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Sun, 5 April 2020

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Vaginal mesh is only one of many medical device scandals and our regulatory system is to blame

Vaginal mesh is only one of many medical device scandals and our regulatory system is to blame
4 min read

Owen Smith MP writes for PoliticsHome, calling for an end to the prioritisation of commercial interests over patient safety in the regulation of medical devices.

This week, I led a debate in the House of Commons calling for reform of the licensing and regulation of our medical devices.

Medical devices are an important and growing part of medicine, they have saved and transformed the lives of millions of patients over many generations. However, when faulty or poorly designed, they have also damaged and ended the lives of many thousands of patients around the world.

The term “medical devices” refers to everything from bandages to syringes through to heart pacemakers and artificial joints. My concern is that more high-risk, implantable devices are developed without any real clinical trials, and without the randomised controlled clinical trials we are familiar with in respect of medicines.

The regulatory system for medical devices in our country, and across the wider world, is simply not fit for purpose and must be properly reformed.

Here in the UK, a recent investigation revealed the Medicines and Healthcare Products Regulatory Agency (MHRA) received 62,000 “adverse incident” reports linked to medical devices between 2015 and 2018. A third of the incidents had serious repercussions for patients and 1,004 resulted in death.

I was first alerted to the issues in our regulatory system of medical devices when I began campaigning on surgical mesh implants several years ago. Thousands of women have suffered devastating complications following mesh surgery which is implanted to treat stress urinary incontinence and prolapse.

Many of the variants of mesh, like most of the other devices now on the market, are developed and marketed with scant clinical data, and with no real certainty of how they might perform once implanted into patients.

Last year, just days after a government-ordered review began taking evidence from women affected by mesh injury, its Chair called for the immediate suspension of mesh procedures. She was obviously left in no doubt – as those of us who have listened to women injured by mesh are in no doubt – that the risks far outweigh any benefits.

The vaginal mesh story is a medical scandal that is only beginning to unfold in court-rooms and in women’s lives around the world. But the terrible truth is that it is just one of many such scandals, with metal on metal hips, PIP breast implants and faulty pacemakers just some of the more infamous recent examples.

How did these things get onto the market? Devices which leak into the body and poison people, devices which migrate or break or transform within the body, devices which are meant to cure but sometimes kill.

Well, the common story here that unites mesh with these other device scandals is the is the weakness of our UK and European Regulatory system for such devices. It’s a system more akin to that which applies to toasters or plugs, and gives them their kitemarks, than to the way in which medicines are approved.

New EU directives on device regulation come into force next year, launched with an acknowledgment that previous regulations were not fit for purpose, were less stringent than those in the United States, and need to be significantly reformed. But even prior to their introduction the new rules have been subject to significant criticism as being insufficiently robust and too favourable to the companies involved. Here in the UK, we face the prospect of not even being protected by the new regulations after Brexit and this poses real questions as to how our regulators are going to respond.

I’m glad that during the debate, the Health Minister acknowledged that commercial interests have been historically prioritised over patient safety in the regulation of medical devices, but the Government needs to go further by toughening up the licensing process and committing to a national registry of all devices to protect patients.



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