DePuy ASR Recall - March 2012 Update - The Lancet and the BMJ Studies
Over the last 2 weeks, studies in the UK have radically changed our understanding of the issues surrounding the defective DePuy ASR hip implant from both a medical and a legal perspective.
To remind readers, the reason why issues surrounding the DePuy ASR implants are so important is that some 2,000 people here in the southeast of Ireland received these types of Metal on Metal hip implants between 2003 and August 2010 when they were finally recalled. Per head of population, there are more of these defective implants here in the southeast than anywhere else in the world!
Metal on Metal implants are so called because both parts of the artificial joint, the ball and the cup are both made of metal and typically the metal used is a chromium and cobalt alloy. Other types of hip implants are made of ceramic or use a metal on plastic design.
The BMJ/BBC Report
On the 28th February last, the British Medical Journal (BMJ) working with the BBC published a report of their investigation into the DePuy ASR disaster.(READ THE REPORT) They made some shocking findings. From a health perspective, they found that apart from the serious harm that these implants have caused to many patients’ hips, the metal particles released into the body from the excessive wearing of the implant can at high levels cause serious health problems including an increased risk of cancer.
From the legal and moral perspective, the most damning finding was that DePuy - a division of Johnson & Johnson - knew of the harm that was being caused by this product as early as July 2005 and kept selling it for profit, year after year. From a leaked 2005 internal DePuy report the BMJ/BBC quote “In addition to inducing potential changes in immune function, there has been concern for some time that wear debris may be carcinogenic….. One study suggested a threefold risk of lymphoma and leukaemia 10 years after joint replacement.”
Despite these alarming risks and the growing concerns in Australia and the UK from 2007 onwards that these products were failing at a rate far higher than other competitor products, DePuy ASR products were recommended to thousands of patients here in Ireland and the majority of the 3000 plus units sold here were implanted after this period. Of all the patients that I have spoken to, not one was warned of these risks. Neither were they told that there were alternative implants on the market offering patients far better outcomes.
The Lancet
The second study came out just last week from The Lancet, which like the BMJ above, is one of the most respected medical journals in the world. On 13th March 2012, The Lancet published a study that compared the performance of Metal on Metal implants with other implant types such as those made of ceramic or metal on polyethylene plastic. The study concluded that Metal on Metal implants have unacceptably high failure rates and it recommended that their use should be discontinued immediately.(READ THE REPORT)
The authors recommended that all patients with any kind of Metal on Metal implant should be kept under annual scrutiny for the full life of the implant due to the health risk that such implants represent. This means that not just people with DePuy ASR implants, but the thousands of others with different makes or models of Metal on Metal hip implants, will require annual checks to test the levels of potentially toxic metal particles in their blood, have x-rays and possibly scans performed to monitor how their implant is performing.
With regard to the statistics on the rate of failure of Metal on Metal implants, at present it looks to some researchers that the failure rate for the DePuy ASR devices will hit 50% meaning about 1,000 people in Counties Tipperary, Waterford, Wexford and Kilkenny have either already had or will have to undergo major surgery, pain and suffering not to mention the risk of further complication because of this defective product.
Recent statistics from the UK show that leaving aside the ASR product, the other types of Metal on Metal implant such as Pinnacle and BHR have an average failure rate of 12% over 8 years. This is very high when compared to the alternative of a ceramic or even a metal on plastic hip which only have a failure rate of about 2% over the same period.
In Ireland, the Irish Medicines Board (IMB) is the State authority charged with licensing the use of such medical devices. It licensed the use of the DePuy ASRs and other Metal on Metal hip implants apparently on the basis that other countries had licensed it. No clinical trial was required of DePuy.
Since April 2010 in the UK, the MHRA which is their equivalent of the IMB has insisted that all patients with Metal on Metal implants be tested annually for at least the first five years after surgery and last week they increased this requirement to cover the full life of the implant. In Ireland however, the IMB has made no such requirement of medical companies such as DePuy. Here it seems to be ‘business as usual’ and Metal on Metal implants are still licensed for use here.
So now we know that metal on metal hip implants perform terribly and of these, the DePuy ASRs perform the worst by far. We know that Metal on Metal implants of every make release metal ions into the blood stream and release wear particles at the hip and both of these releases of metal can cause serious harm to the patient. We know that the metal at the hip can cause an immune response leading to inflammation and damage to soft tissues and bone. We know that metal ions in the blood can cause damage in other organs. We know that the metals cobalt and chromium used in the manufacture of these products have been declared by the World Health Organisation as potential cancer causing agents. We know that DePuy knew of all these risks to patient health long before they recalled their product in 2010 and knew much of it as early as 2005.
To remind readers, the reason why issues surrounding the DePuy ASR implants are so important is that some 2,000 people here in the southeast of Ireland received these types of Metal on Metal hip implants between 2003 and August 2010 when they were finally recalled. Per head of population, there are more of these defective implants here in the southeast than anywhere else in the world!
