BoneSmart® Hip / Knee Replacement Forum
Knee Replacement & Hip Replacement
Patient Advocacy & Online Community
  1. Your support makes a difference...BoneSmartie Member

    Industry changes have drastically reduced orthopedic partner contributions, which for 13+ years supported the operation and development of BoneSmart.org.

    Our patient-focused articles and world-class joint replacement community forum have helped millions of people. Your gift today provides the important funds necessary to keep this valuable resource online.


    Donate Now
    Dismiss Notice

Metal on Metal warning (old but ongoing news)

Discussion in 'Hip Replacement Pre-Op Area' started by Dingbat7, Jan 28, 2012.

  1. Poppet

    Poppet Nutritional Advisor

    Member Since:
    Sep 5, 2011
    Messages:
    14,949
    Gender:
    Female
    Country:
    Australia Australia
    Absolutely.. More scrutiny... Other articles indicated how our Therapeutic Goods Association Government Department is really putting companies through the hoops on all sorts of items related to joint replacements... a very good move!
     
  2. Bumpa

    Bumpa Sr Bonesmartie

    Member Since:
    Aug 7, 2011
    Age:
    79
    Messages:
    760
    Gender:
    Male
    Location:
    Bedfordshire
    Country:
    United Kingdom United Kingdom
    Alister Hart of the UK reported a paper to the AAOS (American Academy of Orthopedic Surgeons) meeting


    Study: No ‘safe’ blood metal ion level helps to predict function in MoM hips
    March 21, 2013

    CHICAGO — In a large, single-center cohort study using one type of metal-on-metal hip bearing (ASR), researchers from the United Kingdom and Finland concluded there is no ideal blood metal ion cut-off level to predict hip function.


    Interestingly was the Disclosure: Hart is a paid consultant for DePuy and has received research or institutional support as a principal investigator from Biomet, Corin USA, DePuy, Finsbury, Mathys Ltd., Smith & Nephew, Zimmer and Stryker.

    How's that for independence? :scratch:
     
  3. Josephine

    Josephine NURSE DIRECTOR, BONESMART Administrator

    Member Since:
    Jun 8, 2007
    Age:
    75
    Messages:
    69,415
    Location:
    The North
    Country:
    United Kingdom United Kingdom
    Puts another spin on the phrase "spreadin' around money"!!
     
  4. Poppet

    Poppet Nutritional Advisor

    Member Since:
    Sep 5, 2011
    Messages:
    14,949
    Gender:
    Female
    Country:
    Australia Australia
    What a mess!
     
  5. Bumpa

    Bumpa Sr Bonesmartie

    Member Since:
    Aug 7, 2011
    Age:
    79
    Messages:
    760
    Gender:
    Male
    Location:
    Bedfordshire
    Country:
    United Kingdom United Kingdom
    And this from today's (04 April 2013) Daily Telegraph:

    Minster Andrew Robathan's fury over faulty replacement hips:
    An MP has spoken of his anger at faulty replacement hips which have left him in agony and needing two operations.

    Andrew Robathan says he intends to sue De Puy, the US makers of the metal joints, which were the subject of a worldwide product recall in 2010.

    The Tory MP and defence minister has developed a non-cancerous tumour at the top of his leg, which his GP believes is linked to the metal hips.

    De Puy have offered to pay for new hips for all those affected by the product.

    About 10,000 people in the UK had the ASR hips fitted before the company recalled them in 2010, after tests raised concerns about potentially toxic metal filings getting into the bloodstream.

    "It is not like a recall of a fridge or a car. It is a bit more difficult than that," says Mr Robathan, a former member of the Coldstream Guards."They are quite long and unpleasant operations. What makes me angry is that there were warnings about this component a year before I had my operation. I am quite capable of looking after myself but a lot of these devices went to older people, in quite difficult situations, who may find it more difficult than me to take action."

