LEFT TO YOUR OWN DEVICES – YOU MIGHT THINK YOU’RE ALONE
In 2017, HIC initiated a public investigation into the unintended injuries caused to thousands of women through the use of trans vaginal mesh implants as the preferred treatment for pelvic prolapse and urinary stress incontinence.
This research has led to far reaching reforms with changes to the information provided to women considering corrective measures, the establishment of care pathways for injured women and changes to the risk rating applied to mesh by the regulator of medical devices the Therapeutic Goods Administration.
Since then HIC has been alerted by consumers to other devices subject to mal-function or unintended complications. In 2018 we investigated patterns of complaint over the IUD device Essure which is now the subject of a class action against its manufacturer, Bayer Ltd. Today we are launching a wide-ranging investigation to see whether there are other devices that are also responsible for adverse impacts.
The list of products referred to us is extensive but by no means exhaustive. It includes:
Hernia and bowel mesh
Metal hip replacements
Total knee replacements
The “green whistle” used by ambos for pain
Breast implants – not just PIP and cereform
Obesity surgery devices
But doubtless there are others that warrant investigation.
If you have had personal (or close family) experience of adverse outcomes from a medical device we would like to hear from you. You can join in our Facebook conversation on Facebook or tell us privately through our de-identified survey HERE
Many people who suffer unintended outcomes may not realise they are associated with a particular device or procedure or may think they are experiencing an exceptional circumstance.
In the case of mesh and Essure aggregating the experiences of individual consumers made it clear that there were clear and consistent patterns that reflected problems with the devices. Problems that had either been undetected or downplayed.
We are not setting out to create distrust in health products nor to negate the enormous benefit millions of people receive from medical devices. But we think any medical intervention involves some risk and that every consumer has a right to understand those risks as well as the potential benefits of their procedure. Consumers should be able to weigh up the pros and cons and to make a considered, informed decision on whether or not to proceed.
HIC’s work has led to a recognition that the safety and quality regimes established to protect public health have failed in their duty of care due to critical shortcomings. These include:
Low barriers to approval – medical devices do not face the same rigorous clinical testing applied to pharmaceutical products. Their safety is largely based on “post-market monitoring” ie “let’s see what happens”.
Informed consent – People commonly complain that the risks of their procedures were understated and the benefits exaggerated. Every consumer has a right to all the information available so that they can make a personal risk determination based on their individual circumstance.
Drug and device company influence – HIC is looking for firmer restrictions on medical device manufacturers from rewarding clinicians for preferencing their devices.
Adverse event reporting – The TGA maintains an adverse event register however this largely relies on device manufacturer/sponsor or surgeon reporting of unintended outcomes. Evidence suggests significant under-reporting and even a difference in perception between clinicians and patients as to whether there has been an adverse outcome.
Need for device registers – In most cases there is no central record of device distribution making it difficult to monitor post-operative consequences that aren’t part of clinical trials.
Inadequacy of complaints processes – Complaints authorities need to take a more proactive approach in detecting patterns of complaint reflecting recurring device failure or adverse impacts. In the case of mesh, most state authorities received individual complaints but nobody connected the dots to recognise a pattern of prevalence.
HIC is actively advocating for the health system to address these shortcomings, specifically through a deeper engagement with and accountability to consumers. Your personal experience will be invaluable in helping us capture an accurate picture of the prevalence of medical device failure.
If you have experienced any issues with devices or implants and would like to contribute to our investigation, you can either contact us email@example.com or fill in our annonymous survey HERE
Alternativley if you have a hernia or vaginal mesh issues please visit http://meshinjuredaustralia.org.au/ who will be able to assist and guide you further on your concern or issue. Their contact number is 1800 MESHED (1800 637 433)