Lois Rogers

http://www.dailymail.co.uk/health/article-5010531/Imagine-horror-hearing-heart-implant-faulty.html

They’re meant to be lifesaving, so imagine the terror of learning that the defibrillator implanted inside your body could have a faulty battery that might stop your heart working at any time.

‘It is a bit like hoping you have the winning lottery ticket when you really need that money,’ says Andrew Wilson, a 49-year-old software engineer from Nottingham. ‘If you have a gun pointed at your chest, you know what’s going to happen, but with this you just don’t know if you have a faulty device or not.’

In March this year, Andrew was given a defibrillator, a high-tech device designed to detect instantly if the heart’s pumping mechanism has gone awry and, if it has, to deliver a bolt of electricity to shock it back into rhythm.

Andrew needed the implant after a bad attack of flu caused damage to his heart muscle. But getting the device was the beginning rather than the end of his problems.

They’re meant to be lifesaving, so imagine the terror of learning that the defibrillator implanted inside your body could have a faulty battery that might stop your heart working at any time.

‘It is a bit like hoping you have the winning lottery ticket when you really need that money,’ says Andrew Wilson, a 49-year-old software engineer from Nottingham. ‘If you have a gun pointed at your chest, you know what’s going to happen, but with this you just don’t know if you have a faulty device or not.’

In March this year, Andrew was given a defibrillator, a high-tech device designed to detect instantly if the heart’s pumping mechanism has gone awry and, if it has, to deliver a bolt of electricity to shock it back into rhythm.

Andrew needed the implant after a bad attack of flu caused damage to his heart muscle. But getting the device was the beginning rather than the end of his problems.

‘Ten days after the operation on a Friday night, I got a call from the doctor telling me to go straight to the hospital the following Monday to have it urgently replaced, because it was part of a batch of 30 which had defective batteries,’ he says. ‘I was told that two of them had already failed, but I wasn’t told whether any patients had died or if the fault had been discovered in time.’

After an extremely anxious weekend, Andrew underwent surgery to replace the faulty device.

‘It took me much longer to recover from the second operation,’ he says. ‘I was tired and I had quite a bit of time off work. I was angry a device that cost £50,000 could be so unreliable.’

Implanted defibrillators — which consist of a battery-powered generator that’s put into the muscle under the collarbone and attached to thin wires that are fed into the heart — are in routine use in Britain’s hospitals.

There are also thousands of external defibrillators, many paid for by charitable fundraising, distributed in railway stations, hotels and sports centres.

Yet they are not as reliable as we might hope. New figures released to Good Health by the Medicines and Healthcare products Regulatory Agency (MHRA), which oversees the safety of medical devices, show there have been 72 external and internal defibrillator safety alerts issued by manufacturers over the past five years — the equivalent of more than one a month.

The problems include batteries that fail, the wires that connect the battery to the heart unexpectedly fragmenting, or other components disintegrating.

‘That failure rate is amazing,’ says Chris Ludlow, of Fort Solicitors in Slough, Berkshire, who specialises in personal injury. ‘It is completely unacceptable.’

One of those 72 alerts involved the same device that Andrew had removed.

In October 2016, U.S. company St Jude Medical (now owned by Abbott pharmaceuticals), one of the world’s biggest manufacturers of defibrillators, notified doctors about a defective battery in 400,000 cardiac resynchronisation therapy defibrillators (CRT-Ds), which had been implanted in patients worldwide — including thousands in the UK.

Two patients in Germany who’d had the defective devices implanted died when the batteries failed — one of them shortly before a scheduled operation to replace the faulty device. There have been media reports of ‘dozens’ of patients being rescued after they collapsed unconscious when their implants failed.

Last April, U.S. regulator the Food and Drug Administration sent a letter to St Jude Medical, accusing the company of failing to act on evidence of a battery problem with the devices as long ago as 2011.

What concerns experts is that when these devices go wrong, there is no system to identify patients at risk; no central register of defibrillator users, nor of most other medical devices.

Patients who suffer device failure either have to report problems to their doctors or rely on hospitals tracking them down to alert them.

An MHRA spokesman said the agency did not have details of how many types of defibrillator are in use in Britain’s hospitals — although it says nine are in common use — nor could it say how many models have been withdrawn, because the information is commercially sensitive for manufacturers.

The MHRA also does not know how many patients have come to harm as a result of problems with heart implants.

Similar problems have emerged with defibrillators used in public buildings. Earlier this year, a safety alert was issued for 10,068 Lifepak 1000 devices in the UK after the manufacturer, Physio Control, revealed eight had shut down unexpectedly during use.

And in October last year, the inquest into the 2014 death of Estelle O’Sullivan, a 37-year-old mother of three from Slough who died hours after giving birth to twin boys, heard about a catalogue of errors, including the failure of two external defibrillators.

There have been repeated scandals surrounding defective medical devices in the UK, raising serious questions about how such devices are licensed and monitored.

As we saw last week in the first of our three-part report into the problems of Britain’s medical device industry, thousands of women have been damaged by the disintegration of implantable surgical mesh, but the problem with heart defibrillators represents a more deadly threat.

