Hernia Mesh in Men

Debate between Jim Shannon and David Hanson

Thursday 5th September 2019 Westminster Hall

[Jim Shannon (Strangford) (DUP)]

I beg to move,

That this House has considered hernia mesh in men.

I have brought this issue to the House because, to be truthful, I was not aware of this problem among men. I am well aware of the hernia mesh issue for women, and have represented their viewpoint for a number of years in this House and back home, where the Northern Ireland health service has responsibility. I asked for this debate after a number of gentlemen came to see me some months ago—I will give a little background on that in a few minutes.

I thank the Backbench Business Committee for selecting this topic for debate. Back in July I accepted its offer of this first Thursday back, even though I know it is the graveyard shift, unless there is a three-line Whip in the main Chamber. Given today’s one-line Whip, many Members have returned home after everything that has happened in the last two days. None the less, I am very pleased to bring this matter to Westminster Hall. I am also pleased to see the Minister in her place. This will be a hat-trick of debates for her—one yesterday and two today. I look forward to her response.

I raised this issue after a meeting I had with some men in Northern Ireland. My party colleague and health spokesperson in the Northern Ireland Assembly, Paula Bradley, who represents North Belfast, initially made me aware of the issue. My hon. Friend the Member for Upper Bann (David Simpson) also brought it to my attention, as he had met constituents to discuss the matter. It is only over the past nine months that I have been aware of it. The men I met that day were aged between 30 and about 55. I understand that in Northern Ireland some 400 men have had problems, and the number across Great Britain will be even higher. They outlined their experiences and the difficulties that they attributed to hernia mesh. I thought that their problems should be considered in this place, as those problems have been replicated throughout the United Kingdom.

The matter has been brought to the attention of the Department of Health and Social Care. The hon. Member for Linlithgow and East Falkirk (Martyn Day), the Scots nats spokesperson, is aware of the issue and will offer his experience. I will not steal his speech, but I understand he will tell us a wee bit about what he has experienced personally and about the health service in Scotland. I am also pleased to see the shadow spokesperson, the hon. Member for Washington and Sunderland West (Mrs Hodgson), in her place.

I urge that serious consideration be given to an investigation, on the same scale as the Australian investigation, and that action be taken after the findings are collated. Australia took action, and I hope the Minister will assure me that the Government will do the same. I promised my constituents and those 400 men across Northern Ireland who have had problems with hernia mesh that I would raise awareness in this House because, unfortunately, we do not have a functioning Northern Ireland Assembly so cannot raise the issue there.

In November 2018, the Health Issues Centre undertook social research to investigate adverse health experiences among Australian men and women who had undergone a medical device implant. The research was product non-specific, to identify any devices that demonstrated a pattern of failure. Many hernia operations are successful. In our job as elective representatives, people do not tell us how good things are; they tell us their complaints. Therefore, we do not always hear about the successful hernia mesh implants, but we certainly hear about the problems.

The issue was highlighted on the “Victoria Derbyshire” programme on 26 December 2018. A spokesperson from the Royal College of Surgeons said that hernia mesh complications “affect more than 100,000” people. They went on to say:

“It is clearly tragic if even a single patient suffers horrible complications from any type of surgery, not just hernia operations. Unfortunately the nature of surgery in general, not just mesh surgery, carries with it an inherent risk of complications which surgeons will always seek to assess, and will discuss with patients according to their individual clinical circumstances before surgery takes place.

It is important to make a distinction between groin hernia, the most commonly carried out repair and other forms of abdominal wall repair where a hernia has arisen, for example, in an incision or scar after a previous operation. These are more difficult and the complications rates are much higher.

A recent 2018 study found that both mesh and non-mesh hernia repairs were effective for patients and are not associated with different rates of chronic pain. The Victoria Derbyshire programme is right to point out how a minority of hernia mesh operations are associated with complications. However, it is also important to stress that such complications range dramatically from minor and correctable irritations to the more serious complications highlighted in its programme. Complications can also occur with non-mesh hernia repairs, and by not operating on a hernia at all. It is extremely important that patients are given the full picture by surgeons, regulators, and the media.”

