Meeting Transcript - Mr Nargol16/04/2011

 

Mr Nargol works from a centre in North Tees which, along with the centre in York, are the biggest centres in the country and possibly the world, for dealing with the ASR hips. The ASR is the hip implant that we are all most likely to have but there is also the Corail Pinnacle and this is one with another big problem. An ASR Hip is often used on a Corail Stem for a full hip replacement or can be used on it' s own where it is connected to the top of the leg bone for the resurfacing.

 

There are many terms for the problems being seen with these implants. These include ALVAL, Metallosis and pseudo-tumour, which is very confusing. Pseudo—tumour scares patients and the press love it. The term was invented in Oxford to describe the swellings often seen with the hip problems. Metallosis means that when you open up the hip, there are bits of metal found and ALVAL is when you react quite badly to it - ALVAL Fluid. This is all very confusing so the term Mr Nargol and his team have come up with to cover the problems is ARMD, which stands for Adverse Reaction to Metallic Debris which means something has gone wrong with the metal hip and is now widely accepted as the umbrella term for the problems seen.

 

In 2007 they saw their first lady to be having problems with her hip and they opened her up to find out what was going wrong. When they did so, there was a milky fluid that came out from the hip. Sometimes this is a milky colour, sometimes it is green, sometimes blue — a weird spectrum of colour of fluid and the presence shows there is a bad reaction.

 

ln 2007/2008 they saw more of these cases and thought it that it was a likely metal reaction and so started doing blood tests. They completed lots of these tests but with all the results, they didn’t know what it meant. So they then had to test to discover what was normal and abnormal. It was in November 2007 — Mr Nargol went to Dallas for a convention and this is the first time that they saw other results of metal Ion tests. This said that the angle that the cup had been placed into the pelvis affected the metal levels. The steeper, more vertical angle of the cup, the levels of metal found in the blood went up. They raised this to DePuy and showed them their concerns and they came back to say they had never seen any problems anywhere in the world and they blamed patients and surgeons for implanting them incorrectly. So they then carefully changed how they did things to make sure the cups were put in at a very low angle to try to reduce the metal ion levels. In addition, they got a grant from the British Orthopaedic Association for a machine that allows them to analyse the implants removed from patients themselves rather than them having to go back to Depuy who always said there was nothing wrong or lost them and you never knew quite what had happened.

The machine looks for wear on the Implants and they were finding abnormal wear. From this they got better at measuring implants and calculating how much metal had come off and they presented the findings to the British Hip Society — which stunned a few people. They kept going back to Depuy to say there was a problem and then in Jan 2009, when they were certain there was a problem with the implant, Mr Nargol stopped using it. He told Depuy the implant was faulty and, at the time, Depuy were fine with the centre completing blood tests but they then stopped funding for the tests and Mr Nargol’s centre and team had to fund them themselves. Depuy basically didn’t want to know about the problems.

 

The team contacted a centre in Belgium and combined metal ion results and from this it became

apparent that the ASR was failing at 40 times the rate of other resurfacing implants. They took this

to American Journals and were dismissed. They continued to go back to Depuy to say there was a

problem and the response they got ranged from being called crazy and denying there was a problem to then saying there were no problems other than NE England, N Ireland and the whole of Australia.

They were in total denial.

 

They eventually called in the MHRA — the Medical Device agency — to present the data and they

acted immediately to bring a warning about the ASR problems and, eventually, managed to force

Depuy to take the products off the market.

 

Currently there is a 1 in 4 chance of an ASR implant failing at 75 months. (1 in 4 when the ASR is used alone). These are failing because of the size of the cup. It was designed with a shallower cup to allow for less bone to be removed on fitting. But this also means there is less arcal cover on the head of the leg implant and this leads to more pressure being put on the hip joint. This affects women more because they have smaller bones and compounds the problem. Also, if the cup is put in at a quite vertical angle, this increases the problems. This could have impacts on the claims going through as, if an implant has been fitted at quite an extreme angle, they may argue that this could be a cause of the failing of the joint.

 

So, the mechanism of the failure of the joints is that the ASR wears out, metal debris gets out into

the surrounding tissues and therefore the bloodstream. (There were some quite graphic images to

accompany this section which I don't have). The metal is very destructive of the soft tissue and bone but the problem the surgeons have is that the patients are not always experiencing pain, but can still have big problems. If you wait for really bad pain, it is sometimes too late as the tissue can still have been eaten away and become necrotic.

 

Further problems occur where an ASR head has been used with a Corail Stem. This gives a second

problem as the area the head connects to the stem — the Taper — is also wearing out prematurely

and failing. This increases the failure rate to 50%, 1 in 2 will fail at 75 months. This could go down to

be the biggest failure in Orthopaedics history. This explains some of the failures that have previously been unclear as to why a hip has failed. The difficulty is that — nobody can test the Tapers other than the Testing Centre at Newcastle where Mr NargoI’s team have their machine. It is therefore important that the revised implants are not sent back to Depuy but to Newcastle when they are removed.

