Safety of Medicines and Medical Devices

Lord Hunt of Kings Heath Excerpts

Thursday 28th February 2019 Lords Chamber

[Lord Hunt of Kings Heath (Lab)]

My Lords, I am very grateful to the noble Lord, Lord O’Shaughnessy, for initiating this debate. I remind the House of my health interests as set out in the register, specifically my membership of the GMC and presidency of GS1 UK and the Health Care Supplies Association.

The noble Lord has focused on the review of the noble Baroness, Lady Cumberlege. I will concentrate on surgical mesh, but I recognise that the review has a much wider significance, assessing the actions of relevant authorities over the years when safety concerns have been raised. On surgical mesh, what is so striking is how long it has taken to get any action. The excellent campaign group Sling The Mesh, led by Kath Sansom, has fought a sustained campaign to draw attention to the problems that we have heard about, with many women left in permanent pain, unable to walk or work and feeling totally neglected by the National Health Service.

Not only have these problems been known about for years, they have been recognised in a series of official reviews. As far back as 2012, the Department of Health reported that, while surgery for stress urinary incontinence and pelvic organ prolapse using mesh can be effective for most women, a small percentage will suffer significant side-effects. The department established a working group between 2014 and 2017—for three years—that came to no hard conclusions at all. At the time of the publication of the final report, the MHRA said that it was committed to addressing the serious concerns of patients, but that it was not aware of a robust body of evidence that would lead to the conclusion that mesh was unsafe if used as intended.

In a Statement that the noble Lord repeated to the House in February last year, he referred to advice from the Chief Medical Officer that experts here and abroad had said that, when the treatment is used appropriately,

“many women gain benefit from this intervention, hence a full ban is not the right answer in the light of the current evidence available”.—[Official Report, Commons, 21/2/18; col.164.]

Even after the early findings of the noble Baroness, Lady Cumberlege, the Government instituted a pause, but significantly not a ban, on the use of vaginally inserted mesh to treat prolapse, and on the use of tape or slings to treat stress urinary incontinence.

So we have had a series of reviews. All have recognised the problem, although there is disagreement about its scale. However, they have all tended to recognise the benefits of the procedures and have resisted the ban called for by campaigners. This ambivalent approach has been very frustrating, and I wonder whether the ambivalence lies behind the very poor way in which the NHS has treated those women for whom mesh has been a total disaster. They feel abandoned by the National Health Service and, frankly, the service seems to be in denial about the problem. There are no support mechanisms and precious few opportunities to have the operations reversed—nowhere near the kind of approach that the noble Lord, Lord O’Shaughnessy, has called for today.

This continues. I do not know whether noble Lords have looked at the draft consultation by NICE that it has yet to finalise. I was struck in particular by section 1.10, entitled “Managing Complications Associated with Mesh Surgery”. It states that the decision to remove mesh for any indication needs to be made in the context of an explanation to women that such surgery may not relieve symptoms and may have significant complications, including organ injury, worsening pain, and urinary, bowel and sexual dysfunction. So this leaves a woman damaged by having mesh inserted with little prospect of amelioration at all.

I received an email this morning from a woman member of Sling The Mesh. She is currently in Germany for a non-mesh hernia repair, following two removals of an incontinence mesh. Why did she have to go abroad and pay for it herself, and why is the NHS so hopelessly inadequate in dealing with the issue?

The issue is not confined to vaginal mesh. Last week I met a senior lawyer in Birmingham who spoke to me about his experiences following a hernia mesh implant in 2011 that left him in constant pain. Before the mesh implant operation, he was very active and ran half-marathons. Now, sadly, because of his pain, his mobility has been greatly reduced and he struggles to sit at his desk for any significant time. His life has changed for the worse. Again, the response from the NHS has been wholly inadequate.

I am uncertain whether the problems are caused by poor diagnosis and poor clinical performance, or whether a certain percentage of patients can expect to suffer harm from the intervention. Alongside the challenge the noble Lord raised about the balance between risk, safety and innovation, this raises moral and ethical questions as much as regulatory ones. The question is whether it is right that these operations should continue when we know that, on one hand, many patients will benefit, and on the other, it seems inescapable at the moment that a number of women will suffer. There is disagreement about the percentage but some campaigners think that it is as high as 10%. If this was a medicine, of course it would not receive approval, based on that balance between risk and benefit. However, a device is different, and the regulatory system approaches it in a different way.

I do not know the answer to that—I hope the noble Baroness, Lady Cumberlege, does. I echo what the noble Lord, Lord O’Shaughnessy, said. It would be a great pity if the Government did not listen very strongly to what she has to say, and I hope that they will consider her recommendations in full. I also hope that she will say something about the need to develop a system of safety culture in the health service. This goes much wider than surgical mesh or the issues that she is looking at for the review. As Ken Lownds, a safety expert, put it to me, our approach to safety compared to other safety-critical sectors has the feel of a cottage industry. That has to change, and I hope that the noble Baroness’s review and this debate will be a catalyst for that.