Medicines and Medical Devices Safety Review

Lord Hunt of Kings Heath Excerpts

Thursday 22nd February 2018 Lords Chamber

[Lord Hunt of Kings Heath (Lab)]

My Lords, I thank the Minister for repeating the Statement. I should also like to thank him personally for meeting representatives from the mesh campaign group two weeks ago, which is much appreciated.

Today’s announcement is an acknowledgement that there are major issues which go back decades in areas that concern safety and a lack of proper scrutiny and research. We have heard how mesh implants have left women in permanent pain, unable to walk and unable to work. Welcome as the Statement is, the Government need to do much more to support those affected. Mesh has been suspended in Scotland and banned in other countries. The most recent interventional procedure advice from NICE on prolapses states that it should be used only for research purposes and not as a front-line treatment, but I ask the Minister whether he thinks we need to go further and suspend the use of mesh until NICE has completed its review into the safety and efficacy of the product. If the Government are not prepared to go as far as suspension, will he at least write to all trusts and indeed private hospitals to remind them that the Health and Social Care Act 2015 requires them not to cause avoidable harm? The review in itself signals that mesh is now acknowledged to cause harm.

I refer the Minister to Owen Smith’s comments in the other place; he chairs the All-Party Group on Surgical Mesh Implants. He said that:

“Lessons must be learned from the awful complications many women have experienced since undergoing mesh surgery and proper processes must be put in place to stop this happening in the future … The mesh scandal shows what can go wrong when devices are aggressively marketed to doctors and then used in patients for whom they were unsuited or unnecessary”.


Will the review chaired by the noble Baroness, Lady Cumberlege, look into that particular aspect?

The Minister mentioned in the Statement the investment of £1.1 million, part of which will go to improving clinical practice. Clearly, one should always seek to improve clinical practice, but mesh campaigners would say that the real issue is not the clinical practice but the product itself, which is not fit for purpose.

The retrospective audit is very welcome indeed, but there is a real question about whether it will capture all the women affected. I have certainly received evidence to suggest that some women suffering greatly from mesh implants are not aware of the reasons and therefore do not approach the health service. Will the Minister also say whether the mesh audit concerns only hospital statistics and records or whether it will cover GPs and primary care as well? Also, will the review extend to when men and women are affected by hernia mesh?

The Secretary of State has said that the review will not go into the science of mesh. But most studies do not use quality-of-life questionnaires, so they do not pick up the devastation of pain, lost sex lives or constant urinary infections. Studies concentrate on whether the mesh has cured the problem of prolapse or incontinence. Many studies are short-term or compare mesh to mesh. Trials should compare mesh to the old-fashioned natural tissue repair to get a proper evaluation of whether the use of these products should be continued in the future. Many trials have low numbers and any woman who has had a mesh implant can feel like a ticking time bomb, as the product can shrink or twist years down the line. No amount of surgeon training can counteract that.

Will the review extend to those with mesh bowel prolapses? Will it also look at what help the NHS needs to give to people currently affected as mesh sufferers? Obviously each country in the UK is taking a slightly different approach but, in his role as the Minister responsible, will he work with Scotland, Wales and Northern Ireland to pull together research and co-ordinated action, which would make great sense?

I hope that the noble Baroness, Lady Cumberlege, will be asked to look at whether device regulation needs to be tightened up. As the Minister knows, it is much less stringent than medicines regulation and there has been an ongoing debate about that. I hope that that will be included within her review.

On Primodos, the Minister indicated that the department would drive forward and accept the recommendations of the expert working group. But in the other place when the report was published in October, it was met with concern from all sides of the House. I hope that he will take that into account.

I am grateful that the Secretary of State has included sodium valproate in this work. The Minister will know that last year a charity found that almost one-fifth of women taking the drug still did not know the risks that this medicine could pose during pregnancy. I therefore welcome government efforts to raise awareness of the dangers of valproate. I also hope that the House can be offered an assurance that the review will gain access to medicine regulation files held in national archives, access to any valuable evidence cited in unsuccessful legal actions and access to documents and information held by pharmaceutical companies, and that all such material will be made public.

I ask the Minister to invite the noble Baroness, Lady Cumberlege, to meet victims to see whether consensus can be agreed on the terms of reference, to maintain trust and confidence in it. That would be a very valuable first step to gaining the confidence of campaigners who have worked so hard and have been gratefully acknowledged by the Secretary of State in his Statement.

[Baroness Brinton (LD)]

From the Liberal Democrat Benches, I am very grateful and thank the Minister for the Statement. I am particularly pleased about its tone, which moves on the Government’s debate with campaigners, families and clinicians about these very serious issues. It makes a break with the past.

I am particularly concerned that there should be regular assessments and updates for people with problems from Primodos and sodium valproate, because we know from our experience with thalidomide that everybody thought that everything had been sorted from the initial diagnosis of the children, but as they entered adulthood and more mature years further medical issues appeared. It will be important to recognise that we need to make sure these young people—and adults as they are now—get that protection.

The yellow card system was not available in its current format for these two drugs. One of the things that concerns me most about the Statement is the assumption that the only people involved with the yellow card are clinicians. Speaking as a patient who has been on a drug that has very serious yellow card incidents, I have been trained to recognise that if I get a side-effect I do not just go back to my hospital; I report it to the pharma company. The pharma companies are notable by their absence in this Statement. Will there be specific links back for clinicians and patients on some of the side-effects of drugs? That is easy to say for those who are formally expert patients. I absolutely accept the point made by the noble Lord, Lord Hunt, that some patients are inexpert for all the right reasons.

There needs to be a real focus on all the other health professionals that these patients come into contact with. Reporting a yellow card incident to a GP when it is very difficult to see your own GP these days means that it could quite often be missed. In the case of sodium valproate this certainly needs to include midwives and people involved in the obs and gynae departments as well. What training is to be provided for these non-specialist healthcare people to make sure that they understand, when a patient talks about a problem, that this may need to trigger a yellow card response? To that end, I welcome the proposal for an electronic yellow card. That will be extremely helpful. Printing out a yellow card, filling it in and sending it in is an absolute deterrent to it happening.

On Primodos and sodium valproate, will the longer-term effects also be covered by the Cumberlege review? It is important to have a reference back there. I am also concerned about the vaginal mesh issues, specifically those reported in the Statement. It would be useful to know what percentage of those who have had vaginal mesh implants have faced problems. It is fine to say that many have benefited. I completely accept that, but one needs to understand what the ratio is between those facing problems and those for whom it has benefited them, to understand whether a ban should be in place. What is the date for publishing the retrospective audit? It is fine to say that it will be done. I have no idea how far along the line the process is. Then there is the timescale for creating that computer database for vaginal mesh to improve clinical practice. When will it be not just commissioned, but completed and used in analysis? Will interim reports go to the noble Baroness, Lady Cumberlege, by the people doing this review if evidence emerges that she will need to take account of?

I am concerned about the idea of the creation of a patients’ champion. We already have panels and expert groups. Yet another person that patients may or may not know about, and may or may not be able to turn to, seems problematic. I urge the noble Baroness, Lady Cumberlege, to look at what is available now rather than creating yet another body.

Finally, I echo the concerns expressed by the noble Lord, Lord Hunt, about whether we should move to a public inquiry at this stage. I wonder whether the evidence that the noble Baroness, Lady Cumberlege, will undoubtedly turn up means that she may come back to Ministers and say, “Actually, this is the point at which this needs to go public”. Campaigners have highlighted for years that there are problems.