A large number of studies have looked at the available treatments, but unfortunately we do not have all the appropriate information. The spokesperson continued:

“There have already been a number of scientific studies looking at the use of different types of mesh in hernia and we should continue to review the evidence and patients’ experiences to make sure the right advice is given and the right action is taken. Along with the regulatory authorities, we will continue to listen to patients’ experiences. Patients suffering complications or pain need help, not silence.”

That is very important and we must underline that point. They continued:

“There must also be an ongoing review of the data to make sure that previous studies have not missed any serious, widespread issue. It remains vital that surgeons continue to make patients aware of all the possible side effects associated with performing a hernia repair.”

Those gentlemen who came to see me earlier this year to ld me that they were not aware of the complications. I will give an example a little later. I do not want to criticise surgeons because they are under incredible pressure, but people have told me that they were not aware of the ins and outs and relevant information, so I believe there is a case to answer.

The Health Issues Centre inquiry specifically focused on people who had suffered a hernia, to better understand the nature and the impact of adverse outcomes. Over a period of four weeks, 183 respondents reported hernia mesh-related injury across a range of brands and of categories of hernia. Several serious problems with hernia mesh implants arose, too. It is hard sometimes to explain the physical, emotional and mental effect. The people I met were very clear that in the vast numbers of cases that they knew of, there were several serious problems. The vast majority of respondents—87% of them—did not feel that they were given enough information before their treatment to give informed consent. Indeed, they were never told about the risks and the impacts. They were not aware of any problems.

A senior member of the Conservative party—I will not mention his name—told me yesterday, “I have had a hernia mesh implant, but mine was successful.” Many are successful, but we should highlight those that are not. Some 91% of respondents suffer ongoing post-operative chronic pain as well as other health impacts. For example, some of the men who spoke to me have had serious bouts of depression and allergic reactions. Only 8.7% of respondents said that they had had successful treatment to address the problematic outcome of the operation.

Past cases of mine have involved women who have had mesh operations, which are intimate operations. I have had cases of ladies who have been unable to work or keep relationships going. They have been unable to cope with life, so the impacts of hernia mesh when it goes wrong are very real.

Men represented some 70% of the respondents to the survey. Those figures are from Australia, of course, but I just want to illustrate the matter. I will move on to the United Kingdom, but those figures are relevant.

Years ago in Northern Ireland a man developed a limp four years after surgery. People told him, “We have experienced pain as a result of similar surgery.” Damien Murtagh, who lives in Banbridge and has given me permission to tell his story, has been left with a limp as a result of his operation six years ago. He said:

“For years no one could tell me what is causing this pain. I can no longer ride my bike, go fishing, I work part-time”,

because of the chronic pain and the effect it has had on his lifestyle. He continued:

“The pain in the lower stomach and groin area makes me feel physically sick. I have no private life.”

It has been difficult for him to maintain relationships with other people. The issues caused off the back of the surgery are genuine and life changing.

I find it odd that this surgery can create such problems. I am not a medical professional. I can make no judgment about the operations, but I can ask whether they should continue without the assurance that every possible investigation has been carried out into the prolonged side effects. The patients should know, at every stage, the potential implications if the operation does not go as planned.

Figures specific to the United Kingdom also outline the problem. In a survey of 653 people, 18.8% said that they had developed antibiotic-resistant infections as a result of mesh complications. A person’s general health can go down dramatically. Some 40% of respondents described their pain levels at worst to be 10 out of 10. Usually, 10 out of 10 means someone is doing well, but in this case it means they are not and that they are in severe pain. In addition, 85.6% of respondents said that they could not sleep because of the pain. The men told me that their sleep patterns had been destroyed. They are in constant, nagging pain that never leaves them. When it gets to that stage and someone’s personal life is so affected, we have to look very seriously at the issue.

The problems of lack of information are not specific to Australia. Some 91.7% of respondents were not even told that they would be getting a mesh implant. Some did not even know what was happening. They went for the operation and knew there would be a repair job; they accepted that, but they were not aware of the implications. Some 96.2% said they were not shown the mesh implant that they were about to be given, while 91.7% were not told that the mesh implant was made of plastic, and 98% said they were not told the size of the mesh implant. When it comes to serious operations—in most cases it is probably a minor operation, but it has the potential to change lives—we need to make sure that patients are aware of such things.

