4th Jun 2015 06:28
LONDON (Alliance News) - Smith & Nephew PLC said Thursday it has voluntarily removed smaller-size components for its Birmingham Hip Resurfacing system from the market, as recent performance data has shown patients may be "at a greater risk of revision surgery that previously believed".
Revision surgery refers to when a hip replacement needs to be replaced.
The products account for around 1% of Smith & Nephew's hit implant revenue in 2014 and 0.1% of group revenues, it said, and will have no impact in its guidance for the full year.
It is recalling the 46 millimetre diameter and smaller femoral heads and corresponding acetabular cup components for the BHR system, and has changed the instructions for use of the system.
It noted that there is no action required from patients, and surgeons should maintain their routine follow-up protocol for patients.
Recent analysis showed that BHR continued to deliver a performance in line with "the best total hip replacements" in male patients under 65 requiring femoral head components 50 millimetre in diameter and larger. However, revision rates for men requiring the 46 millimetre or smaller components, and with all women patients, exceed the current benchmark put in place by the UK National Institute for Health and Care Excellence.
"Patient welfare is Smith & Nephew's top priority. Based on our analysis of our most recent data, we are taking the necessary steps to ensure that the BHR is only used in those patient groups where it has demonstrated strong performance. These represent the vast majority of current patients," said Chief Medical Officer Andy Weymann in a statement.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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