At the age of 36, Nola Borcherds could hardly walk ten steps without gasping for breath. A viral infection years earlier had weakened her heart and left her with a constant wheezy chest.
Her heart was failing and she needed a new one. No transplant was available, but the next best thing was an implant called HeartWare. Unlike pacemakers, which send an electrical pulse to keep it beating regularly, the device would attach to Nola’s heart and keep her alive by taking over its function, continuously pumping blood around the body.
Brochures promised the gadget could be life changing. It was smaller, safer and more effective than others, and designed to last up to ten years, raising her chance of a transplant.
When Nola’s pump was implanted in December 2018 it made a tremendous difference. “Two to three months after she had it fitted, she could virtually run up the stairs,” her mother, Jenny Kiddie said.
But on 21 May 2021, two and a half years after the device went in, it stopped working. Doctors at Harefield Hospital in Hillingdon, west London, were carrying out maintenance when it failed to turn back on, cutting the supply of blood to her brain.
“The hospital called and said, ‘Nola’s become very unwell. How quickly can you get here?’” her mother said. “By the time we arrived, she was already in the morgue.”
What her family believe Nola did not know, and what the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), failed to react to, was that HeartWare pumps had already been linked to hundreds of deaths globally.
As early as 2011 some doctors switched to alternatives. Yet the UK regulator allowed them to stay on the market — and they continued to be implanted on the NHS until last year. Some patients are still living with the pieces of equipment, because surgery to remove them is so risky.
Families, medical experts and lawyers want to know why the MHRA failed to take firm action despite repeated warnings about the devices, which they believe could have contributed to patients dying. By Nola’s death last year, the health regulator had passed on at least 16 safety alerts to doctors warning of problems identified by the manufacturer.
Source: The Sunday Times, 23 January 2022
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