank you. [Applause.]

We cannot go into specifics, but can you briefly take me through the kind of conversation that one might have with a GP about the products?

When I went to my GP, I was initially tested for possible causes of my symptoms, but my GP was not aware of mesh medical device complications. I kept repeating, “It’s my mesh”, but she just said, “Oh, no. We have done this, that and the other.” She had no knowledge of the complications. I was eventually referred to a consultant.

To date, 11,000 women have been through the procedure.

Yes.

There is no indication from the cabinet secretary or from the health officials that they would be prepared to consider suspension of the operations.

Prior to diagnosis of your problem, were you taken through the range of options? How much focus was there on the particular product?

It is approximately 11,000. There are no accurate data.

Do you mean from the consultant?

That is the number in the past seven years.

No.

I mean from the GP or the consultant.

No records are available before that.

My next question goes back to Anne McTaggart’s question. In the background information to your petition, you say that more than 10,700 women have had the operation. That figure is based on freedom of information requests. There are no accurate data from prior to 2007, because the figures were not recorded. Do you think that the figure is accurate, or is it way out? Could we be looking at double that number?

I consulted my GP only when I started having problems. I was referred to a consultant. GPs are unaware of mesh complications, so there is a point to be made about their education. My GP did not know anything about mesh medical device complications. Eventually, after the tests had been exhausted—most had come back inconclusive—I was referred to a consultant.

If a patient presents to a GP with mesh medical device complications or complains of symptoms that are on the British Society of Urogynaecology list of reportable complications, that should be reported to the MHRA and the patient should automatically be referred to a consultant, rather than a GP trying for months and months to find out what the problem is.

11:30

I have been dealing with the matter through my casework and have tried to get questions answered. I have been a member of this committee for around two years, I think. I am not sure whether the witnesses are aware that the committee has a non-political make-up, so we do not talk about political parties; rather, we take each petition as it comes. The petition is one of the most horrifying that I have come across.

I am unsure why we have not done anything. I have heard the issue being raised in the chamber. The details that we are getting now were flagged up nine months ago, so I am unsure why, and am surprised that, nothing has been done about it.

It is probably more than double that number.

It is difficult to know, because there are no accurate data that would allow for reporting and follow-up, and in order keep track of who is suffering. In the car industry, if there is a problem, a recall is issued, but that cannot be done with mesh, because they have no clue.

There is no precautionary principle when it comes to medical devices. In the airline industry, if something goes wrong, aircraft are grounded right away, but that does not happen with medical devices. There is no precautionary principle at which the line is drawn and matters are investigated—they just keep putting in the medical devices while they are waiting to find out what the problem is.

And they tell us that the benefits outweigh the risks.

As other members have mentioned, we might just be scratching the tip of the iceberg in relation to the cases that are coming forward.

Absolutely.

I believe that you are.

Is the demand for information through the survivors network increasing daily?

Yes.

The women are struggling to do it on their own. The only support network they have is one another.

We are not medically or legally trained. We can only offer support.

About the only good thing that has come out of the mesh medical devices is the new friendships that have evolved through people finding each other. Initially, everybody sat thinking that they were the only one.

We thought that we were unique.

That is what consultants told people.

The same consultants.

The consultants were telling several people, “This is very rare.”

Is that evidence that you have picked up from the survivors helpline?

Yes.

Are the same names appearing?

Yes.

Yes—the same names appear consistently. So, there are an awful lot of very rare and unique people.

Thank you. That leads me to a couple of recommendations, which we will deal with later.

Thank you for explaining that to the committee. It is very helpful. I now bring in my colleagues, starting with Jackson Carlaw.

I declare that I have met Elaine Holmes previously and encouraged her on her petition. I thank both witnesses for your evidence and how you have given it.

I want to try to get a few things on the record. What is the age range of the women who are most likely to be affected by the mesh treatment?

We have women in their late 20s right through to women who are 70-plus.

So the range is very comprehensive.

Yes.