Independent Medicines and Medical Devices Safety Review

Alec Shelbrooke Excerpts

Thursday 8th July 2021 Commons Chamber

[Emma Hardy]

I thank the hon. Lady for her intervention and I agree with her absolutely, which brings me on to the point about the redress agency, which is one of the recommendations in the report that has been rejected. Instead, the Government have said:

“The government and industry have previously established redress schemes without the need for an additional agency.”

That goes to the point that she made, because this puts the burden of redress in entirely the wrong place: on the victims, not on those responsible. Seeking redress requires enormous effort on the part of those who are already suffering, not just financially but emotionally, as was set out in Baroness Cumberlege’s report. It recommends that without waiting for the establishment of a redress agency:

“Separate schemes should be set up for each intervention…to meet the cost of providing additional care and support to those who have experienced avoidable harm”.

Sadly, no such moves have been made, so I would be interested if the Minister gave an indication of the progress on such schemes.

The report also recommends transparency on payments to clinicians, with a UK-style Physician Payments Sunshine Act 2010 to require the mandatory reporting of all payments made to doctors, teaching hospitals, research institutions and charities. The Government’s interim response said that they would “consider” this recommendation, in discussion with other parties, including the General Medical Council. I understand that there are suggestions that this could be done by expanding the voluntary system of reporting, but, as we have seen, voluntary systems simply do not work.

By way of a quick example, a high-profile academic recently admitted that he had failed to declare £100,000 from the manufacturer of one of the types of vaginal mesh implants that he was assessing. He has now published a correction, but this is almost seven years after he first did his report and it came only after a complaint was made about him. A section 60 order in the Health and Care Bill would allow for legislation to cover this, because transparency is vital to patient safety. There should be no opportunities for payments made by industry to introduce bias into prescribing or the scientific literature that is used to inform our National Institute for Health and Care Excellence guidelines. This report recommended creating a database to record which device was used when, in which person, and what the outcomes were in terms of safety and patient feedback.

The roll-out of the medical device information system has begun, but questions are arising as to what data is being collected. This is really important. To give an indication of that, let me raise the case of Kath, an extremely fit and healthy woman who used to be interested in skydiving. She had mesh implants and afterwards was in such pain that she was unable to move or get out of bad. This completely changed her life forever. However, her procedure was recorded as a success because she no longer had incontinence and that was the measure being looked at. We need to be looking at all patient outcomes when we are recording that data in those data sets.

That brings me on to my next point, which relates to the current moratorium on using mesh, as recommended in the report. Kath has said that there is no way she would ever have had this procedure had she had any indication of the risk of harm. I understand that there is pressure from some of the surgeons to reintroduce mesh, but I do not believe we can do that without fully informed consent, and we can have that only if patients are fully aware of all the risks. They can be fully aware of all the risks only if all the data is collected and recorded accurately. Until that is done, we cannot have informed consent and we should not consider lifting the moratorium on the use of mesh implants.

[Alec Shelbrooke (Elmet and Rothwell) (Con)]

I am grateful to the hon. Lady for joining me to help to secure this debate. I will be speaking later, but I wanted to touch on this specific point about the pressure we are coming under. Does she agree that nothing has changed from a clinical point of view in the past 18 months, yet the clinician pressure is to stop the suspension? Does that not represent the pressure we are under coming from the clinician side of this argument?

[Emma Hardy]

I completely agree and thank the right hon. Gentleman for bringing this debate forward and championing it from the other side of the House. He correctly says that we need to have all that evidence so that people can give that informed consent.

Finally, the report recommends establishing specialist treatment centres

“to provide comprehensive treatment, care and advice”.

Some of these care centres are being established, which is good news, but again there are concerns about the data collection on patient outcomes after mesh removal and not all women are having all their mesh removed—some of this is only a partial removal. Again, what questions are being asked and what data is being collected? I have submitted numerous written parliamentary questions to the Department but have yet to receive a clear answer on exactly what data will be collected.

There are also important questions to be answered on the competence of surgeons to undertake removals. I know that my hon. Friend the Member for Washington and Sunderland West (Mrs Hodgson) has a very difficult story on this issue. The Department says that it is for individual trusts to decide which surgeons to use for removals, but I do not share that view. How can it be fair to ask a woman to return to the same surgeon who put the mesh in, causing her all that harm, in order to have it removed? I really think we need to look at this issue again.

