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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

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    I hope there is a final settlement, I am always a bit suspicious of the "tentatively agreed to a settlement".
     
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  2. Josephine

    Josephine NURSE DIRECTOR, BONESMART Administrator

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    I'm sure I heard about that a while ago :scratch:
     
  3. Pumpkln

    Pumpkln Forum Advisor

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  4. Poppet

    Poppet Nutritional Advisor

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    Thanks Pumpkln

    This is a little disappointing - "Several lawyers involved in the case said the plan would most likely appeal to patients who did not have any complications after the device’s removal, a group presumed to comprise the vast bulk of claimants"

    Watch and wait.. Medical/legal cases are always long and protracted.... I have had experience with this.. :(
     
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  5. Bumpa

    Bumpa Sr Bonesmartie

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    Some more news from the British Medical Journal about mortality and metal-on-metal prostheses:

    Mortality rates at 10 years after metal-on-metal hip resurfacing compared with total hip replacement in England: retrospective cohort analysis of hospital episode statistics


    Results 7437 patients undergoing metal-on-metal hip resurfacing were matched to 22 311 undergoing cemented total hip replacement; 8101 patients undergoing metal-on-metal hip resurfacing were matched to 24 303 undergoing uncemented total hip replacement. 10 year rates of cumulative mortality were 271 (3.6%) for metal-on-metal hip resurfacing versus 1363 (6.1%) for cemented total hip replacement, and 239 (3.0%) for metal-on-metal hip resurfacing versus 999 (4.1%) for uncemented total hip replacement. Patients undergoing metal-on-metal hip resurfacing had an increased survival probability (hazard ratio 0.51 (95% confidence interval 0.45 to 0.59) for cemented hip replacement; 0.55 (0.47 to 0.65) for uncemented hip replacement). There was no evidence for an interaction with age or sex.
    Conclusions Patients with hip osteoarthritis undergoing metal-on-metal hip resurfacing have reduced mortality in the long term compared with those undergoing cemented or uncemented total hip replacement. This difference persisted after extensive adjustment for confounding factors available in our data. The study results can be applied to matched populations, which exclude patients who are very old and have had complex total hip replacements. Although residual confounding is possible, the observed effect size is large. These findings require validation in external cohorts and randomised clinical trials.
    http://www.bmj.com/content/347/bmj.f6549
     
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  6. Pumpkln

    Pumpkln Forum Advisor

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  7. ARHip

    ARHip Senior

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  8. Bumpa

    Bumpa Sr Bonesmartie

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  9. Bumpa

    Bumpa Sr Bonesmartie

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  10. Josephine

    Josephine NURSE DIRECTOR, BONESMART Administrator

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    Phew! That's a relief!
     
  11. Bumpa

    Bumpa Sr Bonesmartie

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    From a recent edition of the Bone and Joint Journal: This article was originally published in the Canadian Orthopaedic Association’s COA Bulletin #95, Winter 2011 edition.
    The case of metal-on-metal implant recalls: what have we learned?
    In recent decades, the introduction of new drugs and implants has often been accompanied by enthusiastic acceptance by the medical community. However there are cases where this initial enthusiasm is dampened by unexpected complications.

    A typical example of this is the case of silicone breast implants that were manufactured in the early 1960s by Dow Corning (Midland, Michigan) and were successfully used by plastic surgeons for several years. Throughout the 1980s and 1990s reports began to arise, claiming that the silicone breast implants were causing systemic health problems. These led to numerous lawsuits beginning in 1984, culminating in a 1998 multi-billion dollar class action settlement. As a result, Dow Corning was in bankruptcy protection for nine years, ending in June 2004. A number of large, independent reviews of the scientific literature, including the United States Institute of Medicine, have since found that silicone breast implants do not appear to cause breast cancers or any identifiable systemic disease. Silicone is, once again, routinely found in breast implants.

    In orthopaedic surgery, there are several examples of recalled implants. In 2008, Stryker (Kalamazoo, Michigan) voluntarily recalled the Trident PSL Acetabular and Hemispherical Acetabular Cup because of poor fixation, squeaking and improper seating due to broach mismatch that resulted in fractures. On the other hand, many implants have been discontinued because of poor performance, but were never actually recalled.

