Medical Implants (EU and UK)

Debate between Andrew Miller and John Pugh

Wednesday 6th March 2013 Commons Chamber

[John Pugh]

I certainly cannot. There are occasions when we talk about general topics, but I think that I am right in saying that the reasons we have estimates days is so that Parliament, as well as the Treasury, can scrutinise the nation’s accounts. I regard that as highly desirable in this age of austerity, when we need to count every penny and record the overspend, underspend, virement and so on.

I will now turn to the subject that appears to be the subject of this debate but is not actually on the Order Paper: medical devices and implants. I would like to make a few observations on what the hon. Member for Ellesmere Port and Neston (Andrew Miller) calls post-market surveillance, which we agree needs to be improved. That is obviously wholly desirable because it will eliminate problems, improve patient security and so on. I would not disagree with a single word voiced by him or his Committee. I agree that there should be more transparency and more feedback from patients and clinicians so that devices are safe and do exactly what they are supposed to do. However, we can improve regulatory vigilance. The MHRA has done a good job so far, but it obviously could do better. There is clearly a role for increased manufacturer responsibility. That is all very important.

The simple point I want to make about implants—I am not allowed to talk about the huge sums of money we are voting through—is that detecting failings is quite a complex matter. It is not as simple as it was with the breast implants, which was a case of the wrong substance being provided, which is fraud. I will illustrate my point with a real-life example. I am familiar with a case in Nottingham involving a number of unfortunate episodes that followed heart surgery in which a particular type and brand of stent was used. A number of people were called back for second operations because the stents leaked. I believe that there were a number of deaths and some litigation. Initially it was thought that the device was at fault, because it looked as though the people who had the device experienced certain problems and complications, and there had been other problems with it elsewhere. It was subject to a court case and prolonged investigation. Ultimately, the blame was attributed—this bears out the point made by my hon. Friend the Member for Truro and Falmouth (Sarah Newton)—to the surgical procedure, rather than to the device itself.

Therefore, there is a particular problem when it comes to post-market surveillance. Is it the equipment or how it is used that is responsible, because the equipment is only as good as its user? That is a particular issue in surgery, because surgeons up and down the land are very particular about what bits of kit they use and what type of equipment they work with.

[Andrew Miller]

The hon. Gentleman is making a perfect case for a proper registry. If a proper registry were maintained, one would be able to see whether the patterns of failure related to a location, which would mean it was a surgical failure, or a particular type or brand of product. He is underlining one of the Committee’s key recommendations.

[John Pugh]

I am grateful to the hon. Gentleman and pay tribute to his Committee for the work it has done. My simple point is that post-market surveillance is complex, because devices need to be judged alongside the patient experience and the clinician experience, and that gets more complex and difficult if the market for a particular device is relatively small. In the Nottingham case, the patients could not get fully informed feedback because it was neither in the manufacturer’s nor the surgeon’s interest to incriminate themselves. There was the added problem, as there is often is, that the manufacturer was in a different country from the user of the device. That is partly why products that have been found over time to be faulty in one country can still be used in another country because its regulatory body has not picked up on the problem.

This is not an easy matter, and I applaud the Committee’s efforts to get things right. I am slightly disappointed that we cannot have a wider debate on the nation’s finances. I hope that the Minister will explain what the £1.2 billion of expenditure that we are agreeing is all about, because that will be a blessing to the House.