Metal Hip Replacement Safety Fears As Medical Regulators Launch Investigation

Metal Hip Replacement

PA/Huffington Post UK   First Posted: 29/01/2012 12:47 Updated: 30/01/2012 08:38

An investigation has been launched by medical regulators into the safety of metal hip replacements, leaving thousands of British patients fearful of the risk of being poisoned by their implants.

The Medicines and Healthcare products Regulatory Agency (MHRA) said it had taken "prompt action" over the safety concerns, but added the majority of people with the devices are at "low risk of developing any serious problems".

The action comes as an investigation by the Sunday Telegraph found more than 30,000 British patients have received the "metal-on-metal" (MoM) hip replacements which are feared to be more dangerous than previously thought.

Problems occur with such devices when friction between the metal ball and cup causes tiny metal filings to break off and potentially seep into the blood. These fragments can also cause a soft tissue reaction, destroying muscle and bone.

The newspaper said there are growing concerns that the implants could also cause "systemic toxicity" in the body, prompting the MHRA to start drawing up new advice for those fitted with them.

A spokesperson for the MHRA said: "On the evidence currently available, the majority of patients implanted with metal-on-metal hip replacements are at low risk of developing any serious problems.

"We are continuing to closely monitor all evidence. This needs more analysis before any conclusions can be drawn and further advice given.

"We have already taken prompt action to investigate safety concerns and have provided advice on patient management to relevant healthcare professionals."

In April 2010, the Government agency, which is responsible for ensuring that medicines and medical devices work and are acceptably safe, issued an alert to healthcare professionals over the safety of metal implants.

It came after some patients began suffering soft tissue reactions "to the wear debris associated with MoM articulations".

The MHRA advised that people fitted with the devices should undergo annual check-ups for five years following surgery.

It also said that those experiencing pain should be given tests to check the levels of cobalt and chromium in their blood, and an MRI or ultrasound scan to check for soft tissue reactions.

In September 2010, DePuy International Limited, a subsidiary of Johnson & Johnson, announced it was urgently recalling two types of its ASR metal hip replacement implants.

It came after data from the National Joint Registry of England And Wales found "failure rates" of 13% for the ASR XL Acetabular system and 12% for the ASR Hip Resurfacing System. However, a report by the British Hip Society seen by the Sunday Telegraph says failure rates of the Acetabular system could actually be as high as 50% six years after surgery.

Following the recall the MHRA advised orthopaedic surgeons to contact and monitor all patients given the implants.

More than 10,000 of the 40,000 Britons who have had metal hip replacements were fitted with the devices made by DePuy, according to the Sunday Telegraph.

Bozena Michalowska, of law firm Leigh Day & Co which is representing more than 300 victims of the MoM implants, said: "We have known for some time the perils of these implants and their widespread use has meant we are now seeing hundreds of cases from people who have had these implants.

"The MHRA needs to be fully able to assess these products before they are implanted and not just pick up the pieces many years after the damage has been done."

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An investigation has been launched by medical regulators into the safety of metal hip replacements, leaving thousands of British patients fearful of the risk of being poisoned by their implants. Th...
An investigation has been launched by medical regulators into the safety of metal hip replacements, leaving thousands of British patients fearful of the risk of being poisoned by their implants. Th...
 
 
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10:46 PM on 01/29/2012
Come on though really, how long have they got anyway.
orthobobsuruncle
Insurance is not the same as welfare
09:27 AM on 01/30/2012
People get them at 50, that's not young but it's not death's door either.
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lynterv
Been there, have the t-shirt.
11:18 AM on 01/30/2012
What a ridiculous and insensitive answer. Did you just move out of cave?
09:11 PM on 01/29/2012
Are all these health scare stories just a government ploy to discourage people asking for treatment to imporve their lives and save the government money?
08:31 PM on 01/29/2012
At least you can always see what's going on by spinning round until you reach the required height; pay children's prices at the cinema, see into football grounds for free etc.
08:12 PM on 01/29/2012
I know many people who have had hip replacements which have been very successful but unfortunately not for my mother. In January 2005 she had a hip replacement then in April 2005 had the other hip replaced. Ever since she has been very ill and is now disabled having had to have another 4 hip replacements and a tumour removed. She also spent a whole year without a hip whilst the infection healed. At the time of the operations she was a full time nurse living a full and healthy, fit lifestyle. Now she can hardly walk. Surely someone wants to listen to her pleas!
07:50 PM on 01/29/2012
For 60 years I have sufferred with hip problems & have had ,calipers,plates & now hip replacements, 2 + 1. I can assure you that it's better to replace than suffer & stop whinging & the american way of whats in it for me . If you had not been allowed a proper childhood or been allowed to do many things as an adult, you would be only to glad to walk without pain. I have been a guinea pig with my dicease since the fifties & believe me medicine in this country improves but it won't if all patients are after is how much can I get back if it goes wrong. gimpy metal mickey
07:41 PM on 01/29/2012
wow. I should have read further down the posts to see the points made. I think the most valid point has to be that main risk is the reduced power of the poor NHS who now have to reduce the urgency and care given to post -op patients. I can assure you one of the leading cinsultants/doctors left his post in digust as a result of the lack of continuity and care he could provide in my mum's (and other's) cases. The replcement doctor is now suffering the same problems. 18 months for a scan and prognosis for a problem that renders the patient virtually inactive is a far worse than any hypothesis about poisoning because this patient delay problem is real and is happening
07:38 PM on 01/29/2012
Having seen for myself the incredible changes to quality of life these hip replacements bring I think the benifits must outweigh the problems unless there is an extreme reaction. I suspect most of the problems are with younger recipients who are more likely to actually wear these joints out, rather than more elderly people who are less active.
Clearly there needs to be research into alternative designs, it is an engineering problem and there may be a solution using flexible materials rather than a mechanical joint using separate components.
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helioszephyr
What do you mean by "micro"?!
11:05 AM on 01/30/2012
I would agree... the benefits far outweigh the risks.
Had one joint replaced, just the cup/head cap no cutting of femur, at 55. Being athletic all my life, I had prematurely wore the joint... it was painful to walk, bend over to tie shoe, couldn't cross my legs... not to mention associated pain in lower back and leg.

