No Metal on Metal Hip Implant Recall says MHRA Boss

Posted on: March 13th, 2012 by Editor

The Clinical Director of the Medicines and Healthcare products Regulatory Agency (MHRA) has stated that there will be no metal on metal hip implant recall following data published in the Lancet which demonstrated that as many as 6.2 per cent of all metal on metal hip implants will fail within the first five years.

Dr Susanne Ludgate made the announcement after researchers from the University of Bristol analysed more than 400,000 hip replacement operations recorded on the National Joint Registry since 2003, and published their findings in the world´s most respected medical journal.

The research showed that 6.2 per cent of all metal on metal hip implants had failed within the first five years, compared to 1.7 per cent of metal on plastic hip implants and 2.3 per cent of ceramic on ceramic hip implants.

A higher level of hip implant failure was identified in women – particularly younger women who may lead a more active lifestyle – and metal on metal hip implants with a “large head”, with the report stating that each 1mm increase in head size increased the risk of revision surgery by 2 per cent.

The refusal of the MHRA to recall metal on metal hip implants will come as no surprise to those who have been following the DePuy hip recall story. Only two weeks ago the MHRA was criticised on BBC´s NewsNight program for allowing metal on metal hip implants to be introduced into the UK without any clinical testing.

The MHRA response was to announce that all recipients of metal on metal hip implants should have annual testing for the life of the implant to ensure the integrity of the hip replacement system and to check against displaced metal debris entering the bloodstream. However, the growing volume of data which suggests that there should be a metal on metal hip implant recall has not swayed Dr Ludgate.

“We recognise that there is emerging evidence of increased revision rates associated with large head metal on metal hip replacements,” Dr Ludgate told reporters, “but the clinical evidence is mixed and this does not support their removal from the market”.

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