Surgical Mesh Implants

Jackie Doyle-Price Excerpts

Wednesday 18th October 2017 Westminster Hall

[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.

[Dr Wollaston]

Will the Minister assure the House that she will investigate clinical governance in the private sector as well as in the NHS, because many women tell me that this issue has affected them in the private sector?

[Jackie Doyle-Price]

I give my hon. Friend that assurance. To be frank, the same standards of consent and regulation apply in the private sector as in the public sector. A number of colleagues mentioned issues in the private sector, but there is no excuse; it is equally regulated by the Care Quality Commission and the General Medical Council, so the same standards apply.

[Jo Stevens]

On that point about the loophole between the NHS and the private sector, and the relationship and liability of private surgeons operating at private hospitals, will the Minister see whether that loophole should be closed?

[Jackie Doyle-Price]

I am not sure that there is a loophole. Surgeons are required to demonstrate their clinical competence as part of their regular revalidation, whether they work in the private or the public sector. Concerned patients may contact the GMC, just as they would do in an NHS trust. In addition, surgeons will be inspected by the CQC and their procedure examined to ensure that it meets standards. I cannot see that there would be any difference, but if the hon. Lady would like to bring to me a specific example, I would be delighted to look into it for her.

Clinicians working in private hospitals are under the same ethical obligations to ensure that treatment is based on consent, that complications are addressed and that information is shared with regulators as appropriate. Private hospitals are subject to CQC registration and must abide by those fundamental standards.

I am very short of time, but I suspect that we will come back to this matter, particularly after the NICE guidelines are published later this year. The most important thing we can do is make sure that the women have access to the support that they need, and that GPs know what to look for in order to give them that support, and I am always open to hearing representations from colleagues on this issue.