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Dear Dr Mercer

Unfortunately we have never had the opportunity to meet, so allow me to introduce myself. My name is Stuart Cain, I am a 42 year old Nurse Educator working in the public health system here in Brisbane and have been a health professional for 15 years.

Unfortunately I am a ‘well-experienced’ Orthopaedic patient who received a Jonson and Johnson/De Puy ASR XL total hip replacement in June 2007 as a 37 year old. Whilst this alone does not qualify me as an ‘expert’ in the field of Orthopaedics, tomorrow I will be being admitted to hospital for the ‘revision, of the revision, of the revision’ of that particular operation with my third surgeon for the process and the expectation, that maybe, just maybe this will actually be able to give me some quality of life back after the last three and a half years of complex medical issues stemming from the ASR. As a fellow health professional, who is committed to the education and development of my own staff into the most competent and current practitioners that they can be, I was wanting to merely ask you a few questions and seek some clarity over some very troubling issues.

I understand that as the President of the Professional Association for Orthopaedic Surgeons in Australia (AOA), your role will be to be and maintain ‘a public voice’ and to provide ‘leadership’ to the members of your association and on occasions to the public of this country, particularly the patients that your members care for. In this capacity I am also aware that you are drawn into issues involving the profession as the President of this Professional Body and I appreciate the importance of your role in providing comment, and where required direction on behalf of your members. As a member of the public, a fellow health professional and an Orthopaedic patient I have developed increasing concern for the tone and content that a number of your statements and media releases have included.

Firstly, in May 2011, on the Four Corners program you stated that much of the issue around the Johnson and Johnson/De Puy ASR hip devices was “media hype” (in reference to Cobalt toxicity). I take grave concern (if not offence) from this on a number of fronts. I expect my staff of Nurses to be ‘current and evidence based’ in their practice and always considering patient safety as their primary concern. I would hesitate to guess that you would certainly expect the same of your surgeons. If so, at this point in time (May 2011), there was already considerable evidence that the ASR was failing at a far higher percentage rate than other prosthesis’ as identified by the Australian National Joint Replacement Registry (which I believe is a wing of the Australian Orthopaedic Association). Johnson and Johnson/De Puy had already issued at least one (possibly more) safety warning notices to surgeons about the ASR. Finally there was already published journal articles from the UK and USA suggesting that not only was there information from surgeons and researchers, but also data to back this up around higher failure rates and patient complications such as dramatically raised Cobalt and Chromium levels, not to mention patient pain and disability. I must ask, how could you possibly put this down to ‘media hype’, when I was able to get this information from some fairly simple Internet searches? I would expect that your organisation, and consequently you as its President would have expectations of your members around currency, competence and evidence based practice in the application of your profession. I would be interested to hear your point of view in response to this.

Secondly, having been involved in the recent Senate inquiry into the ‘approval of medical devices in Australia’, I am also acutely aware of the role that the TGA has played in all of this, not just with the ASR product, but also now it seems with a number of other products/devices as well. I am also aware that Dr Stephen Graves and the National Joint Replacement Registry (NJRR) were actively trying to warn the TGA about the alarming increases in early revisions for the ASR as a priority from at least 2006 onwards. My second question to you, Dr Mercer, is why were you not a more vocal supporter of this information throughout any of the media reports/articles that have been written about the ASR when the NJRR is under the control of the AOA? In the very Four Corners story mentioned above, Dr Graves identified that they, the NJRR, had first notified (“waved a flag”) about the ASR re-surfacing device

in 2006, which was followed by further notification about the ASR XL total system as well in 2007 as more data became available. If the NJRR is under the auspices of the AOA, surely you would have been aware that there were very real problems with the ASR devices and that this could become a major issue for your members? I find it difficult to understand then that you were unable to speak out in support of the findings of a wing of your own organisation. Of course I am not privy to internal communication with your members, however given that according to the NJRR these implants were still used after these concerns were raised, I wonder if the AOA was indeed keeping it’s members ‘up-to-speed’ with the rapidly developing issue. I would be interested to also hear your thoughts on why, if there was acknowledgement from the NJRR that the TGA were not acting on the advice given to them by the NJRR, did the AOA not act independently in advising or even directing surgeons to take more care or even reconsider the actual use of these implants?

