Independent Medicines and Medical Devices Safety Review

Alec Shelbrooke Excerpts

Thursday 9th July 2020 Commons Chamber

[Ms Dorries]

I commend the right hon. Gentleman for his compassion and for his commitment to campaigning on this. I just have to repeat what I said in my previous answer. I have every—every—sympathy with every parent, mother and family who have been affected, but due to pending legal action I cannot make a statement.

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

Today is a day of strongly mixed emotions—one of joy that we have such a comprehensive and thorough report recognising what many women and others have been through, and of course one of absolute sadness and anger that it ever had to come to this. I first raised the issue of sodium valproate in 2013 or 2104, and vaginal mesh in October 2017. I pay tribute to my right hon. Friend the Member for South West Surrey (Jeremy Hunt) for putting the inquiry in place, and to my hon. Friend the Minister for the way that she has handled today’s statement.

The Government, as my hon. Friend said, are now going to take note of what happened. I would like two particular areas to be looked at. First, we need to make sure that the complaints commissioner is thoroughly independent of the healthcare sector, because we cannot again ask people to mark their own homework. Secondly, there is the issue of powers of redress and ex gratia payments. One of my constituents has had to borrow tens of thousands of pounds to correct her mesh implant through private surgery. This operation was done and recommended by the NHS. If we can speedily get these recommendations in place and compensate women who have had to take on their own financial burden to correct this surgery caused by the NHS, that would be most welcome.

[Ms Dorries]

I thank my hon. Friend for his comments and for his campaigning. It is the campaigning of Members of this House on behalf of their constituents that has got us to the position where we are today. It demonstrates how this place works at its best when MPs represent their constituents in campaigning on issues such as this. On his specific question, I would like him to write to me, because I am not quite sure why, if the operation was undertaken by the NHS, his constituent had to pay tens of thousands of pounds. If he would like to write to me and let me know the details, I will give him a more detailed response.

Oral Answers to Questions

Alec Shelbrooke Excerpts

Tuesday 5th May 2020 Commons Chamber

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

What support the Government are providing to dental practices during the covid-19 outbreak.

[The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)]

NHS England and NHS Improvement have published detailed guidance setting out the support for NHS dentistry during the pandemic. To minimise the spread of infection, routine dentistry is currently suspended. NHS practices are providing telephone advice and triage at urgent dental centres to patients with urgent needs. NHS dentists will receive their usual remuneration in full, or in part if they do part-NHS, part-private work. Dentists can also seek help via all the Treasury means for lost income.

[Alec Shelbrooke [V]]

My constituents in Elmet and Rothwell have reported difficulties in obtaining emergency dental care in Leeds. Will the Minister detail what actions her Department is taking when this specific issue comes up in, say, Leeds so that patients can access emergency care during the lockdown?

[Jo Churchill]

Of course. As of the week ending 30 April, there were two urgent dental care centres in the Leeds area to provide urgent dental treatment and care for patients on referral either from the patient’s own dentist or from NHS 111. As with all urgent dental care centres, there is also a triage service that will give people advice, antibiotics or painkillers and then refer them through if clinical work is required. There are 308 urgent dental centres open across the country. I regularly talk to the chief dental officer and to the British Dental Association about the needs and requirements in the profession so that we can care for patients in the best way.

Coronavirus

Alec Shelbrooke Excerpts

Tuesday 3rd March 2020 Commons Chamber

[Matt Hancock]

The broader point is that it is very important that schools do not close if they are not advised to close. Again, it is about following the medical advice. If there is no epidemiological reason to close, a school should not be closing.

As of 11 am today, I understand that 10 schools are closed. Seven of the 14 schools that were reported yesterday as having closed are now open, so this is a dynamic situation. The DFE is doing a fantastic job, and I pay tribute to my right hon. Friend the Minister for School Standards, who has been working night and day to make sure that, where possible, children are at school.

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

My right hon. Friend will recall that I raised the issue of motorway service stations a couple of weeks ago. Coming down this week, I still did not see any signage about the health precautions that can be taken. May I urge him to investigate whether he can buy up advertising space in lavatory areas to make sure the message is clear so that people understand the hygiene steps to take?

[Matt Hancock]

That is an important point. We are launching an enhanced communications programme tomorrow, and I will check with my team whether it includes adverts in motorway service stations.

