Medical Device and Implant Failure

Medical Device and Implant Failure

Health Issues Centre works together with consumers to identify poor practice, policy and regulation within the health sector that put people at risk of potentially catastrophic consequences. We then support service providers and policy makers in an advisory or consultancy role to make positive improvements and build a better and safer health system.

As a result of our consumer-focused approach, we have a track record or bringing about real change. In 2018 we investigated patterns of complaint over the IUD device Essure. The device is now the subject of a class action against its manufacturer, Bayer Ltd.

We also played a pivotal role in bringing to light the many thousands of women injured by transvaginal mesh – the preferred treatment for pelvic prolapse and urinary stress incontinence.

This medical catastrophe lifted the lid on an even bigger issue impacting the Australian health system – the systemic failure to test, regulate and monitor the use of all medical devices. The alarming reality is that the microchip in your pet is more effectively monitored than the majority of devices implanted into human patients in Australia. 

Our work on Transvaginal mesh has led to far reaching reforms that you can read about here.

But this is only the beginning. Since that disastrous situation came to light, consumers have alerted HIC to a variety of other devices subject to malfunction or unintended complications. The list of products referred to us is extensive but by no means exhaustive. It includes:

We have no doubt this is the tip of the iceberg. 

Health Issues Centre continues to work on this issue, including working with the Therapeutic Goods Administration (TGA) to urge more stringent medical device regulation in Australia.