Scandal of the 1,000 deaths from faulty medical implants
surgical innovations are introduced without clinical trial data or centrally held evidence.”
Rules making it tougher for devices to get approval are due to be introduced in Europe in 2020.
At the moment across Europe, 58 companies or “notified bodies” issue CE marks indicating a product is safe and can be used anywhere in the European Economic Area.
But if one body says no, a manufacturer can shop around.
The Nanostim pacemaker was turned down in Germany due to a lack of evidence but approved by the British Standards Institute. At least two people have since died and 90 others been harmed by it, from battery failures to bits falling off inside patients.
In 2014, Maureen McCleave, 82, was the first person fitted with one in the UK. Within three years she began suffering dizziness, palpitations and exhaustion. Doctors discovered the device’s “10-year” battery had died. She said: “I was just assured that [it] would last me until I died.”
The BSI could not discuss Nanostim due to “confidentiality requirements”.
Its manufacturer, US firm Abbott, said: “Upon CE Mark approval Nanostim was further assessed through a European clinical follow-up study.”
Other danger devices included vaginal mesh products sold to hospitals without clinical trials and a treatment for children with severe spinal curvature only tested on pigs and cadavers.
Carl Heneghan, professor of evidence-based medicine at the University of Oxford, said it meant “patients are in one big experiment and they often don’t know it”.
Medical devices industry trade body MedTech Europe said: “Millions of people have safely benefited from medical devices.”