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

At the outset I join with the chair of the committee, Senator Siewert, in the remarks she made about the assistance of the secretariat and other support that the committee received. I heartily endorse those remarks on the professionalism of the secretariat in preparing this important report.

This report came to the committee as a result of a referral, a motion I put up in the Senate as a result of being contacted by a number of constituents who have suffered severe, some would say life-threatening, health problems as a result of DePuy hip replacements and joint resurfacing. These are issues that ought not to have occurred in the first place. That is why this report is important. I have added additional comments to this report where I agree with the committee's recommendations but say I believe there ought to be some further rigour in the recommendations in terms of time lines in dealing with these important issues.

Let us put into perspective what is at stake here. We have a watchdog, the Therapeutic Goods Administration, that is supposed to have appropriate processes to deal with medical devices such as this. I believe the watchdog has failed Australian consumers. I believe that the watchdog, the Therapeutic Goods Administration, could have and should have done much better. There was significant evidence given to the committee that points out a failure of process, a failure in dealing with these matters.

Let us put this into perspective in the context of what has occurred here. In the case of the DePuy hip replacements and the joint resurfacing devices, approximately 5,500 Australians have received such devices. Many people who have received these devices have had to undergo multiple revision surgeries. We know that the average surgical revision rate is in the order of 3.5 per cent but the current revision rate for these devices in Australia is 10.2 per cent after five years. We know that independent UK research indicates a failure rate for some of these DePuy devices to be in the order of 49 per cent.

This is made even more tragic by the fact that many of the people who are undergoing these revisions are having severe health effects relatively young. Many of them are in their 40s. The problems caused by these devices relate to the trauma of surgery, the risks inherent with surgery—particularly for older patients—and also cobalt and chromium leeching into patients' systems, into their bodies, from the devices. This has caused a wide range of problems—and the committee heard evidence in relation to this—from depression, memory loss, fatigue and tinnitus to bone necrosis in the affected joint. Many of the patients who gave evidence to the committee stated they were not aware that their health problems stemmed from their devices until they saw the issue raised in the media or they conducted their own research. That shows there is a failure of transparency, and the committee has made some good recommendations in respect of that.

Some also stated that they had problems getting their health practitioner to take them seriously, and I have also been contacted by people who have been faced with similar problems from metal-on-metal devices, indicating that the whole category of device may be problematic.

What is particularly significant is the evidence that the committee heard from the National Joint Replacement Registry. I am very grateful for the work of that registry and for the work of the head of the registry, Professor Stephen Graves, whom I think is eminently qualified and well respected nationally; indeed internationally, given his role internationally in setting up a register for these devices.

I have been questioning the TGA on these issues at estimates hearings for several years and it has been a valuable opportunity to explore this through this committee process. I must say, for those who are listening on NewsRadio and those who are following this, that I think one of the things the Senate does best is the way the committee process works—without political rancour, without any party political basis to it and where the committee as a whole is looking to get to the truth of matters.

While the committee focused on these devices, it is important to remember that they are not the only problem devices and there are systemic issues in the way we deal with these devices. And then there is whether we ought to go to the French system, where you need to show the efficacy, the benefit, of new devices before they are put onto the market and before they get, if you like, government assistance. I believe the TGA has failed in its role as regulator and it is vital that new systems and processes are put in place to adequately protect Australia's health consumers. I believe the TGA's response to the DePuy situation was very poor, as evidenced in the report. In one case, information on the failure of the devices provided by the National Joint Replacement Registry was not examined by the TGA adequately until over a year after it was provided. That is clearly unsatisfactory.

One of the recommendations is to introduce legislation to require medical practitioners to disclose any financial, commercial or other interests they have which are relevant to the treatment of the patient. I will be providing instructions for legislation to be drafted along these lines in the near future if the government declines to do so. We need to have that transparency legislation.

In relation to DePuy devices, it should be pointed out that Dr Roger Oakeshott, one of the orthopaedic surgeons who implanted a number of these devices, did not, according to patients I have spoken to, disclose his commercial interest as one of the co-designers of the device. I think that is clearly unsatisfactory.

It is important that patients are able to give informed consent with regard to these devices. It is important that we have a better system in place. It is important that we have increased regulation of devices, including postmarket monitoring, and overall increased transparency in the operation of the TGA from the health technology assessment review and the Therapeutic Goods Administration transparency review. The fact is that many Australians who have had these DePuy devices implanted are looking at a ticking time bomb in terms of the impacts it can have on their health. At the moment the revision rate is some 10 per cent. If we go anywhere near the UK revision rates, that will be a very significant issue. I commend this report and I look forward to the government acting seriously to deal with a number of fundamental issues of reform.