Thousands of Britons are suffering serious health problems or even dying because of faulty medical equipment, experts warn today. Implants ranging from hi-tech hip replacements and heart pacemakers to breast augmentations have been responsible for injuries – and in some cases deaths – with patients being used as "guinea pigs" by a largely self-regulated industry, according to researchers.
Scores of failing or inadequate devices remain available for doctors to use in operations – despite manufacturers being aware of the problems. One manufacturer kept a metal hip replacement on the market till 2010 despite repeated serious criticism of it by doctors from 2007. In a second example, a combined heart pacemaker/defibrillator was recalled only after the reports of five deaths and 600 reports of a broken component.
The British Medical Journal criticises manufacturers for failing to monitor the safety of devices adequately. It has also criticised European regulators for not looking out for patients' interests properly. It says regulation is not "fit for purpose".
"We have still not learned from past failures," says Dr Deborah Cohen of the BMJ. "Nearly 20 years ago, the BMJ highlighted the dangers of early failure of unproved implants, yet the NHS is currently picking up the bill for faulty devices. Unlike kettles and toasters, which come with warranties, when devices do not last as long as they ought to, companies are not necessarily held financially responsible."
The numbers of devices replaced or discarded is not known, although analysts estimate the worldwide market to be worth an estimated £200m annually. The Medicines and Healthcare Products Regulatory Agency, responsible for monitoring medical equipment, received more than 9,000 reports of "adverse incidents" involving medical devices – 1,885 of which involved serious injury and 202 resulted in death – in 2009, the latest figures available.
"The true extent of medical device recalls in the UK is currently unknown," said Dr Carl Heneghan, director of Oxford University's Centre for Evidence-based Medicine. "It is likely that hundreds, if not thousands of patients each year are suffering serious injury and/or dying. The current costs to the NHS are also unknown but it is likely to run into millions of pounds." Patients are "acting as guinea pigs", he said.
Details of some of the failures are highlighted in a Channel 4 Dispatches documentary to be shown tomorrow night. BMJ researchers warn that patients will continue to be at risk unless better access to safety data is provided. They call for a registry of the highest-risk devices.Reuse content