Licensing of Medical Devices

Paul Masterton Excerpts

Tuesday 12th February 2019 Commons Chamber

[Paul Masterton (East Renfrewshire) (Con)]

I pay tribute to the hon. Gentleman for the work he does as chair of the all-party group on surgical mesh implants. He will be aware that when the Medicines and Healthcare Products Regulatory Agency appeared before the Public Petitions Committee in the Scottish Parliament it admitted that its verification process for use of mesh implants amounted effectively to a two-week desktop exercise carried out by three people at a cost of £20,000. Does he agree that that example fundamentally shows that the way the MHRA is reviewing these devices is not fit for purpose, is completely inadequate and, as we know from the work of the APPG, puts patients, and in the case of mesh implants lots of women across the UK, at risk?

[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.