Sunday, 2 October 2011

The Truth About Going Under the Knife - Dispatches Reports (DePuy ASR Hip Implants)

Article by
Kevin Timms
On Monday 16 May 2011 Dispatches reported on investigations into whether manufacturers of medical devices have been putting innovation before patient safety. The focus was very much on the artificial hip implant protheses manufactured by DePuy International Limited.

‘The Truth About Going Under the Knife’ primarily explored the ASR hip implant, which applies to both the resurfacing system and the total hip replacement. The programme focussed on the manufacturer DePuy.

Dispatches reported that medical drugs receive much more stringent testing than medical devices, despite approximately 40 million people using medical devices every day. Furthermore, approximately 70,000 people receive hip implant surgery every year in the UK alone.

Though most hip implants last for between 10 and 15 years, many of the ASR hip implants last but a couple of years.

Those who have received an ASR hip implant are urged to seek regular check ups with their GP or surgeon to ensure that their implant is functioning properly. Those who are unsure what brand of implant they have should seek confirmation of this from their surgeon, particularly if they are experiencing adverse symptoms.

ASR hip implants are an implant which was designed for the active person and it was manufactured using metal comprising of Cobalt and Chromium. The ASRimplants are designed to lubricate as the metal rubs together, however, with the ASR hip implant, this lubrication breaks down leaving the raw metal to rub together.

This rubbing causes the metal to wear and release Cobalt and Chromium particles (ions). The symptoms of this can vary depending on how quickly treatment is sought and the consequences can range from inflammation to the formation on non malignant pseudotumours and dead tissue. In the most extreme circumstances the bone can even be destroyed

1 in 8 patients have required revision surgery within five years of implantation (approximately 13%). One centre in the UK had even reported a failure rate of almost 50%.

Symptoms experienced by patients included pain in the groin and hip, trouble walking and swelling, though all need not be present at once.

Metal from the ASR hip implant can enter the blood stream and blood tests are therefore a good indicator of whether an ASR hip implant is functioning properly. Generally, Cobalt and Chromium blood levels should be below 2 parts per billion (ppb) but some patients with ASR hip implants have shown up to 150 ppb. The indicative relevant level is 7 ppb and anything higher than this should be investigated further with an MRI scan or ultrasound.
Though it has been shown that when defective ASR hip implants have been removed blood levels return to normal, surgeons cannot be certain what long term effects these metal ions will have on the body.

The American Academy of Orthopaedic Surgeons conducted research which showed that up to half of ASR hips they put in shed metal, one of the highest failure rates ever. DePuy initially disagreed with the finding that their ASR hip implants had an inherent defect. Subsequently DePuy withdrew their ASR hip implant from the market for ‘commercial reasons’ prior to issuing a voluntary recall of all its ASR products in August 2010.

In 2007 DePuy stated that the problems experienced by patients with ASR hip implants were as a result of inexperienced surgeons, however, they have now conceded that their ASR hip implants are not fit for their intended purpose.

Hundreds of people in several countries are making claims against DePuy for injuries they have sustained as a result of the defect in the ASR hip implants. If you have received a DePuy ASR hip implant and are experiencing adverse symptoms you may be entitled to make a claim. Please contact Kevin Timms to discuss your claim further on 01992 422 128 or email Kevin at kevin@gardenhousesolicitors.co.uk

In order for a company to market a medical device within the EU that company must first obtain a CE mark for each product. One problem that arises is that companies do not necessarily need further investigation or clinical trial to obtain the necessary authorisation to alter products already on the market, unlike brand new products which need extensive clinical trials. Furthermore, in many circumstances, companies only need to show that a device is the equivalent to something already on the market in order to obtain permission to market.

“Appalled at how many devices are brought to market with a lack of appropriate clinical data” – Susanne Ludgare (MHRA).

One example to illustrate the above quote from Ms Ludgate is the ASR hip implant. This particular implant did not receive clinical testing on people, only simulator testing. Surgeons are now requesting that medical devices have at least two years clinical data before being marketed for sale.

No one can dispute the fact that advances in medical devices is saving lives, however, as Dispatches have reported, some manufacturers may be putting innovation before patient safety.

If you have had received a DePuy ASR hip implant since July 2003 and are experiencing adverse symptoms you may be entitled to make a product liability claim. Please contact Kevin Timms on 01992 422 128 or email Kevin at kevin@gardenhousesolicitors.co.uk


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