    Mr Robathan had both his hips "resurfaced" in 2006, at the age of 54, after wear-and-tear on his joints caused by his time as a paratrooper in the special forces. "I had worn out my cartilage, partly because I had given them a good hammering in the army for the best part of 20 years," he says. His NHS surgeon recommended the ASR hips, as they were designed for relatively young people who lead active lives.

    At first the operations seemed to have worked well, but by 2011 he was in severe pain, had difficulty climbing stars and was unable to stand for long periods. He said he was prepared to accept the fault was with the ASR hips until he discovered a British surgeon, Derek McMinn, inventor of the widely-used Birmingham hip resurfacing system, had warned about potential problems with them in 2005.

    At every step of the way, the company carefully considered the data on ASR and actively engaged with surgeons about their general feedback on the ASR system” De Puy spokesman

    "What makes me angry is that there were warnings about this component a year before I had my operation. They were warned that they would fail and they continued marketing them until 2010," says Mr Robathan.

    De Puy, a subsidiary of US multinational Johnson and Johnson, is being sued by more than 100 people in the UK over ASR replacement hips. About 93,000 people around the world are ASR patients.

    A De Puy spokesman said he could not comment on the McMinn study but the product had been thoroughly tested and peer-reviewed prior to launch and had met EU standards.
    "At every step of the way, the company carefully considered the data on ASR and actively engaged with surgeons about their general feedback on the ASR system," he told BBC News.

    The company believed the product was performing well until August 2010 when it "received new information from the National Joint Registry of England and Wales reporting that 12% of ASR resurfacing patients and 13% of ASR Total Hip Replacement patients were undergoing second hip replacement surgery sooner than expected".
    "We believe we made the appropriate decision to recall at the appropriate time given the available information," the spokesman added.

    He said the company "regrets that the ASR Hip System did not perform as expected for some patients, and we understand the voluntary recall has been concerning for ASR patients and healthcare providers".

    But De Puy was "committed to working with patients and hospitals to address medical costs directly associated with the recall," as well as patients' lost wages and travel costs.
    The spokesman advised concerned patients to call the company's helpline on 0800 2794865.
     
  6. Poppet

    Poppet Nutritional Advisor

    Member Since:
    Sep 5, 2011
    Messages:
    14,949
    Gender:
    Female
    Country:
    Australia Australia
    Interesting article, thank you Bumpa.

    I wonder what the world wide numbers of patients with MoM are?

    I would imagine a lot of patients would not make a connection to some of the health issues they may be experiencing... and I would imagine this continuing to emerge for years if not another decade...
     
  7. AlbinoRaven

    AlbinoRaven Junior Member

    Member Since:
    Feb 9, 2013
    Age:
    30
    Messages:
    40
    Gender:
    Male
    Country:
    United States United States
    Very good reads, it is certainly a murky situation, there is so much money in this and so many unknowns (a risk, but there always is). It seems that some doctors know as little about things as the patients (doctors were installing recalled hips after they were recalled for quite some time). There does seem to be an exception for later models though (and I've heard the birmingham is one of those, as long as you select the patient carefully), but it certainly makes patients uneasy. Some of the articles are very sensationalist, but you could take it as warning the public. Then there are those espousing how great they are, but there is money in this (Some are independent).

    A lot of this is also that the human mind is trained to see the negative, in the days of old it saved us a lot, so its much easier for the public to latch onto the negative. The longest lasting hip was all metal....
     
  8. Josephine

    Josephine NURSE DIRECTOR, BONESMART Administrator

    Member Since:
    Jun 8, 2007
    Age:
    75
    Messages:
    69,415
    Location:
    The North
    Country:
    United Kingdom United Kingdom
    and you know this from where? Just interested.

