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Author Topic: UK article about banned metal on metal devices  (Read 7907 times)

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Pat Walter

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UK article about banned metal on metal devices
« on: October 27, 2013, 10:12:21 PM »
I thought I would make a post before someone else does.  We all have read that metal on metal devices are not being used, but this article said there is now a ban on them in the UK.  It is, as far as I can tell, a ban on all devices except the BHR.  This is very disturbing. 

I wrote to Mr. McMinn's offce to get some more input before we take what is in the newspaper as gospel.

I know I am not supposed to print a full article, but I am going to do it until someone says to remove it since it is so important to all of us.

The article is


NHS hospitals to be banned from fitting metal-on-metal hip replacements after high failure rate

NHS hospitals are to be banned from fitting most metal-on-metal hip replacements after a study found unacceptably high failure rates among implants in 17, 000 patients


http://www.telegraph.co.uk/health/nhs/10406198/NHS-hospitals-to-be-banned-from-fitting-metal-on-metal-hip-replacements-after-high-failure-rate.html

By Laura Donnelly, Claire Newell and Holly Watt
9:57PM BST 25 Oct 2013

NHS hospitals are to be banned from fitting most metal-on-metal hip replacements after a study found unacceptably high failure rates among implants in 17,000 patients.

The devices have already been subject to safety alerts, amid fears they can leak toxic metal. Surgeons are concerned that they fail far too early as joints wear away.

Two common models have been taken off the market and thousands of patients fitted with the implants have been told to have annual checks, often including blood tests.

New draft guides drawn up by regulators say the NHS should stop using any hip implant with a failure rate higher than five per cent at five years. It means that almost every type of metal-on-metal hip implant - including five more devices still used - should no longer be fitted in patients.


The warning from the National Institute for Health and Care Excellence (Nice) has been issued after research uncovered failure rates as high as 43 per cent among some of the implants.

An audit of all hip surgery in England, Wales and Northern Ireland found that most types of metal-on-metal hip devices in use had failure levels below the standards Nice deems acceptable. The traditional varieties use a metal ball in a plastic socket.

One device, the DePuy ASR, which was withdrawn when manufacturers admitted to failure rates of 13 per cent within five years, required revision surgery in almost a quarter of cases within that period. After nine years, failure rates are estimated to be 43 per cent, the audit says.

When a similar model was used in hip resurfacing procedures — an operation introduced to achieve better results for younger, more active patients — failure rates were 14 per cent after five years, and 36 per cent after nine years. Both types of implants were given to almost 6,000 patients. Six metal-on-metal models and a ceramic-on-metal model implanted in more than 11,000 resurfacing patients had five-year failure rates of five per cent or worse.

Some rose to 16 per cent within nine years, the figures show.

The metal-on-metal resurfacing models found to have such high failure rates are: the Adept; Cormet 2000; Durom; Recap Magnum; and Conserve Plus.

A sixth device, the Corail/Pinnacle full hip replacement using ceramic on metal, also failed to meet the standard.

Just two types of metal-on-metal device in current use fall within the proposed national standard — and only barely — the figures show. Stephen Cannon, an honorary consultant surgeon for the Royal National Orthopaedic Hospital, welcomed the report.

He said: “I think there is a question about whether it goes far enough, but this is definitely a step in the right direction — it amounts to a ban on most of them.

“The figures speak for themselves — even the best metal-on-metals have four times the failure rate of the rest. This is a really significant problem because these were given to an awful lot of people.”

Senior surgeons said the full scale of the failings in hip replacements given to thousands of men and women was only now becoming clear. Martyn Porter, past president of the British Orthopaedic Association, said: “It first started to become apparent among surgeons about three years ago.

“We were starting to see high revision rates but this is like watching a car crash in slow motion — at first, you just don’t know how bad it is going to be.”

He said the scale of the problem was “extremely disappointing”. He said: “These devices, which were supposed to be innovative, had such poor results.”

Mr Porter said any patients who suspected problems with a metal-on-metal device should see their doctor.

