Program Transcript

Read the transcript of Quentin McDermott's report "Joint Reaction", first broadcast Monday 16 May 2011.

Reporter: Quentin McDermott

Date: 16/05/2011

KERRY O'BRIEN, PRESENTER: A new type of hip replacement that's now being described as perhaps "the biggest disaster in the history of orthopaedics".

Welcome to Four Corners.

In this age of mass manufacturing, we've grown used to stories of cars being recalled to replace a faulty part. If it happens to be yours, there's a moment of inconvenience and you get your car back.

It's a different proposition when it's your body, and you may have to go back under the knife. Far worse still, when the recall comes only after your body has been poisoned by the faulty part and you're suffering intense pain - or worse again, the damage cannot be repaired.

That is what has happened with a relatively new type of hip replacement using "metal on metal" technology, made partly from cobalt and chromium, sold originally to doctors and patients as a big leap forward in joint replacement.

By last year, 93,000 people worldwide had had hip replacement surgery to implant this type of device. Five thousand five hundred of them were in Australia. Most have all now been alerted that their device is suspect, but many had already found out the hard way that something was badly wrong.

The question is, should the manufacturer and the medical profession have responded quicker when the alarm bells began to ring? And should the government regulator in Australia have given the green light to these cobalt and chromium devices without any clinical trials? Those questions will now be dealt with in court, and possibly in the Parliament.

For hundreds of Australians who trusted their doctor's advice, this has now become a horror story, investigated for Four Corners by Quentin McDermott.

RON BARNES: (Pulling up to his home) You've done a marvellous job. The car looks wonderful. I expected to see a jungle when we got back (laughs).

QUENTIN MCDERMOTT, REPORTER: After five operations and six months in hospital, Ron Barnes is finally back home in Adelaide with his devoted wife Yensie.

RON BARNES: God it's good to be home, I recognise the place.

YENSIE BARNES, WIFE: It's flaming nice to have you home.

RON BARNES: I recognise it.

QUENTIN MCDERMOTT: But all is not well with Ron. Just putting one foot in front of the other is an ordeal.

YENSIE BARNES: I'll just open the door first love.

RON BARNES: One leg, two legs, come on legs don't let me down.

YENSIE BARNES: Now I'm sorry, I didn't park the car very well so you'll have to...

QUENTIN MCDERMOTT: And now that he's missing one hip, walking up the two small steps to his front door is like climbing Everest.

RON BARNES: On three, one two three, up! (Takes a step) Lovely, and we'll do it again.

YENSIE BARNES: Yep. Leg up to heaven.

RON BARNES: Hips playing up. Ready? One, two, three (takes a step) up.

YENSIE BARNES: A little bit more love and you can sit down. You right?


YENSIE BARNES: Still don't know how you can walk up those.

RON BARNES: Oh home! Home at last! Oh my goodness it feels good.

QUENTIN MCDERMOTT: Once upon a time, Ron Barnes led an extremely active life.

RON BARNES: I was 16 when I went to sea during the Second World War in the Merchant Navy and I finished up many years later as a master mariner. I retired as captain out here in Australia.

I produced the Boy Scout Gang Show at Elizabeth, Comedy Capers. That was for 37 years. About 25 of us, we'd go around to RSL clubs, senior clubs and so forth and entertain the over 50s with songs and we'd make them laugh and make them cry, we'd make them sing.

YENSIE BARNES: We used to dance and all sorts of things. We used to walk all the time, take the dogs for walks. On holidays we'd trek for hours.

RON BARNES: We've been spending the kids' inheritance by going on, I think we've had about 14 cruises. This is what's killed me, this has.

YENSIE BARNES: (To Ron) Okay darl, Buddy's out so now we'll get you down these steps.

QUENTIN MCDERMOTT: "This" is the total hip replacement Ron Barnes had in 2005, with a new kind of metal prosthesis. It was meant to make him more mobile.

RON BARNES: I had this one, the right hip done and about six months later something went pear shape in there. I never did find out what and they did operate it again. After that I got this bursas coming up on my, on my hip.

QUENTIN MCDERMOTT: The bursa, or inflammation, grew worse and worse.

YENSIE BARNES: It ached. That's how he put it, it ached all the time. And it did no good at all to the line of a pair of trousers either, with a great big bursa the size of a grapefruit on the side of his leg.