Wuhan Coronavirus

Alec Shelbrooke Excerpts

Tuesday 11th February 2020 Commons Chamber

[Matt Hancock]

I am very happy to ensure that that case is taken up with the Home Office.

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

I congratulate my right hon. Friend on the way he and his officials have handled this crisis, which has helped to keep the threat at “moderate”, and Members across the House on the non-partisan approach they have taken. I am concerned, however, that because we have broadcast that the threat is moderate people may become complacent. Will he increase the number of public health messages? I have heard them on the radio, but it struck me at motorway service stations on the way down yesterday that there was no public health information there. In areas of handwashing and bathroom use, it would probably be quite advisable.

[Matt Hancock]

That is an excellent idea. We are open to all ideas of that kind and I will look directly into it.

Surgical Mesh Implants

Alec Shelbrooke Excerpts

Wednesday 18th October 2017 Westminster Hall

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

I pay tribute to the hon. Member for Kingston upon Hull West and Hessle (Emma Hardy) for securing this debate. I did not know about the subject until a constituent came to see me on Friday. The stories in the Chamber today from all parts of the realm—from Northern Ireland, Wales, Scotland and England—with every Member of Parliament telling a similar tale, show that this is the tip of the iceberg and that there are many hundreds, if not thousands, of women out there who could be struggling. Of course, they may not know yet that they will have a problem, because we do not have the data.

My constituent who came to see me is incredibly brave. She could not make herself at all comfortable during my surgery, but leant forward with her hands on the table. She could not sit, could not stand straight and could not bend over. As the consultation went on, she was sweating more and more with pain. It is all very well having sweeping statements about ruined sex lives and constant pain, but what does that mean? My constituent, who is only 47 years old, was more concerned about my embarrassment as she told me her story than she was about herself. A lot of women do not want to embarrass us, but we are the postmen for relaying stories back to Government.

My constituent said that during sex four years after the operation her husband ended up with a cut and bleeding penis. Further surgery has taken place and intercourse is now completely impossible. This lady had had a loving and physical relationship with her husband, and after further surgery now has no sexual stimulation at all. Indeed, she told me that any clitoral stimulation had immediately become a huge abdominal pain. She has also been diagnosed with a low level of infection. There is a shocking statistic: research has shown that 83.6% of implants have been found to have vaginal bacteria on them. That is an important statistic because the Medical Devices Regulations 2002 state that before a medical device can be placed on the market, the manufacturer must ensure that the device meets essential requirements, which include sterility and minimising the risks of contamination.

My constituent was a physiotherapist and had led a very active life. She can now barely get through a day. She was not told about the risks of the operation. Her prolapse was not serious enough to demand such an operation, but she was told, “We can sort that out.” It was not until 2013 that she was told she had a vaginal extrusion. Even then she was told by the surgeon, “Don’t worry; you truly have a designer vagina now,” which showed a complete lack of sympathy and understanding that is scandalous.

We are debating the issue and showing that the scandal has moved forward. I did a lot of work on the thalidomide campaign and I thought this was the next thalidomide scandal. That is how Sky News described it this morning in recognition of how serious this matter is. As my hon. Friend the Member for Totnes (Dr Wollaston) has said, there may be areas where the procedure can be used, but at a minimum the situation warrants a suspension of use at this stage, as has happened in the United States and in Scotland. My constituent is a generous woman. She said, “I don’t expect you to understand this quickly, but please raise my voice today in Parliament.”

Suspension and study of the data is vital; otherwise, we could be creating the biggest scandal in years in the NHS.

--- Later in debate ---

[Jeff Smith (Manchester, Withington) (Lab)]

It is a pleasure to serve under your chairmanship, Mr Owen. I congratulate my hon. Friend the Member for Kingston upon Hull West and Hessle (Emma Hardy) on securing the debate and on her powerful speech. I also congratulate my hon. Friend the Member for Pontypridd (Owen Smith) on raising the issue and on forming the APPG to raise the profile of an issue that I confess I knew virtually nothing about until quite recently. I congratulate the many Members who have made powerful speeches explaining the experiences of women in their constituencies.

As I have said, I knew nothing about this issue, but its seriousness was brought home to me when a constituent came to see me. He had had an inguinal hernia repair that developed complications because of the mesh used in the procedure. It left him in agony; he described it as like having a metal plate wedged in his lower abdomen. Eventually, he had to have corrective surgery, but it did not resolve the chronic pain that he suffers. That points to one of the unique aspects of this problem, which is the difficulty of removing the mesh and correcting the initial surgery. He had the mesh removed, but he is still in constant pain. I think that is partly due to the fact that the expertise in removing mesh implants is not really there.

