The Medicines & Healthcare Regulatory Agency has released an urgent safety notice published by the makers of the Birmingham Hip Modular Head (BHMH)
A Government regulator has put out an urgent notice after the makers of a replacement hip known as a ‘Birmingham Hip Modular Head total hip replacement’ revealed it was performing much worse than previously thought, following extensive research.
The Medicines & Healthcare Regulatory Agency (MHRA), which regulates medicines and medical devices in the UK, today released an Urgent Field Safety Notice published by Smith & Nephew Orthopaedics Limited the makers of the Birmingham Hip Modular Head (BHMH) total hip replacement.
As one of the controversial ‘metal on metal’ hip prostheses, Smith & Nephew have already published two previous Field Safety Notices, which are sent out by manufacturers to warn users of potential problems, in relation to the BHMH.
These were published in October 2012 and May 2013.
According to lawyers acting for over 700 perople taking claims against manufacturers for allegedly fauly replacement hips, this latest notice goes significantly further in outlining the true scale of the problem affecting the BHMH device which was phased out of use in mid-2014
Having previously accepted that research showed a “decline in the performance of BHMH” and that “patients implanted with the BHMH device may be at greater risk of revision surgery”.
Today’s latest notice from Smith & Nephew explains that they have received a report of a clinical study conducted in the UK, analysing the clinical results of a group of patients who had been implanted with BHMH hip replacements using the Smith & Nephew Synergy femoral stem.
The study apparently shows that 43.7% of the patients were found to have levels of Cobalt and Chromium (the metals the BHMH is made from) above 7 parts per billion, and that the study indicates that there is “a potential increased risk” of metal debris release at the femoral head / stem junction.
The MHRA has previously issued guidance advising that metal on metal hip patients with Cobalt and Chromium levels above 7 parts per billion should undergo further investigation to ascertain the performance of their hip replacement.
Smith & Nephew’s statement includes data fromJanuary 2015 showing that the BHMH has a failure rate of 10.6% at 6 years follow-up.
The National Institute for Health and Care Excellence (NICE), who are tasked with advising the NHS on effective healthcare products, currently advises that only hip replacements with a failure rate of 0.5% or less per each year of follow-up should be implanted in NHS hospitals. This new data suggests that the BHMH has over a 3 times higher failure rate at 6 years follow-up than is regarded as acceptable for use in the NHS.
As a result of the above, Smith & Nephew recommended that BHMH patients are followed-up by their surgeon as appropriate.
Leigh Day currently represents approximately 35 patients who have required early revision surgery to remove their BHMH hip replacements.
Proceedings were first issued against Smith & Nephew Orthopaedics Limited on 7 August 2013. These patients were found to have adverse reactions to metal wear debris, and have suffered greatly as a result of the early failure of their BHMH hips.
Many live with long-term damage to their hips which continues to limit their quality of life long after the BHMH hips have been removed.
If you have been affected by a BHMH and would like to discuss joining the action being brought against Smith & Nephew Orthopaedics Limited please call our team of experts.
The Notice does not relate to the Birmingham Hip Resurfacing.