QUENTIN MCDERMOTT: When Yensie Barnes went to see her own orthopaedic surgeon, she asked him to take a look at the growth on her husband's hip.

RON BARNES: And he said, oh my God. He said, let's drain it and have a look and see. He said, look there's pieces of metal in here, in the tray. And what it meant was that the whole hip had been disintegrating in my, in my hip here, and pieces of metal were all floating around inside the bursa. He said that's got to come out.

QUENTIN MCDERMOTT: In an operation like this one, the metal joint was removed, but it proved to be a gruesome business.

RON BARNES: A lot of the flesh had turned black and he had to cut away a lot more flesh and more muscle than they would under normal circumstances.

QUENTIN MCDERMOTT: Ron Barnes's horror story didn't end there. Four more operations were needed to deal with a serious infection, culminating in the decision to remove his hip altogether.

His surgeon gave him little to cheer about.

RON BARNES: He said you could have six months of acute pain, three years of adjustment. I've lost about two to three inches off this leg. When I walk without a shoe on, it's like walking on sponge rubber. While I can move the leg backwards and forward, I have major problems trying to move it sideways. I pick my leg up, it just flops around like that.

QUENTIN MCDERMOTT: DePuy Orthopaedics, part of the huge Johnson & Johnson health care empire, provided the replacement hip that caused Ron Barnes so much grief.

This promotional film advertises the range of devices marketed by DePuy as replacement bones and joints, including hips.

The implant Ron Barnes received was known as an ASR - or Articular Surface Replacement - and was part of a wider group of prostheses known as metal on metal. Its components are made from cobalt, chromium and titanium.

Two versions were marketed by DePuy, one involving a total hip replacement, the other designed to resurface the hip without replacing it totally.

ROGER OAKESHOTT, SURGEON: By definition a resurfacing is exactly what it sounds like, it resurfaces the head and it resurfaces the socket. Functionally patients get better quicker and they're back to normal activity within about six weeks, whereas as with a total hip replacement it often takes up to three months.

QUENTIN MCDERMOTT: Roger Oakeshott, an orthopaedic surgeon from Adelaide, is one of six surgeon designers from around the world who helped develop the ASR hip, and were rewarded with royalties.

Here, Dr Oakeshott demonstrates the finer points of resurfacing for the benefit of doctors and surgeons attending a conference.

(Excerpt from film of surgery)
MAN: What kind of cement do you use Roger?
ROGER OAKESHOTT: This is SmartSet with gentamicin.
(End of excerpt)

QUENTIN MCDERMOTT: Between 2003 and 2010, surgeons implanted the DePuy ASR in 93,000 patients around the world - 5,500 of whom were Australians.

The implant was approved for use in Australia by the Therapeutic Goods Administration, or TGA, which regulates medical devices.

But the TGA relied on overseas expertise in making its decision.

ROHAN HAMMETT, THERAPEUTIC GOODS ADMINISTRATION (TGA): The DePuy hip prosthesis went through the usual assessment process and was approved on the basis of European certification by the British Standards Institute.

It was thought at the time to have advantages over other hip prostheses because it required a smaller surgical incision, so it was thought to be better for patients was the reason it was originally marketed.

QUENTIN MCDERMOTT: Resurfacing the hip, rather than replacing it totally is heavily promoted to younger patients as a means of giving them greater, lasting mobility.

But in 2006, when Roger Oakeshott carried out this operation, concerns about DePuy's resurfacing device were already being raised by the organisation that monitors artificial joints - the National Joint Replacement Registry.

The problem was the amount of corrective surgery - or revisions - having to be done to deal with implants that had failed.

DR STEPHEN GRAVES, NATIONAL JOINT REPLACEMENT REGISTRY: We were a little bit surprised about the number of revisions occurring. So we did actually sort of wave a flag and said, you know, there may be an issue with the ASR. So we mentioned that in 2006 and that was specifically with the resurfacing device.

QUENTIN MCDERMOTT: Twelve months later, alarm bells started to ring.

STEPHEN GRAVES: The situation changed the following year when the ASR resurfacing certainly did become statistically significant from other resurfacing devices. And the company did respond on that occasion and it released a warning on the, about the device in 2007 to surgeons.

QUENTIN MCDERMOTT: DePuy's safety alert, however, suggested that surgeons were at fault for not implanting the ASR correctly, and that "sub-optimal patient selection and surgical technique" were to blame.

There was no admission by DePuy that the device itself might be failing.