    Sulzer Medica issued a voluntary recall of its Inter-Op metal-on-metal (MoM) shell in January 2001, after a series of adverse reports from surgeons1 led to the discovery that a lubricant had leaked into the manufacturing device coolant and contaminated approximately 25 000 units, of which 17 500 were implanted. The lubricant was a mineral oil-based substance that remained as residue and prevented bone ingrowth, resulting in loosening of the implant. In our department, of the 163 Inter-op prostheses implanted, 11 were revised because of the manufacturer’s recall at a mean of 1.1 years. The overall survivorship rate for all-cause revision was 91.3%, with this rate increasing to 97.5% at nine years when excluding the recalled hips.

    The Articular Surface Replacement (ASR) hip resurfacing and MoM arthroplasty (DePuy Orthopaedics, Warsaw, Indiana) system were introduced in early 2004. In September 2010, DePuy recalled the ASR hip implants. Data from the national joint registries of England and Wales and Australia found that the ASR Resurfacing System had a revision rate of 12% and the ASR XL Acetabular System had a revision rate of 13%. Reasons for failure include loosening, fracture, dislocation and rarely a localised soft-tissue reaction called ‘pseudotumour’. Jameson et al2 reported on 214 ASR resurfacings, of which 40% were in women, with a mean follow-up of 43 months. There were 12 revisions (5.6%) and the overall survival was 93% (89% for hips with acetabular components < 56 mm in diameter). Lower diametrical clearance and the subhemispherical acetabular component may have contributed to the higher failure rate when compared to other designs. Langton et al3 reported a 25% failure rate at six years of the ASR resurfacing and a 49% failure of the ASR THR. They concluded that the design of the ASR acetabular component and its predisposition to edge wear are likely to be the most important contributors to failure. They also reported that abnormal wear at the head–neck junction may be a major contributing factor to the development of pseudotumour in MoM hip replacements using bearing diameters ≥ 36 mm.

    In our department, 594 ASR resurfacings were implanted over 80 months with a mean follow-up of five years. Overall, we had 16 failures (2.7%), five femoral neck fractures, two acetabular component loosening, two femoral component loosening, two avascular necrosis of the femoral head and three infections. Two cases were revised since the recall was announced. One for fear of having a recalled implant and one because of high ion levels, both in well-functioning prostheses. The survivorship rate is 97.3% at 7.5 years. We have undertaken no revisions for pseudotumours. Given the wide discrepancy in clinical outcomes with the same implant, there seems to also be technique and patient selection variables at play.

    On April 2010, the British Orthopaedic Association (BOA) issued a medical device alert for all MoM hip replacements with specific recommendations for follow-up, testing and metal ion levels, without highlighting a particular device. In February 2011, the Canadian Orthopaedic Association (COA) issued similar recommendations but pinpointed ASR specifically. DePuy sent a letter, prepared by lawyers, to all patients, which included recommendations for evaluation and treatment. However, many of these recommendations are not based on solid scientific data. We issued a letter to all of our patients explaining the situation and discussing our outcomes. We reassured our patients that in the absence of pain or symptoms, the serious soft-tissue reactions are rare. We closely follow our patients annually, evaluating them clinically, radiologically and by measuring cobalt and chromium ion levels. In the presence of symptoms or high ion levels, an MRI using metal artifact reduction sequence (MARS)4 is routinely performed.

    ‘Recall’ is an unfortunate word to use for any implanted material and some have argued that the word should be changed to ‘medical advisory’. It is essential to closely follow patients, answer all their questions and calm their anxiety. Use of the term recall leads to an expanding wave of hysteria, fanned by lawyers and the Internet, that can lead to unnecessary or even risky actions. In many cases, the true reasons for failures are multifactorial, including improper patient selection, surgical technique and implant design. As we are currently dealing with incomplete data in a very volatile environment, it is imperative that cooler heads prevail and that a panel of experts be consulted anytime an official position is taken by any association. All recommendations should include the level of evidence on which they are based. Our goal should be to minimise needless fear while keeping both surgeons and patients informed.

