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 (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One device, the DePuy ASR, which was withdrawn when manufacturers admitted to failure rates of 13 per cent within five years, required revision surgery in almost a quarter of cases within that period.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 â€" an operation introduced to achieve better results for younger, more active patients â€" 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 â€" and only barely â€" 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 â€" it amounts to a ban on most of them.
“The figures speak for themselves â€" 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.â€
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 â€" at first, you just don’t know how bad it is going to be.â€
He said the scale of the problem was “extremely disappointingâ€. He said: “These devices, which were supposed to be innovative, had such poor results.â€
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.â€
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.
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.
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!
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.
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
"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.
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
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
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).
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.
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)
B.I.LL. - your last sentence said it all!
It's a very technical operation and only top surgeons should do it!
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?
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...
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
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
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!
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
That's great info Top man Toby! :)
Quote from: toby on October 29, 2013, 07:23:22 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
Toby
Great info and would love to hear more. I'm not a hippy yet, but have been seeing Mr Latham hence good to see the relative performance of the Adept.
Putting my analytical hat on, wouldn't a sceptic say that these stats prove a point as I thought a THR had a like for like failure rate of sub 5% (i.e better than all of these). You then have to overlay that there are large nuances between THR & HR failures on demographics in that HR failure of large men aged 40-50 might be sub 1% if fitted correctly and THR could be 5%+ for the same group due to excessive wear and tear. The contrary could be true for a group that is better suited to THR, but generalising THR may have a better outcome on average, simply because it suits a wider range of circumstances and is not as technically demanding.
Debates of this kind are good for us "non-hippies" holding out, as just as you get your head around the whole thing, you see 2 or 3 threads here in the space of days with members either facing revision within 3 years (or 3 months for Bryan) or generally casting doubts in your mind. It's a big decision.
For all those who say thr's are the answer to preyers. I point you in the direction of the paper published by Mr Treacy and Birmingham university that proves a link between the thr and mortality!!!
Toby, thanks for publishing that the high revision rate for the Conserve plus are a bit depressing for me personally. I did look at the report and see that (Unsurprisingly) the BHR dominates all other implants in terms of numbers in the UK (BHR 18,280, C+, 1320, the Cormet is 2nd most popular has only 3,629 patients reported).
I know there are leading "independent" surgeons who have chosen Conserve plus (Or Cormet) over the BHR (Dr De Smet published a paper on his preference for the C+ that is on this site somewhere). And everything I have seen would indicate that other than the ASR device, there is no systemic reason for different failure rates between the devices listed, the predominant issue is surgeon placement angle and patient selection for HR (High failure rate with small head sizes).
Based on those numbers none of the HR devices seem to meet the criteria the consultation document is proposing which is less than 5% after 10 years.
One thing the statistics do not evaluate is the ease of revision, my understanding is a HR revision is a much easier operation the THR revision, this may explain some of the differences between THR and HR revision rates.
That metric will be hard to meet for both HR and THR. Based on the results of the Australian registry, which follows a much larger sample (over 200,000 procedures), neither meet that demand:
THR revision at 11 years: 7.4%, HR revisions at 11 years: 9.8%
Results are cumulative, all devices, including high failure rates / recalled and all surgeons and patients.
For THR MOM components, only the pinnacle was less than 5% (at 4.4%) at 7 years. The worst was the ASR THR with a 44% revision rate.
I don't want to spam the site, but if you are interested, look at the report and you'll see most THRs fall within the 5-10% range at 7-11 years. No matter the components and materials (ceramic, etc).
The same seems to hold true at a slightly higher rate with HR.
So I guess my point is to consider the source. A study made with a small sample size or a very large sample size for a long term.
I've attached some information from the 2012 registry pertinent to this thread, but there is a wealth of information in there that may answer many questions. It's worth it to look if you're curious or concerned.
As always statistics are just that - massive compilations of averages. A highly experienced, skilled surgeon with a constant practice and the right device will be much more successful than the norm on either THR or HR.
I feel it's extremely difficult for most of us to make the decision as to which way to go when we find ourselves in this situation. Will we ever know if we made the right or wrong decision when we choose to go either with a THR or HR? I know I spent a lot of time researching my decision, but there wasn't a Dr. who was able to convince me one way or the other of my choice. My decision was based a little on statistics-and Hern, you said it clearly that statistics are just a compliation of averages-, but more on the best Dr. in his field who felt extremely comfortable with his evaluation of my situation. I received a lot of advice from many Drs. who looked at me as a statistic and not from a clinical perspective, what my expectations where, what my activity level is, overall, my general health level.
I looked for someone who was confident and comfortable and extremely capable of performing this skilled procedure. Many of the other consults I had were from Drs. who were not comfortable with HR's and the discussions became very unprofessional. Questions where not answered fully and completely.
I am 2 weeks out from my second resurfacing. I look at it this way - I chose this based on the best available data available to me. The last thing my surgeon said to me in the hospital was, everything went well, no complications, strong bones, great muscle quality, you are a good candidate for this procedure. My plan is to go slow and steady in my recovery. Going forward, I will treat these new hips with respect to my age, health and with appreciation that I'm not getting younger so I will take care on my choice of activity levels.
We all need to be at peace with our decisions and who's to say if we chose another path, it would have been more successful. Look for the best qualified surgeon who feels confident with this procedure and who evaluates you thoroughly and together, as a team, you will have made the best decision for yourself.
