Medical devices have revolutionised medicine and improved the lives of millions. But as Health Issues Centre investigations into pelvic mesh demonstrated, they also have the capacity to inflict irreversible damage when something goes wrong.
HIC has long argued that there are a variety of systemic failure points in Australia’s Quality and Safety regime that virtually guarantee that the pelvic mesh catastrophe may be repeated in other devices.
Now, an article in the New Yorker magazine provides evidence that problems with devices are widespread. The USA’s FDA received around 16,000 reports of deaths associated with medical devices in 2015 but a study the Government Accountability Office estimates that 99% of such ‘adverse events’ are never reported.
The medical devices field suffers from significant underreporting of such events, as Jeanne Lenzer dissected in detail in her book “The Danger Within Us” (2017), noting that the more serious the complication with the device, the less likely it was to be reported. Lenzer argues that the actual deaths attributable to medical devices could be as high as 1.6 million, making medical devices one of the leading causes of death in the USA.
Unfortunately, there is no equivalent reliable database in Australia but Health Issues Centre intends to continue its research into medical device failure once the Covid-19 Crisis abates.
Over 500 Australians have shared complaints about their medical devices – including harrowing personal stories. The data has been collected by Health Issues Centre in what may be the largest survey of its kind. If you or someone you know would like to share their information and add to this body of research, please do so here.