[Alec Shelbrooke]

My constituent described it as trying to remove hair from chewing gum, which shows just how utterly complicated this surgery is.

[Jeff Smith]

That is an important, well-made point. The failure of the procedure that my constituent went through has changed his life. He was previously a runner, cyclist and mountain-climber—a very active man. He now struggles to get around. When he came to see me, he had to stand throughout our meeting because of the pain that he is in. He is now suffering with a chronic condition as a result of the failed procedure.

My constituent has been in contact with a number of other men—and is aware of many others—who are in this difficult situation. He asked me to ask the Minister two questions. First, how many men have gone through this procedure and had it fail? Secondly, will the scope of any future NHS investigations be widened to include men as well as women? I do not want to downplay the seriousness of the issue for women, which has been clearly explained by a number of Members today, but any investigation needs to take the experience of men into account.

As it happens, my constituent underwent his procedure in a private hospital, which points to three wider issues that he asked me to raise. First, there is a lack of clarity—as we have already heard—about the roles and responsibilities within private hospitals and between hospitals, surgeons and others involved in the process. Secondly, there is no mandatory reporting of chronic pain incidents following unsuccessful operations; that clearly needs to be addressed.

Thirdly, there is a three-year limit to medical negligence claims, which has had an impact on my constituent and possibly others as well. My constituent had his operation just under three years ago, but he has been managing his agonising pain and chronic condition for the last two years and has not really been able to think about whether there is a medical negligence claim. He does not really have time now to lodge one within the three-year limit. I would be interested to hear the Minister say something on those matters.

I conclude by supporting the other points that have been made by hon. Members about the prioritisation of this issue by the National Institute for Health and Care Excellence and the need for a full public inquiry.

--- Later in debate ---

[The Parliamentary Under-Secretary of State for Health (Jackie Doyle-Price)]

It is a pleasure to serve under your chairmanship, Mr Owen. I thank the hon. Member for Kingston upon Hull West and Hessle (Emma Hardy) for securing this debate and shining a light on a condition that is very distressing for far too many women. Clearly this is not where we would like to be.

Obviously, many hon. Members would like an immediate ban on mesh products. From my perspective, the issue is not with the product but with clinical practice. That is what is going wrong. That is where we need to be much clearer, ensuring that women are treated properly by their clinicians, given proper advice and risk assessments, and given the opportunity to report any complications and the ability to complain and challenge. The Government also need to ensure that all clinicians have the most up-to-date and appropriate advice.

The focus of this debate is the women who are suffering. The most important thing we can do—my priority—is to ensure that they get the support, care and treatment they need to alleviate a debilitating condition.

With regard to the evidence, we expect to produce the NICE guidelines before the end of 2017. We will bring them forward as soon as possible. I am sure that hon. Members will want to review those guidelines, to see whether they are satisfied that they have moved forward.

The advice I have received from the MHRA is that mesh is still the best product for treating stress incontinence, but the evidence regarding prolapse is more mixed. I can give that advice to hon. Members today, but we await the NICE guidelines before the end of the year.

The women are the most important aspect of this debate. We should be focusing on them. We must make sure that they are fully supported to make informed decisions about the surgery, and I have heard from many hon. Members that in many cases they were not. This is a risky process and, as my hon. Friend the Member for Totnes (Dr Wollaston), the Chair of the Health Committee, said, many women have benefited from this surgery but there is a risk to it, and those risks were not properly communicated to allow women to make an informed choice. That is not acceptable and we must make sure that does not happen in the future.

To do all of that, we are working with patients, NHS England and the MHRA, to come together with the mesh oversight group. The most recent report was published in July and its recommendations are being implemented. The updated guidelines will be published before the end of 2017. It is important that regulators ensure that advice and guidance keep up with developments in clinical technology and practice. We will constantly review evidence as it comes in to keep advice and guidance up to date.

A number of hon. Members mentioned that there have been no clinical trials for these devices, and I agree that we need to continue to draw on emerging evidence. There have been a number of research studies which have directly informed the guidelines issued by the regulators and led them to reach their conclusions, on which I have just advised the House.

It is still important that we listen to the concerns of women, and I encourage all hon. Members who speak to their constituents suffering with the consequences, to make sure that they report those complaints through the MHRA yellow card scheme, so that we can build a body of evidence about where things have gone wrong.

