Smith & Nephew has issued a safety alert for its Birmingham Hip Resurfacing (BHR) system. Smith & Nephew issued a notice updating the instruction for use (IFU), after the manufacturer confirmed certain population sub-groups have been identified to be at risk of adverse outcomes if fitted with the product.
The urgent field safety notice (FSN) from Smith & Nephew revealed that women patients, men aged 65 or above and patients requiring an implant size of less than 48mm are at greater risk of requiring revision surgery earlier than expected.
It has been confirmed that the IFU changes are applicable to specific catalog numbers of the BHR Resurfacing Head, BHR Acetabular Cup and the BHR Dysplasia Cup, with more detail being available on the Smith & Nephew website. However, the website currently does not provide any information about the urgent field safety notice.
Kevin Timms, a lawyer at Irwin Mitchell’s London office who specializes in providing support to victims of faulty medical products, said: ” The new guidance issued by Smith & Nephew is a welcome step towards preventing certain sub-groups of patients from being at an earlier-than-expected risk of revision.”
“However, it also raises concerns regarding the number of patients who fall into those categories and may have already been fitted with the affected devices. As such, it is vital that the manufacturer works quickly to provide more information regarding the issues, as well as providing an explanation as to why a recall has still not been issued for small BHR implants and why the instructions for use were not updated in 2012 when a revision rate of 11.76% was confirmed in women with a 42mm femoral component. The delay is clearly unacceptable.”
“An issue of this nature is just the latest in a long line to raise concerns regarding the safety of hip replacement devices and many patients will be concerned to see these further concerns being raised.”
“Patients put great faith and trust in the fact that the devices they are being fitted with are safe for use and meet the required standards. An issue of this nature once again calls into question how specific devices are able to make it to market and whether the regulatory system in place is fit for purpose.”
“Every effort must be made to always put patient safety first and it is clear that there are many questions to be answered regarding these issues.”