Licensing of Medical Devices

Paul Sweeney Excerpts

Tuesday 12th February 2019 Commons Chamber

[Owen Smith]

The hon. Gentleman, who has also done excellent work on mesh as co-chair of the group, is completely right.

Our regulatory system for these devices, including mesh, is more akin to the system that applies to toasters or plugs, and the way in which they get kitemarks, than to the way in which medicines are approved. It is so problematic that, last year, the journalist I was talking about applied to get a kitemark—known as a CE mark—for surgical mesh. However, the item in question was a bag that had previously been used to keep oranges in, but they still succeeded in getting a CE mark for it. It obviously was not put into a woman, but real mesh has been and is being put into thousands of women all over the world, including those suffering from organ prolapse and stress urinary incontinence. The real impact of the mesh has been revealed in the chronic pain, disability and even death suffered by many women as a result of the mesh warping, breaking, morphing, changing its constitution and cutting into organs inside the body. This was revealed only after years of sales.

[Mr Paul Sweeney (Glasgow North East) (Lab/Co-op)]

My hon. Friend is making a powerful speech about the devastating impact that mesh has had on women. I discovered the real impact of it when a constituent came to visit me on Friday. Wendy talked about the impact that it had had on her life. She said that she had been concerned about the mesh and had discussed it with her surgeon, who had insisted that it was not mesh but tape. She was therefore misled by a medical professional. Does my hon. Friend agree that that is another worrying aspect of how these medical devices are being marketed and communicated to patients?

[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.