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[Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)]

I thank my hon. Friend the Member for Kingston upon Hull West and Hessle (Emma Hardy) and the right hon. Member for Elmet and Rothwell (Alec Shelbrooke) for securing this very important debate. As we have heard, today marks one year since the independent medicines and medical devices safety review was published. I was speaking virtually that day and I have to say that I am thrilled to be able to speak in the Chamber today; thankfully, it is starting to feel a bit more normal. I wholeheartedly thank Baroness Cumberlege and her team for their excellent work; it is great to see her with us today. I also thank the right hon. Member for Maidenhead (Mrs May) for commissioning the review in the first place. It was a brave and bold thing to do—and the right thing to do, as she has so often done in this place.

The problems with the medicines and medical devices that the review reports on—Primodos, valproate and vaginal mesh—have been ongoing for much, much longer than just the past year, as we all know. I have had the privilege of working with campaigners over many years on these issues; I pay tribute to Janet Williams, Emma Murphy, Marie Lyon and Kath Sansom, to name just four, for their dedication and expertise. They are normally with us for these debates, and it is sad that they are not able to be here.

I first spoke in this House about surgical mesh implants in October 2017, as shadow Minister for public health—there were always lots of debates in that brief, as my hon. Friend the Member for Nottingham North (Alex Norris) will know. My mam always likes to see my speeches, so one Saturday, while I was making lunch, I showed her that speech and said “Oh, thank goodness you’ve never had any of this awful mesh put in.”

That was when our world was turned upside down. She said, “No, no, I only had a bit of tape put in a few years ago, before all my troubles started”—the “troubles” she refers to being numerous health problems that appeared one after the other. She had had scans and cameras everywhere, with no diagnosis. Obviously there was no solution that could be found. Does that sound familiar to those who have had constituents with mesh problems get in touch?

Fast-forward three and a half years—coming up to four now—from that first debate, and my mam still has all sorts of complications. She is now in constant pain all the time. She is 76 this year. She has all sorts of autoimmune reactions and she just wants her mesh removed, no matter her age. She was very healthy and had a great life before, and her life now is a shadow of its former self. She wishes constantly, every day, that she had never had it put inside her.

She is not alone. I know that there are tens of thousands of women in exactly the same position, so I support all the recommendations of the excellent Cumberlege review. Recommendation 5 calls for specialist centres to be established, which is excellent; it has happened, they are open and I think some have actually started to do some of their work. But therein lies the issue that I want to specifically mention today—I am pleased that my hon. Friend the Member for Kingston upon Hull West and Hessle and the right hon. Member for New Forest East (Dr Lewis) have already raised it, so I am not alone in being concerned.

The issue is that the very surgeons who implanted this awful, life-devastating mesh are in most cases the very same ones now offering to remove it. As the right hon. Gentleman said, after gaslighting women and telling them that their pain was in their head or that they just had to learn to live with it—or to lie back and think of England when they tried to have sex, as was once mentioned in Westminster Hall—they are the very same surgeons these patients, including my mam, are expected to trust again to remove this mesh. That trust is, unsurprisingly, all gone.

[Alec Shelbrooke]

I am most grateful to the hon. Lady; I really appreciate all the work that she has done on the issue alongside us. To take what she says one step further—she may be coming on to this point—does she agree that the other problem is that the evidence we have had in APPG meetings is that the very same surgeons still think that this is the best cure for women? They are not actually accepting some of the problems that are blatantly obvious.

[Mrs Hodgson]

The right hon. Gentleman makes a very good point; I was not moving on to it, so I am glad he has made it. They are very keen to start reimplanting and reusing the mesh; they still say that it is great and that it transforms 90% of women’s lives. For the 90% whose body can tolerate it, that is great, but for the 10% who cannot, it devastates their lives. It transforms their lives in a devastating way; in many cases it can leave them crippled and unable to work.

