Independent Medicines and Medical Devices Safety Review

Debate between Sharon Hodgson and Nadine Dorries

Thursday 9th July 2020 Commons Chamber

[Ms Dorries]

In the Department of Health and Social Care, we work daily and continually on improving patient safety to make our NHS the safest healthcare system in the world. Procedures such as the national guardian scheme, which my hon. Friend mentioned, and others that have been put in place all work towards that goal. This report, as tragic and harrowing as the stories in it are, will go a long way towards enabling us to develop systems that enable the patient’s voice to be heard earlier.

That is the core issue. The thread that runs through is how long it takes somebody who has a complaint to have their voice heard and their complaint acted on. That is something that we need to resolve. If we can do that—if patients’ complaints can be heard and can be resolved as soon as they are raised—no Minister will, hopefully, ever have to come to the Dispatch Box in the future, because situations will have been dealt with effectively and promptly, and lessons will have been learned.

My hon. Friend will also be aware that we have introduced the Health Service Safety Investigations Body, and there are other measures that will help us to take the learning from incidents and move forward. Work therefore happens daily on improving patient safety and getting to the place he outlined, where a Minister will never have to come here and apologise again.

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

I thank the Minister for her statement today. First, may I express my sincere gratitude to Baroness Cumberlege and the review team, who have shown such empathy and understanding to patients, their families and campaigners who have campaigned tirelessly on these issues for years? My mam is one of the thousands of patients who had her life and her health ruined because of this quick fix with a bit of tape. She was never warned of the damage that this plastic mesh could cause her body.

The review recommends setting up a network of specialist centres to provide comprehensive treatment, care and advice for those affected by implanted mesh, and that is to be welcomed. Does the Minister agree, however, that it would be abhorrent for any of those centres to be led by any of the surgeons who promoted mesh or put it into women, knowing it damaged them? For some women, it has caused the most unimaginable pain and life-changing damage.

[Ms Dorries]

I thank my hon. Friend—I do regard her as a friend because she is such a principled campaigner on issues such as this. I hope she does not mind my saying that I know that her mother gave evidence to the review and went along to one of the hearings. I thank her for that, because it was a very brave step to take. This is not an easy thing to talk about, so that was incredibly brave of her. We owe her for her bravery in coming forward, and I thank the hon. Lady for mentioning that.

I completely agree with the hon. Lady. I cannot comment on the specific point about individual doctors with expertise because work has to go forward on removals of meshes and on where we go in the future. However, on specialist centres—I think she is aware of this—NHS England is assessing bids from NHS providers to become specialist centres and to provide treatment for women with complications from mesh inserted for urinary incontinence and vaginal prolapse. Following the covid-19 pandemic, during which some of this work has unfortunately been halted, every effort is now being made to finalise the centres quickly. Stakeholders will be kept up to date with progress, but we do want to see more of that work.

Hernia Mesh in Men

Debate between Sharon Hodgson and Nadine Dorries

Thursday 5th September 2019 Westminster Hall

[Ms Dorries]

I thank my hon. Friend for his absolute honesty and openness in bringing forward his own case.

The bowel can come through the opening in the muscle wall, strangulate and develop into peritonitis, with dire consequences. The fact is that the alternative method of repair—just to stitch the muscle wall—is nowhere near as effective, and the same dangers can present. There can be a rupture, and the hernia will present again with the same complications.

[Mrs Hodgson]

The Minister, with her medical knowledge, can give the details on hernia repairs in men that otherwise would have been missing from the debate. The hon. Member for Burton (Andrew Griffiths) speaks from his experience. Although I do not want to be a harbinger of doom, for him it is very early days; often the pain that comes in 10% to 15% of cases appears a few years later, as the hon. Member for Strangford said in his speech. The Minister rightly points out that it is a good operation for what is a life-threatening condition in men, as opposed to stress incontinence in women, but still in 10% to 15% of cases we are talking about real pain. I would like her to elaborate on what we should do about that.

[Ms Dorries]

The hon. Lady is absolutely right. No one should suffer with chronic pain. There is a difference between acute and chronic pain, with acute pain happening immediately post operation and the chronic pain continuing afterwards. In inguinal mesh repair operations, the chronic pain is due to the mesh—like a small piece of net curtain—rubbing up against nerve endings and causing inflammation. For many men, the pain is quickly cured by an injection of local anaesthetic such as lignocaine with a steroid, which reduces the inflammation and takes away the pain completely. For many men who present back in out-patients, their pain is quickly sorted.

I do not want it to sound as though I am trivialising in any way the problems of those who continue to suffer pain. I believe that the Cumberlege report covers mesh as a wider issue, as well as issues related to the use of mesh, so we may gather more information from the report that will inform the debate on inguinal hernia mesh repair.

There are, however, other options. The best practice is shared decision making between the patient and the clinician, with the clinician fully explaining the operation to the patient, what is involved and what the options are. One option for patients who present with a hernia is for the clinician to reduce it in the clinic back in through the muscle wall. At that point, the patient may know how to handle it and manage it by not over-exercising and being careful when they cough. The patient will be registered as having had a hernia reduced and, if they want it operated on, they just ring up and go straight on to the operating list. That is a good option for many men if they think they can carefully and responsibly manage the hernia and come back to hospital only if it gets worse, if it pops again or if they need immediate attention. Whatever happens, they will be registered as having had an inguinal hernia and seen a clinician and therefore in need of treatment should it reoccur.

