Licensing of Medical Devices

Debate between Ann Clwyd and Owen Smith

Tuesday 12th February 2019 Commons Chamber

[Owen Smith]

Yes, I absolutely agree. There are many instances of similar mis-selling of these products to women. We need to examine the relationship between the doctors who are selling or marketing these products to their patients and the companies that develop them. Some have an interest in those companies, and others are getting a money benefit through doing this in the private sector. All these things desperately need to be looked at.

The terrible truth is that the surgical mesh scandal that is unfolding is just one of the scandals relating to medical devices. We had the metal-on-metal hip joint scandal, with metallosis poisoning people’s bodies. We had the scandal of textured PIP breast implants poisoning women’s bodies. Those implants are now connected with increased incidences of cancer. We had spine-straightening devices for children that were only ever tested on corpses. We had pacemakers such as the Nanostim, which was designed to sit inside the heart and work for up to 19 years. It has now been removed from the market because the batteries started to break down and cease to work and, worse, it was giving people electric shocks. The devices are now being cut out of people. Between 2015 and 2018, UK regulators alone received reports of 64,000 adverse events involving medical devices. A third of those incidents resulted in serious medical repercussions for patients, and 1,004 resulted in death.

[Ann Clwyd (Cynon Valley) (Lab)]

I would like to pay tribute to the tremendous work that my hon. Friend has done on mesh. Quite a number of people in my constituency have suffered as a result of the use of mesh, and they are extremely grateful for the work that he has been doing. About 20 years ago, we had the scandal of silicone implants, and someone in my constituency had a double mastectomy because the silicone had leaked inside her body. These problems are still happening. We set up a register, but suddenly the register disappeared. I am glad that my hon. Friend has made a point about the register and asked for the Minister’s commitment on this.

[Owen Smith]

I am grateful to my right hon. Friend for her kind words. She is completely right to say that there are devices on the market here and across the world that are still causing grave medical problems for patients. The question we have to ask is: how did these things get on to the market in the first place? How have we got so many of these devices that are causing such significant problems? The common problem that unites mesh with all the other device scandals in our country and across the globe is the weakness of the regulatory system in the UK, in the EU and, to a lesser extent, in America, where the pathway for testing approval, marketing and surveillance of such devices just is not good enough.

How does the system work? It will shock people to hear that we do not have a central body that is responsible for checking out, authorising and licensing devices in the same way as for medicines. If a company in the UK wants to create a new prosthetic hip joint, it does so and then it shops around among a group of what are called notified bodies. These are effectively commercial organisations that are in turn licensed by the MHRA to be a body that checks safety and efficacy through the clinical data provided by the companies and then gives them their conformité Européenne—their EU kitemark. Once a company has received that mark, the device can be sold all across the EU.

Companies do not need clinical trial data in order to substantiate their claims that devices are efficacious and safe. Quite often—this is true of a remarkable proportion of the devices on the market—they do not even have to undertake first-hand clinical evaluations themselves and can rely on being follow-on products that go through a regulatory pathway that is termed as being “substantially equivalent” to the products that have gone before. For instance, there are examples of mesh on the market now that are the 61st iteration of an original licensed mesh that is no longer on the market because it was proven to be dangerous. There is no real mandatory post-marketing surveillance of these devices.

Given that the difficulty of randomised control trials versus placebo for a device—someone cannot put a wooden heart into one patient and a pacemaker into another in order to see which one works—means that there will be a degree of risk in testing such things in the real world, one would think that we would have a system that would test how devices are doing in the real world and get companies or the Government to monitor them, but we do not, which is in stark contrast to the regime for medicines. Changes are coming into effect, however. A new medical devices regulation was launched across the EU in 2017 and will come into effect in May 2020. It was introduced with the acknowledgement of many of the problems that I have highlighted.