Nick Xenophon (SA, Independent) Share this | Hansard source

When it comes to health care, as consumers and laypeople, we trust in our doctors, our nurses and our hospitals. But in the last few years, a question mark has been raised over just how much trust we should be investing in our regulator, the Therapeutic Goods Administration, known as the TGA. I have spoken in this place before about increasing problems with regulated medical devices.

In particular, these concerns sparked two community affairs committee inquiries, one into medical devices generally and one into PIP breast implants. The first inquiry looked broadly at regulatory issues, and then focused on the problems with DePuy hip replacement devices. During the inquiry, we heard from many people whose health and quality of life had been destroyed by these replacements.

Using 'metal on metal technology', a fault with the devices meant the metal layers gradually wore away, leaching chemicals into patients' bloodstreams. Microscopic shards of metal ground off the devices and embedded themselves in flesh and bone, causing inflammation and tissue death. In some examples, the bone itself was destroyed and patients are now having to go through additional painful surgeries to try and regain some mobility.

The Australian National Joint Replacement Registry, the NJRR, was instrumental in providing advice and information to the committee. As it turned out, they had provided the TGA with information about high revision rates for the devices a significant time before the TGA acted on it. 3In one case, data supplied to the TGA by the NJRR in September 2008 was not discussed by the TGA's Orthopaedic Expert Working Group until December 2009, after the NJRR had also supplied the TGA with the 2009 report. Even then only 10 of the 30 devices flagged in the 2008 and 2009 reports were addressed in the meeting. Some of the devices flagged in the NJRR reports were not discussed until 2010. The devices were finally withdrawn, some years after the NJRR starting flagging concerns about their performance.

Because the NJRR is so comprehensive—it has an almost 100 per cent data collection rate, even though it is not compulsory—it has been able to provide thorough, independent information that can be used to track the performances of individual devices. The NJRR is operated by the Australian Orthopaedic Association and, unfortunately, is only limited to joint replacement devices.

At this stage I want to pay tribute to Professor Stephen Graves from Adelaide and his team with the National Joint Replacement Register, because it is world class. In fact, other countries seek advice from Professor Graves and his team about the quality of their work, and for that I think we should all be grateful.

The absence of this type of registry had a significant impact on the PIP breast implant case. When the devices were withdrawn, there was no reliable source for data such as how many had been implanted, which surgeons had performed the operations and who these devices had been implanted in. Madam Acting Deputy President Moore, you sat on that inquiry and you are well aware of the evidence that we heard of a company based in France, which has since gone broke—bankrupt—and of the real questions about the integrity of that company and flaws in the design. The committee went on to recommend that the Department of Health and Ageing establish an opt-out registry for breast implants.

I want to make mention of the Australian Society of Plastic Surgeons, which is currently trying to establish a breast implant registry along world's best practice lines. The Department of Health and Ageing has since released a regulation impact statement in relation to establishing clinical device registries. This statement presents three options for discussion: maintaining the status quo, establishing national registries or establishing hospital-based registries. The statement recommends the establishment of national registries, but there seems to have been no further progress since then. That is just not acceptable. There are still some concerns about how national registries would be formed. Hand in hand with the need for registries is the need for a culture of mandatory reporting by medical practitioners. Without a complete picture, the information becomes meaningless.

Last week, I met with representatives of the Heart Foundation. They were visiting members of parliament and senators to try and get the minimal amount of funding they need to establish and maintain a registry for heart devices. The Heart Foundation is asking for just $2.5 million a year. In terms of preventative health dollars, this is almost nothing. We know the benefits such a registry would provide: better informed regulators and practitioners, a better level of care and better patient outcomes.

But still we are dragging our feet. Only yesterday the TGA announced yet another problem with a metal-on-metal hip replacement device. They are using the same old model. Possible recipients need to contact their surgeons for more information, but how are possible recipients supposed to know to do that in the first place? What if they have moved and their surgeon cannot contact them? What if they do not constantly monitor the TGA website to see an alert? What if they do not religiously comb other media just to make sure a device they might be implanted with has not been recalled?

The NJRR is fantastic, but it is limited—in part because of its budget—in the amount of information it can collect. An appropriately resourced registry can use a multitude of measures to make sure people who have been implanted with devices can be contacted by the regulator through Medicare accounts and other information. The Heart Foundation is pushing for more registries to be established, because they know it leads to better outcomes. One of the examples they provided me with was the New York State Cardiac Registry, which was established in 1988. As a patient, you now have a 30 per cent lower risk of dying as the result of a cardiac procedure in a New York hospital compared to the rest of the country.

Approximately 50,000 Australians were admitted to hospital with cardiac failure in 2001-02. If more effective treatment of acute ischaemia reduced this rate by just two per cent—or 1,000 fewer admissions—the savings would equate to 7,500 bed days or approximately $8 million. Approximately 35,000 Australian patients also undergo PCI, otherwise known as angioplasty, annually, and about three per cent of these experience prolonged hospitalisation following the procedure, due to complications. An average hospital stay is approximately four days, but with complications this doubles. If the rate were reduced from three per cent to 1.5 per cent through improved monitoring and benchmarking, the savings would equate to 2,100 bed days or approximately $2.3 million dollars. These savings, in exchange for better practice, make the expenditure on registries an excellent investment.

We have now reached the stage where medical devices are relying more and more on emerging technologies to try and produce a better product. Unfortunately, the very nature of these devices means pre-market testing on how they perform in the human body is limited. Therefore, we, and the regulators, rely on post-market monitoring to pick up any potential issues. Unfortunately, this is where the lack of registers has let Australian health consumers down.

As an example, I want to share the story of one of my constituents. He recently underwent his fifth operation to try and correct the damage caused by one of the DePuy hip devices. The biggest difficulty is that his femur has a fracture that will not heal due to the damage caused by the microscopic pieces of metal that flaked off his hip replacement. At this stage, he is not sure how many more surgeries he will need, and whether he will be able to regain his mobility. He is waiting on compensation from Johnson and Johnson, but the legal system takes time, and I do acknowledge the efforts made by that company—the manufacturer of the device—to try and expedite a number of claims. He had his original hip device inserted in 2007. At the time, he was only 37. He is now in his early 40s, with the rest of his life ahead of him. He is fortunate that the problems with the DePuy devices were picked up when they were, and not even later. But a whole scheme of properly resourced and operating registries would mean his chances of having it implanted in the first place would have been much slimmer. In that case, he would not have gone through five surgeries, he would not be living in pain, and he would be living his life to the full.

To me, that's worth more than any dollar amount, and that is why it is important that we learn from the mistakes of the past. It is important that we heed what the Heart Foundation is calling for—$2.5 million worth of funding, which will make a huge difference. It will pay for itself many times over, let alone the level of pain and suffering, needless hospitalisation and, may I say, in some cases death, as a result of not having a properly funded, properly operating registry. The time has come. I only hope that this government, in the May budget, will allocate a measly $2.5 million that will save many lives and save the health system many millions of dollars each year.