Tipp FM Legal Slot – 10th July 2012
John M. Lynch on DePuy Deadline[soundcloud id=’167071820′]
When were DePuy hip implants recalled and how much time do patients have left to lodge a claim?
There is now less than ONE MONTH REMAINING for those affected by the DePuy Hip Recall to lodge a claim.
As many people will be aware, on the 26th August 2010 DePuy Orthopaedics Inc., a division of Johnson & Johnson, announced a worldwide recall of two of it’s metal-on-metal hip replacement devices; the ASR XL acetabular total hip replacement and the ASR hip resurfacing system. Both hip implants were recorded as having “higher than expected failure rates”.
How many patients are affected in Ireland and what is the failure rate?
As matters stand, 3,282 Irish patients were fitted with defective DePuy ASR hip implants. Experts have found “unequivocal evidence” of high failure rates and the ASR total hip implant has now been shown to have a failure rate of up to 50% within six years.
How long have we known about the problem with the DePuy devices?
The problems with the two DePuy devices were known long before the recall. In Australia, the National Joint Replacement Registry (NJRR) reported in 2007 that data for the previous year showed that these devices had twice the risk of failure in comparison to similar devices. In 2008, the NJRR re-confirmed that these devices had a much higher than expected failure rate. Again, in 2009, the NJRR found the same failure results. In 2005, just 2 years after these products were put on the market, a DePuy internal memo set out the company’s concerns of health risks from wear debris of metal-on-metal hip implants.
In December 2009 DePuy Orthopaedics withdrew from the Australian market and in March 2010 DePuy issued an alert about the ASR implants. Despite these developments many Irish patients continued to be implanted with the DePuy devices until the recall of the device in Ireland in August 2010.
Those affected by the DePuy Hip Recall are at risk of serious health implications.
How would DePuy patients know if the device is failing – what symptoms are they experiencing?
We represent many patients who received the faulty DePuy implants. Some patients have symptoms showing that the device they received has started to fail and have even had their revision surgery at this stage. Other patients, however, have no obvious symptoms at all.
Our experts have given us a list of symptoms, which show the failure of the device:
- Continuing hip, groin, leg, or low-back pain;
- Audible noises such as crunching, clicking, grinding, or metallic sounds coming from the ASR device;
- The sensation that one`s hip is not “in place,” especially when standing up or starting to walk;
- Loss of ability to perform physical activities, reduction in mobility and noticeable limp;
- Swelling in the affected hip area or generalised hip pain, discomfort, pressure or tenderness and;
- Loosening of the various components in the implant, necrosis or soft tissue damage and elevated cobalt and chromium levels in the blood due to exposure to metal.
We have identified common symptoms in patients with elevated blood ion levels:
- Rashes, skin patches and skin discolouration;
- Memory loss/difficulties;
- Eyesight deterioration;
- Changes in urine.
Despite recent research, there is still a lack of certainty as to the actual affect that these metal ions in the bloods can have.
What is metallosis and how is it affecting DePuy patients?
One of the greatest concerns for patients is what is called Metallosis and its relatively unknown effects. The DePuy hip devices are metal-on-metal, therefore wear and tear caused by movement over time can lead to metal ions being released into the blood and urine. This can lead to a build-up of metal debris around the hip device itself. There is an alarming degree of ignorance out there about the effect metal on metal implants have on patients where there are high chromium or cobalt readings.
In 2007, the Lancet medical journal said that the recommended levels of ions in the body had not yet been clarified. Five years on there is still no definite agreement in the medical profession.
Our experts have told us about the metal ion levels:
- Less than 1 ug/l – normal
- With metal on metal replacement – 2ug/l can be normal
- 2-5ug/l – grey area
- 5-10ug/l – suspicion of excess wear
- 10-20ug/l – Newcastle studies show that in patients with these levels 60% will have failure issues within 3 years
- Over 20ug/l – very excessive wear of joint – revision necessary
Since the recall of the DePuy devices has further research been carried out into metal-on-metal devices?
In two recent medical reports published in the British Medical Journal and the Lancet Medical Journal experts new findings indicate a necessity for patients with Metal-on-Metal implants to be monitored at least once yearly.
The BMJ report advises that metal ions can seep in to the local tissue can cause reactions which can destroy both muscle and bone and in turn result in long term disability. They can also seep into the bloodstream and are toxic to the lymph nodes, spleen, liver, kidneys and other organs as they pass through the body. The report warns of potential link between the release of metal ions into the body and the risk of developing cancer. The report also advises that levels of cobalt in the blood in excess of 7μg/L should be investigated.
The Lancet Report recommends that MoM implants should no longer be used and for those patients who have received MoM implants it is recommended that clinical and radiological reviews be carried out at least once per year for the lifespan of the implant to monitor metal ion levels in the bloods and changes in the implant.
When should patients contact you about lodging a claim?
Immediately! In most cases the deadline for lodging a claim seeking compensation is fast approaching and those affected by the recall need to take precautionary action before the 25th August 2012 to avoid the possibility of your case being out of time.
There is a lot of work involved in lodging a claim so the sooner DePuy patients start the better.