Faulty Hip Replacement Claims made on BBC
A BBC news program has made new faulty hip replacement claims about the dangers of metal-on-metal hip replacements – especially concerning those manufactured by DePuy Orthopaedics Inc, whose ASR hip replacement systems were recalled in Ireland in August 2010.
The faulty hip replacement claims were made following a joint investigation by Newsnight and the British Medical Journal (BMJ) which alleged that “patients have been kept in the dark about their participation in what has effectively been a large uncontrolled experiment”.
The investigation revealed a long history of alleged cover-ups by the UK medical regulator – The Medicines and Healthcare products Regulatory Agency (MHRA) – claiming that an eight-person “expert” advisory group, established by the MHRA in 2006 to report on the carcinogenic potential of metal-on-metal hip implants, contained two paid DePuy consultants and the director of product development for Smith and Nephew – another metal-on-metal hip replacement system manufacturer.
The advisory group – it was claimed in the Newsnight/BMJ investigation – had the brief to determine the “risk-benefit context” of metal-on-metal hip replacements and although a recommendation was made that patients should sign a consent form “which sets out the fact that the risks associated with metal wear debris have been discussed, including the genotoxic risk and possible sequelae”, the risks and the recommendation were never communicated to orthopaedic surgeons and their patients.
It was also alleged that the MHRA ignored faulty hip replacement claims from the American Food and Drug Administration (FDA) that high levels of metal ions had been found in umbilical cords and the placental blood of women who had received metal-on-metal hip replacements. Indeed, the MHRA criticised the FDA for issuing a warning without conducting a full risk analysis, when no clinical trials had been conducted in the UK to establish the safety of metal-on-metal hip replacements.
In 2008, Dr Tony Nargol – a consultant orthopaedic surgeon from the University of North Tees – advised DePuy Orthopaedics that he was witnessing a high level of metal debris in patients implanted with the Pinnacle metal-on-metal hip replacement system – not only the ASR hip replacement system which was recalled in 2010 due to a higher than expected failure rate. He claimed on the Newsnight report that he was witnessing system toxicity levels of 20-50 times the permitted levels, with patients suffering inflammations, muscle necrosis and bone decay. This information should have been passed onto the MHRA by DePuy, but was not done so.
The program concluded that the MHRA – the government agency which responsible for ensuring that medicines and medical devices work, and are acceptably safe – had failed in its duty of care by allowing faulty hip replacements to be introduced in the UK without due diligence and had failed to monitor the performance and safety of the metal-on-metal devices. In response to the faulty hip replacement claims, the MHRA announced it was advising 49,000 patients in the UK with “large-head” hip implants to have annual blood tests for life to check for the presence of metal ions.