DePuy - Pinnacle artificial hip - patients at risk of complications - MHRA advice - Newsnight - BMJ
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Home > News > DePuy metal hip replacement patients at risk of complications

29th February 2012

DePuy metal hip replacement patients at risk of complications

A joint BBC Newsnight and British Medical Journal investigation report has revealed that around 49,000 out of 65,000 patients who have received metal-on-metal artificial hips that are sized 36 millimetres or more and made of cobalt and chromium, may be at risk of complications. As parts of the ball and cup design rub together, minute metal fragments can be generated. These can seep into tissue, causing inflammation, destroying muscle and bone, and entering the blood stream.

The problems with such devices have been known for a long time and in relation to one specific type of metal-on-metal hip, the ASR which is manufactured by DePuy, subsidiary of global health giant Johnson & Johnson, a total recall was commissioned in 2010. However the MHRA have so far resisted issuing a recall on other metal devices made both by this manufacturer and others such as Smith & Nephew.

MHRA amends advice to surgeons and doctors

Although a total recall of all metal-on-metal hip replacements has not been forthcoming, the government's health regulator, the MRHA, has amended it's advice to surgeons and doctors. The position had been that patients should only be monitored for the first 5 years following their surgery.

However the new advice, issued only this week, is that patients who have received large head metal-on-metal hip replacements should be monitored for the life of their artificial hip. They are to receive annual blood tests to check for the presence of metal ions and follow up MRI scans (magnetic resonance imaging) if the blood test shows increased metal levels or the patient shows other adverse symptoms.

Patients show worrying levels of metal ions in blood tests

One consultant surgeon, Tony Nargol at the University Hospital of North Tees, has stated that following extensive checks on nearly all the patients at his Trust who have been fitted with one type of metal-on-metal hip replacement, the Pinnacle, which is also manufactured by DePuy, 75 out of 970 patients had artificial hip failure related to metal debris. He also told Newsnight that the amount of metal ions in blood tests on these patients ranged from 10 to 50 times higher than normal levels, with one patient having measured nearly 300 times the normal level.

Approved by the British Standards Institute

There is no centralised database within Europe where medical devices such as metal-on-metal hip replacements are registered. There are a number of institutions for manufacturers to chose from in order to get their devices approved. DePuy, whose ASR hip replacement has already been recalled, used the British Standards Institute to approve their products and as such they hold the “kite mark”.

As Carl Heneghan, Director of the Centre for Evidence-Based Medicine in Oxford, points out whilst new drugs have to be subject to several years of clinical trials before receiving approval for human use, products such as artificial hips, breast implants and other devices can be approved within days with no clinical data requirement.

There is no current obligation for a manufacturer to advise the MRHA if the design of a medical device changes. In the case of the Pinnacle the BBC and BMJ report states the design was altered after they had been used in the UK for decades. DePuy altered the design of the Pinnacle. They made the “head” larger and part of the “stem” shorter, claiming it would prevent dislocation and increase movement. It is alleged by experts that it was this change of design that is causing the current problems.

DePuy were aware of potential risks to patients

The Newsnight and BMJ investigation shows that as early as 2005 DePuy were aware of the damage that could be done to patients. Mr Nargol has stated that he told DePuy about the problems with the Pinnacle, as early as 2008. It is further alleged that there is documentary evidence that warnings were also given by Japanese surgeons in 2009, and in 2010 a senior DePuy executive expressed concern internally that the situation may be more serious than anticipated. The investigation also shows that concern had been expressed in internal DePuy memos that there may be an increased risk of patients developing cancer.

Metal-on-metal hip devices recalled - compensation claims

Despite all of this evidence the MHRA have only issued a recall in relation to one specific device, the ASR, manufactured by DePuy. This recall was issued in 2010. Some patients who received the ASR are taking legal action and seeking compensation for their injuries. It is yet to be seen whether any of the other metal-on-metal devices manufactured by DePuy and others will be recalled at a later date. If they are then there may also be a possibility for patients who have received these other devices to make claims for compensation if they have suffered metal poisoning or other injuries as a result of being fitted with this type of hip replacement.

Compensation claim for medical negligence

Have you or a member of your family suffered as a result of medical negligence such as failed surgery procedures? Or are you concerned about a hip replacement and want advice as to whether or not you need to get an annual check or can make a claim?

For more information about our service or for advice about whether we can assist you with a medical negligence compensation claim contact us today on 0800 783 9019 or complete one of our online compensation claim forms. One of our representatives will contact you (without obligation) to discuss the matter further within 24 hours (48 hours at weekends).

Please go to our Costs and Risks section for more detailed information on these and how Clear Answers will handle your claim and funding.

Alternative funding arrangements may apply in Northern Ireland due to differing procedures and Law Society regulations.

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