Now I'm back to rollerblading, tennis and other crazy things I do.
Actually considering the other hip now as its showing slight indication of the same.
07:33 PM on 01/29/2012
I am really worried for my mother now as this is the second issue that is affecting her health after a hip replacement 2 yrs ago. I now fear they may be related and this makes it more scandelous of her tratment by the NHS so far

The first issue is a common one. Funding/cancelled appointments. My mum first suffered pain 18months ago and went for several scans (in theory). Several cancelled scans, lost results, cancelled appointments (despite surgeries only being every 2 weeks) she has been chair bound for 18 months and my parents have had to buy their own stair lift. Eventually she has been diagnosed with an infection around the hip (which even us 'armchair' doctors could have guessed at 12 months previously) and the hip will have to come out and be cleaned and replaced ( a further 6 month event). And guess what. the first consultation was cancelled last wekks so she now has to wait a further two weeks before begining the process. I hope therefore this is not a 'poisoning' as an already unacceptable treatment of my mum will have been made even worse. She was a very active person and to think 18 months of unnecessary wait could render secondary problems (due to reduced activity) is frightening.
09:14 PM on 01/29/2012
So when will you be making your compensation claim?
Kali03
I am an Obama supporter
10:24 AM on 01/30/2012
I'm sorry for her suffering. That sounds abysmal.
07:02 PM on 01/29/2012
This is so stupid =if you take stainless steel and introduce a friction element you get what is called gauling ,and if you were a proper surgeon you would know that ! what looks like has happened here is these so called joints are probably made in india from something other than surgical stainless, there was a scandal with medical instruments not to long ago ,you could buy medical instruments from india for a fraction of the price of of the surgical stainless ,some one needs to check on the origin of the implants !
09:56 AM on 01/30/2012
Steel on steel without a good lubricant will gall. It is worse in the case of a ball joint, where any galling is not restricted to a linear groove. Machines solve the problem by using soft bearing surfaces on hard steel parts. They are less likely to abrade each other and the soft bearings absorb any particles and limit wear. We need a biologically inert material that won't gall a steel ball, won't be eroded, but which has enough structural strength to handle the stresses involved.
01:55 PM on 01/30/2012
No stainless steel - The "ball" is made from cobalt chrome and the stem is made from a titanium alloy. The "cup" is made from high molecular weight polyethylene implantable grade. neither the ball nor the cup will flake off if they are pristine at the implant. If there are imperfections, flakes may happen. It is the responsibility of the physician to make sure that the implant is pristine and sterile prior to implantation. And the vast majority of implants are made in the USA. Check with the FDA on fda.gov before making uneducated guesses.
06:44 PM on 01/29/2012
Having smashed my hip picking a fight with a concrete pillar at forty miles an hour, I now have a replacement one. Before I got it, I lived in constant pain. I've had fourteen years of a new lease of life since it was inserted. That's a big thank you, if we subsequently decide there might be a secondary problem, you still can't take it back out, I'm keeping it. You can keep the panic to yourself, I don't care.
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Fozwords
Abandon hope when you post on here
06:42 PM on 01/29/2012
This story is at least 8nmonths old and has to a degree been investigated and is being dealt with, get a grip AOL/hUFF
06:42 PM on 01/29/2012
Did you say "they also need to learn how to spell" look at what you have written!.

However, what you say is to a degree correct regarding benefits to patients, and those who really suffer need relief to constant pain, especially if they have a condition more life threatening than the cure on offer.

I do think however there is all too often commercial risk taking for profit in the medical industries before products are fully tested. Breast implants come to mind as a fond discussion.
The lists seem to grow by the month so, its good watchdogs are at least vigilant.
06:14 PM on 01/29/2012
pot calling kettle black re spelling, I know i spelled weigh wrong, sorry!
06:46 PM on 01/29/2012
Spelt please, not spelled.
07:18 PM on 01/29/2012
Spelt not spelled, please.
06:06 PM on 01/29/2012
I would of thought metal on metal would be a serious design flaw. Is it not better to investigate or research products before they are actually put in a human body?, perhaps it costs too much??
08:32 PM on 01/29/2012
Why is it that people tend to put 'I would of thought' instead of 'I would have thought'? It is simple English. Please use it correctly.
01:05 AM on 02/04/2012
I would of thought it's because they don't give a monkeys?.
05:52 PM on 01/29/2012
I agree, some folk on here not only need to educate themselves they also need to learn how to spell, total hip replacement surgery is carried out for a variety of reasons, arthritis, trauma, ageing process, etc, please people dont be so quick to judge others, you never no what type of replacements you may require in the future. The millions o people that have had hip replacements most of them have regained their mobility, are for the most part pain free. I think it must be very hard to say that anything is 110% safe, so i suppose they way the benefits against the risks in their decision making.
08:10 PM on 01/29/2012
You're absolutely right. They do need to learn to spell, but what about punctuation and capital letters? Yours are terrible. Where are the other full stops you should have had in there and the capital 'I'? Talk about the pot calling the kettle black!