But the following year, the National Joint Replacement Registry went even further, reporting a problem with the total hip replacement version of the ASR.

STEPHEN GRAVES: In 2008 we also identified the ASR conventional hip as being an issue, in that it had also twice the risk of revision, at least twice the risk of revision compared to other conventional hip replacements.

QUENTIN MCDERMOTT: Despite these repeated warnings that the risk of failure from the ASR hips was high, DePuy kept marketing them and surgeons continued to use the devices in their patients.

Bob Lugton had his total hip replacement in Brisbane in January, 2008.

Last year when he had become ill, he asked his GP to test his blood for cobalt and chromium, believing that metal ions had been worn away from the joint and entered his blood.

BOB LUGTON: When the result of that came back showing that I had 750 per cent higher cobalt levels than you should have, I rang my surgeon again and he suggested then I have a CT scan and a nuclear bone scan.

(Pointing to X-ray) You can see here that darker section there, that's where the cobalt's eaten away, started to eat away my hip and these sections down here have been eaten away.

QUENTIN MCDERMOTT: These X-rays showed the damage done to his thigh bone by cobalt leeching from his joint, and shortly afterwards Bob Lugton had surgery to remove his ASR hip.

But what the X-rays didn't show was the full extent of the damage caused by the metal to the tissue surrounding the joint, which the surgeon only found when he was operating.

BOB LUGTON: When he opened me up he found that my flesh had turned a grey black around the hip area. The bone he said looked like a sewer pipe and was full of a sludgy grey material and that was the same in my hip area where the acetabular cup was. That had to be ground out and all cleaned all the sludge out of that.

QUENTIN MCDERMOTT: There were other, less visible symptoms which Bob Lugton believes were also caused by cobalt poisoning.

(To Bob Lugton) What other symptoms did you get from this actual implant?

BOB LUGTON: I had a lot of problems with my sight, troubles focussing, I had terrible tinnitus which still remains, I had heart palpitations.

QUENTIN MCDERMOTT: Catherine Sullivan experienced similar symptoms to Bob Lugton's after she had her right hip resurfaced.

CATHERINE SULLIVAN: Every single one of those symptoms I had plus more.

QUENTIN MCDERMOTT: She takes a range of medication, including morphine to manage the pain.

CATHERINE SULLIVAN: (Injecting her leg with medication) One two three... nah I can't do it, okay go again (laughs). One two three. Ow god! How do people ever get used to doing this?

QUENTIN MCDERMOTT: Roger Oakeshott performed Catherine Sullivan's hip replacement at this clinic in Adelaide in November 2008, two years after concerns were first raised about the resurfacing version of the DePuy ASR hip.

Catherine was 43 years old.

CATHERINE SULLIVAN: He suggested that they had this new product available called hip resurfacing and it was a metal on metal product. We thought that would be the way to go. It was it was designed for younger people to do.

QUENTIN MCDERMOTT: But after the operation, Catherine Sullivan says she began to feel more and more ill.

CATHERINE SULLIVAN: I had lots of fainting spells. I started feeling nausea. My eyesight sort of went good and bad. I had tinnitus. I started having seizures. Just this feeling of being completely unwell all the time.

QUENTIN MCDERMOTT: Over the next two years, she estimates, she visited 20 to 30 doctors and underwent a battery of tests to try and discover what was wrong with her.

CATHERINE SULLIVAN: I had X-rays and blood tests and CTs and MRIs and ECGs and cardiograms and all of these scans that they do for your brain, all of these scans they do for your heart, things that they can look at for your liver and kidneys. It was ongoing. It was a night- became a nightmare.

QUENTIN MCDERMOTT: Finally, after hearing about Bob Lugton and his experience, Catherine Sullivan asked her doctor to arrange a blood test for cobalt and chromium.

CATHERINE SULLIVAN: The cobalt came back at 1,042 nanomoles per litre and the chromium came back at 400 and something, low 400s I think nanomoles per litre.

QUENTIN MCDERMOTT: This note from a leading pathology laboratory says that cobalt levels are normally 0-20 nanomoles per litre, and that levels greater than 85 nanomoles per litre "indicate toxicity".

Catherine Sullivan's reading was 50 times as high as it should have been - a dangerously high level.

Her cobalt level was so high that more blood was sent away for further analysis - but that test showed her cobalt level had climbed even higher to 1,239 nanomoles per litre.

