The Health Service Executive (HSE) last week stated that 2,022 of the approximately 3,500 patients affected by the recall of DePuy ASR hip implants have at this stage attended for their initial recall appointment, with the remainder to be dealt with by the end of January.
Bearing in mind that DePuy Orthopaedics announced the worldwide recall on the 26th August 2010, and that a recall had been announced in Australia some considerable time before this, it is hard to understand the slow pace at which the HSE is dealing with the matter. We have been contacted by many worried clients who are obviously anxious to have their tests performed as soon as possible. These individuals are, quite understandably, extremely annoyed at the pace at which the HSE is addressing the issue.
Since the ASR recall was announced significant attention has been afforded to studying the long-term medical implications of metallosis, more particularly cobalt toxicity, which is caused by metal debris that comes off the prosthetic joint being released into the surrounding tissue and bloodstream.
The effects of cobalt poisoning are believed to include physical symptoms varying from visual impairment, heart disease, hearing loss and other complications. However, evidence is also emerging in the wake of the ASR recall that many patients who had high levels of cobalt in their systems also complained of neurological complications including forgetfulness and cognitive impairment.
The really troubling question for those people who have received ASR devices which are not presently causing them any pain or discomfort is what remedial steps, if any, should be taken at this stage?
The UK’s Medicines and Healthcare Products Regulatory Agency (MHPRA) has recommended that if either cobalt or chromium ion levels are elevated above seven parts per billion (7 ppb) in a person’s bloodstream further surveillance should follow, with revision surgery in the future to be considered.
However, a number of experts who work in the field have queried this figure of 7 ppb, noting that the level to be expected in a patient with a properly functioning metal-on-metal device would typically be expected to be less than 2 ppb.
Very serious questions will therefore arise for those individuals who are not presently experiencing any pain or discomfort and whose metal toxicity levels are below 7 ppb but significantly above 2 ppb. Based on the views expressed by several of our clients who are awaiting their test results, we expect that many individuals will want to have their ASR device removed to avoid any future complications caused by metal toxicity, irrespective of whether or not mechanical issues are presently manifesting themselves.
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 us or email him at john@mccarthy.ie to discuss your case in complete confidence and without commitment.