“The important thing is identifying and investigating the cases where there are problems because if you leave it too long it can cause tissue destruction.”

Senior surgeons said their results still compared badly with those of traditional hip replacements. Some called for all types of the implant to be forced off the market.

The devices were introduced in the 1990s, but became most popular among surgeons over the past decade, with more than 11,000 a year being implanted by 2008 because it was hoped that they would offer better results.

DePuy said rates of revision on its Corail/Pinnacle ceramic-on-metal device might be lower than five per cent when data confidence intervals were taken into account.

Corin, the makers of Cormet 2000, said it had produced excellent clinical outcomes since being introduced in 1997. The manufacturers of Adept, Durom, Recap Magnum and Conserve Plus did not respond to calls.

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Juno

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Re: UK article about banned metal on metal devices
« Reply #1 on: October 27, 2013, 10:33:36 PM »
Yikes. Thanks for posting this Pat. I will be anxious to hear what Mr. McMinn's response is. Interesting that of course he or Mr. Tracey are not quoted in the article.
Right resurfacing, Dr. Gross, 7/11/13
Left resurfacing, Dr. Gross, 12/11/13

Dannywayoflife

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Re: UK article about banned metal on metal devices
« Reply #2 on: October 28, 2013, 07:58:39 AM »
I really wish that smith and nephew would kick all this crap into touch with the mountain of positive clinical data they have. The bhr is wonderful and is giving me my life back! But this does worry me that if/when my right hip goes down the swanny I might not be able to have another bhr!
Train hard fight easy
LBHR 10/11/2011 Mr Ronan Treacy Birmingham England
60mm cup 54mm head
Rbhr 54mm head 60mm cup 12/02/15 Ronan Treacy ROH Birmingham England
;)

Jason0411

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Re: UK article about banned metal on metal devices
« Reply #3 on: October 28, 2013, 11:41:50 AM »
I was thinking exactly the same as you Danny. My left is on the way out and I really want a BHR on that when the time comes but now am worried I might not be able to. I hope the Mcminn Centre get their weight behind some positive publicity. My brother had his done nearly 14 years ago and is still fine lets get more positves out there.
RBHR Mr McMinn 6th December 2011.
Tripped and crushed head under cap 31st January 2012.
Self repairing.

chuckm

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Re: UK article about banned metal on metal devices
« Reply #4 on: October 28, 2013, 06:08:00 PM »
That was a poorly written article. It contains a great deal of bias and intentional obfuscation of facts with a purpose only to create hysteria. Some of the quotations and statistics seem really "cherry picked". The ARS was not a good product and is no longer implanted so why the author wants to use that as a current indication of metal on metal products is a mystery. There were many bad THR poly products in the past too but I'm not sure the author would be willing to talk about those.
Chuckm
Left BHR 11/30/12
Hospital for Special Surgery
46 years old

Gazza2

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Re: UK article about banned metal on metal devices
« Reply #5 on: October 28, 2013, 06:26:04 PM »
"The metal-on-metal resurfacing models found to have such high failure rates are: the Adept; Cormet 2000; Durom; Recap Magnum; and Conserve Plus."

Thats rather disturbing, I do not recall ever seeing the Conserve Plus resurfacing implant reported as having high failure rate before.  I thought previous concerns published in the UK were concerning Metal on Metal THR devices not HR devices.
Dr Kim Ottawa LHR Cementless C+ Feb 2013

Dannywayoflife

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Re: UK article about banned metal on metal devices
« Reply #6 on: October 28, 2013, 08:37:09 PM »
Something many people don't realise is that you can get high metal ions from a non metal bearing thr thanks to the neck taper that can Leek just as much as a poorly fitted HR.