[Alec Shelbrooke]

Will the Minister make a specific inquiry to the MHRA about the evidence of bacterial infection on the product, which flies in the face of its advice that the product must have sterility in order to be implanted? There seems to be a contradiction in the MHRA’s advice as to how it should be licensing products.

[Jackie Doyle-Price]

I hesitate to give a full answer, but the advice I have received is that over the years these products have been reviewed and there are clinical standards for the size of the mesh. I will write to my hon. Friend in more detail, because I am not an expert in that.

The hon. Member for Kingston upon Hull West and Hessle calls for a public inquiry. I think it is more important that we get the treatment that is needed, but I encourage everybody to report their cases through the yellow card scheme.

I am horrified to hear from my hon. Friend the Member for Totnes that many women did not know they were having the device fitted in the first place. That general issue indicates some arrogance of the medical profession towards women. The stories I have heard from colleagues, about how their constituents have been treated by their GPs when they have gone for treatment, are indicative of that. Women tend to suffer in silence. Quite often that means they are not the best at championing themselves. That is clearly unacceptable. This issue has been considered by the mesh oversight group, and it has been clear that improvements are needed to ensure informed consent.

NHS: Learning from Mistakes

Alec Shelbrooke Excerpts

Wednesday 9th March 2016 Commons Chamber

[Mr Hunt]

I am more than happy to look into that case, which is exactly the kind of thing that we are trying to stop with the measures we are bringing forward today.

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

I congratulate my right hon. Friend on once again ensuring that patient healthcare and outcomes are at the forefront of his thinking, and that of professional health service workers who do such a brave job and can sometimes be caught in the crossfire. Does he agree that comments from people on the front line supporting the doctors strike—such as Mr Usman Ahmed, who started a post on Facebook by saying:

“I’ve always hated the Conservatives—a complete and utter bunch of…”;

I shall leave it there as I would not like to offend you, Madam Deputy Speaker—show that they do not care about healthcare and are more interested in their own political gain?

[Mr Hunt]

This, I am afraid, is the problem with some elements in the BMA, who are putting politics ahead of patients. As we have heard today, that is the problem in the Labour party as well.

Mental Health Taskforce

Alec Shelbrooke Excerpts

Tuesday 23rd February 2016 Commons Chamber

[Alistair Burt]

Although I read the answers to my own questions, I cannot recall one on that point, so the hon. Gentleman has caught me out. I genuinely do not know the answer, so I will write to him about the devolved Administrations or place an answer in the Library. I think we are talking about responsibility in England, because this is a devolved matter, but there is good, close co-operation between officials on the development of mental health services in the devolved Administrations, which will certainly continue. I will make sure that an answer on the finances is placed in the Library.

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

The work that the Minister has outlined is, to my mind, one of the most important pieces of work in this Parliament, and I very much welcome the investment and improved services that have resulted.

May I build on the comments of my hon. Friend the Member for Halesowen and Rowley Regis (James Morris) and the hon. Member for Central Ayrshire (Dr Whitford) about the stigma of mental health? Depression is one of the most terrible diseases that people can suffer, and they often suffer because of the stigma attached to it, too. I congratulate the writers of “Coronation Street” on the Steve McDonald storyline, which was dealt with sensitively and addressed some of the stigmas and stereotypes. I urge my right hon. Friend the Minister to ensure that as much effort is put into tackling the stigma of mental health as into the practical investment in services.

[Alistair Burt]

My hon. Friend is absolutely right. I praise the storyline editors of “Coronation Street” just as much as I do those of “EastEnders”, which has done a remarkable job in relation to perinatal mental health with Stacey’s story over the past few weeks.

The Government’s anti-stigma campaign will certainly continue. We are much informed particularly by young people, with whom we have worked on Time to Change, to which we have made a further commitment of financial support. Stigma is a terrible thing, and is partly responsible for breaking the link between physical and mental health. The taskforce recommended that the Government deliver on the objective to make sure that more people with mental health problems receive help for their physical issues, so that we can deal with the terrible difference in mortality rates between those with mental health difficulties and other people. Dealing with the stigma, so that people feel able to raise their problems, is an important part of that.

