Licensing of Medical Devices

Debate between Mark Tami and Owen Smith

Tuesday 12th February 2019 Commons Chamber

[Owen Smith (Pontypridd) (Lab)]

I rise to talk this evening about medical devices and the way in which they are licensed and regulated. They are a very important and growing part of medicine, and they can save and transform lives—indeed they have done for millions of patients over many generations. However, when faulty or poorly designed or poorly looked into and proven, they have also damaged, and indeed ended, the lives of many thousands of patients around the world. My principal point is that the regulatory system for medical devices in our country, and across Europe and arguably the wider world, is simply not fit for purpose and must be properly reformed.

The term “medical devices” is rather vague. It refers to everything from bandages to syringes through to heart pacemakers and artificial joints, and I want to be clear that what I am talking about is the more complex end of the spectrum: the more high-risk, class III as they are called, implantable devices.

[Mark Tami (Alyn and Deeside) (Lab)]

I want to put on record my thanks for all the work my hon. Friend has done on mesh. Does he agree that we must be careful that what might appear to be a relatively cheap quick fix can turn out to be a massive problem for a lot of patients?

[Owen Smith]

I thank my hon. Friend for his thanks, and I will talk about mesh shortly as it is illustrative of the wider problem.

The problem is best summed up not in my words but those of the Royal College of Surgeons, which said at the tail end of last year, in response to a big journalistic investigation, that we need to see in our country urgent and drastic regulatory reform and in particular that we need to start with the creation of a compulsory register for all new devices and implants that go into patients in the UK. Will the Minister commit to that?

Let me give a couple of examples of what I am talking about. Last year alone in the UK surgeons operated on patients for 80,000 knee joints, 60,000 hip replacements, 50,000 pacemakers and 7,000 usages of surgical vaginal mesh, down from its height in 2008 when there were 14,000 instances of surgical vaginal mesh inserted into women. Let me pause for a moment to talk about that example of vaginal mesh and why its use has declined so precipitously. The answer lies in what I am talking about—in the development and marketing, and the fact that, as with so many of these devices, their true safety and efficacy is only revealed in the real world once they have been implanted into patients, and sometimes after many years. Many of the variants of vaginal mesh, like most of the other devices now on the market, are developed without any real clinical trials, and certainly without the randomised controlled clinical trials we are familiar with in respect of medicines; that is an extraordinary fact. We understand why that is the case, but there are other ways in which the device manufacturers could ensure their devices were safer and definitely not going to harm patients.

Surgical Mesh

Debate between Mark Tami and Owen Smith

Thursday 19th April 2018 Commons Chamber

[Owen Smith]

Yes. The long and the short of it is that this has become such a widespread problem because younger women, in particular, were told by their doctor that there was a quick and easy way in which a minor inconvenience for many women—although a major inconvenience for some—could be dealt with.

Clearly, the scale of the side-effects was not apparent, for all the reasons my hon. Friend the Member for Kingston upon Hull West and Hessle listed, but notably because there is no long-term trials data in respect of devices. The sorts of complications that we now see emerge over a long period. That is why, in our country and across the world, such widespread concern about mesh has been emerging in every health market.

[Mark Tami]

My hon. Friend mentioned removal of mesh. Does he agree that there should have been a lot more research about how easy it is to remove, because it is actually very difficult and only a few surgeons will undertake that work?

[Owen Smith]

My hon. Friend is right. The whole point of mesh is that it is designed to induce scar tissue in order to fuse the mesh with the muscle, and therefore trying to excise the mesh is incredibly difficult. That is why there are partial removals and some women are left with pieces of mesh inside them, even after surgery. Those sorts of complications are clearly very worrying. They ought to have been explained properly to women, but obviously were not, in very many cases.