Patient Safety in DePuy ASR Cases: DePuy Know the Facts?

 

The words hip replacement can fill many people with dread, and rightly so as it is an immense procedure to undergo, particularly as a person approaches the winter of their life.

But what about when the brand of hip used, notably DePuy ASR hip implants, are recalled due to a higher than normal failure rate? The ASR recall happened in 2010, but these products are still causing pain and suffering for many patients to this day.

DePuy state on their website that they ‘deliver total solutions to help people live full lives”, yet for a lot of people this has not been their experience.  In fact, patients can end up in a worse position than they were prior to hip replacement surgery, meaning that their golden years are tarnished by a defective product.

As a nation, we often have products we purchase (for household use for example) recalled and replaced for our safety, yet the products that we never expect to be recalled are those medical, prosthetic ones which have been implanted to replace our own worn, broken joints and bones, products that we expect to be ultimately better than what we were born with.

 

The Reason for the ASR Recall?

The replacement DePuy ASR hip implants have been known to wear, they can release metal particles (or metal ions) which can then react with the soft tissue that surrounds the hips, such as muscle and ligaments, and can then enter the blood stream. These problems lead to a high revision rate. Other symptoms such as dizziness, loss of cognitive function (memory loss for example), hearing loss and organ failure have also been reported.

 

The Solution?

The Medicines and Healthcare products Regulatory Agency (MHRA) urged surgeons to inform patients who received the DePuy ASR implants about the product recall and these surgeons were told not to implant ASR hips into patients and return any unused ASR products.  This was all very well and good butwhat about those people who had an ASR product implanted in them prior to the recall?  The MHRA have urged these patients to be monitored and if necessary the defective DePuy ASR implant should be removed and replaced.

But what about patient safety relating to issues with hip prostheses in the future?  In January 2014, the National Institute for Clinical Excellence (NICE) raised the standards for all hip implants, deciding that only those which failed only 5% or less after 10 years will be allowed to enter the NHS Supply Chain. It is hoped that this will provide better protection to patients who require a hip replacement in the UK because it used to be that the NICE guidance (in 2000) was that a hip prosthesis should demonstrate a benchmark revision rate of 10% or less at year 10 or, as a minimum, a 3 year revision rate consistent with the 10 year benchmark.

 

Public Safety Concerns

Back in 2009, the National Joint Registry reported high revision rates of the ASR at 7.5% in 3 years, more than twice the NICE benchmark at that time. Some people are therefore wondering whether the amended NICE guidelines will make a difference to patient safety.

Some have questioned why the MHRA did not take precautions to safeguard the public’s health sooner, given the increasing amount of evidence regarding the failure of the ASR products. Perhaps the drama surrounding ASR products will encourage the regulator and key stakeholders to learn from past shortcomings and to respond to increased revision rates for other implants in the future in order to enhance patient safety.

But what about the once active, confident patient who had previously trusted their hips to surgeons implanting the ASR products?  Some, regrettably, need further surgery, others will be monitored on a regular basis by specialists in Orthopaedics.  Yet the fact remains that lives can and have been changed forever, with people being left unable to perform the most basic day to day activities, let alone enjoy their retirement, being able to travel abroad on holidays or to visit relatives across the country and worldwide.  An unfortunate way to spend the latter years of life.

 

If you, a family member or friend have been fitted with a DePuy ASR or Pinnacle hip  implant, please contact our defective medical products team for free advice on 0151 733 3353/0208 209 0166. Alternatively, you can email us at info@gadllp.co.uk or fill out our online contact form and we will contact you directly.

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