The metal from her joint was poisoning her system.

CATHERINE SULLIVAN: The doctor certainly thought it was very serious. It needed to be dealt with straight away.

QUENTIN MCDERMOTT: Catherine Sullivan travelled to Melbourne to have her prosthesis removed. Her surgeon there recorded the damage done by the cobalt leeching from her implant.

"A significant large effusion was discovered with gross metallosis throughout the joint," he wrote. It was one more patient for whom DePuy's device had failed.

Historically, hip replacements are among the Western world's most popular and successful operations.

PROFESSOR ROSS CRAWFORD, ORTHOPAEDIC SURGEON: It's a fantastic operation. Hip replacement, I always say if you're going to have one operation in your life it should be a hip replacement because it transforms you and it works well and it's got great long term success.

QUENTIN MCDERMOTT: But some orthopaedic surgeons, like Ross Crawford, are becoming increasingly concerned about the potential risk posed to patients by metal on metal hips.

Professor Crawford knows the damage that can be caused to surrounding tissue by metal prostheses like the DePuy ASR, when the implants fail badly.

ROSS CRAWFORD: You get very high local concentrations of both metal ions and at times you can see the metal deposited through the tissue, it's just a black sheet of metal, metal particles in the local tissue.

QUENTIN MCDERMOTT: Ross Crawford will not carry out resurfacing operations, which require a metal on metal prosthesis. And he won't use metal on metal at all, believing it isn't worth the risk.

ROSS CRAWFORD: I never adopted it but I'm very risk averse. Other surgeons still think it's worth the risk. They still think that it's a, that the benefits outweigh the potential downsides and that's really very much a clinical judgement that that each of us as individual surgeons has to make.

QUENTIN MCDERMOTT: Ross Crawford is now testing a controversial theory - that cobalt toxicity in patients with hips that fail may not be limited to localised tissue damage - but may affect patients' health in other serious ways.

ROSS CRAWFORD: The people I speak to now who've had hip replacements that have come to revision, in retrospect they've all had some symptoms that I think are consistent with the cobalt poisoning.

But they are patients whose hips have failed so whether we're just seeing a small number of patients who have problems and they're the ones who've come or whether we're at the tip of something is hard to predict.

QUENTIN MCDERMOTT: So it could be the tip of an iceberg?

ROSS CRAWFORD: It could be.

(To Eileen Webber) Hi Eileen how are you going?

EILEEN WEBBER: I'm well thank you.

QUENTIN MCDERMOTT: Ross Crawford has first-hand evidence of this.

ROSS CRAWFORD: So we're about a few weeks after your revision.


ROSS CRAWFORD: And how's it all going?

EILEEN WEBBER: My mobility has finally eased, it's coming a little better as from yesterday. I still need the help of a crutch but not two anymore. The pain at night is still horrendous. During the day it's not so bad.

QUENTIN MCDERMOTT: Last July Eileen Webber's life changed dramatically, four years after she had her right hip replaced with a DePuy ASR. Ross Crawford was the surgeon who removed it in March this year.

EILEEN WEBBER: I had the hip put in 2006. It was fine. My health was great. We were going on holidays, everything you know. I was a very, very active elderly lady. Lots of volunteer work and stuff and then July 2010 I had a stroke and couldn't understand why because I'm not stroke material.

QUENTIN MCDERMOTT: She kept a journal of how her health was steadily deteriorating.

EILEEN WEBBER: My stroke, the 21st July, no evidence or obvious reasons why. Spoke to my son John in Singapore and John urged me to act as soon as possible because of the possibility of debris in my bloodstream. Feeling constantly tired.

ROSS CRAWFORD: She was suffering from quite marked systemic complications, which are complications away from the hip joint. Her symptoms fit perfectly with cobalt toxicity.

QUENTIN MCDERMOTT: Last year, Eileen Webber suffered a mild stroke.


QUENTIN MCDERMOTT: Was that caused by her hip implant?

ROSS CRAWFORD: The answer is we don't know. It's... we just have to put it in context. She had all these neurological problems. She had cobalt levels in her blood of 20 times normal. It is consistent with the cobalt but you'd never say for certain that it caused it.

QUENTIN MCDERMOTT: Eileen Webber is highly unusual - she had her ASR implant removed, even though mechanically it was functioning reasonably well.

