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London – A survey found that more than 1,000 people died in just three years as a result of defective medical implant problems.
The UK authorities received 62,000 reports of adverse incidents between 2015 and 2018 related to components such as pacemakers, artificial hips, breast implants and contraceptives.
One-third of the incidents had a severe impact on the patient and 1,004 resulted in death.
Experts have long warned that medical devices are poorly regulated, especially compared to pharmaceuticals. Professor Derek Alderson, president of the Royal College of Surgeons, said the findings "underscore the need for radical regulatory changes".
He said that many devices are inserted without sufficient evidence that they work or are safe.
"Unlike drugs, many surgical innovations are introduced without clinical trial data or centralized evidence," he told The Guardian.
"This represents a risk to patient safety and public trust."
There have already been a number of high profile security alarms regarding medical implants.
Last year, the government suspended the use of the vaginal grid, which has been administered to approximately 100,000 women for incontinence over the past decade. Approximately 50,000 British women who received PIP breast implants were notified in 2011 that they were at risk of contracting cancer due to the use of an industrial grade mattress silicone.
And in 2010, regulators removed two types of artificial hip joints metal on metal.
The new figures were revealed by the International Consortium of Investigative Journalists, a team of 252 people including staff from the British Medical Journal.
In some cases, patients received defective pacemakers even though manufacturers were aware of the problems. The regulators have also approved intervertebral disc replacements that have disintegrated.
A shocking case centered on a wireless pacemaker. Maureen McCleave, 82, of Essex, became the first person to receive the implant because of an irregular heartbeat.
She told the BBC that she was the first to be "on the moon" and that she felt like a "good guinea pig" when she received the implant.
Three years after installation, her battery broke down and the surgeons could not get it out. She now has a traditional pacemaker that keeps her alive – but the wireless version is still in her heart.
Although drugs must be rigorously tested and approved by British and European health agencies, there is no equivalent system for devices. Instead, a series of companies called notified bodies issue EC approval marks.
MedTech Europe, the body representing the medical device industry, said: "Millions of people have benefited from medical devices and can now lead healthier lives. Life is unimaginable today without the hundreds of thousands of medical devices in our hospitals and homes. "
Daily mail
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