Debate will hear how more than 1,000 patients have died and 20,000 suffer serious consequences from medical implants
PUBLISHED: 13:55 12 February 2019 | UPDATED: 14:29 12 February 2019
Weak medical device regulation has cost more than 1,000 people their lives in three years and left thousands suffering agonising pain, prompting a call for radical reform into how implants are approved.
Scandals involving surgical mesh, defective pacemakers, faulty artificial hips and harmful breast implants, have shone a spotlight on failings in device licensing, says MP Owen Smith.
Worse, patients may not even be`protected after Brexit, he said.
Tonight, he leads a debate in the House of Commons for radical reform of the rules regulating licensing and marketing of implants.
Owen Smith, MP for Pontypridd, and chairman of the All Party Parliamentary Group on Mesh, said: “More and more patients are undergoing surgery involving innovative, implantable devices, the vast majority of which can transform and save lives.
“However, a number of recent problems involving medical devices have called into serious question the way in which they have historically been tested, approved and marketed to patients and doctors.
“Medical devices cannot, of course, be tested against placebo in randomised control trials, as is the case with medicines, but current checks on the safety and efficacy of these devices are far too weak, with many simply having to prove on paper that their effect and design is equivalent to earlier and similar devices.
“This has led, for example in the case of surgical mesh, to such follow-on devices being made of completely different, inappropriate and even toxic materials, compared to the original licensed device.
“The weaknesses in the current testing regime has led to changes at the European level, 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.
“The MHRA must now set out robust regulations, starting with tougher device licensing and the introduction of a national registry to monitor all devices through a publicly available national database.”
A Guardian investigation in November 2018 revealed that in the UK, 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.
The investigation showed examples of failure in the devices market including replacement hips and vaginal mesh products sold to hospitals without any clinical trials.
It also highlighted patients relying on faulty pacemakers when manufacturers were aware of problems, and regulators approving spinal disc replacements that later disintegrated and migrated in patients.
These scandals have led to calls for tightening of the regulations globally. The EU has responded by introducing a new Directive for Medical Devices which is due to come in to effect next year.
Owen said: “Brexit will, of course, place the UK outside the scope of this new Directive and it remains how the UK Government and Regulators intends to ensure our patients are similarly safeguarded with a tougher licensing and monitoring regime.”
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