Finally, apart from my own circumstances, what really prompted me to write to you was your response in the Australian newspaper, on the 3rd of March 2012 (article: Toxic scare for artificial hip joint patients), in respect to the recently published investigation by the British Medical Journal (BMJ) and the BBC’s Newsnight program (How safe are metal-on-metal implants? 28 Feb, 2012). Whilst as a patient, and indeed a health professional, it is actually justifying to see the BMJ and now The Lancet (13 March 2012), both publishing damning evidence in the form of editorial comment and investigations into not only the ASR, but also all metal-on-metal devices, I still remain bitterly disappointed by the response, or lack of it from the AOA, or indeed prominent Orthopaedic Surgeons here in Australia. Is this because of the evidence of the plight of surgeons such as Dr Tony Nargol (United Kingdom), who was almost laughed at by members of the Orthopaedic profession when he first raised concerns about initially the Johnson and Johnson/De Puy ASR, but now more recently all metal-on-metal technology as used in the manufacture and design of joint replacement prosthesis’. I am also aware of the condemnation that was passed onto our own Professor Ross Crawford in this country when he dared to raise the prospect of issues with and around these implants in the recent past to colleagues and in the settings of professional gatherings.

In the article in The Australian, you were quoted as saying that “Australian guidelines recommended annual assessment of patients with metal-on-metal hips, but blood tests would normally be done only if pain or other symptoms were detected”. Whilst I am not questioning this statement, it does rely very heavily on the reliability of those surgeons charged with fulfilling these guidelines. I understand that the vast majority of these people will do the right thing, however I would point out, from a patient’s and an outsider’s point of view there has been enough evidence to suggest skepticism of this occurring in every case. I wonder whether the patients of Dr Roger Oakeshott, who I am assuming is/was a member of the AOA, would feel that ethically and morally he could have been relied upon to fulfil these guidelines. I would suggest from evidence provided in the Four Corners report that this would be highly doubtful. In my own circumstances, even though I had been symptomatic for almost 18 months, it was only after the media exposure that the De Puy ASR was originally given in September 2010, and at my request, did the surgeon who implanted the ASR (also a member of the AOA), grant me a blood test for Cobalt and Chromium. These blood tests and consequent nuclear bone scan completely explained the severity of the effects of my ASR and resulted in my first revision. (This same surgeon has since apologised to me for putting the ASR in my body and mentioned that he had heard of some poor results with the ASR prior to my surgery). The surgeon that carried out my first two revisions, (also a member of the AOA), the second of which required emergency surgery and complex banding of the femur after an Osteotomy because of obvious metalosis in my femur, has been very cooperative and helpful until just recently when I continued to have complications including pain, lack of sleep and decreasing mobility. Even though I had sought a second opinion, I returned to this surgeon to give him the opportunity to discuss with me the situation that my hip and femur were really in. He chose to disregard the x-ray evidence that I had showing a fracture in my femur and explained it in another way, whilst commenting to me that I shouldn’t be in pain because of what had been done. I have since changed surgeons again for tomorrow’s operation.

It is my experience, and that of many thousands of other patients here in Australia, which is now causing patients to ‘doubt’ and even ‘mistrust’ what they are being told by Orthopaedic Surgeons, because it is our experiences, that we are never getting the whole truth! I have always espoused that any patient entering into medical care in this country could do so with a high level of faith and belief that they will be looked after, certainly not harmed further and provided with the most up-to-date medical care in the world. I implore you to think about what I have written here, I do not expect a reply, but to remain silent on issues or dismiss them as anything less than actually affecting patient’s lives does your profession a grave disservice. Entering into an Orthopaedic procedure like a hip replacement, should not be seen as a risky move for a patient to take, however I can honestly tell you that in the lead-up to my operation tomorrow, I am filled with doubt, not only about the outcome, but also as to whether I still have all of the information to make an informed consensual decision about what is going to be done to me, but most of all, I am terrified that I will come out of the operation worse off than I am now. I have been fortunate to have met a large number of patients affected by the ASR, all of them have lost their faith in the ethics and morals of some in your fine profession, I urge you to use your position to not only deal with those found at fault, but also to speak out and remind all Orthopaedic patients that they can rely on their doctors and the decisions that they will make on behalf of their patients.

Thank you for your time, please think about what I have written, as remember, I am only one patient among the Thousands of Australians who have been irreversibly affected by this horrible medical error. At the very least, think of how the AOA could lead their profession back to the high moral and ethical position that it once occupied, where patients do not have to think that dollars or even kick-backs might interfere with sound clinical judgement.

Kind Regards,

 

Stuart Cain

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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