Hernia Mesh in Men

David Hanson Excerpts
Thursday 5th September 2019

(11 months ago)

Westminster Hall
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Department of Health and Social Care
Jim Shannon Portrait Jim Shannon (Strangford) (DUP) - Hansard
5 Sep 2019, 3 p.m.

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 came to see me earlier this year to tell 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 that 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 (Martyn Day) 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) Hansard
5 Sep 2019, 3:27 p.m.

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.

Martyn Day Portrait Martyn Day (Linlithgow and East Falkirk) (SNP) - Hansard
5 Sep 2019, 3:27 p.m.

It is a pleasure to serve under your chairmanship today, Mr Hanson. I am grateful to the hon. Member for Strangford (Jim Shannon) for introducing the debate. He has a brought number of debates to the House over the years, and I have learned an immense amount about issues that I did not know about. This, however, is one of which I have had some personal experience. Indeed, in my personal life since I have been in Parliament I have had two such hernia mesh operations—in my case, both successful. However, 2015 and 2018 are well within the timeframe that the hon. Gentleman highlighted, in which people have developed complications. So far, touch wood, everything has gone fine.

Hernias are fairly common operations. They usually go without any problem, but not everyone has the same experience, and I am grateful to the hon. Gentleman for highlighting the issue as it affects men. Health issues are, of course, devolved in Scotland, and the Scottish National party Scottish Government have a strong record of ensuring that no one suffers unduly from mesh. In 2014, the SNP Government requested a suspension of the use of medical mesh by the NHS in Scotland, pending safety investigations, and in 2015 the Cabinet Secretary for Health and Sport, Shona Robison, apologised to women who had been left in severe pain by such operations. Between 2009 and 2016, the number of women receiving mesh surgery in Scotland fell from 2,267 to just 135.

An independent review published in March last year in Scotland made eight recommendations—notably that surgical mesh implants should be used only after all other appropriate alternatives have been exhausted. Scotland’s chief medical officer accepted those recommendations in full.

The hon. Member for Strangford mentioned people not being told adequately about the potential complications. I have to be honest: having been through the process myself, I probably agree. We were told some things, but a patient suffering from a hernia is more concerned about when they will get their operation and be able to get back on with their life, so they probably do not pay appropriate attention to what is a fairly minor risk. Perhaps that risk needs to be emphasised to people, or they need to be reminded at a later stage in the process; as I know from experience, it can take a while after having seen the consultant to get the operation.

Although health is devolved, the regulation of mesh is a reserved matter. We therefore call on the UK Government urgently to review its effects and to legislate accordingly. Although regulation of these devices is reserved, we really need a UK-wide clinical audit database for recording device identifiers. We were pleased with the review of the guidelines for mesh following the finding by the National Institute for Health and Care Excellence that the evidence for the long-term efficacy of vaginal mesh implants was inadequate in quantity and quality, but we would like to see a review of the use of mesh to repair hernias.

Scottish Government officials are working with UK colleagues to consider the possibility of an automated implant registry, which would allow unique device identifiers to be entered on the patient’s electronic record. The SNP hopes that Ministers will be willing to work with their counterparts in the devolved Administrations and consider a UK-wide summit on that issue.

It is imperative that the highest possible standards for mesh are maintained. EU regulation 2017/745 on medical devices will change mesh implants for long-term or permanent use from class IIb to class III devices, meaning they are generally regarded as high risk. Those regulations will not take effect until 2020, after the date on which the Government desire to leave the EU. How will important EU regulations to monitor the use of devices across EU territories be implemented or reflected in UK law and regulation after Brexit? I reiterate that it is important that we maintain the highest possible standards, and I look forward to the Minister’s comments on that.

When I saw the title of the debate, I knew my Whips would be in touch because I had personal experience; having missed various other engagements while waiting for my operations, I knew I could not get out of doing this. In some parts I feel more mesh than man, but as I say, so far, so very successful.

Break in Debate

Ms Nadine Dorries Portrait The Parliamentary Under-Secretary of State for Health and Social Care (Ms Nadine Dorries) - Hansard
5 Sep 2019, 3:41 p.m.

It is a pleasure to serve under your chairmanship, Mr Hanson. I was alarmed when you walked in, because I think you have held more ministerial posts than anyone else in the House of Commons—or you are pretty close to holding the record, anyway. So to have you in the Chair, judging me as a Minister, is quite daunting.