    Key summary points

    1. The use of the term “recall” when it comes to implants is controversial. The medical community may be better served by terms such as “medical advisory”.

    2. Given the mounting hysteria surrounding a recall, communicating and informing all affected patients is very helpful in mitigating undue stress.

    3. Professional associations should communicate official recommendations based on the informed opinion of an expert panel. The level of evidence behind the recommendations should also be cited.
     
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  12. Bumpa

    Bumpa Sr Bonesmartie

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    Well now, this is a bit of a surprise in view of the many adverse comments about metal-on-metal:
    Study: Good results found for second-generation metal-on-metal total hip bearings
    Patients who underwent total hip arthroplasty with second-generation metal-on-metal bearings had results similar to patients who received other hard-on-hard bearings at the 17-year follow-up.
    http://www.healio.com/orthopedics/h...-generation-metal-on-metal-total-hip-bearings
     
  13. FraidyCat

    FraidyCat Member

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    I am confused as to why all of the posts on this topic have a date of 2012 beneath them if the thread was begun within the last 24 hours. It appears that the thread is nine webpages long, with oldest posts being listed first, which may be the source of the confusion. Also, the link from The Telegraph is recent. Since this is a UK publication, I'm not familiar with whether it's considered a sensationalist tabloid vs. a reputable media source. Leaving that question aside for the moment: the writing does not sound hyperbolic. And I see nothing in the piece suggesting that the MoM problem is limited to "only" one model of implant; it sounds as though there is growing concern about MoM implants in general.

    Also, this piece, with link provided in a sidebar to the above article, cites a study published in BMJ (British Medical Journal) that cites a high rate of not-proved-safe implants: http://www.telegraph.co.uk/health/healthnews/10528969/No-proof-quarter-of-hip-implants-work.html

    I don't see why this is something that we need not all be concerned about, at least to the extent that we question our surgeons very closely about the devices they are choosing. I do not subscribe to the doctors-know-best doctrine.
     
    Last edited: Mar 27, 2014
  14. Hoppy Nanny

    Hoppy Nanny Sr Bonesmartie

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    @FraidyCat... Understand where you are coming from but sometimes the more questions you ask...the more confused it all becomes. I think I was lucky insomuch that I just left it all to my surgeon...didn't even know what implant I would have, what approach he would use,...etc.....because so many different protocols that I think I would have driven myself mad. Sometimes ignorance is bliss!! X
     
  15. Josephine

    Josephine NURSE DIRECTOR, BONESMART Administrator

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    I don't understand what you mean by this. January 2012 is 2yrs and 3 months ago! Or did you think that number was the time? :scratch:

    mom.PNG
     
    Last edited: Mar 28, 2014
  16. Kbill1955

    Kbill1955 New Member

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    Just in passing, from Colorado in the USA.
    I have had a m to m hip since June 2001 and I have no issues with it. The surgeon told me when it went in, it was the 3rd of it's type in the World, but I have no idea who made it. I know that after 13 years holding up a 290 pound 6'5" (131.541 kg 195.58 cm) pretty active guy, the X-Rays show very little wear. My surgeon said he used the smallest one he could due to later replacements.
     
  17. Poppet

    Poppet Nutritional Advisor

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    That is interesting @Kbill1955 - it would be good to know the manufacturer :) very pleased you are having no issues :)
     
  18. pitzer434

    pitzer434 New Member

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    Alex is right!
     
  19. Bumpa

    Bumpa Sr Bonesmartie

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    Pumpkin, my apologies, I have just come across your comment.
    In my early days involved with hip replacements and McKee Farrar replacement in particular we were told of the dangers of cobalt salts as a result of beer drinking in Saskatchewan. The cobalt was added to the beer to give it a better 'head'. However, it was demonstrated that heavy drinkers (not weighty!) demonstrated cobalt in their hair follicles and urine.
     

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