ROSS CRAWFORD: This is something that I think as surgeons we're all going to face over the next few years. That, if in fact the systemic complications of the metal ions are causing enough problems elsewhere, then we're going to have to make some very hard decisions about who to operate on.

QUENTIN MCDERMOTT: The jury is still out on how widespread and dangerous cobalt toxicity is in patients with metal on metal hips.

But despite the experience of leading surgeons like Ross Crawford, the Australian Orthopaedic Association is reluctant to embrace the idea that it poses a real problem.

DR GRAHAM MERCER, AUSTRALIAN ORTHOPAEDIC ASSOCIATION: Cobalt toxicity certainly is anecdotal at this stage. We are open minded as to whether there may be an issue with cobalt toxicity in the future but at the moment there's not the scientific evidence to support that.

There's a lot of media hype about it and I think the media hype really at this stage hasn't got the scientific background or evidence to actually support an issue with it.

QUENTIN MCDERMOTT: A growing number in the medical profession are now taking issue with that view.

DR LEE PRICE, SULLIVAN NICOLAIDES PATHOLOGY: We're seeing vastly higher levels than previously.

QUENTIN MCDERMOTT: Dr Lee Price, a specialist chemical pathologist, says one patient with an ASR joint whose blood was tested at this lab had a cobalt level of 5,000 nanomoles per litre - 250 times higher than normal.

LEE PRICE: We were astounded. Five thousand is as high as I've ever seen in the literature. Certainly it's the highest value that we've ever recorded. That patient is seriously toxic.

QUENTIN MCDERMOTT: At this pathology lab, growing numbers of patients with dangerously high levels of cobalt have been recorded in the last nine months.

The majority have been over the normal limit of 20 nanomoles per litre.

LEE PRICE: We've seen 50 patients with a level greater than 1,000 nanomoles per litre, and 500 patients greater than 100 nanomoles per litre, which is in the toxic range.

And when you get up to levels greater than 1,000, then you're really in trouble. You could develop heart failure, hearing, visual loss, and I'm talking about blindness and deafness, as well as seizures, cognitive problems.

So you know we're talking serious toxicity in a large number of patients that have received faulty hip joints.

QUENTIN MCDERMOTT: Bob Lugton is now an advocate for patients whose ASR hips have failed, and he is one of hundreds of Australians who have joined class actions against DePuy and its parent company, Johnson & Johnson.

What has angered patients like Bob Lugton, is learning that Australia allowed the ASR hip to be marketed here, without first subjecting it to clinical trials.

BOB LUGTON: In actual fact the patient is the clinical trial.

QUENTIN MCDERMOTT: So patients are virtual guinea pigs?

BOB LUGTON: The patients are the guinea pigs yes and then they, they use the result when they put them in a patient to look at that and then decide whether it's a good hip.

GRAHAM MERCER: The Australian Orthopaedic Association's very supportive of more rigorous pre-market testing and we have been for quite some time. Ideally what we'd like to see is a minimum of two year data, independent data before a prosthesis can be released into the market. So it's actually tested quite extensively.

QUENTIN MCDERMOTT: That didn't happen with the DePuy ASR, which was cleared for use in Australia, on Australian patients, without the TGA testing it in any way.

(To Rohan Hammett) Doesn't the ASR experience show that more rigorous testing needs to be done before it reaches the marketplace?

ROHAN HAMMETT: Quentin, there are about a million individual medical devices available on the Australian market at the moment, that's one million.

It's not possible to individually test a million medical devices, but we need those devices to improve our lifespan, to provide treatment, to take away the pain that patients who walk around with osteoarthritis in their hips suffer from every day.

QUENTIN MCDERMOTT: Some of the most alarming results from research into the DePuy ASR hip have come from a small team in England.

Three hundred miles north of London, this research has been carried out by Tom Joyce from Newcastle University and doctors from University Hospital of North Tees.

DR TOM JOYCE, BIOENGINEER, NEWCASTLE UNIVERSITY, UK: I received an email out of the blue from someone called David Langton and he was working with a local surgeon and they had some issues with some of their patients.

A group of their patients, all female at the time, had been implanted with a state-of-the-art metal on metal hip, the ASR. They should perform for years and years but we were getting patients coming forward after just two or three years reporting pain. It was, it was amazing.

QUENTIN MCDERMOTT: The team decided to look at the problem from an engineering as well as a clinical perspective.