I thank the hon. Member for Strangford (Jim Shannon) for bringing up this important debate. You always bring debates to the Chamber that you are heartfelt and passionate about. That is so important. It is a delight to be opposite the hon. Member for Washington and Sunderland West (Mrs Hodgson). We have both been in this place for 15 years, and I know that you also bring the same passion and same commitment. You always speak from your heart. We might be a bit similar in that way.

David Hanson (in the Chair) Hansard
5 Sep 2019, 3:41 p.m.

Order. “You” refers to me.

Ms Nadine Dorries Portrait Ms Dorries - Hansard
5 Sep 2019, 3:42 p.m.

Of course, Mr Hanson. I am amazed that after 10 years in the Chair I make these mistakes—it is because I am nervous. I am delighted to serve opposite the hon. Lady; it will be great.

This is a serious subject. It is incredibly important to hear the voices of patients who have suffered as a result of inguinal hernia mesh repair operations, because without allowing those patients to be heard, we cannot move forward to find solutions to deal with this issue. I will go off-piste from my speech, because there has been some conflation during the debate of vaginal mesh repair for the purpose of urinary incontinence and inguinal mesh repair for an inguinal hernia. The two operations are entirely different and have completely different outcomes. Vaginal mesh repair is for urinary incontinence. Inguinal mesh repair is for hernia, and without repair, there is a possibility of death. That is because of the pattern of development of an inguinal hernia. It is due to a break in the muscle wall. The hernia is a part of the bowel that comes through the muscle wall, and it can quickly strangulate and develop into peritonitis. The result of that can be death.

Break in Debate

Ms Nadine Dorries Portrait Ms Dorries - Hansard
5 Sep 2019, 3:57 p.m.

We will take that question away. I will come back to the hon. Gentleman, because that is a detailed question with more complexity in it than I could answer today. For those people who suffer from pain, is it alleviated by the steroid and local anaesthetic injection? Are those numbers just people who present back once with pain, or do they go on to have chronic long-term pain, and, as the hon. Member for Washington and Sunderland West says, come back three or four years later? Some drilling down into that data is needed.

Work is under way both within and independent of Government to improve safety and how we listen to patients, in order to gather the information to work with. In July, we launched the patient safety strategy, which sets out the direction of travel for future patient safety. It was developed through speaking to not just staff and senior leaders but, importantly, patients from across the country. As much as it looks at system improvements, such as digital developments and new technologies, it also looks at culture, so that the NHS becomes ever more an organisation with a just culture of openness to concerns, whether they are raised by patients, family members or staff. Concerns of all kinds should be welcomed, valued and acted on appropriately.

We are also waiting to hear back from the independent medicines and medical devices safety review, which is led by Baroness Cumberlege. The review examines how the healthcare system has responded to concerns raised by patients and families around three medical interventions, one of which is vaginal mesh. To do so, the review has focused on meetings with a broad range of stakeholder groups; I think the hon. Member for Washington and Sunderland West may have attended one of those with her mother.

I close by acknowledging just how difficult the subject matter is. No one should suffer from chronic long-term pain without every effort being made to reduce it and find out why it occurs in the first place. This is not an easy subject for men who are suffering from ongoing pain to speak about. We know that men are always very reluctant to come forward and go to the doctors about anything. I pay tribute to the many impassioned contributions of the brave men who have allowed their stories to be told, who have visited their MPs and contributed, because men are not good at sharing information when it comes to their health.

As I mentioned earlier, however, it is vital that the use of mesh to treat hernias continues. It remains the best course of action for patients where the appropriate treatment pathway leads to surgery. As with all treatment, shared decision making should be central to this process. It is vital that we continually examine the evidence together on the best means of treatment. Decisions in healthcare are often about weighing potential benefits against risks, and I thank those in our healthcare system who strive always to offer us the best treatment possible.

David Hanson (in the Chair) Hansard
5 Sep 2019, 4 p.m.

Although we have finished early, the hon. Member for Strangford can have three minutes to respond should he wish to, but no more than three minutes.

Jim Shannon Portrait Jim Shannon (Strangford) (DUP) - Hansard
5 Sep 2019, 4 p.m.

Thank you very much, Mr Hanson. I will certainly take no longer than three minutes. I had that advantage earlier on—I may have taken advantage of it, but there we are. Three minutes is more than enough.

First, I thank the hon. Member for Linlithgow and East Falkirk (Martyn Day) for his contribution. If we wanted a headline for the hon. Gentleman, it would be “More mesh than man” because of the number of operations he has had, if he does not mind me saying so.