Sue Boyce (Queensland, Liberal Party) Share this | Hansard source

I would like to add my thanks to the secretariat of the Senate Community Affairs References Committee, particularly the co-opted members of the secretariat, who were in the main responsible for the production of this report, The regulatory standards for the approval of medical devices in Australia. My thanks go also to the committee members for the amount of effort that went into coming up with a consensus report. I think it is a great feature of the community affairs committee that we very often produce reports that are consensual, because we are looking at issues that we believe affect everyone.

The biggest issue that came out of this report was the complete disconnect between the idea of a hip implant, a hip replacement device, and the needs of health consumers in Australia. The TGA, as Senator Moore has said, dealt perhaps not so promptly but certainly reasonably when they discovered the problems with the DePuy ASR hip replacement devices, but I do not think there was any consideration in that of the effect on patients. It is quite easy to talk about the 'revision' of a hip replacement as though it is something like a piece of paper where you might revise the words that have been written before, but we know in this case that the revision of a hip involves surgery, hospital stays and very large problems for patients.

I would just like to talk about some of the evidence that came out of the submissions of people who have been affected by these hip replacements. Amongst the problems that developed were the need for revision and for other surgery, the need for repeated and extended hospital stays, multiple and extended courses of antibiotics, major personal and family impacts and—in many, many cases—significant financial loss caused by their health problems and the need for other members of the family to care for them. Health problems that were cited by submitters include severe pain, loss of mobility and a complex mix of physical and psychological effects that were due to the shedding of cobalt and chromium ions from the DePuy implanted device. We had evidence from submitters saying that the excessive amounts of cobalt and chromium in their bodies had produced symptoms such as bone loss, extensive damage to bone and soft tissues, hip dislocation, pus coloured fluid and pseudotumours, and depression. And, as has been mentioned by a number of speakers, one person who received a DePuy hip replacement in fact is now in a terminal condition as a result of complications that have developed from that hip replacement. But let us just talk about the straight revision surgery. The symptoms for patients who get to the stage of needing a replacement of the replacement are pain, swelling and problems with walking, which can be on a recurrent or a continuing basis. That is enough of an issue, enough of a productivity problem, surely, and enough of a human problem for us to do better than we do here.

Wearing another hat, I happen to know that for at least 15 years the place and time of manufacture and the path to its final resting place of a septic tank in Australia has been very, very carefully monitored. You can look at any septic tank installed in Australia in the last 15 years and know exactly who made it and when. If we can do that well with a product like that—which I admit could be very unpleasant if it fails as a product and may cause some local environmental damage—surely we can do much better with products that are being put inside patients, not just in terms of the fact that having the revision done causes pain but also in terms of the fact that it is leading to a poisoning of their system.

The other topic I want to very briefly cover whilst I am here is recommendation 18 of our report, which looks at the conflict-of-interest issues regarding surgeons and others involved in perhaps recommending these products without suggesting that there are alternatives and certainly without giving patients the ability to make an informed decision about which implant to have. I think we also need to notice that Johnson and Johnson Medical have agreed to pay $21.4 million as a criminal penalty as part of a deferred prosecution agreement for improper payments by Johnson and Johnson subsidiaries to public healthcare providers in Greece, Poland and Romania, in violation of the Foreign Corrupt Practices Act. This is a US decision. Similarly, the UK Serious Fraud Office obtained a civil recovery order against DePuy International Ltd in recognition of unlawful conduct relating to marketing and the sale of orthopaedic products in Greece between 1998 and 2006.

I find it difficult to believe that, if that sort of behaviour had been going on in Europe, there is not at least the potential that that had also been happening in Australia. We have no direct evidence of that, but there are suggestions by people who have been affected by these hip replacement devices that they certainly were not aware of options and they were not aware that the recommendations to them about having these hip replacements were being made by people who had a direct or indirect financial interest in their accepting that hip replacement. So I think it is important that particularly recommendation 18 be taken up quickly by the government. I seek leave to continue my remarks later.

Leave granted; debate adjourned.

Sitting suspended from 18:30 to 19:30