Is your medical device causing you concern?

Following feedback from consumers experiencing unexpected complications with their medical devices or concerned they could be prone to malfunction, leading consumer health advocate, the Health Issues Centre (HIC), is launching a nationwide investigation.

The intent of the investigation is to determine if these concerns are wide-spread … and if, in fact, there is a problem at all.

Devices could include (but are not limited to) hernia and bowel mesh, metal hip replacements, IUDs, insulin pumps, pain pumps, resuscitation devices, ventilators, the “green whistle” used by ambos for pain, breast implants – not just PIP and Cereform -  obesity surgery devices, stents, intraocular lenses and so on.

No stranger to medical device malfunction, in 2017 HIC initiated a national public investigation into the unintended injuries caused to thousands of women as a result of trans-vaginal mesh implants.

These implants were the preferred treatment for pelvic prolapse and urinary stress incontinence prior to this research.

The research led to far-reaching reforms - the most important being changes to information provided to women considering corrective prolapse and incontinence 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 TGA.

In 2018 HIC investigated complaints about the IUD device, Essure, which is now the subject of a class action against its manufacturer, Bayer Ltd.

However, HIC CEO, Danny Vadasz, believes this is not the end of it and that other devices warrant investigation. He is calling on health consumers nationwide to come forward should they or family members have experienced adverse outcomes from a medical device.

“Join us our Facebook conversation or tell us privately through our de-identified survey.”

For more information about the current research go to: http://www.healthissuescentre.org.au/government-policy/projects/current-projects/medical-device-and-implant-failure/

Mr Vadasz says 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, by aggregating the experiences of individual consumers it quickly became clear that there were distinct and consistent patterns which indicated problems with the devices … problems that had either been undetected or had been downplayed.”

Mr Vadasz is adamant that HIC is not setting out to create distrust in health products or negate the enormous benefit millions receive from medical devices.

“However, we do believe any medical intervention involves some risk and that every consumer has a right to understand those risks, not to mention the potential benefits, and to weigh up  the two and to make a considered, informed decision about whether or not to proceed.”

HIC’s investigative work has led to the recognition that the safety and quality regimes established to protect public health have failed due to critical shortcomings.

These shortcomings 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 i.e. ‘let’s see what happens’.

·        Lack of 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.

·       Undue influence by drug and device companies – HIC is looking for firmer restrictions on medical device manufacturers. This includes cutting out rewarding clinicians for preferencing their devices.

·       Under-reporting of adverse events – The TGA maintains an adverse events register however this largely relies on device manufacturers/sponsors or surgeons reporting 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 and usage so it becomes 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 to detecting patterns of complaint reflecting recurring device failure or adverse impacts. In the case of mesh, most state authorities received individual complaints but no-one 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.

More about HIC … it is a not for profit Vic based consumer health advocate  which fosters  better health outcomes by encouraging consumers to become involved in their own health care and by ensuring the health system is responsive to their needs.

More media information:

Danny Vadasz on 0419 419 988 OR Wendy Parker on 0422 694 503

http://www.healthissuescentre.org.au/