 

Mr Nargol uses Cobalt in the blood to measure the likeliness the implant has failed, and he also uses

micrograms per litre (mg/l). A normal level for somebody without an implant would be 1mg/l. The

normal/acceptable level for somebody with an implant is 2mg/l. lf there is anything above 7 mg/I

then this indicates there are big problems.

 

To convert from Nanomoles per litre to mg/I:

 

Nm/l X 0.059 (for Cobalt)

 

Nm/l X 0.052 (for Chromium)

 

So for a level of 100nm/I — this would give 100 x 0.059 = 5.9 mg/I of Cobalt.

 

Anything more than 4 mg/l Mr Nargol and his team would investigate.

 

If there is 2 of 3 of a combination of high metal levels, groin pain and fluid on the joint then they

would revise the joint. lf Cobalt levels are more than 50mg/I then there would be no question, the

implant needs to come out.

 

There have been reports of other problems seen when people have metal hips — such as tinnitus,

heart and neurological problems. Although there is no absolute evidence that can connect these

problems to the hip implants currently.

 

The problems the metals cause are soft tissue and bone necrosis. There have been cases where

patients have had little pain but high metals and on operating on the joint to remove the implant, it

has been found that the muscles around the joint have been destroyed and the patients have been

left on crutches for the rest of their lives.

 

X-rays often don't show the problems but Mr Nargol showed a few x-rays that showed the bone had

been eaten away by the metal debris.

 

Mr Nargol has said that you are entitled to go anywhere you like for an opinion. He is getting

patients from all over the country going to see them at the Cleveland Nuffield. If you have an ASR

you are entitled to go and see them. lf you don't have an ASR you can still go up using the Choose

and Book system at the Cleveland Nuffield.

 

Questions

 

Q: Will GPs know about this?

A: GPs are unlikely to know or recognise the problems with high metal levels in the blood. The

Surgeon is the best to question. There are problems in that the there is a margin of error in testing.

 

Q: If we have a Corail stem and an ASR head and we are being advised a revision, what should be happening?

A: If the Stem is not lose, it should be left. The problem is the bearing surface so, as long as the head is changed to a ceramic head and the liner is changed to plastic or ceramic then that is fine and that is what they would recommend.

 

Q: I am still getting pain in my revised hip, why?

A: 90% of my revisions have done brilliantly. 10% have rumbling on discomfort. Sometimes in a

revised hip that is still causing problems, the inflammatory tissue and scar tissue can continue to

cause pain. Sometimes a further opening up to clean up this can help.

 

Q: I have been told that due to my age, I shouldnt go for a revision as the complications could mean I am left in a wheelchair.

A: Surgeons are not used to removing an un-cemented cup and resurfacing, if they don't have the

right tools and experience, they can be frightened of doing this. Without a revision, where problems

are occurring, you could end up in a wheelchair. The British Hip Society states revisions should be

done by surgeons who are dealing with revisions all the time and have a good amount of experience.

There are not many of us in the country.

 

Q: I have had both hips done and my second one seems to be causing problems, where they have found fluid. lve had ultrasound and MRI done. I know one hip has gone wrong, can I assume that the flrst hlp has also gone wrong? (There had been no sign of any problems until the second hip)

A: This has been seen several times, what happens is that you have one hip doing well, you have the

ASR or corail pinnacle one side and your body copes with the metal debris in your kidneys, it is

passed through in our urine. When you introduce a second hip the metal debris gets into your blood

stream and tips the balance, your body can no longer cope with the level of metals, suddenly, the

first hip that has been doing well, starts giving you problems. lt can be that the second one could

trigger problems with the first one.

 

Q: If we want to come and see you, how do we go about that?

A: My Secretary's number is on the sheet handed out. If you have an ASR hip in, you can come and

see me privately and that doesnt cost patients anything - it is paid for by Depuy.

 

If you have a Corail Pinnacle you can ask your GP for referral to any hospital and you can come to the Cleveland Nuffield on the NHS and be seen there. You can come to North Tees Hospital in Stockton.

We are in the process of setting up clinics at the York Nuffield but that will take a few months.

 

Q: I have a lot of Clunking in the joint, can you explain that?

A: Because the ASR cup is so shallow, the head rides onto the ridge of the cup in any position — it is

part of the design problem. But of the Cup has been put in at an extraordinary angle this could be

worse.

 

Q: What is the recommended procedure for revision?

A: There are also problems being found with metal head and ceramic cup so ideally, it should be

Ceramic head and plastic liner. The metal cup can be left in and given a plastic liner which has a lip around the edge to protect against dislocation.

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