The only bad devices I've read about are the asr and durom. That's as far as resurfacing is concerned
Train hard fight easy
LBHR 10/11/2011 Mr Ronan Treacy Birmingham England
60mm cup 54mm head
Rbhr 54mm head 60mm cup 12/02/15 Ronan Treacy ROH Birmingham England
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Gazza2

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Re: UK article about banned metal on metal devices
« Reply #7 on: October 29, 2013, 02:40:49 AM »
I did some digging into the source of this article. In the article it mentions the warning comes from the National Institute for Health and Care Excellence (Nice).  NICE has a very comprehensive website,  there is no new guidance or warnings over hip replacement listed on the site.  Digging further I found this recently issued consultation document (Updated 17th October 2013) which I believe is the source document

www  nice.org.uk/guidance/index.jsp?action=folder&o=65484  (link broken as I cannot post links)

It is quite a big document but the key recomendations are:-

1.1  Total hip replacement and resurfacing arthroplasty prostheses are recommended as treatment options for people with end-stage arthritis of the hip only if the prosthesis has a rate (or projected rate) of revision of less than 5% at 10 years.
1.2  If more than one type of prosthesis meeting the above criteria is suitable for a patient, the prosthesis with the lowest acquisition costs should be chosen......

This may exclude some currently available implants, but I think the Telegraph article has widely extrapolated this interpretation (quelle surprise)  I also did not find anything specific to avoiding MOM implants (section 3.6 specifically mentions MOM HR as an option)

The evaluation report linked to the consultation document is a 350 page study on hip implant study. I only skimmed this, it is quite the tome, including a cost effectiveness study of HR vs THR.  Key conclusion for me is that HR has a higher revision rate than THR - again not a surprise and not a holistic view on HR vs THR imo

Dr Kim Ottawa LHR Cementless C+ Feb 2013

Granton

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Re: UK article about banned metal on metal devices
« Reply #8 on: October 29, 2013, 10:17:39 AM »
It is not quite true that this means they would be banned in the UK. It actually says they would not be used in NHS hospitals. I suspect it means that the NHS would not pay for them.

I recently had my second BHR fitted. This was done in a private hospital, but paid for by the NHS. If you could pay yourself, or your insurer was prepared to pay, I am sure you could still opt for MoM resurfacing.

The fact that the BHR is not mentioned at all seems bizarre. It must be the most widely used of these devices in the UK. If some surgeons are getting 98% success after fifteen years, there cannot be much wrong with the prosthesis or the concept (apart from, maybe that it is technically difficult to get right).
David
Rt BHR Nov 1999
Lt BHR Oct 2013
Mr D McMinn

Dannywayoflife

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Re: UK article about banned metal on metal devices
« Reply #9 on: October 29, 2013, 11:53:41 AM »
From my understanding granton the only issue with MoM in general is either poor surgery or poor design. The bhr is certainly not poorly designed and Mr McMinn is certainly as good as it gets surgeon wise! It looks like as usual someone has their own agenda and so the truth about how wonderful the bhr is gets neglected.
Train hard fight easy
LBHR 10/11/2011 Mr Ronan Treacy Birmingham England
60mm cup 54mm head
Rbhr 54mm head 60mm cup 12/02/15 Ronan Treacy ROH Birmingham England
;)

B.I.L.L.

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Re: UK article about banned metal on metal devices
« Reply #10 on: October 29, 2013, 03:19:56 PM »
It's all about the geometry, put in perfect bhr's are awesome, anything less than perfect, and they're well, less than perfect, and pretty far from awesome. Experienced surgeons and knowing who might not be a good candidate are the keys (imo) 

sharleen

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Re: UK article about banned metal on metal devices
« Reply #11 on: October 29, 2013, 03:26:56 PM »
B.I.LL. - your last sentence said it all!

Dannywayoflife

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Re: UK article about banned metal on metal devices
« Reply #12 on: October 29, 2013, 03:50:23 PM »
It's a very technical operation and only top surgeons should do it!
Train hard fight easy
LBHR 10/11/2011 Mr Ronan Treacy Birmingham England
60mm cup 54mm head
Rbhr 54mm head 60mm cup 12/02/15 Ronan Treacy ROH Birmingham England
;)

whyme

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Re: UK article about banned metal on metal devices
« Reply #13 on: October 29, 2013, 06:27:06 PM »
Indeed it's disturbing to read news like this (even if we know the press many times does not show the facts properly). In my case I'm not even 2 months out and I'm feeling great, but you have to have a very thick skin to ignore it and carry on.
Let's see how this develops, but so far it seems like another spin on the known NHS approach of lately with no new facts?
Left hip resurfacing (Conserve Plus) 2013-09-04
Dr. De Smet

Jon

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Re: UK article about banned metal on metal devices
« Reply #14 on: October 29, 2013, 08:09:40 PM »
Curious to see how this one shakes out.

