As recently reported by the BBC, patients have been fitted with unsafe medical implants which have not been appropriately tested. These implants include; rods to correct spines, artificial knees and hips, and heart pacemakers.
An investigation found that these implants were unsafe because they had failed tests in baboons or were only tested on pigs or dead bodies.
The reason that these products have come to market is due to a relaxed regulation system which has allowed companies to ‘shop around’ different safety organisations until they find one which approves their product.
The investigation also revealed that doctors have not been fully informed of the risks of the implants which they are recommending to patients.
The investigation highlighted that the following implants have caused lasting damage:
- Implants inserted in to people’s backs which have cracked; these implants had failed tests on baboons
- Birth control implants which have caused internal damage and bleeding
- Implants inserted for incontinence which have caused abdominal pain
- Misfiring implantable defibrillators
Europe does not have a governmental body that checks medical devices before they are put on to the market. Instead, a series of companies called ‘notified bodies’ issue CE marks.
CE marks are applied to products to indicate that they conform to EU directives regarding health and safety. However, they are also given to devices such as toasters and kettles.
Maureen McCleave, aged 82 from Essex, was fitted with a ‘Nanostim’ pacemaker which failed within three years. Maureen had an irregular heartbeat so was given a pacemaker to deliver electrical pulses to her heart to keep it beating regularly. Traditional pacemakers have leads from a battery that runs to the heart, however the cables can break. The Nanostim pacemaker was the first leadless pacemaker that sat inside the heart. Maureen’s Nanostim pacemaker failed after three years as the battery failed and surgeons could not remove it. Maureen now has a traditional pacemaker but the Nanostim is still inside her heart.
The pacemaker has since been withdrawn for safety reasons as at least two people have died and at least 90 patients have been seriously harmed by the device.
However, MedTech Europe which represents the medical device industry, has commented that millions of people have benefited from medical devices which have helped them to live heathier and more independent lives.
Moosa-Duke Solicitors are specialists in clinical negligence law. If you believe that you or a family member have been a victim of negligence, due to private or NHS treatment, please do not hesitate to contact us on 0116 254 7456 to discuss your concerns.