Patients feel that they are not being told the risks of the surgery and the potential issues. We understand that that is partly because a decision is made when the patient is open and the need dictates the method; sometimes a decision has to be taken when the operation is at an advanced stage and it might not be possible to let the person know. I understand the pressures that surgeons and their staff are under, but I feel that an essential part of the care is an understanding of what to expect, and that can make a difference to the outcome. It would certainly have made a difference to the 400 men in Northern Ireland who have experienced problems. It would certainly have changed their lives if they had known about the implications for them. None the less, we find ourselves in a very difficult position, and they find themselves physically, mentally and emotionally changed. For some of them, their relationships have broken down as well.

Informed consent is fundamental to any surgery. I had three minor operations in 2017 and, to be honest, I would have signed any paper just to get the operations over because the pain was so extreme. At the end of the day, you sign the paper and you understand. In my case, it was a straightforward operation on the three occasions.

I mentioned Damien from Banbridge earlier. Outlining his case could help people make the all-important decision to go ahead with surgery, knowing that there could possibly be some serious downsides, although not in every case. That would be a more ideal situation for the patients, rather than being struck with post-operation issues without having been aware of the risks. At least they would know that they had taken the risk, not the surgeon, who they might feel had hidden the risk from them. It is a natural reaction. It is not pointing the finger or judgmental. I stress again that in no way can I ever accuse surgical teams of deliberately withholding information from their patients.

In an ideal world, post-operative problems would not exist and the NHS and private hospitals, which some patients are transferred to, would be able to shape the surgery in such a way that the pain that many patients cite would not occur. Problems created by surgery have knock-on effects. Physical problems quickly become mental problems. If Members had heard the stories of the gentlemen I met, they would understand where the mental problems come from. The pain is absolutely unbearable. Many experience depression as a result of surgery. They all cite anxiety, panic attacks and nightmares, and—this is serious—some people hear things that are not there. It clearly affects them mentally.

I congratulate and thank the men for making their information and backgrounds known. I also thank my colleagues from my own party who took the time to let me know about their individual cases. When we hear their stories, we clearly see how their lives have been changed.

In the United Kingdom study, 27.6% of respondents had been formally diagnosed with a mental health condition such as PTSD, which can affect people in many different ways, and 4.7% said that they had self-harmed because of mesh complications. That is probably off the back of the depression and the pain that becomes almost unbearable. I never realised just how much pain can affect people. I met a lady who had a problem following an operation—it was nothing to do with hernia mesh. The pain was so bad that she asked for her right knee to be taken off to remove the pain. Doing that removed the pain, because that is where the pain was, but it was a dramatic step to take, so when people start to self-harm, as some have said they have, because of the mesh complications, we must take serious cognizance of what has happened.

Some 24.3% of respondents had psychotherapy or counselling as a result of mesh complications. Again, the counselling was to try to stop them self-harming, and to help them to deal with a physical, surgical problem that would be long-term. Almost half of respondents—43.6%—revealed that they had suicidal thoughts, which underlines their clear anxiety and the importance of doing something; and 4.7% had tried to take their own lives. Unfortunately, nearly every day of the week we elected representatives deal, in our offices, with people suffering depression and anxiety, whatever the reasons may be. We understand what drives people to the brink of despair. It can be money issues, marital problems, family issues or a physical problem, as in the case we are considering. The figures reveal the dark reality of post-operation life for many of the respondents, and reinforce the urgency of the issue, which needs to be addressed as soon as possible. That is why I have brought the matter to the House for consideration, and it is why the Backbench Business Committee was pleased to provide an opportunity to highlight it. Many complications surround the issue of hernia mesh surgery, and there is a need to give urgent attention to solving them. The figures more than reinforce that point.

I mentioned the effect on families. The gentlemen who came to see me and my colleague, Paula Bradley MLA, on the occasion I spoke of, were able to tell me something about that. More often than not, when someone is sick or ill or having problems they are not the only one travelling that road; their wife or partner and family travel it with them, so there are also family issues. Post-operation care is prevalent among the issues, and 33.1% of respondents in the UK survey said that their partner was now their carer. When we get married we know it is for better or for worse—and sometimes a partner becomes a carer. Clearly that is a great responsibility for them. Three per cent. of respondents said that they had to put their parents into a retirement home as a result of mesh complications and problems with the surgery. People would obviously have loyalty and feel a duty to try to look after them, so that tells me, and should tell everyone present in the Chamber, that clearly the problem affects all the family. If one suffers, all suffer.

