In a series of articles titled, The Implant Files, The Guardian has brought together data and research from 252 journalists, 59 media organisations, in 36 different countries, which they state has: “uncovered a litany of problems in the global $400bn (£310bn) industry”.
Some of the headline figures are eye-catching:
62,000 adverse incidents between 2015 and 2018 related to medical devices in the UK;
5,400,000 adverse event reports collected by the FDA in the US over the past decade (not all US related);
Of the above, 1,700,000 related to injury and 83,000 to deaths.
500,000 required surgery to remove a device.
Some of the medical devices discussed in the articles are those which have been widely reported on such as breast implants, mesh repairs in hernia and vaginal prolapse and metal-on-metal hip prosthesis, among others. Particular criticism is levelled at the scrutiny given to devices before market, but also once they are being used and how quickly regulators are able to detect and act upon findings.
These figures, and the issues raised, highlight the need to review the current regulation of the industry and how devices are brought to market and how central registers of adverse events are managed and reviewed to ensure that patterns of failures are noticed quickly and remedied. This will not only minimise risk, but will ensure that there is faith in the industry and system.
“Carl Heneghan, a professor of evidence-based medicine at the University of Oxford, said systemic failings in the way medical implants were regulated meant ‘patients are in one big experiment and they often don’t know it’”.
Knee-jerk reactions however need to be avoided. Medical devices is an extremely broad term and the number of patients receiving such devices is huge. In addition, medical devices are often at the forefront of both technology and medical treatment and it would be counter-productive to blunt innovation. Being at the cutting edge will inevitably mean that the risks and limitations, and; in worst cases, dangers (although also in best cases, the extended benefits), of devices are not known until they are used in a clinical setting often over a period of time. What is needed is a safe system to ensure that implementation is based on trials and logical analysis, and that central registers are managed appropriately in order to quickly highlight issues when they arise so that devices can be reconfigured or removed from market.
Revealed: faulty medical implants harm patients around world