Watchdog slaps ban on metal hip joints
The Medicines and Healthcare products Regulatory Agency said the implant had an “unacceptably high revision rate” and recommended close monitoring of the 271 patients in England and Wales who already have one.
Information from the National Joint Registry for England and Wales shows the implant has a revision rate of 10.7 per cent just four years after initial surgery.
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Hide AdLast month, experts writing in The Lancet medical journal called for all metal-on-metal implants to be banned over high failure rates.
The MHRA is examining all data on metal-on-metal implants but has said the clinical evidence is mixed and does not support their removal from the market.
At the centre of the announcement is a total implant using a special kind of coated casting made by Finsbury Orthopaedics, used in combination with Accolade femoral stems made by Stryker Orthopaedics.
The implant, which is no longer being manufactured, was last distributed in October. Some patients with partial as opposed to total implants are not affected.
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Hide AdThe alert follows analysis of the National Joint Registry on March 10.
Dr Susanne Ludgate, clinical director of the MHRA, said: “The majority of patients implanted with metal-on-metal hip replacements have well-functioning hips and are at a low risk of developing any serious problems.”
In February, the MHRA issued guidance on all metal-on-metal implants, saying 49,000 patients in the UK will need annual blood or MRI checks.
Metal ions of cobalt and chromium are thought to leak into the blood from the implants, with fears that this causes medical complications in patients.
Last month’s research in The Lancet, found that metal-on-metal implants failed much more quickly than ceramic-on-ceramic implants and metal-on-plastic types.