I have been told that there are clear problems associated with mesh implants that need to be addressed. We are dealing with issues, following the surgery, that people believe are related to it. They include adverse mental health issues and the fact that 78.4% of people experience depression—more than three quarters of the people in question. For the people I met, depression was clearly now a part of life. Some had stopped work altogether. Family relationships had broken down; they were no longer able to hold them together. Some 40.7% of respondents said that their child acted as a temporary carer. I know the good things that many children do for parents and perhaps siblings, but whenever a child, growing up, who should be enjoying childhood and focusing on their education, must be a temporary carer, there are clearly issues to address. Some men cannot have children after surgery, as some of the men I met told me. That is another issue that means we need to hasten an investigation.

There is also a need to address the issue of post-operative pain that lasts many years. I understand that what I have said is perhaps topical and anecdotal. The hon. Member for Linlithgow and East Falkirk will tell the House about some of the cases, but it is clear to me from meeting the men I have mentioned, and from the evidence that I have seen, that some hernia mesh operations in men have led to serious physical problems. That is why I have brought the matter forward today for consideration. It is the reason for this debate in Westminster Hall today.

We need a governmental investigation, and there must be a directive to do that, and funding to enable it to happen. That is why I look to the Minister. I hope that we will get a helpful response. I hope that in the future all the post-operation issues with hernia mesh surgery can be resolved. I hope that the NHS will receive appropriate funding to tackle mental health issues caused by the surgery. I am very pleased that in the Chancellor’s statement yesterday he reaffirmed the commitment to spending on health—I think it was £34 billion. Is the Minister in a position to suggest that some of that money could be focused on enabling the investigation to happen, and getting the data to try to address the issue? The mental health issues can never be ignored, any more than the physical ones. Perhaps the NHS will be able to improve the surgery process so that patients will not have to cope with being left in serious pain for years and perhaps for ever afterwards.

Now that the issue has been raised it is important that it gets the attention that it deserves and that the problems are tackled. I again ask the Minister—and she knows I do so respectfully and sincerely—whether we can start the process of answering the questions and providing empirical data on the side effects of hernia mesh in the United Kingdom. I know that her responsibility is to the mainland, but the inquiry will have to start somewhere, and I hope that it starts here.

[David Hanson (in the Chair)]

The hon. Member for Strangford (Jim Shannon) has summarised the case very succinctly. We move seamlessly to Front-Bench responses. I call Mr Martyn Day.

Cystic Fibrosis Drugs: Orkambi

Debate between Jim Shannon and David Hanson

Monday 10th June 2019 Westminster Hall

[Jim Shannon]

I thank my hon. Friend for those words. This is not an easy subject for the Minister to respond to, but it is one that has captured the interest of us all on behalf of our constituents, and we need the Government to grasp that and move it forward to the next place. We look for that.

If the Republic of Ireland is able to come to some arrangement with Vertex, if the Scottish Parliament is able to do similar and if, according to the background information, it is possible to go to Argentina and buy a year’s course of drugs for one patient at £23,000, compared with £104,000 for a year’s supply here, that tells me that something can be done if we had the willpower to do it, as my hon. Friend the Member for East Londonderry (Mr Campbell) has said. We can look around at our UK neighbours and look toward Scotland, whose Government have reached an agreement with Vertex.

The permanent secretary went on to say:

“In the absence of this positive NICE determination, the Health and Social Care Board…may take into account guidance produced by other appropriate HTA”—

health technology assessment—

“bodies based in other UK countries such as the Scottish Medicines Consortium…when making decisions about access to new drugs.”

I say to the Minister that I have made a comment about the Republic of Ireland, but I also make a comment about Scotland, because I think that the process enables us to use what Scotland has done as an example for us elsewhere.

The permanent secretary continued:

“The Department is aware that Vertex have re-applied to the SMC for consideration of approval for Orkambi, and that in the meantime there is currently limited access to the drug in Scotland via their PACS”—

peer approved clinical system—

“Tier 2 scheme, which is broadly analogous to our Individual Funding Request Process.