Not all these women are of pensionable age like my mam, who is 76 this year. Some are still of working age and have all the problems associated with trying to get recognition in the benefits system when so little is still known, not just by GPs but by the Department for Work and Pensions people who are dealing with them. The last thing we want to do is create more victims of this terrible medical device. Mesh-injured women are between a rock and a hard place: either they have their mesh removed by the very same surgeon who implemented the mesh, often—in the case of my mam as well—after it was widely known that it was devastating some women’s health, or they do not have it removed at all. This should never be a choice, so I call on the Minister to work with NHS England to reconsider that and put patients first by giving them a genuine choice about where they go for their mesh removal and who removes it. There are only eight of these centres, so this is not often as easy as saying, “Oh well, you can go to Manchester or London,” as was said to my mam; obviously, I will bend over backwards to enable that to happen, but some women just will not have the wherewithal. There must be a way for surgeons from other parts of the country to travel to where those women are, so that they do not have to face and deal with the surgeon who put the mesh in them.

I want to briefly mention valproate and Primodos. Since the review was published a year ago, very sadly 10 members of the Association for Children Damaged by Hormone Pregnancy Tests have died, still suffering with the enormous guilt of feeling, even though it was not their fault, inadvertently responsible for the damage to their babies. This has been an ongoing battle for them since 1978 and we have heard and will hear further this afternoon how devastating this drug has been for those who took it in all innocence, with full trust in their doctors to do them no harm.

On valproate, I have huge respect for the noble Lord O’Shaughnessy. When he was the Health Minister responsible he put in train excellent guidance and safeguards and tried to help more than anyone before him, yet shockingly still around 400 babies are born per year who have been exposed to valproate—even now, after all we know and all that the noble Lord put in train. That is truly shocking. Some 15,000 women in England alone are prescribed valproate in their child-bearing years with the majority still not receiving the pregnancy prevention programme or given a change of medication should they seek or want to become pregnant. This is without even beginning to estimate the additional tragedies of stillbirths, miscarriages or terminations that are due and necessary because of valproate.

This Minister’s lasting legacy could be to right these historical wrongs once and for all. We must ensure that everyone in the healthcare system is protected and treated with care, and when there are failings, as will happen—they cannot all be prevented, much as we would like it to be so—the Government must take action to ensure that those harmed are treated with respect and given proper healthcare and restorative surgery where possible and are, if they can be, properly compensated. But mostly we need to ensure that this sort of harm from medicines and medical devices never happens again.

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[Alec Shelbrooke (Elmet and Rothwell) (Con)]

I thank the Backbench Business Committee for allowing this debate in my name and that of the hon. Member for Kingston upon Hull West and Hessle (Emma Hardy).

When the hon. Lady and I met to discuss the progress that may or may not have been made, we felt it was important to hold this debate today because it is one year since the publication of the report. Everybody in this House, and I am sure a lot of people around the country, understands that the past year has created a set of circumstances that was always going to put some aspects on the back burner and not move them forward. So today’s debate is not designed to criticise and have a go at the Government—I have a great deal of respect for the Minister and the Department—but merely to say, “Please don’t forget about this report.” It is one of the most important reports on health matters that has come before this House in many years.

What is important today is that none of us loses sight of the people we are talking about. Hon. and right hon. Members from across the House have already raised issues relating to the people themselves—real stories about real people. The hon. Member for Washington and Sunderland West (Mrs Hodgson) has done enormous amounts of work on this and speaks with passion and from the heart of the effect it had personally on her family and her mother. I can only wish her and her family the best and hope that those matters can be resolved.

This first came to my attention when a constituent came to see me. I know that some hon. and right hon. Members will have heard this story before—in fact, the hon. Member for Washington and Sunderland West touched on it—but it is worth telling again. The constituent was a very, very brave lady. She was in her 40s. She had had a child. She was a physiotherapist for the NHS. She was fit and healthy. She stood in front of me and could not sit down. She was having to bend her body into a position to feel as comfortable as she could. She sweated throughout the entire surgery because she was in crippling agony.

I knew nothing about this subject when my constituent came to see me and explained what had happened. What was even more terrifying was that it was an operation she never needed. She had had her child. She continued to have a full, loving and sexual relationship with her husband. But every now and again she had some urinary leakage, and she was told, “Don’t worry, we’ve got a cure for that. It’s a great cure. We can put some mesh inside you. We’ve done it for years. You’ll be fixed and there’ll be no problem.” She went ahead and had the operation done.

