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When: Jul 30, 12
Where: DePuy Hip Implants, Litigation, Medical negligence, News
Who: Staff
With: No Comments »

DePuy Orthopaedics Inc introduced two hip implant devices to the market in July, 2003.  The two devices, the ASR™  XL Acetabular System and the ASR™ Hip Resurfacing System, were metal-on-metal devices and were intended to replace the traditional metal head and plastic socket system to the benefit of younger patients in particular as the metal-on-metal was supposed to last longer.

In England and Wales a national joint register is maintained whereby doctors log implant details on a central database.  A similar registry exists in Australia.  As a result both the implant and the patient in receipt of the implant are monitored and any difficulties or issues which are identified are logged accordingly.  Thanks to the national joint registers in the UK and Australia higher than expected failure rates for both DePuy devices were detected.  The normal limits for failure are between 3 and 6% however the National Joint Registry in theUK identified failure rates of 12% for theASR™ Hip Resurfacing System and 13% for theASR™ XL Acetabular Hip System (DePuy’s total hip replacement system).  Consequently, a worldwide recall of the two medical devices was announced by DePuy in August, 2010.  The devices had already been voluntarily recalled in Australia in 2009 due to the high failure rates detected in the Australian joint registry as early as 2007.

The absence of a national joint registry in Irelandmade the task of identifying all of the patients affected by the recall a difficult one for the HSE.  DePuy did not maintain a list of patients who received these devices.  Interestingly, the United States does not maintain a national joint registry either and therefore the medical authorities there have had to rely on the data obtained in the UK and Australia.  The Irish Institute of Trauma and Orthopaedic Surgery is hopeful that a national joint registry will be established in Ireland by the end of this year following consultations with the H.S.E.  In the meantime the H.S.E.’s official patient information page on its website continues to state a failure rate of 12% for these devices while the British Hip Society is reporting failure rates of 21% after 4 years up to 49% after 6 years.  Recently the UK Medicines and Healthcare products Regulatory Agency (MHRA) advised surgeons to conduct annual check-ups of their DePuy implant patients for the lifetime of the implant.  This advice has now also been extended to surgeons here inIreland.

Aside from possibly having to undergo revision surgery to replace the DePuyASR™ implant either now or into the future, patients who received these implants are also dealing with the fear of the unknown risks from the microscopic metal fragments released from these artificial hips which have entered the bloodstream.  Patients who received one of the DePuyASR™ implants should have, by now, had their blood tested to monitor the levels of these metal ions (cobalt and chromium).  It is expected with all metal-on-metal medical devices that some metal particles will enter the bloodstream, however when excessive levels of these particles enter the bloodstream the surrounding tissues may react adversely to their presence and patients can be at risk of developing inflammatory conditions such as metalosis, necrosis and ALVAL (aseptic lymphocytic vasculitis-associated lesions).  Some symptoms a patient may develop from these conditions include swelling or lumps, a rash and pain near the site of the implant.

If you, or someone you know, received one of the recalled DePuy hip implants you should contact Gráinne O’Donovan, solicitor, for immediate legal advice on 021 4275220


 

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