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25 JUNE 2020

Last week, Painaustralia was disappointed to learn that the Australian Government will be delaying the commencement of significant medical device reforms.

Painaustralia has been working closely with the TGA as part of the Medical Devices Consumer Working Group to ensure that these reforms reflect the concerns that millions of Australian consumers share.

Concerns about medical devices are well and truly warranted. The recent spate of device failures has revealed a poorly regulated industry that has put consumers at considerable risk of harm, including those with persistent and chronic pain. The inability of regulators to trace devices represents a systematic failure of our health and safety regulatory regime. It is also in stark contrast to the regulatory controls that are applied to pharmaceutical products.

We know medical devices can improve people’s lives. Medication delivering pumps can reduce people’s pain or help maintain a diabetic’s insulin levels. Hip and knee replacements can, where necessary, return people’s mobility.   

ABC National Medical Reporter and Pain Champion Sophie Scott’s report on this issue for the ABC over the weekend, pointed out the concerns that many patient groups have expressed about these delays which could put patient safety at risk. 

As part of Sophie’s report, I highlighted that ‘we have seen such catastrophic failures in medical device regulation, breast implants, more recently surgical mesh, hip implants, heart valves.’ There is no doubt about the benefit of these devices in improving quality of life, but good regulation and timely information is key to consumer confidence in these products.  Fundamentally, when these devices fail they can significantly reduce quality of life, pain and suffering as we have seen time and again.

The last few years there have been a number of stories published linking medical devices to a range of illnesses, including breast implants linked to rare forms of blood cancer and medical pumps becoming dislodged and moving inside the person. Many of us have heard the horrific stories of vaginal mesh implants growing stiff and cutting women internally, while there are thousands of deaths globally which implicate various medical devices in all kinds of injuries and illness. 

Many of these problems span multiple countries and are known to manufacturers and medical authorities. Despite this knowledge, some who still have faulty devices implanted or those who are about to, are alarmingly not informed about potential harms. In 2018, a major international investigation involving journalists from 36 countries, including Sophie Scott, found 170 Australians had died and more than 8,500 Australians had been injured in the past decade due to potentially dangerous medical devices.

The resulting scrutiny led to the announcement of much needed tightening of regulations. Painaustralia has been supportive of the reforms, working collaboratively with the TGA on a consumer co-design process for the Action Plan for Medical Devices, which aims to strengthen Australia’s medical device regulatory framework. The Plan sets out a range of actions that continue to improve the safety, performance and quality of medical devices in Australia, as well as enhancing transparency and increasing public confidence in our regulatory system.

These significant reforms are now delayed. As noted on the TGA website, the delay occurred ‘reflecting the challenges identified by the medical devices industry and healthcare professionals as they have focussed on the COVID-19 crisis.’

While we recognise that COVID-19 has caused an unprecedented and unforeseen barrier to progress on a number of policy issues, this response was not consistent.  The pandemic, for instance, did not result in a similar delay to the rollout of opioid regulatory reforms which were implemented on 1 June.

For people living with pain conditions, accessing ongoing treatments and support during the pandemic has been challenging. Many consumers have informed us of the difficulties they have experienced in accessing their usual care, script and medication provision issues as well as symptom exacerbation due to reduced physical activity and increased psycho-social stress during this period of pandemic. This is supported by evidence suggesting that mental health problems among people living with chronic pain have escalated during recent months.

With the tightening of access to common pain medications like opioids and MR paracetamol, it is arguable that more consumers will be inappropriately sent down the path of high-intervention surgery. This is now made riskier in an environment where the regulatory safety nets to prevent harm have been delayed.

Medical devices have been a life-changing intervention for many, but people with implants or those considering them have a right to be well informed. At present, there is no mechanism to ensure they can be contacted in relation to their device when large scale failures become apparent.

Additional steps also need to be taken to ensure that consumers are aware of these regulatory mechanisms. Targeted education and awareness campaigns are required to aid in informed decision-making by consumers, especially around device failure adverse events as well as replacement rates.

Mandatory medical device reporting obligations are long overdue as indicated by reviews and inquiries over many years. We need to see some practical improvements such as a patient database for contact tracing, community awareness and information campaigns so that consumers are well-informed of developments relating to the devices already implanted as well as any devices they may be considering for their treatment. These safety nets should go hand in hand with broader reforms that are aimed at reducing harm and enabling better pain management.

Anything less than implementing these long overdue reforms represents a failure of our health system to inform patients and ensure health professionals do no further harm when it comes to medical devices.

Carol Bennett,
Painaustralia CEO