DePUY ORTHOPAEDICS ASR HIP REPLACEMENT RECALL

FOR FURTHER INFORMATION AND RELATED BLOG ENTRIES VISIT OUR DEDICATED DePUY HIP IMPLANT RECALL PAGE

The fallout from the DePuy Orthopaedics worldwide recall of the ASR XL Acetabular System and the DePuy ASR Hip Resurfacing System is still unclear for many of the over 3,500 Irish patients who have received either of these implants.

While the figures which have been circulated by DePuy suggest that ASR patients have a one-in-eight chance of experiencing complications within the first five years of the implant surgery, information which we have received from a UK-based orthopaedic surgeon who has conducted extensive research on the complications associated with these devices casts serious doubt on these official figures.  The research in question has involved the examination of 100 ASR components recovered from fifty implant patients complaining of post-surgery complications.

If the devices studied are in any way representative of the approximately 93,000 devices which have been issued worldwide, the failure rates quoted by DePuy are altogether misleading, with the actual likelihood of failure within five years being 15% for ASR resurfacing systems, and as high as somewhere between 20% and 30% for the ASR XL acetabular hip replacement systems.

There is a cruel irony in the fact that many younger and more active implant patients opted for DePuy ASR implants on the basis that these metal-on-metal devices were the most durable available, with the result that further surgery (if any) would be postponed for as long as possible.  These individuals now have to swallow the bitter pill of facing potentially complicated and painful reparative surgery which will place them in a worse position than if they had opted for alternative more conventional devices which were not targeted at younger, more active individuals.

For those patients who had already been experiencing significant difficulties before the announcement of the recall (the proportion of whom, based on the enquiries which we have received, is quite significant) the obvious remedial course of action, while by no means appealing, is at least clear: they will have to undergo corrective surgery involving the removal and replacement of their existing DePuy ASR hip replacement systems.

The real condundrum, however, faces those individuals who have received either of the ASR XL acetabular hip replacement systems or the ASR hip resurfacing systems and who are not presently undergoing manifest complications.

This is because the information which we have received suggests that the volume of chrome and cobalt ions which is typically absorbed by the bloodstream and organs of an ASR implant patient is disconcertingly high.  High levels of these toxic metals may be being released into a patient’s bloodstream irrespective of whether or not any pain or discomfort is being experienced.

The evidence compiled suggests that in the absence of perfect alignment being achieved on implant, the metal components are liable to wear quite vigorously, with the initially ultra-smooth surfaces eventually roughening and grinding away against one another aggressively.  This grinding process causes the release of nano-sized chrome and cobalt particles into the body which are absorbed into the bloodstream and surrounding tissue.

While typical wear debris levels associated with prosthetic hip implants are in the region of one cubic millimetre per annum, the research findings suggest that the volume of detritus from DePuy ASR systems can be anywhere from four times to thirty or forty times this rate, with the average occurrence being about ten times that of conventional metal-on-plastic systems.

DePuy ASR hip implant patients have been observed with cobalt concentrations of as high as twenty micrograms per litre of these ions in their bloodstream, whereas a density of one microgram per litre would typically be expected for properly functiontioning systems .

The evidence suggests that even if one is not experiencing discomfort or pain in the immediate location of the hip implant, soft tissue inflammation and destruction can nevertheless be occurring, which is likely to give rise to significant complications when the ASR device ultimately requires replacement.

Apart from the local destruction to tissue caused by the release of these ions, it is also feared that there may be other health complications associated with persistently high levels of chrome and cobalt in the bloodstream.

What is clear from the findings of this study is that the failure rates, and the consequences of such failure, being circulated by DePuy should be treated with extreme skepticism.  What is not nearly as clear is what remedial treatment an ASR hip implant patient who is not presently suffering from manifest complications should undergo.

The fact that alarmingly high levels of metal debris are being eroded from these ASR devices and released into patients’ bloodstreams is more than enough justification for declining DePuy’s wholly improper demand to be given custody of the removed systems after reparative surgery.  Every patient who undergoes such remedial surgery should insist that they retain control of the explanted hip replacement system so that appropriate tests can be conducted to determine the precise volume of chrome and cobalt debris which has been released into their system prior to the removal of the device.

If you have been affected by the ASR hip implant recall and would like to arrange a free initial consultation with John McCarthy feel free to call him on 023 883 3348023 883 3348 or email him at john@mccarthy.ie to discuss your case in complete confidence and without commitment.

FOR FURTHER INFORMATION AND RELATED BLOG ENTRIES VISIT OUR DEDICATED DePUY HIP IMPLANT RECALL PAGE

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John specialises in personal injury and medical negligence claims. His practice focuses on high value compensation cases. He has extensive experience in this area of litigation for over 10 years. Read more