About eight years later, things started to go wrong. The fundamental problem is the time between having the operation and problems becoming apparent. That is why the recommendation of a proper database is so very important. As the hon. Member for Kingston upon Hull West and Hessle said, inserting the mesh is being recorded as a successful operation, but what happens afterwards is not recorded. To be blunt, thalidomide was successful in what it was supposed to do because it stopped morning sickness. Nine months later, the consequences were horrific. We do not class that as a successful drug that was administered. Indeed, we could talk about other drugs today, such as sodium valproate and Primodos, which raise a very important point in relation to this report. However, I am going to focus on the vaginal mesh issues.

One reason why I will focus on vaginal mesh is that my jaw hit the floor at some of the stories that my constituent told me. First, let me get rather graphic, because I think it is important. She described to me how during sexual intercourse, her husband’s penis was sliced. That is not a successful operation in anybody’s book. She then went through several operations, where, to be blunt, she was butchered to the point where she has no sexual stimulation whatever. She was told, “On the bright side, you now have a designer vagina.”

In what circumstances does anybody feel it is appropriate to comment on the perceived attractiveness of somebody’s genitalia, especially when they are suffering the pain and agony that my constituent is going through? I am afraid that that comment alone shows the arrogance of clinicians that we are up against with this issue. It is appalling, and it is one of the reasons why, as I said to the hon. Member for Kingston upon Hull West and Hessle, and indeed to the hon. Member for Washington and Sunderland West, we have to push back against clinicians saying, “We want to stop the suspension of the use of mesh because it works in so many circumstances.” I am sorry, but there is too much information out there about patients simply not being listened to.

It took two and a half years for Baroness Cumberlege to put the report together. The review went around the country. Indeed, the constituent I am speaking about sat and spoke at a table with my noble Friend. She said to me afterwards, “It is fantastic. I was really listened to.” Normally when a Government set up an inquiry, you think, “Yeah, yeah, yeah, they will take some hearings and everything else”, and you get, “You’re my Member of Parliament, can you feed in?”, and so on. She said to me afterwards, “I was really listened to.”

When that report came out, women felt that they had finally been listened to and things were moving forward. I have to say that the Minister, my hon. Friend the Member for Mid Bedfordshire (Ms Dorries), performed brilliantly that day when she stood at the Dispatch Box and first of all issued the apology. My constituent said to me she had nothing but praise for the Minister. I hope the Minister knows that the comments I am making today are in no way directed towards her; they are more directed towards what is going on in the NHS and the clinicians. Obviously the driver of this debate today is making sure, as we come out of this global pandemic and all the strains that have been put on the health service, that we reinvigorate these reports and say that they must, must, must be at the forefront of what happens.

I am afraid there is a pattern forming. One of the things that struck me when we had the debate about vaginal mesh in Westminster Hall, which I believe was around 2017, was when I described what I have just described to the House about my constituent’s sex life. In that debate—it is in Hansard—I used the word “clitoris”. It is incredible how much notice was taken of what I had said because a man used that word. I am afraid there is a blunt truth to this debate: it appears to be that only when men talk about women’s issues do people perk up and listen. It seems to me that there appears to be a huge gender blindness in the NHS to how it approaches the health issues of women.

It simply cannot be right that a woman goes time and time again to a doctor and is just dismissed out of hand. As my right hon. Friend the Member for Maidenhead (Mrs May) clearly outlined in her speech, we hear, “There, there. You will get over it.” I have heard that so many times.

Today’s debate does not include endometriosis—that is a different debate, but many in the House will know that I feel very passionate about it, and the hon. Member for Kingston upon Hull West and Hessle works very hard on it alongside me. To deviate for one minute, if you will allow me, Madam Deputy Speaker, endometriosis is a crippling disease that affects 10% of women in this country, yet there is still an eight to 10-year diagnosis period before anything is done. That again shows the problem. Why are women not being listened to? Why does it take a male Member of Parliament to say these things and get noticed? It is not good enough. The reality is that the recommendations in Baroness Cumberlege’s review need to be implemented.