The newspaper articles on this general topic strike me as investigative witch hunts...  Some juicy disclosures, but never the whole story...

Curious as well that there is no mention of BHR.

Looking forward to McMinn's response.

I'm almost at two years and happy as a lark...! Swimming, riding, running and chasing my kids...

McMinn RBHR, December 2011

toby

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Re: UK article about banned metal on metal devices
« Reply #15 on: October 29, 2013, 10:26:18 PM »
Hi all,
I've a Finsbury Adept (almost identical to BHR-designed and made by the original manufacturers of BHR) as several from the Uk who post on Pat's site!
I know that my surgeon and Jeremy Latham uses the Adept, knowing that Mr Latham frequently updates his site news, I was interested to see if there was a response..
Here it is...
'Latest
Metal Hips in the Daily Telegraph

There was a sensational headline in the UK Daily Telegraph this weekend.

‘NHS banned from using toxic metal hip implants’

No doubt it will cause a great deal of anxiety for patients who not only have had these devices, but also those on a waiting list for hip resurfacing surgery. It was a very unbalanced article, which failed to discuss the excellent results of hip resurfacing in men.  The failure of some types of metal implants has been a catastrophe, but overly sensational journalism isn’t helpful. If you need advice on your hip, you should in the first instance contact the hospital where the surgery was done. Most patients who have had these devices should already be enrolled in surveillance programmes to monitor the performance of the hip implants. We have seen reactions in some hips using a large metal head on a plastic bearing, so it’s not just metal-on-metal hips that are at risk.'
Regards
Toby
ps I'll remain vigilant and post any UK updates I see and email my surgeon Prof Cobb
LHR Adept-Prof Cobb-30-1-10

toby

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Re: UK article about banned metal on metal devices
« Reply #16 on: October 29, 2013, 11:23:22 PM »
Hi again,
 Bearing in mind the article mentioned high revision rates for HR devices-so to get some accuracy-went straight to the latest UK National Joint Registry data 2012 which showed the following % revision rates for each device after 8 years:
Adept 8.7
ASR 26.9 (36.4 expected at 9 years)
BHR 6.61 (8.1 at 9 years)
Cormet 13.85 (16.34 at 9 years)
Conserve 12.22

Going to bed now but the above is well worth discussing. I've sure got some points to make.
Toby
LHR Adept-Prof Cobb-30-1-10

sharleen

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Re: UK article about banned metal on metal devices
« Reply #17 on: October 30, 2013, 12:16:35 AM »
Toby - look forward to your updates! Out of all the thousands of members on this web site from all over the world who have made the decision to have a BHR there are VERY few with serious  complaints. I don't know where they are getting their statistics. I know that if I wasn't a bilateral girlie I would be in a wheel chair!

lgbran

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Re: UK article about banned metal on metal devices
« Reply #18 on: October 30, 2013, 09:21:29 AM »
Thanks to this site I am now 11 days from having a right BHR performed by a very competent surgeon. No regrets whatsoever regardless of the outcome which I'm sure will be fine as long as I do my bit
RBHR 11/11/13 by Stephen McMahon @
The Avenue Hospital Melbourne Australia

Dannywayoflife

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Re: UK article about banned metal on metal devices
« Reply #19 on: October 30, 2013, 11:15:33 AM »
That's great info Top man Toby! :)
Train hard fight easy
LBHR 10/11/2011 Mr Ronan Treacy Birmingham England
60mm cup 54mm head
Rbhr 54mm head 60mm cup 12/02/15 Ronan Treacy ROH Birmingham England
;)

 

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