TOM JOYCE: If it came to the point where these joints were actually removed from patients once it had been decided they failed patients in a lot of pain, then we could take those joints, we could examine them from an engineering point of view to try and determine where those high levels of chromium and cobalt were coming from. Because we felt if we could do that then that would explain where this pain was coming from.

QUENTIN MCDERMOTT: This equipment, known as a coordinate measurement machine, allowed the team not only to see the damage on the surface of a joint but to measure it in 3D as well.

Dave Langton and Tom Joyce believe they now know how the DePuy ASR device actually failed.

TOM JOYCE: When new, these artificial hips should have a perfect mirror finish. You should be able to see your face in them and this is needed so that the lubrication is optimised within the body.

We found that those surfaces had roughened and they become excessively rough. And once that happens then the lubrication fails and essentially you have metal grinding on metal. And this to us explained why we had the high chromium ions, the high cobalt levels in the patients.

QUENTIN MCDERMOTT: Dave Langton and his colleagues have been warning DePuy for years that their research was uncovering high failure rates for the ASR hip, and high concentrations of metal ions in some patients.

TOM JOYCE: The results as soon as we had them went straight to DePuy. All the clinical results, all the engineering results. So that was happening throughout 2008/2009 as well.

QUENTIN MCDERMOTT: And how did they respond?

TOM JOYCE: Obviously they were concerned. They were also upset as well. You know they've got a state-of-the-art product that was not performing well, so they weren't happy.

QUENTIN MCDERMOTT: Did they concede that there was a problem with the design?

TOM JOYCE: Not initially, no. No.

QUENTIN MCDERMOTT: In the past few weeks, alarming data collated by Dave Langton and his colleagues has confirmed the extremely high failure rate of the DePuy ASR among their patients in Newcastle.

In just over six years, 417 patients had their hips resurfaced, and 26 per cent of those hips failed.

Out of 87 patients who had a total hip replacement, 49 per cent needed operations to remove them.

QUENTIN MCDERMOTT: How bad are those figures?

TOM JOYCE: They're terrible. They are absolutely terrible. The guidelines within the UK and what we've become accustomed to in terms of hip replacement is better than a 10 per cent failure rate at 10 years. So to have an almost one in two failure at six years is absolutely terrible.

QUENTIN MCDERMOTT: The failure rate being recorded in Australia is nowhere near the results reported in Newcastle.

STEPHEN GRAVES: We do have a high risk of revision with the ASR, but our latest information for this year, the six year data, is just under 14 per cent for conventional ASR, and just over 11 per cent for the ASR resurfacing hip. So you can see we're not in the ballpark of that 49 per cent.

QUENTIN MCDERMOTT: But that difference may be due in part to the doctors in Newcastle being more aware of ASR hips that are failing, and cobalt levels that are high.

Tom Joyce and Dave Langton's most recent research suggests that the problem of wear and resulting cobalt toxicity is far more widespread than the failure of just one brand - the DePuy ASR.

TOM JOYCE: People are now very concerned with all metal on metal implants and so surgeons are stopping fitting them.

QUENTIN MCDERMOTT: If your suspicions are proved to be right, how many implants worldwide are we talking about that could be affected?

TOM JOYCE: Hundreds of thousands. There's a massive number.

QUENTIN MCDERMOTT: For years, DePuy knew its ASR hip was failing. But only after 5,500 patients had been implanted with the device did the company decide to stop selling it in Australia - claiming this was because it was "streamlining its hip portfolio".

ROHAN HAMMETT: Australia led the world in removing this device from the marketplace.

QUENTIN MCDERMOTT: Well Australia didn't remove it, the company removed it.

ROHAN HAMMETT: Well the practical realities are that the device came off the market in Australia as a result of the TGA and its expert clinical groups analysing data and presenting that to the company, making it quite clear that we regarded the performance of this device as no longer acceptable.

QUENTIN MCDERMOTT: The Australian public wasn't told the real reason for DePuy's decision in November 2009, and it took the company another nine months to announce a worldwide recall.

One person who believes the recall came too late is Stephen Graves.

STEPHEN GRAVES: We had some early information that it was a problem. That information was confirmed again in 2008 and 2009, and I would've thought that that was enough to say that maybe there was an issue here and that it could well have been withdrawn.

NICK XENOPHON, SENATOR FOR SOUTH AUSTRALIA: There seems to be a disconnect between the National Joint Register and the work it's doing on the one hand, and the TGA on the other.