As I bring my comments to a close, I want to focus on the issue of redress. Redress is not about compensation culture. It is about the fact that my constituent— a healthy and active woman in her 40s who was a physiotherapist and worked for the NHS—as a result of an operation she never asked for, has seen her marriage break down, her career disappear and her life destroyed. The destroying of her life has meant that she can no longer operate as a physiotherapist. She physically cannot do the job. To a certain extent, she has had sick pay and has been looked after, but that is not the point. The point is that the NHS did the operation, said it was all fine and ignored her. She had to take out a loan and go privately to have the mesh removed because of the waiting list. It got to the point where, after she had the operation and was still not getting better, she had further scans that revealed that the mesh had intruded into her bones. Someone commented, “It’s like trying to remove hair from a piece of chewing gum.”

My constituent cannot work. She will never, ever return to the life that she had. Not to mention the breakdown of her marriage, she will never return to the profession that she trained for. She has a caring attitude. She always points out to me, “Alec, you’re too fat. Your knees are going to collapse. I see it all the time.” In fact, I bumped into her in Wetherby market square about two weeks ago, and she said, “Well, at least you’ve listened and lost a bit of weight, but there is still some way to go.”

My constituent was part of the caring profession. That is who she is, but she cannot work again. That is why redress is important. It is important that we are able to look after the people the NHS damaged. She did not need the operation and was damaged. This is not about compensation culture; it is about looking after such people. As my right hon. Friend the Member for Maidenhead made clear, the NHS is an all-encompassing caring body and society. We cannot just pick out parts of it and say, “That was the care, but now we are going to ignore you.” We either believe in what it was set up for and what it is meant to do or we do not; it is as simple and black and white as that.

I believe that everybody in this House believes that; I certainly know that my hon. Friend the Minister does. I read her comments in the Daily Mail this week about women’s pain being ignored and about the idea that women can just accept a bit of pain—I think it was about the implanting of the contraceptive coil. It is high time that we start to recognise the institutional picture that that paints. The first step, and the reason why I wanted to speak in this debate—I know my hon. Friend the Minister is absolutely dedicated to these causes—is to bring this as high as we can in the public spotlight. We must move as quickly as we can to implement the nine recommendations, because we are destroying people’s lives. We have destroyed people’s lives, and although we will never rectify the situation, we have a responsibility as a society to do everything we can to support the people who have suffered.

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[Dr Julian Lewis (New Forest East) (Con)]

I must say it is quite hard to speak unemotionally after hearing the tragic story that the hon. Member for Ayr, Carrick and Cumnock (Allan Dorans) has relayed to the House. How much more difficult must it have been for Baroness Cumberlege to hear dozens, if not hundreds, of such stories of individual human suffering? She came up with a truly magnificent report and the House of Commons had what I thought was one of its best days for a long time when we discussed it, in no small measure due to the Minister for Patient Safety, Suicide Prevention and Mental Health, my hon. Friend the Member for Mid Bedfordshire (Ms Dorries) and her response to the report. We would all have felt quite justified in thinking that, at last, there was real light at the end of this horrible, terrible, awful tunnel, but it does not seem that we have got to the end of it yet.

I took from Baroness Cumberlege’s report one particular area of hope, and that was the establishment of the specialised mesh centres, and I wish to focus in my contribution on three questions. First, are the mesh centres truly dedicated and comprehensive one-stop shops offering all the types of treatment likely to be needed and all the types of investigation likely to be required, if not under one roof, then at least within a single footprint, or are they merely specialists hubs in name only?

Secondly, there is another problem related to the centres. Are we seeing a situation in which surgeons who could have been described as mesh problem deniers are now reinventing themselves as mesh problem remediators? I do not think they are qualified to hold that role. I fear that there is an attitude of mind that says, “Well, it’s not that easy to find people who specialise in this area, and therefore, even though these are the people who put the mesh in, maybe they are the people who are best qualified to take the mesh out.” I absolutely refute that. Not only did those people put the mesh in, but when the patients came along time and again to say what terrible problems they were suffering, those were the people who refused to listen to them. They were the people who, in some cases, insisted on putting more mesh in, and they were the people who, in other cases, refused to let the patients have a referral to figures such as Miss Sohier Elneil in London or Professor Hashim Hashim in Bristol, who are—or were at that time—the true, and possibly the only, specialists in mesh removal.

