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Bionic Blunders: The Great Implant Scandal

Following revelations by leading media organisations across the world into defective medical implants being used on patients, head of the product safety and consumer law team and medical devices expert, Boz Michalowska and solicitor Sarah Moore, discuss the emerging global scandal.

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Boz (pictured) is head of the product safety and consumer law team and has specific expertise relating to defective medical devices. Sarah is a solicitor on the team and has successfully represented clients seeking compensation for historic Thalidomide injuries and played a key role in the DePuy Pinnacle Metal on Metal Hip Group Litigation.
An investigation by BBC Panorama, which has been working with the International Consortium of Investigative Journalists and 58 media organisations around the world including The Guardian newspaper and the British Medical Journal, has exposed the extensive usage in the UK and many other countries of unsafe and inadequately tested implantable medical devices.

These devices are wide-ranging in purpose, cost and function, ranging from, cosmetic breast implants, through to implantable female sterilisation devices – such as Essure, to cardiac pacemakers – such as the Nanostim Leadless pacemaker.

These devices are implanted not only to improve quality of life and healthcare outcomes, but also, in the case of pacemakers, perform critical life-sustaining functions.

Needless to say, when these products go wrong, the consequences for patients are extremely serious. By virtue of the implantable nature of such medical devices, the so called ‘bionic’ synthesis between device and patient, a defectively functioning device can cause local or systemic health problems and it can be very difficult to effect correction, removal and/or replacement, without causing further harm to the patient.

For that reason, most people would presume that implanted medical devices are rigorously tested, both in the laboratory and through small-scale clinical trials in which patients are fully consented, prior to being released within the UK market for use within the NHS.

However, these fresh revelations, due to be broadcast in a BBC Panorama programme tomorrow evening, will call that presumption into question – raising concerns about the way in which medical devices, specifically implantable devices, are regulated in the UK in terms of pre-marketing clinical testing and post-marketing surveillance.

Over the past 10 years, the medical device team at Leigh Day have undertaken extensive work in relation to defective medical devices, assisting hundreds of claimants who have suffered personal injuries and other losses as a result of their implantation with defective devices. They have included patients implanted with a wide range of defective medical devices, from cardiac pacemakers, to breast implants, and metal-on-metal hips and other skeletal implants including spinal discs and spinal rods.

In all cases, we are dealing with individuals who have suffered often devastating and life changing injuries as a result of implantable devices that have not only failed to perform their intended function but have caused additional harms to the patient as a result of that failure.

This investigation shines a spotlight on the fact that whilst these failing medical devices are wide-ranging, in nature and function, a common reason for their failure is inadequate pre-market testing by the manufacturers who race to get these devices to market.

The problem is that if products are not properly tested before they go to market – then patients who are implanted with these devices, becoming the unknowing guinea-pigs for profit-making manufacturers.

Through our work on the Independent Medicies and Medical Devices Safety Review (IMMDS review) and in representing those injured by defective devices we continue to push the Government to impose more exacting pre-market testing requirements on manufacturers and to improve access to justice for patients when things do go wrong.

The results of this investigation should be a source of shame for the UK Government and its regulatory bodies – the lack of regulation around medical devices will only be improved when there is real political will to protect patients in the UK.

The team at Leigh Day are currently investigating concerns regarding a range of implantable medical devices including:

MAGEC spinal rods, produced by NuVasive:

These devices, are intended to treat children with spinal scoliosis. The system comprises an implantable adjustable growing rod, made of titanium, and an external remote controller. The device utilises a novel magnetic system which allows surgeons to manipulate and extend the spinal rod in situ, without the need for repeated surgeries. In theory this means that paediatric patients can have spinal rods extended, as they grow, without the need for repeated surgeries. However, earlier this year researchers at Newcastle University, have published concerns regarding the high levels of metal debris that are released by the MAGEC spinal rods as they are manipulated, which is known to cause local and potentially systemic tissue and muscle damage:

A novel stent grafting system produced by Nellix:

These stents were highly novel and were intended to reduce morbidity and mortality in the proactive management of aortic aneurysms. Since their introduction in 2013, the Instruction for Use have been progressively narrowed for this product, as a result of high failure rates experienced by those implanted with these devices. Research published by clinicians in Cambridge, earlier this year, warned Vascular Surgeons to increase post-operative monitoring of patients implanted with this product because of higher than anticipated failure rates: Eur J Vasc Endovasc Surg (2018) 56, 342e348
 

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