    As it happens, the first hip replacements were always MoM but not steel, they were cobolt chrome. Whether that made a difference or not is impossible to know but it is a fact that the numbers done then were minuscule compared to 20-30 years later when there was a veritable explosion in numbers! Of course, by then Charnley had cornered the market with his metal-on-plastic hip which rather postponed this issue. As for the resurfacing, there have been almost as many HRs with this problem as THRs though Derek McMinn (inventor and prolific HR surgeon on both sides of the Atlantic) insists he has no MoM issues arising in his not insignificant number of patients but sadly other HR surgeons cannot say the same.

    As for MoM now, it is what you might call a totally blacklisted device and patients should avoid them at all costs.
     
  9. Allycat

    Allycat Graduate

    Member Since:
    Mar 24, 2013
    Age:
    57
    Messages:
    511
    Gender:
    Female
    Location:
    Sydney
    Country:
    Australia Australia
    Before coming on this forum I had no idea about the metal on metal problems. I was probably a bit naive and actually didn't realise there were so many different types. When I saw my OS for the initial consultation, he said to me "I suppose you've heard all the controversy about MoM replacements". When I said I hadn't, he said, well you just need to know that I don't use them.
    Thank Goodness!!
     
  10. AlbinoRaven

    AlbinoRaven Junior Member

    Member Since:
    Feb 9, 2013
    Age:
    30
    Messages:
    40
    Gender:
    Male
    Country:
    United States United States
    The longest lasting hip was the McKee hip? You posted about it previously...

    I didn't realize that other doctor's were having such bad luck with the resurfacing, that certainly stinks.
     
    • Agree Agree x 1
  11. Bumpa

    Bumpa Sr Bonesmartie

    Member Since:
    Aug 7, 2011
    Age:
    79
    Messages:
    760
    Gender:
    Male
    Location:
    Bedfordshire
    Country:
    United Kingdom United Kingdom
  12. Poppet

    Poppet Nutritional Advisor

    Member Since:
    Sep 5, 2011
    Messages:
    14,949
    Gender:
    Female
    Country:
    Australia Australia
    That must be devastating to the patient and not a good precedent for the future cases..
     
  13. Bumpa

    Bumpa Sr Bonesmartie

    Member Since:
    Aug 7, 2011
    Age:
    79
    Messages:
    760
    Gender:
    Male
    Location:
    Bedfordshire
    Country:
    United Kingdom United Kingdom
    The Daily Telegraph (UK) today records a letter from a patient who had a metal-on-metal hip. I think this is not good as organs may be at risk from metallic ions.
    Sir,

    I had an MRI scan on my metal hip replacements at the National Orthopaedic Hospital at Stanmore on April 16. I have just heard that my appointment for the results is July 31, three and a half months after the scan.

    The good news is that I am on a waiting list for an earlier appointment.

    xxx,

    Luton, Bedfordshire
     
  14. Josephine

    Josephine NURSE DIRECTOR, BONESMART Administrator

    Member Since:
    Jun 8, 2007
    Age:
    75
    Messages:
    69,415
    Location:
    The North
    Country:
    United Kingdom United Kingdom
  15. Bumpa

    Bumpa Sr Bonesmartie

    Member Since:
    Aug 7, 2011
    Age:
    79
    Messages:
    760
    Gender:
    Male
    Location:
    Bedfordshire
    Country:
    United Kingdom United Kingdom
    Jo, sorry it was only on the letters page. I have forwarded it to a colleague who is the Lead Patient Governor on the Luton & Dunstable Foundation Trust for comment and exploration.
     
  16. Bumpa

    Bumpa Sr Bonesmartie

    Member Since:
    Aug 7, 2011
    Age:
    79
    Messages:
    760
    Gender:
    Male
    Location:
    Bedfordshire
    Country:
    United Kingdom United Kingdom
    I was involved over 18 years in Corporate and European Medical Devices Directives (regulations) and I still believe that the regulations are adequate; it's that they are neither consistently applied nor rigorously followed. 10 Notified Bodies have a wide range of variation!