When I was thinking about what to say in the light of what had gone before, I was debating whether I should use the word “butchered”, but my right hon. Friend the Member for Elmet and Rothwell (Alec Shelbrooke) did use it in his most powerful speech and I will use it as well. The idea that someone who has butchered your body is an appropriate person for you to go back to, after all that, and that they could then say they are going to take the mesh out, when that person may well have stood in the way of your perhaps going to see Miss Elneil or Professor Hashim, who could have done something for you, is unconscionable.

My third question is: what research is being undertaken on new methods of safe removal? If indeed it is the case that an argument is going to be made that there might be some future use for mesh in safer ways, what research is being done to see whether or not something could be developed that would not run the risks of this disaster?

I shall say something very fanciful now, and it is probably nonsense, but the thought occurs to me, hearing about the way in which the flesh grows around the mesh, the mesh fractures and it becomes so very difficult to remove: has anybody ever thought that it might be possible to develop a future type of mesh, if this is not possible with the mesh that has already been put inside people, that might conceivably be harmlessly dissolved within the body if something went wrong, by the addition some sort of chemical? That may be absolute nonsense, but the point is that unless specialist research is carried out, this sort of botching and butchery is going to continue.

As a result of the three constituency cases that I originally cited in a debate on—it is hard to believe that it is more than three years ago—19 April 2018, I have received certain amounts of information and concerns from Kath Sansom, who does such wonderful work with the Sling the Mesh group. I conveyed a message to her and basically said, “If you were standing up in this place today, what points would you like to put over?” She said:

“The debate is calling for all Cumberlege recommendations to be implemented without further delay, including financial redress for women and sweeping reform of the healthcare and regulation framework. Women are losing hope that they have been properly listened to. They need urgent financial redress for the many losses they have suffered. They want to know also when they go to a specialist centre that it is not a postcode lottery of care. To date the specialist centres are special in name only.”

In other words, is there really a new centre, or are people being sent from pillar to post for all the different parts of the investigations and having to wait months between each particular appointment for each particular type of investigation?

Kath also said:

“There has been no national training programme and no agreed way to measure success—they haven’t even agreed on outcome logging measures to standardise the data capture.”

She also made the point, which I think I have made strongly enough, about some of the centres

“being run by pro mesh surgeons who have denied mesh is a problem”.

[Alec Shelbrooke]

I said this in my speech, but it is worth emphasising again. We are talking about what needs to be done and what is happening, but we must also come back to people; as my right hon. Friend says, people are very important. Women are killing themselves. They are killing themselves. Look at the suicide rates for women with mesh problems and endometriosis. Women go through crippling pain, and dozens a year are taking their own lives. Does that not make the point that my right hon. Friend is making—that we have to move more quickly on this?

[Dr Lewis]

It totally does. I shall share a little something with the House. Although it does not compare with the agony of what these women are going through, I lost a year and a half of my life when I was given some inappropriate treatment that resulted in my being unable to read for a year and a half during my early 20s. What really made it worse was the knowledge that, if I had not asked for a particular treatment to try to improve my tired eyes because I was studying, none of it need have happened. How much worse must it be for these women, many of whom are not only undergoing all this suffering, but are undergoing it because they were told it was a minor procedure and they thought, “Oh, well—maybe I will have it, then.” If only they had known, they would never have gone within a mile of it. They must be saying that, over and over again. To expect them to go back to the same surgeons who did not tell them what the consequences could be is inhumane and totally unrealistic.

The issue of some people having a financial interest in promoting certain products has been touched on. We are obliged to declare our interests in this House and perhaps something like the Physician Payments Sunshine Act would be the equivalent for people in this context.

Finally, Kath draws attention to what she calls a black hole in official statistics. She says, for example, that according to hospital statistics, in the year 2008-09, 1,038 women were readmitted to hospital with problems within 30 days of a mesh sling having been implanted. In comparison, data derived from surgeons says that only 104 women were admitted to hospital—that is something like 10% of the total. Some 934 women have somehow gone missing from the surgeons’ data.

These are strange and disturbing features. This House has shown itself at its best in condemning what happened. The Government need to build on that and put in place the measures recommended by the report to make it far less likely that it could happen again.