Hi again, thanks to Danny, Gazza and Hern-I agree with your sentiments/discussion points about the stat's and difficulties comparing HR and THR, below were my thoughts after posting.
Excuse any crude analysis here but based on the stat's I presented from NJR:
BHR-8.1% revision rate after 9 years-data based on all UK surgeons using the devise. Quick deduction from this-92% have enjoyed successful resurfacing and almost all will continue to have as the cumulative results year on year do not increase greatly. This figure also has to take into account surgeon learning curve. Additionally, many surgeons tried HR during this 9 year period and failed to master this more complex replacement method (particularly the disastrous Oxford Study). These surgeons have had a significantly detrimental affect on these statistics-great most now leave it to the experts! Over the last 9 years HR surgeons have learnt a lot re-patient selection/device placement etc So one would presume that fig's for more recent years would be closer to the Mcminn 98% etc. Hence, I've an Adept despite not quite as good as the BHR stat's, the same factors apply and the results are still pretty good, certainly not justifying the alarm bells.
If you read the opening line of the article, I think it tells a lot.
"NHS hospitals to be banned from fitting metal-on-metal hip replacements..."
And perhaps as a whole they should be banned if they can't get the difficult surgeries done right as a group.
I don't know much about the NHS hospitals but are they having poor results as a group using MOM hip replacement and resurfacing components?
I would not expect a national group like that to say MOM's can be really good but we are going to discontinue offering them because they are a little too difficult for our pool of surgeons as a whole to implant. Trashing MOM's is not unexpected in my opinion.
Chuckm
Quote from: Dannywayoflife on October 30, 2013, 10:29:26 AM
For all those who say thr's are the answer to preyers. I point you in the direction of the paper published by Mr Treacy and Birmingham university that proves a link between the thr and mortality!!!
That's it , I'm done in here, too depressing. Good luck future hippies !
Ronan Treacy and Derek McMinn responded jointly to the UK article on October 29 highlighting the success rate of the Birmingham Hip, which was essentially ignored in the article. Additionally, John Timperley FRCS and John Skinner FRCS of the British Hip Society responded the same day by reporting that the BHR has a failure rate of only 3% at 7 years for 55 year old males. Their letters can be read online by accessing the UK Telegraph. These are powerful voices doing their best to counter the incomplete reporting by the UK Telegraph staff.
These articles can be a bit scary. The problem is there are inexperienced surgeons doing hip resurfacing procedures on patients that fall outside the ideal candidate selection, and with unproven devices. It would be helpful if some of the news coverage would highlight the importance of patient selection, surgeon experience and the proper device instead of simply reporting overall poors results. Too much to expect I guess.
We can take comfort in the knowledge that if you have your BHR done by one of the top surgeons, and you follow the recovery protocol and love your new hip, you will probably enjoy a very active life.
I've got two Birmingham hips, and life is good. I have no regrets. I have my two year check up in early December. I'll report back then. Stay positive.
Boomer
Thank you Boomer - I think that you have put a lot of people's minds at rest!
Reference Boomer's comment. The letter can found on the page linked to below. The page includes many letters on various topics, but the Treacy and McMinn one is there.
http://www.telegraph.co.uk/comment/letters/10409764/The-cost-of-scaring-workers-away-with-exaggerated-storm-reports.html
David
Danny,
Hey buddy, I am a little late to this thread please forgive me, please give me a cite on that comment about THRs.
Do you mean mortality as in large quantity of deaths or failures of devices?
Chuck
Quote from: Dannywayoflife on October 30, 2013, 10:29:26 AM
For all those who say thr's are the answer to preyers. I point you in the direction of the paper published by Mr Treacy and Birmingham university that proves a link between the thr and mortality!!!
I think it is mortality but I wouldn't worry if you think about the average age of thr patients against hr patients. It would stand to reason that more wouldn't out live the implants. :)
I think Danny is probably referring to this:
http://www.mcminncentre.co.uk/response-dispatches-program.html
See the paragraph immediately above "Summary".
David
Wow.
Note that it says the benefit persists after adjustment, but does not put a number on that.
I wrote to them asking them for information on the causes of the mortalities.
We'll see if they respond to my inquiry, seems strange that having a THR could cause for an increase in mortality.
Thanks
Chuck
Obxpelican
If the work has not been done any response would be speculative, I guess. Mr McMinn has expressed concern about fat and marrowbone being forced into the bloodstream by the action of forcing the femoral component of a THR down into the femur. Could be that?
As I said earlier, the difference once factors of age etc are adjusted for was not quoted. I bet it's a lot less than the unadjusted difference.
That is my thought, during the actual surgery, not long term after affects because once the bone forms around the stem it's essentially the same result except for the stress shielding and stress shielding is not going to kill you.
I was always with the understanding that the fat being forced into the blood stream causing issues a very rare thing.
I guess we're seeing lot's of changes to hip surgery, this will be interesting what happens in the future.
Chuck
Quote from: Granton on November 01, 2013, 10:16:17 AM
Obxpelican
If the work has not been done any response would be speculative, I guess. Mr McMinn has expressed concern about fat and marrowbone being forced into the bloodstream by the action of forcing the femoral component of a THR down into the femur. Could be that?
As I said earlier, the difference once factors of age etc are adjusted for was not quoted. I bet it's a lot less than the unadjusted difference.