To ask Her Majesty’s Government whether they intend to review the safety of the use of pelvic mesh implants.
My Lords, NHS England’s mesh working group report outlined recommendations to optimise care when surgical mesh is used to treat stress urinary incontinence and pelvic organ prolapse. We continue to implement those recommendations. NICE has now published eight pieces of updated interventional procedure guidance related to vaginal mesh. Updated clinical guidance covering urinary incontinence and mesh will be published in February 2019. The MHRA continues to review available evidence to make sure that our regulatory position is up to date, liaising with EU and non-EU partners.
My Lords, I thank the Minister for his personal involvement in the decision to conduct a retrospective audit into vaginal mesh surgery, but will he go a little further? He will be aware that an increasing number of women have reported suffering from complications that include debilitating pain, infection, inflammation, the loss of sex life and mobility issues. A number of countries have now banned the use of mesh implants completely. On the precautionary principle, will he suspend the use of mesh until the audit that he has announced has been completed and new guidelines issued by NICE?
I am grateful to the noble Lord for raising this issue, because there is certainly a complication rate. I know that a lot of women are suffering as a result of complications from this procedure. As he will know, we have asked the MHRA, NICE and NHS England to have a look at the correct use of this kind of mesh. They have all concluded that they do not support a complete ban. They propose a range of restrictions on usage. Indeed, the most recent interventional procedure from NICE on prolapse said that it should be used only for research purposes and not as a front-line treatment. However, I am aware that Australia and New Zealand are implementing bans for particular usage. I have asked NICE and MHRA to investigate why they have done that and to report to me urgently so that I can see the grounds for the ban. We have different regulatory systems, but I want to know what is happening there.
My Lords, will my noble friend explain to the House what the alternative might be if pelvic mesh implants were to be stopped? Is it not appropriate to be absolutely sure that any alternative is fool-proof and that there are no consequences?
My noble friend makes an excellent point. This is one procedure, and for some women it can be positive and life-enhancing. But we also know that it carries a risk of complications. That is one reason why we wanted to carry out the audit, because it will look not only at areas and procedures where there have been problems and complications but where it has been successful, so that we can have a proper understanding of what the complication rate is and therefore what the safety concerns are.
“Evidence of long-term efficacy is inadequate in quality and quantity. Therefore, this procedure should only be used in the context of research”,
as he said. But will he tell the House how confident we can now be that that is the case and that the information has been effectively disseminated? What is the mechanism for informing clinicians and women about this NICE guidance?
The noble Baroness is quite right to say that it is not just about having the guidelines but making sure that clinicians follow them. Professional standards demand that clinicians do follow them, and indeed a clinician would need to be strongly justified in using mesh implants outside of the guidelines. They include things like gaining consent, providing information and registering operations that have been carried out. The guidelines are very strict and we expect clinicians to follow them.
My Lords, does the noble Lord agree that, while we cannot be sure why New Zealand and Australia have suddenly announced total bans on the use of mesh implants, the evidence suggests that of the 20% of women who suffer from complications, most of them had been treated for pelvic floor prolapse, not stress incontinence? Banning their use completely at this stage for women with certain conditions who may benefit from them would, without further evidence, be completely wrong.
The noble Lord speaks with great experience. Obviously, a number of procedures are involved, and NICE is now looking at extra procedures to provide the guidance. It does look like it is not the right thing to do in cases of prolapse, but it can be a very successful course of treatment for other conditions. It is important to take a differentiated approach.
My Lords, does the Minister share with me a sense of puzzlement that this subject was brought to the House in the first place? I find it very odd given that we have royal colleges and NICE with people to assess the efficacy of particular treatments. Many treatments, both medical and surgical, carry a risk of complications. Are they all going to be brought to the House of Lords for discussion?
Our job in this House is to scrutinise the decisions that are made in our publicly funded health services. I think that it is absolutely right that we do scrutinise these issues and make sure that the care being provided in this country adheres to the highest and safest standards.