If Orkambi is approved by the SMC, details of the funding models in place, which are currently bound by commercial confidentiality, will be shared with the other UK countries. This will allow for us to have full access to the evidence and costs associated with this therapy and will inform any further decisions on access.”

The hon. Member for Colne Valley (Thelma Walker) referred to the destruction of some medications. Whatever the reason for that was—whether they had run out of time or whatever—I think it is disgraceful that people have destroyed some medicines rather than letting them be used by the general public, by those who need them. If that is not unacceptable in this day and age, I do not know what is. It is absolutely disgraceful; it really annoys me.

It is simply terrible that we are in a position where our hand are tied. I say again to the Government: look to your Scottish counterparts. I firmly believe that we can and must do more from this place and that that must start with acknowledging that the NICE guidelines do not currently take into account the differences, when it comes to pricing, between treatments for rare diseases and a new antibiotic strain. We need a new form of assessment for rare diseases and I would like to see that taking place as soon as possible to ensure that the mummy of my two-year-old constituent, who is asking me for this drug in order to give her child as normal a life as possible, can look forward to securing the best for her child. That is what every Member has said here today on behalf of their constituents.

Again according to the background information that I have, in May 2019 the Government said in response to a parliamentary question that discussions between Vertex, NHS England and NICE were ongoing. You know something? They have been ongoing for more than a year. Let’s get them sorted. Time is passing fast. I am joining colleagues in asking the Department to make the administrative changes necessary to end the Orkambi stalemate with NICE and to put in place a body designed specifically to address rare disease patients and their needs. We acknowledge that NICE does a tremendous job in ensuring that safe, cost-effective medicines are available on prescription, but we need a different set-up for those whose illnesses are very different and for the sake of my constituents and those represented by other MPs who have spoken today. I am asking that those decisions be taken and the changes made to enable Richard Pengelly, the permanent secretary at the Department of Health in Northern Ireland, to do what he knows he needs to do and allow the prescription of Orkambi to those whose lives would be radically altered and enhanced by it. It would give them life-changing opportunities. As others have said, give those children a chance.

[David Hanson (in the Chair)]

The previous Chair set a time limit on speeches of six minutes, which has been successful, in that all right hon. and hon. Members have been able to take part in the debate, but it leaves us with a maximum of one hour and 10 minutes for the Front-Bench speakers to respond. Front-Bench speakers, who have more than the normal 10 minutes, can be more flexible and take interventions should they so wish.

The other point I wish to make is that because the winding-up speeches have started early, some Members who have spoken in the debate are not present for these speeches and they should be. If you are watching on television, please return to the Chamber now. This is an important debate; you have contributed to it and you should be present for the Front-Bench responses.

Persecution of Christians: Role of UK Embassies

Debate between Jim Shannon and David Hanson

Tuesday 4th July 2017 Westminster Hall

[Jim Shannon]

I thank all right hon. and hon. Members, both new Members and those who have been here for a while, for their significant and helpful contributions on an issue that is very important to all of us—it is why we are here. It is good that there has been comprehensive political representation, from all parties, in Westminster Hall today. That has ensured that we have highlighted the relevant issues.

I think the shadow Minister, the hon. Member for Heywood and Middleton (Liz McInnes) summed up, in her response to the debate, the feeling of us all in this Chamber. I found out that the shadow Minister for the Scottish National party, the hon. Member for Glasgow East (David Linden), is a fellow Baptist, so there is more than just me in the House as a Baptist. It is always pleasing to see someone from a similar denomination in the House, and we wish him well in his new position.

The Minister, in his reply, summed up the things that we all want to see in place, and I thank him for that. He referred to his personal commitment to the issue, and I know that he is committed.

I will leave the last word to Matthew in chapter 5, verse 10:

“Blessed are they which are persecuted for righteousness’ sake: for theirs is the kingdom of heaven.”

Motion lapsed (Standing Order No. 10(6)).

[David Hanson (in the Chair)]

Order. We must now move on to the next debate. I call Alison Thewliss to move the motion. Would Members who are leaving please leave quietly, including officials?