PRIVATE medical companies have been selling deficient pacemakers to the NHS knowing full well that they have failed tests, the Royal College of Surgeons says, and, as a result, at least two patients have died!
Implants have been put into people despite failing in trials on baboons, pigs and dead bodies. The pacemaker was withdrawn for safety reasons. At least two people died and 90 events were recorded in which patients were seriously harmed by the device.
The College demands urgent and drastic changes to the rules around medical devices to protect patients.
It wants a register of every device in every patient set up so doctors know if new innovations are causing harm. Medical devices range from implanted contraceptives to hip replacements to heart pacemakers.
Boz Michalowska, a medical devices lawyer at the firm Leigh Day, said: ‘It should be a source of shame for the UK government and its regulatory bodies that patients continue to suffer from such avoidable harm.’
In one example, Maureen McCleave, 82, from Essex, was the first person in the UK to be fitted with the ‘Nanostim’ pacemaker because of her irregular heartbeat. Pacemakers are life-saving implants that deliver electrical pulses to the heart to keep them beating regularly.
Traditional ones have leads from a battery to the heart that deliver the electrical pulse, but the cables can break, and the Nanostim was the first leadless pacemaker that sat inside the heart.
Maureen said she was ‘over the moon’ to be the first and felt like a ‘good guinea pig’ when she was implanted with the device at Bart’s hospital in London. ‘I was so grateful that I’d been chosen, because it sounded too good to be true.’
But three years after it was fitted, the battery in Maureen’s Nanostim failed and surgeons could not get it out. She now has a traditional pacemaker keeping her alive. The Nanostim is still sitting inside her heart. She says: ‘I don’t like the thought I’ve got a piece of metal or whatever in my heart that’s doing nothing and it’s just lying there.’ However, she is not alone – a number of batteries failed, and parts fell off inside patients.
• The Royal College of Physicians has warned that six out of ten doctors report that they are extremely concerned about their hospital’s ability to cope with the influx of patients over the winter period.
The poll of UK foundation doctors, trainees and consultants conducted from 14–21 November 2018, also found that doctors don’t know how emergency funding for social care will help. Professor Andrew Goddard, RCP president, said: ‘When we’re concerned that the wheels could fall off any moment, the pressure goes up and morale goes down.’