    Trials are needed before new devices are used in routine practice in Europe
    BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f1646 (Published 18 March 2013)
    Cite this as: BMJ 2013;346:f1646
    Philipp Storz-Pfennig, consultant, Mechtild Schmedders, consultant, Matthias Dettloff, consultantAs the EU debates new legislation to regulate medical devices, Philipp Storz-Pfennig, Mechtild Schmedders, and Matthias Dettloff provide examples from Germany to show why the current proposals do not go far enough and call for further assessment after market approval

    A growing number of examples, including metal on metal hip implants and breast implants, show the harm that can result from new devices and procedures being introduced without a rigorous assessment of their safety and efficacy. This has led to the wide acceptance that the system for regulating medical devices, particularly in the European Union (EU) is flawed. The European parliament is currently debating proposals put forward last year by the European Commission to reform the EU legislation for medical devices and in vitro diagnostics.

    However, the new proposals will not change market access to new devices appreciably. Notified bodies will continue to grant market approval (through CE certificates), although quality assurance will be stepped up - the European Commission will have to set up a medical devices coordination group to supervise notified bodies and advise on their assessments of new high risk devices and diagnostic tests, and there will be harmonised criteria for accreditation. After a device is approved, there will also be stronger postmarketing surveillance. The proposals include the introduction of a “unique device identifier” and unheralded inspections of device manufacturers by notified bodies.

    The proposals fall short of what is required to prevent high risk devices being used without reliable evidence on their safety and efficacy—as is required for new drugs. And manufacturers will still be free to define and amend the intended purpose of their devices without having to get approval from any authority. EU member states will therefore still have to make decisions about …
     
  17. Bumpa

    Bumpa Sr Bonesmartie

    Member Since:
    Aug 7, 2011
    Age:
    79
    Messages:
    760
    Gender:
    Male
    Location:
    Bedfordshire
    Country:
    United Kingdom United Kingdom
    Perhaps having an MRI can is a better way of diagnosing problems with these prostheses:
    Study: MRI predicts failure in MoM hips by identifying tissue damage
    May 20, 2013
    Researchers from Hospital for Special Surgery have found a way to identify synovitis using MRI in patients who underwent metal-on-metal hip resurfacing arthroplasty before symptoms appear.

    http://www.healio.com/orthopedics/imaging/news/online/{ED4A6D54-132F-4B8B-89EA-BA4B0A8BDC7E}/Study-MRI-predicts-failure-in-MoM-hips-by-identifying-tissue-damage
     
  18. bottomshollow

    bottomshollow Moderator

    Member Since:
    Sep 17, 2011
    Age:
    74
    Messages:
    15,188
    Gender:
    Female
    Location:
    Eastern NC
    Country:
    United States United States
  19. Josephine

    Josephine NURSE DIRECTOR, BONESMART Administrator

    Member Since:
    Jun 8, 2007
    Age:
    75
    Messages:
    69,415
    Location:
    The North
    Country:
    United Kingdom United Kingdom
    “The study shows that synovitis exists in asymptomatic people in a fairly high prevalence,” chief of the Division of Magnetic Resonance Imaging at Hospital for Special Surgery, stated in a press release. “If that is the case, symptoms alone are insufficient to determine the health of an implant. You can’t wait for people to be sore before we evaluate them for this potential problem.”

    A very accurate statement.
     
  20. pcal

    pcal New Member

    Member Since:
    May 24, 2013
    Age:
    62
    Messages:
    11
    Gender:
    Male
    Country:
    United States United States
    hey everyone

    This is a long thread so hard to find in it what I am looking for;

    I am led to believe the Birmingham resurfacing does not have a greater occurrence if issues than conventional hips, is this true or is the Birmingham also considered a culprit?

    BHR 2010, Dr Ron Light, Long Island Jewish, currently going to have another BHR unless my research indicates otherwise
     

Share This Page

If this forum is helpful to you, please consider a donation!

Support BoneSmart with a Tax Deductible Donation

Sponsors
Close X