Surgical Mesh Implants

Sarah Wollaston Excerpts

Wednesday 18th October 2017 Westminster Hall

[Dr Sarah Wollaston (Totnes) (Con)]

I congratulate the hon. Member for Kingston upon Hull West and Hessle (Emma Hardy) on securing this important debate. In the brief time available, I would like to touch on the issues of how we allowed this situation to continue to for so long, consent, clinical quality and governance, including in the private sector, and what we should be doing going forward.

First, I pay tribute to the many women who have been courageous in coming forward and discussing intensely painful and personal experiences, not only with myself but with other Members. I would like to quote one, who said:

“I am in so much pain at times that I just give up on the day…The pain never goes, it just varies in intensity.”

We have heard numerous examples of how these devices are deeply impacting on people’s lives with life-changing symptoms. In many cases, those symptoms were not life-changing before the procedure. Many women have delayed symptoms or were unaware that they had these devices inserted in the first place. Women have told me that they did not consent to these devices being inserted and were not informed of the risks. A fundamental principle of consent is that unless the consent is informed, it is not consent at all.

It is very difficult for women to be properly advised of the complications when we have such poor data, and that goes to the heart of the scandal. The clinical trials of these products were inadequate. We know now that variations in the type of mesh lead to a greater or lesser risk of complications in the first place, yet these products were varied and introduced and marketed aggressively without adequate clinical trials, and that is why there has been such a long delay before action has finally been taken. I hope the Minister will address that in her remarks, because if clinical trials are not a fundamental condition for the introduction of new devices, we will see this situation with other devices.

Another concern is the way that such procedures are used. We saw variation in the techniques with which these devices were introduced. We must have an absolute guarantee that there will be proper clinical trials, just as we would expect for the introduction of medicines.

[Chris Ruane (Vale of Clwyd) (Lab)]

Does the hon. Lady agree that if the companies failed to introduce proper clinical trials at the outset, they should now be queueing up to ask these women to come forward so that they can look at the specific cases where the devices have failed? They should be begging these women to come forward.

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[Dr Wollaston]

The hon. Gentleman raises an important point, but many women were not even informed that they had the devices in the first place. Other Members have touched on the fact that because the complications can be late in arising and because of the inadequacy of recording, it is very difficult for women to come forward.

In the brief time available, I would like to mention the yellow card scheme—I will add links on my social media later—which enables women to self-report complications. However, if someone does not know they have had the device fitted they will not report those complications. There is work to raise awareness among GPs of the possibility that symptoms that women present with are related to mesh, to ensure that those women are referred. I welcome the specialist centres that have been set up to treat women who have been so adversely affected by mesh, but if mesh is inserted in the first place, it should absolutely be done in specialist centres.

I do not agree that we should ban mesh, because for some women the symptoms of stress urinary incontinence or prolapse can be life-altering. We should retain it as an option where alternative procedures may create worse outcomes or worse complications, but there must be adequate consultation with women about the risks so that they can weigh them up. I agree with Members who have said they hope that NICE can prioritise the development of more detailed guidance, so that we may have it as soon as possible.

A fundamental absence of data is at the heart of the issue. There has been cavalier practice, and we cannot allow that to continue. The women who have been affected deserve an apology and recognition of the extent of the problem and the delays in recognising and dealing with it. I welcome the findings of the mesh oversight group report, which describes pragmatic and practical recommendations, but clear failings have been allowed to continue for so long. At the heart of those failings is the inadequacy of clinical trials, recording and consent. Finally, we know that the devices are regulated by the European Union. I hope the Minister will comment on how the Government propose to take this issue forward after we leave the European Union. At the heart of it is the need to ensure that the safety of women is prioritised at all times.

[Albert Owen (in the Chair)]

I thank the Chair of the Health Committee.

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[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.