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.