Junior Doctors Contracts

Alec Shelbrooke Excerpts

Thursday 11th February 2016 Commons Chamber

[Mr Hunt]

I will be pithy, Mr Speaker. This is not just about cost-neutrality, but about dealing with weekend care, which is why that proposal was not accepted.

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

May I congratulate my right hon. Friend on always having at the forefront patient care and the wellbeing of young doctors? Did it not give the game away when the BMA said that this was a blow against austerity? Will he remind the House how much extra money has gone into the NHS, by contrast to what happened under the Labour party?

[Mr Hunt]

My hon. Friend is absolutely right. I am afraid that, regrettably, there are some political elements inside the BMA. The great irony is that, without the austerity measures that those same people opposed in the previous Parliament, we would not have been able to give the NHS its sixth biggest funding increase ever.

Drugs (Ultra-rare Diseases)

Alec Shelbrooke Excerpts

Tuesday 20th January 2015 Westminster Hall

[Greg Mulholland]

Absolutely. That is very much the case with Morquio, too. Simon and Katy Brown have told me that the drug is having a huge impact now. I met Sam and saw him running around when he visited my surgery. When there is deterioration in such conditions, the clock can never be turned back, which is why we are urging the Minister to address the situation. I am delighted that we had meetings with him. All the organisations involved, the MPS Society, the Muscular Dystrophy Campaign, Action Duchenne and Joining Jack, are urging the Minister and NHS England to find a way to ensure that all these children, not only the 111 who are currently on the trials—some of whom are, of course, receiving placebos—but all 138 children with these conditions, are able to access the drugs now. We have asked for a decision on that by the end of January.

We are in this situation because a decision was supposed to have been taken by NHS England on 15 December 2014, but a letter was sent by the MPS Society and a young man with Morquio syndrome, Kamal—I am delighted that his family are visiting Parliament today—and on receipt of that letter NHS England, realising that its process was potentially discriminating against people with ultra-rare conditions, pulled the entire process, leaving all these families in limbo. NHS England has a responsibility to put another proper, robust process in place.

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

I am grateful to my hon. Friend for giving way. I will be meeting my constituent Angela Paton on Friday afternoon. She was part of the trial, which helped her immensely, but she is worried that the drug may now be withdrawn. Would my hon. Friend like me to report to him after that meeting on Friday?

[Greg Mulholland]

Absolutely. It is critical that we all work together on this issue. Indeed, I would like to hear from the MPs for all these families across the country so that we can have one voice to say to NHS England and the Minister, who has been very helpful, that we need a solution and that we need to hear some news by the end of January.

NHS England is now consulting on a new process, and it has said that it will take 90 days. That may seem a reasonable time to come up with a process, but considering that the old process was flawed, there needs to be something to fill the gap that enables all these children to access the drugs now. At the moment, the drugs in this case are being supplied through the good will of the drug companies: BioMarin in the case of Vimizim and PTC in the case of Translarna. Both companies are engaged in the process, both have a part to play and both are involved in dialogue with the Minister and NHS England.

I will briefly explain the two conditions so that people understand. Morquio is caused by the lack of an enzyme needed to break down certain chains of sugar molecules used in building bones, cartilage, tendons and other bodily tissues. Those unbroken molecules are stored in parts of cells called lysosomes, which become swollen, disrupt cell functions and cause progressive damage. Babies with the syndrome grow normally, but growth slows significantly after 18 months. Those severely affected stop growing at about age eight, and their final height may be three or four feet, which has many effects on their quality of life. There is no cure for Morquio, but the enzyme replacement therapy Vimizim, for which clinical trials are ongoing at the moment, has been shown to be effective. As we have said, any delay with the drug will cause damage that cannot then be reversed.

Oral Answers to Questions

Alec Shelbrooke Excerpts

Tuesday 25th November 2014 Commons Chamber

[Mr Hunt]

There are more doctors and more nurses operating at Medway hospital and I know that when the hon. Gentleman was sitting on this side of the House he was very pleased with the progress that was being made in turning it around from special measures, but, like UKIP’s policy on the NHS, everything changes.

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

May I welcome the recent launch of MyNHS? Does my right hon. Friend agree that transparency of NHS performance, whether it be that of hospitals, GPs or surgeons, will be a major driver in improving patient care, as international evidence suggests, and help us avoid a scandal such as Mid Staffs, which happened under that lot over there?

[Mr Hunt]

Two thirds of the information we are publishing on MyNHS was actually collected by the previous Labour Government, but they refused to publish half of it. That is the difference.