Annual checks for patients with all-metal hips

 
Hip replacement X-ray The Medicines and Healthcare products Regulatory Agency says 49,000 patients are in the risk group

A huge amount of media attention in recent months has focussed on PIP breast implants, but far less on another potentially faulty device - hip replacements.

Around 70,000 people a year get a new hip and they are among the most successful operations in modern medicine.

But concern has been emerging for some time about certain types of metal-on-metal hips, in particular those where the ball head has a diameter of 36mm or more.

Some 49,000 patients in the UK have these implants and they've been shown to have a much higher failure rate than metal and plastic or ceramic implants.

In addition, the constant wear of the all-metal hip can allow microscopic metal ion particles to enter the bloodstream, potentially causing tissue damage.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued new advice saying patients with these large head diameter metal-on-metal hips will need monitoring for the life-time of the implant. At present the monitoring stops after five years if the patient has no adverse symptoms.

In future patients will continue to have annual blood tests to check for the level of metal ions - a high level can be indicative of tissue damage around the hip which - left untreated - could make replacement more difficult. If the ion levels are rising then patients will be given an MRI scan to check for damage.

Professor Sir Kent Woods, MHRA chief executive, says these checks should reveal problems early on:

"There is a rough correlation between the pattern of wear of the joint and the level of ions in the blood. We think the ions can at high levels produce local effects on tissue which is why we recommend regular screening so if the levels are high we can recommend repeat surgery at an early stage."

The MHRA said all-metal hips had a failure rate of about 12% after seven years, three times that of metal and plastic or ceramic hips.

It is unlikely to be a coincidence that the new advice comes on the day that a combined BBC Newsnight and British Medical Journal investigation reports that problems with such devices have been long known, but no action taken to block their use. You can see the report on Newsnight at 10.30pm on BBC2.

But Dr Susanne Ludgate, clinical director of the MHRA, says they had first become aware in 2008 of a small number of cases where patients suffered swelling around the hip and tissue damage.

Patients with metal-on-metal hips should be contacted in due course by their orthopaedic surgeon but the MHRA said any patient who was concerned should see their GP.

Professor Sir Kent Woods, Chief Executive, MHRA

 
Fergus Walsh Article written by Fergus Walsh Fergus Walsh Medical correspondent

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  • rate this
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    Comment number 11.

    I have watched the Paxman interview and have to say the head of the MHRA explained the situation very well, despite Paxman's obvious attempt to trip him up. There are fundamental differences to the way medical devices work to that of drugs. Clinical trials of long term devices are not always achievable and how would you have a control group?

  • rate this
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    Comment number 10.

    Both hips replaced by the implant discussed on newsnight in 2007. The right one has never been right and I had to have my first revision in 2009 followed by a further revision to replace the implant with a ceramic one in 2010. I am now in constant pain and walk with crutches often having to rely on a wheelchair I have been told there is nothing more they can. Don't let this happen to you!

  • rate this
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    Comment number 9.

    Please go to www.meshiesunitedgroup.co.uk and see how we are suffering from a mesh device which has not had robust clinical trials.

    Teresa Hughes

  • rate this
    0

    Comment number 8.

    hip resurfaced 5 yrs ago. ok for first year or so, gradually worsened.called in for blood tests ,levels were low.pain in groin worsened,back to see consultant,xray,ultrasound, suspected fractured hip.. had revision surgery last sept hip tested and found flaking and skin tissue damage,metalosis present.. goes to show levels dont always have to be high so beware...

  • rate this
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    Comment number 7.

    I wish to highlight the fact that Zimmer products are just as bad as the Du Puy product discussed tonight. I had a Zimmer Durom Cup fitted in 2007 only to suffer the same fate as others and had it removed in 2011 due to pain and metal debris.

  • rate this
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    Comment number 6.

    Hip resurfaced metal on metal January 2010. Have suffered severe cramp-like pain on thigh for a number of months, not in groin or wound area .Contacted hospital and had date for MRI within two weeks, then appt with consultant the week after.
    Hospital definitely taking this seriously considering how long had to wait for replacement. NE England.

  • rate this
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    Comment number 5.

    Hello I had my right hip resurfaced in 1996 . My hospital has always done blood checks and hip reviews every year . I've never had a problem until last year when it started to fail . But then I was 26 when my hip was done and I haven't looked after it . I would like to point out that its not the hip replacement thats failing but the bone its self .

  • rate this
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    Comment number 4.

    I got the Birmingham hip 7 years ago which is a metal on metal implant and I have been having tests done for these ions for the last 2 years. Although they say I am ok I have always had pain and wonder could this be a related problem.Anybody know anything.

  • rate this
    0

    Comment number 3.

    I have just listened to the Paxman interview on TV and I am astounded at what I heard. It appears to be nothing less than engineering incompetence ! How on earth can a device, of this nature, be released into the market without significant meaningful testing. I am a chartered engineer and I am astounded at the facts revealed in the interview. I can only hope the decision can be justified.

  • rate this
    0

    Comment number 2.

    Hi, I had my right hip resurface in 2006, In May last year i had to have revision surgery as i was in so much pain with my hip and i high amounts of cobalt and chromium in my blood and i was living on painkillers. I have now a ceramic hip implant but i am not 100% as i think the damage has already been done. I am due to see my Consultant in May and i will be having blood tests to check metal ions

  • rate this
    -1

    Comment number 1.

    PIP implants, De Puy ASrRnow the De Puy Pinnacle. Only ones standing up for patient rights are solicitors working on a no win no fee basis. The regulators have been far too cosy to big pharma and medical device companies for far too long. The coalition want to do away with no win no fee agreements. Then these companies can do whatever they want and give the bill to the taxpayer. Crony capitalism.

 

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