‘It’s one thing having a defective hip, but quite another to have a defibrillator which might cause instant death by malfunctioning,’ said Professor Carl Heneghan, director of the Oxford Centre for Evidence-Based Medicine, whose organisation began raising concerns about our system for regulating medical devices as long ago as 2005.

Peter Redman is another of the UK patients affected. As he sifted through the post on his 75th birthday last November, an ominous letter from his hospital was lying among his cards.

It warned that the battery in his implanted defibrillator could fail at any moment, and he was requested to return to his hospital cardiac unit as soon as possible.

Peter was understandably panic-stricken. ‘I phoned the hospital straight away and got a call back from my consultant within half an hour,’ he recalls. ‘He said some of the devices were failing completely without warning.

‘I went to see him the next day. He said it wasn’t a question of assessing the risk and monitoring it — it could stop working instantaneously. The doctor said he couldn’t take the chance of oxygen starvation to my brain if it suddenly stopped working.’

Peter had initially been fitted with a defibrillator in 2009 due to heart disease — the implant that had to be urgently removed was a replacement for that first one, and had been fitted in 2015, little more than a year before the global safety alert was issued.

‘When I had mine taken out, there were at least three people on the ward who had the same problem,’ says Peter, from Potters Bar, Hertfordshire.

But removing Peter’s device led to a cascade of health problems.

A year on, the previously fit retired chartered engineer says he is a shadow of his former self.

‘Before this, I was a healthy man, going to the gym regularly and taking long walks,’ he says.

‘Now, walking any distance is difficult, and getting up stairs or any sort of hill at all is very hard indeed. I don’t blame the doctors — they did fantastic work. It’s down to the manufacturer.’

Recalls are ‘not great’ for the patient because they have to go through another procedure, says Professor Jaswinder Gill, a leading cardiologist at Guy’s and St Thomas’ Hospital in London.

He says he has removed ‘between 50 and 100’ devices in his career, but believes the overall failure rate is much less than 1 per cent, and maintains that a certain failure rate is unavoidable.

‘They are very complicated devices, and the more complicated the device, the greater the likelihood of something going wrong,’ he says.

‘The manufacturers put a lot of effort into managing device failure, and they will tell us fairly quickly.’

But other experts are not so forgiving. Professor Heneghan, who is about to publish a report raising concerns about the system for regulating devices, says it is a free-for-all in both their licensing and monitoring.

The MHRA, along with other healthcare regulators around Europe, relies on a network of 59 commercially run ‘notifying bodies’ to approve the safety and efficacy of medical devices. The notifying bodies are paid by manufacturers to win approval for their products.

The requirements for scientific validation are vague, says Professor Heneghan. ‘It is 12 years since we started looking at the problems with medical device regulation,’ he adds. ‘We’re still talking about the same issues, and in the meantime we have had industrial silicone in breast implants, defective hip joints, defective surgical mesh, defibrillators and so on. I can’t understand why no one has got on top of the problem.’

Recent efforts to demonstrate the weakness of this system have included a successful undercover exercise by the British Medical Journal (BMJ) in 2012, to gain approval for a fake hip joint identical to a U.S. one previously recalled from the market because it was leaking dangerous metal into patients’ bloodstreams.

Deborah Cohen, who masterminded the BMJ ‘sting’, points out that new rules have been introduced by the European Commission to tighten up device regulation, but, she adds: ‘It’s too early to say if they will make any difference because they have not yet been implemented.’

Michael Kipping, who heads the MHRA’s medical devices and surveillance division, says that despite the lack of available statistics or a register of patients, problems are rare.

‘New EU medical device regulations are coming in, which will mean every device has to have a unique barcode,’ he says. ‘That will allow the NHS to track any device to a specific location in its supply chain or to a specific patient.’

Critics remain unconvinced. Jill Paterson, of solicitors Leigh Day, says she has dealt with 45 defibrillator claims in the past four years. Most are settled confidentially with gagging clauses to prevent patients talking about their ordeal.

‘Some have been so psychologically affected they don’t want a replacement,’ she says. ‘They would rather risk sudden death than be worried about what’s inside them all the time.’

Labour MP Owen Smith is among a growing number of politicians concerned about medical device safety. ‘The number of people working in medical device regulation is tiny,’ he says.

‘They are regarded as the poor relations of drug regulation and they need to get closer to the standards of safety evidence covering pharmaceutical products. Clearly you can’t put a dud defibrillator into a patient in a clinical trial to test whether a real one works, but there needs to be a much higher standard of evidence and regulation to make sure that the benefits of these devices outweigh the risks.’

Even when a device is voluntarily removed from the market by a manufacturer, the problems go on, with the authorities effectively washing their hands of them (as we will reveal next week, in the final part of this series). Instead, it is left to patients themselves to pursue the matter.

After Andrew Wilson’s implant was removed, he was offered just £2,000 by St Jude Medical, but is taking legal action for more compensation. Peter Redman is also taking legal action.

A spokesperson for Abbott pharmaceuticals said: ‘At the time of our field action related to our high-voltage devices, Abbott developed a strong set of patient management recommendations in partnership with global regulatory partners and our medical advisory board.

‘Those recommendations helped our physician partners continue to provide optimal care to their patients.’