Metal on Metal implants are so called because both parts of the artificial joint, the ball and the cup are both made of metal and typically the metal used is a chromium and cobalt alloy. Other types of hip implants are made of ceramic or use a metal on plastic design.
The BMJ/BBC Report
On the 28th February last, the British Medical Journal (BMJ) working with the BBC published a report of their investigation into the DePuy ASR disaster.(READ THE REPORT) They made some shocking findings. From a health perspective, they found that apart from the serious harm that these implants have caused to many patients’ hips, the metal particles released into the body from the excessive wearing of the implant can at high levels cause serious health problems including an increased risk of cancer.
From the legal and moral perspective, the most damning finding was that DePuy - a division of Johnson & Johnson - knew of the harm that was being caused by this product as early as July 2005 and kept selling it for profit, year after year. From a leaked 2005 internal DePuy report the BMJ/BBC quote “In addition to inducing potential changes in immune function, there has been concern for some time that wear debris may be carcinogenic….. One study suggested a threefold risk of lymphoma and leukaemia 10 years after joint replacement.”
Despite these alarming risks and the growing concerns in Australia and the UK from 2007 onwards that these products were failing at a rate far higher than other competitor products, DePuy ASR products were recommended to thousands of patients here in Ireland and the majority of the 3000 plus units sold here were implanted after this period. Of all the patients that I have spoken to, not one was warned of these risks. Neither were they told that there were alternative implants on the market offering patients far better outcomes.
The Lancet
The second study came out just last week from The Lancet, which like the BMJ above, is one of the most respected medical journals in the world. On 13th March 2012, The Lancet published a study that compared the performance of Metal on Metal implants with other implant types such as those made of ceramic or metal on polyethylene plastic. The study concluded that Metal on Metal implants have unacceptably high failure rates and it recommended that their use should be discontinued immediately.(READ THE REPORT)
The authors recommended that all patients with any kind of Metal on Metal implant should be kept under annual scrutiny for the full life of the implant due to the health risk that such implants represent. This means that not just people with DePuy ASR implants, but the thousands of others with different makes or models of Metal on Metal hip implants, will require annual checks to test the levels of potentially toxic metal particles in their blood, have x-rays and possibly scans performed to monitor how their implant is performing.
With regard to the statistics on the rate of failure of Metal on Metal implants, at present it looks to some researchers that the failure rate for the DePuy ASR devices will hit 50% meaning about 1,000 people in Counties Tipperary, Waterford, Wexford and Kilkenny have either already had or will have to undergo major surgery, pain and suffering not to mention the risk of further complication because of this defective product.
Recent statistics from the UK show that leaving aside the ASR product, the other types of Metal on Metal implant such as Pinnacle and BHR have an average failure rate of 12% over 8 years. This is very high when compared to the alternative of a ceramic or even a metal on plastic hip which only have a failure rate of about 2% over the same period.
In Ireland, the Irish Medicines Board (IMB) is the State authority charged with licensing the use of such medical devices. It licensed the use of the DePuy ASRs and other Metal on Metal hip implants apparently on the basis that other countries had licensed it. No clinical trial was required of DePuy.
Since April 2010 in the UK, the MHRA which is their equivalent of the IMB has insisted that all patients with Metal on Metal implants be tested annually for at least the first five years after surgery and last week they increased this requirement to cover the full life of the implant. In Ireland however, the IMB has made no such requirement of medical companies such as DePuy. Here it seems to be ‘business as usual’ and Metal on Metal implants are still licensed for use here.
So now we know that metal on metal hip implants perform terribly and of these, the DePuy ASRs perform the worst by far. We know that Metal on Metal implants of every make release metal ions into the blood stream and release wear particles at the hip and both of these releases of metal can cause serious harm to the patient. We know that the metal at the hip can cause an immune response leading to inflammation and damage to soft tissues and bone. We know that metal ions in the blood can cause damage in other organs. We know that the metals cobalt and chromium used in the manufacture of these products have been declared by the World Health Organisation as potential cancer causing agents. We know that DePuy knew of all these risks to patient health long before they recalled their product in 2010 and knew much of it as early as 2005.
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So once again we get a glimpse of the interface between medicine and commerce. It is a murky world where truth and the best interests of the patient clearly come a poor second to the interests of profit.
At present Cian O'Carroll Solicitors is at an advanced stage of court proceedings for the first group of our clients who have had to have surgery to remove their ASR implants. There are many more to follow but now it seems likely that given the scale of the deception by DePuy uncovered by the BMJ/BBC report, almost all patients who have received these implants will have a potential cause of action. Meanwhile the study published in The Lancet suggests that many more people who received metal on metal implants other than the DePuy ASR may well have the right to seek legal redress also. |
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If you have a query regarding the DePuy ASR Recall or any Metal on Metal hip implant you can contact Cian O’Carroll Solicitors on Freephone 1-800 60-70-80 or CONTACT US
