An alarming report by the International Consortium of Investigative Journalists, including the Guardian and the British Medical Journal, together with the BBC Panorama Programme has uncovered an alarming failure in the assessment of suitability and safety of medical devices and implants in the UK.
The report found that many medical devices, such as implants, pacemakers, artificial joints and spinal rods were only tested on pigs or dead bodies and had failed in earlier tests on baboons.
Whilst implants change the lives of many patients, it is taken for granted by the recipient that the quality of the devices meet the highest standards and have been subjected to rigorous testing. However the report found:
- Birth control implants led to internal damage and bleeding
- Mesh implants for incontinence that cause abdominal pain and unsuitable
- Misfiring implant defibrillators
- Implants that crack or degenerate quicker than anticipated.
The BBC also discovered that treatments involving children were also affected.
In one case, an elderly patient had received a nanostim ( a wire free pacemaker). The implant failed quickly and couldn’t be removed. A convention pacemaker had to be inserted with the old one still in place. Prof Rita Redberg, one of the worlds leading cardiologists, pointed out that the trial for the Nanostim, was performed in just 33 patients over 90 days. “ These trials are suppose to last 10, 20 years. A 90 days follow up isn’t enough to learn about a pacemaker”, she stated.
The BBC reported that the situation arises out of the fact that there are 58 companies ( referred to as notified bodies) around Europe that can issue CE certificates which then allow the devices to be used. Many medical device companies are simply shopping around until they get a certificate issued. Once issued the certificate allows the device to be used all over Europe including the UK.
MedTech Europe that represents the medical device industry, in an attempt to balance the findings of the BBC, highlighted that many millions of people benefit from the devices and many are extremely successful. “Life is unimaginable without the hundreds of thousands of medical devices in our hospitals and our homes”.
The UK’s Royal College of Surgeons, however, expressed their concerns at the situation, calling for drastic changes. “ All implantable devices should be registered and tracked to monitor efficacy and patient safety in the long term”, stated Professor Derek Alderson, President of the Royal College of Surgeons.
Whilst new rules will come into force in 2020, many say the regulations don’t go far enough and point out that devices can get approved in Europe 3 years quicker than in the US, demarcating a deviance in safety standards.
The report reiterates the continued failure of medical devices against a culture of low safety standards and inadequate research. The NHS relied on the CE certificates to validate their use and currently the NHS is putting lives at risk by the situation.
If you feel you have suffered as a result of medical negligence or defective medical implants, speak to Farleys’ medical negligence team who can assess your claim. Call 0845 287 0939 or contact us by email.