We are encouraging clinicians to have that conversation with patients. I do not know whether the clinicians treating my hon. Friend the Member for Burton (Andrew Griffiths) did, but clinicians should do so that patients can decide whether they want to go ahead with an operation.

--- Later in debate ---

[Ms Dorries]

I am delighted to hear that.

I am pleased to say that shared decision making is set out in the NHS long-term plan and I hope we will see more of it in other areas. As the hon. Member for Strangford mentioned, it has the full backing of the Royal College of Surgeons and the Royal College of Anaesthetists. I know from my own experiences in the health service that the role of patient voices is critical at every stage along the treatment pathway. Indeed, as we have said, the Government have asked Baroness Cumberlege to lead a review on the theme of patients’ voices. I will say more about that later.

All of us, including Ministers, regulators and clinicians, must listen to patients, such as the constituent mentioned by the hon. Member for Strangford who has had an ongoing problem, when they raise concerns. Only by listening to those patients’ voices and understanding the issues they have after hernia repair can we learn and develop what we need to do to ensure that it does not happen to people in the future. We must strike a fine balance as we steer through innovation, emerging science, clinical advice and the voices of a multitude of patients.

Hernias are relatively common. One in five men will get an inguinal hernia in their lifetime and it is worthwhile briefly outlining why men are mostly affected. Inguinal hernias are a type of groin hernia, which are the most common type of hernia. Some 98% of them are found in men, as the male anatomy is particularly vulnerable in this region. The main reason to operate on a hernia is to reduce the risk of bowel obstruction or necrosis, which is tissue death. Both of these conditions require major emergency surgery, where there is a risk of death.

Hernia surgery is therefore often a necessity. I have been advised by clinicians that when an individual’s condition indicates surgery, mesh repair is the standard operation for adults with inguinal hernias. It is safer than non-mesh repair in the first instance and is less likely to lead to pain post operation. It is also less likely to lead to hernia recurrence. To address the point made by the hon. Member for Strangford, I hope he understands not only that this treatment is the most effective but that the alternative is more likely to result in complications. Mesh is therefore used in approximately 97% of all surgical inguinal hernia repairs in England.

All the expert scientific advice that Ministers have received does not support a ban. It is important to emphasise that internationally no other country has banned the use of mesh to treat hernias. According to the National Institute for Health and Care Excellence, approximately 70,000 surgical inguinal hernia repairs are performed in England each year, at a cost to the NHS of £56 million a year. These mesh repairs are performed by either open surgery or laparoscopic surgery, as my hon. Friend the Member for Burton described.

NICE has developed guidance which recommends laparoscopic surgery as one of the treatment options for the repair of inguinal hernia. The guidance states that it should only be performed by appropriately trained surgeons who regularly carry out the procedure. This evidence was reviewed by NICE in February 2016 and the recommendations have remained in place since then. The Medicines and Healthcare Products Regulatory Agency and others will continue to review the situation as further evidence and analysis emerges, and will take any appropriate action on that basis. That is why this debate and the recounting of the experiences of constituents is important. They have ensured and will continue to ensure the safety of patients who need treatment.

Unfortunately, no type of surgery is without risk, both during and post surgery. The right balance between risks and benefits for individual patients must be achieved, which places patient autonomy and consent at its heart. I stress that I am deeply concerned to hear about instances where these conversations may not have happened, or have not been conducted in a manner that sufficiently informs the patient. Every patient should expect to receive safe and effective care, and to have an opportunity to raise concerns and feel confident that they will be listened to.

I will talk about the pain and suffering experienced by some men after mesh surgery. The vast majority of patients who undergo surgery using mesh to treat hernias go on to live normal, independent lives. While we do not know the exact number of complications, we believe it is low. However, I understand that those who experience the most adverse outcomes are those who suffer chronic pain or long-term discomfort.

I have been advised that 10% to 12% of men experience moderate to severe chronic pain post surgery. While that number is high, it is lower than for those who have non-mesh repair. I have been advised that acute pain is normal during healing, but chronic pain is not normal. As I said, one example of pain management is to treat chronic pain by injecting local anaesthetic and steroid. Long-term discomfort or pain is fortunately rare, but can still occur in one in 20 inguinal hernia repairs. While this number is still concerning, and, I believe, too high, the risk is dependent on the circumstances of each case. For example, there is an increased likelihood of it where patients have small hernias and where the predominant symptom before the operation is pain. Patients present at the clinic with pain and continue to have the pain after the operation. Both these adverse outcomes—the severity and the longevity of pain—remind us that regrettably complications can arise when any person undergoes surgery.

[Mrs Hodgson]

What we are establishing is that there are still many unknowns with regard to the numbers and when the pain occurs. That is what we need to drill down on. The hon. Member for Burton said that his surgery has been totally successful, however many months it is since it took place. However, the problem is not just post-surgery. Often, as we have heard, people are fine for two or three years and then suddenly, “Boom!”—they are hit with whole host of pain and autoimmune reactions. We need to drill down on that when we are looking at the problem. Will the Minister commit to trying to use the data to do that?

[Ms Dorries]

I am hopeful that the Cumberlege report will touch on that area to some degree. I will study the report in some detail, as will officials in the Department, and we will decide where we go from it, but I emphasise that the alternative of not having the mesh repair is more dangerous and has more complications, as we know from the data, than having it.