You'd think that there should be some cause and effect - if there is a joint that is failing time and time again, that the TGA should be alarmed about that, they should act rather than having what seems to be a cosy arrangement with industry to ask them to voluntarily recall, which I think sends the wrong message to patients and to consumers at large.

(To Catherine Sullivan) A chopper had to take you from the mid-north back to Port Adelaide?

CATHERINE SULLIVAN: Yeah, yeah, I had systemic organ failure.

NICK XENOPHON: That's because of the cobalt toxicity?

CATHERINE SULLIVAN: They didn't know at the time, we didn't know, no one knew, there was no tests done or anything.

QUENTIN MCDERMOTT: South Australian Senator Nick Xenophon knows Catherine Sullivan, and he will soon be calling for a senate inquiry into the approvals process for medical devices in Australia.

The TGA, for its part, has promised to reclassify joint prostheses to allow a greater level of oversight, before a joint is approved.

(To Rohan Hammett) What would you say to those patients who've had this hip implanted and are now are going through hell?

ROHAN HAMMETT: The last thing that we, as the regulator, or the implanting surgeons would want is for any patient to suffer as a result of an operation. The reality is the use of medical devices is a complex interaction between the surgeon, the patient and the device involved. And the factors associated with all three parts of that relationship may come to bear on whether a particular patient suffers an adverse event.

QUENTIN MCDERMOTT: While patients have struggled to cope, the other two major players in that relationship - the company and the surgeon designer - have backed away from the controversy. Neither DePuy nor Dr Roger Oakeshott would appear on this program, or answer our detailed questions.

DePuy Orthopaedics sent Four Corners a one-paragraph statement, promising support to patients who need testing and treatment.

Roger Oakeshott himself has gone to ground. His silence provides no comfort to those who've suffered terribly from the implants he helped to design.

(To Ron Barnes) Did he tell you that he himself had a commercial connection with the company?

RON BARNES: No, I didn't know anything about that no, no. There was no reason for him to tell me that, I suppose.

QUENTIN MCDERMOTT: Did he tell you that he had helped to design the hip?

RON BARNES: No (laughs). No, I didn't know that. Now that's news to me.

GRAHAM MERCER: Certainly the AOA policy would be that any doctor who implants or designs a prosthesis should, should notify the patient. In fact if you look at it realistically, most surgeons who are designers of prostheses would be quite proud of the fact that they've actually designed an implant because it's actually quite a demanding and rigorous process to look and design and then successfully implant prostheses.

QUENTIN MCDERMOTT: Ron Barnes says that when the bursa grew on his hip he returned to Roger Oakeshott to see if anything could be done.

RON BARNES: He said, no, nothing can be done, we can just drain it for you.

QUENTIN MCDERMOTT: Did he tell you that there was anything wrong with the hip?


QUENTIN MCDERMOTT: He didn't tell you that the hip was faulty?

RON BARNES: No, never.

QUENTIN MCDERMOTT: Did he offer to replace it, to take it out and replace it?

RON BARNES: No, no, no.

QUENTIN MCDERMOTT: When he drained the bursa, did he send the liquid off for analysis?

RON BARNES: No. He poured it down the sink.

QUENTIN MCDERMOTT: Roger Oakeshott retired in June last year.

In his downtime, away from a highly successful career, Dr Oakeshott enjoyed racing fast cars and was even once the proud owner of this car shown here being raced by Niki Lauda. In retirement, Dr Oakeshott enjoys the high-profile role of team doctor to the Adelaide netball team, the Thunderbirds.

But he didn't respond to an invitation from Four Corners to come out and meet three former patients of his whose hips have failed.

Like Ron Barnes, these ladies all had their operations at SportsMed, and three of them were operated on by Roger Oakeshott.

Each one is grieving the loss of a previously active life: Catherine Sullivan, Catherine Gunson, Kathy Plowright, Kay Griffiths.

KAY GRIFFITHS: They had to cut my femur out or cut it away to get to the whole thing, take it out. I had six weeks without a hip.

KATHY PLOWRIGHT: My hip had - all the metal had formed like a tumour wrap, it was all wrapped around the sciatic nerve and there was a hole in my pelvis which had to, I had to end up having a bone graft on that and two big screws holding the cap in place.

QUENTIN MCDERMOTT: Until Four Corners invited these ladies to meet, they had no idea there were others with similar experiences, of difficult revisions, intense pain, and resultant lack of mobility.

