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Patients given unsafe medical implants

A UK pensioner who had a wireless heart pacemaker implanted before it failed has asked for answers after it was reported thousands of unsafe medical devices may have been used on patients.

Maureen McCleave told BBC Panorama she felt "over the moon" when she was the first in the UK to have the Nanostim device installed in 2014.

The battery was supposed to last about 10 years but gave out in just three years owing to a technical fault and is now lodged uselessly in her heart.

"I'd like to know why it stopped working", the 82-year-old said. "I felt like a bit of trash that had been thrown to one side. When it went wrong, I just felt like I'd been dismissed."

Faulty medical devices have reportedly been used widely due to lax regulation in Europe, a lack of transparency, and poor regulation, according to a wide-ranging investigation by the International Consortium of Investigative Journalists, the BBC, Guardian and others.

Artificial joints, spine-correcting rods, pacemakers and breast implants are among devices that have led many patients to suffer pain and in some cases die, according to the investigation.

In the UK, about 62,000 "adverse incident" reports linked to medical devices were sent to regulators between 2015 and 2018, the Guardian reported.

About one-third led to "serious repercussions for the patient and 1004 resulted in death", the newspaper said.

A Freedom of Information request revealed an adverse incident report was received every half-hour by the Medicines and Healthcare Products Regulatory Agency during the past three years.

Implantations of the Nanostim device were halted after 34 reports of premature battery failure were reported in 1423 patients.

It was reportedly rejected by German safety bodies but approved by the British Standards Institute.

At least two people died and 90 events were recorded in which patients were seriously harmed by the device, according to the BBC.

The BBC said its inquiries found inadequate clinical trials, including some tests performed only on pigs and dead bodies before coming onto the market.

Smaller than a AAA battery, the Nanostim is less than 10 per cent the size of a conventional pacemaker and does not require surgery.

McCleave now has a traditional pacemaker fitted.

The Royal College of Surgeons called for "drastic regulatory changes" following the investigation.