CATHERINE GUNSON: In August we had first heard about the worldwide recall and I did happen to know that I had bilateral ASR hips because Roger had given me copies of the operating notes because I'm a doctor.

QUENTIN MCDERMOTT: How mobile or immobile are you now?

CATHERINE GUNSON: Well I have trouble getting my shoes and socks on in the morning, going up and down stairs.

KATHY PLOWRIGHT: It's been nearly three months now and still in quite a bit of pain, can't drive, can't do my housework. All aspects of my life you know, it's just no more rock and rolling, no more walks, I'm just waiting to get better.

QUENTIN MCDERMOTT: Three of these ladies were Roger Oakeshott's patients.

KATHY PLOWRIGHT: I didn't have a clue that he'd helped to design it until I came here today.

QUENTIN MCDERMOTT: What did he say when you went back to him with bursitis?

KATHY PLOWRIGHT: Just gave me some exercises to do. Told me to sit like a man with me legs apart and walk like Charlie Chaplin and...

CATHERINE GUNSON: They told me that too.


QUENTIN MCDERMOTT: What did they tell you?

CATHERINE GUNSON: Exactly the same, because when my rheumatologist thought I had bursitis he said I should check with my surgeon whether it was safe to have a cortisone steroid injection and Roger said no, he'd rather I didn't and do all these other things.

QUENTIN MCDERMOTT: In both your cases, did he did he indicate at any point that this might be a sign there was something wrong with the hip?

KATHY PLOWRIGHT: No, not at all. No.

ROSS CRAWFORD: (To Doug Cope) I'll get you to stand up for me. Can you walk without your stick?


QUENTIN MCDERMOTT: Back in Queensland, Ross Crawford has taken on another patient.

Doug Cope had an operation last November to remove the ASR implant in his right hip. Since then, following two dislocations, he has been in constant agony.

ROSS CRAWFORD: Now I want you to stand on this leg.

DOUG COPE: On this one?

ROSS CRAWFORD: Yep. Just basically bend that one up like that. Good, down. Now stand on this one. I've got you.

(Doug Cope struggles to perform the exercise) Okay, it's not great is it?

QUENTIN MCDERMOTT: Doug Cope has a cobalt level of 140 nanomoles per litre - seven times higher than normal.

Like many patients with an ASR hip, he was told about the recall but has no idea how and why the implant failed.

Now he has just been told that he may have had two ASR's and not one, as he always thought.

DOUG COPE: So you're telling me at some stage this one could pose a problem? I haven't got one, I've got two of them?

ROSS CRAWFORD: Well it looks to me like they're, yeah they're the same implants. So I'm presuming they're the same implants. And that's one of the mysteries one is that perfect and one is not and that's one of the dilemmas we're actually being faced with at the moment and you're being faced with.

QUENTIN MCDERMOTT: A former Navy man, now driven by pain, Doug chooses to spend most of his life alone on an island off the coast of Queensland, separated from his friends, and away from Wendy his wife, suffering in solitude.

DOUG COPE: I've always been tough in veneer. I played sport tough. I put up with injuries tough. But for someone to continually show misery and show pain and be heard to groan and whinge and be totally dependent on somebody else, you know, was beyond my comprehension of who I was.

I wasn't stubborn. I just felt that in a lot of circumstances I just want to be on my own.

QUENTIN MCDERMOTT: What's your life like now?

DOUG COPE: Oh you know, poor hey. Poor.

QUENTIN MCDERMOTT: The number of patients whose ASR hips have failed is still growing. All of them now, like Doug Cope, are reliant not just on families, friends and GPs but on the vision and integrity of the orthopaedic profession.

ROSS CRAWFORD: There's going to be an enormous amount of research over the next years trying to actually understand the best way to deal with this issue. I think it's important we don't have everyone running out tomorrow and saying I need my hip out. I've got a metal hip. I'm going to have cobalt poisoning.

There are many, many hips functioning with cobalt within the normal range and it's not something that is going to affect everybody.

QUENTIN MCDERMOTT: How big could this problem become?

TOM JOYCE: Well it's already huge. We've had nearly 100,000 of these devices implanted around the world. The latest data from here and the UK suggests a potential failure rate of up to 49 per cent at six years. So essentially we're looking at perhaps the biggest disaster in the history of orthopaedics.

KERRY O'BRIEN: That's a chilling statement for those involves. Too late for some, a mess in the making for untold others.


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