The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK’s regulator for the safety of medical devices, has issued a medical safety alert relating to the Birmingham Hip Resurfacing (BHR) System manufactured by Smith and Nephew Orthopaedics.
Previously thought to be one of the safest hip resurfacing products available, the manufacturer has identified that certain groups of patients, who have had the BHR system fitted, are at a higher risk of revision than other groups of patients. There is now real concern as to its safety.
The affected patients include all females, as well as other patients who require a femoral head component 46mm in diameter or smaller, and the corresponding acetabular and dysplasia cups. The manufacturer has identified that these smaller products perform less well than the larger products, and exceed the current revision rate benchmark established by the UK National Institute for Health and Care Excellence (NICE). Accordingly, the manufacturer has withdrawn these products from the market and has updated its guidance to say that the BHR System is contraindicated in all female patients.
An urgent field safety notice was sent to patients and doctors on 3 June 2015. It does not advise active revision of the BHR System, but all patients are recommended to have an MRI or ultrasound scan to check its viability. Blood tests are also recommended to check for increased metal ion levels.
The manufacturer has said that any patient with abnormal imaging, raised blood metal ion levels, symptoms including limited mobility, pain, swelling, enlarged bursae, pseudotumors, tissue masses, fluid collections, or local build-up of excessive metal particles or metal hypersensitivity, may require revision surgery.
Arran Macleod, a solicitor in the Penningtons Manches product liability team, said: “The problems associated with metal-on-metal hip resurfacing/replacement systems appear to be escalating and this recent alert is another cause for concern. We are currently acting for a number of clients with claims against manufacturers as a result of problems with their metal-on-metal hip. Many are profoundly affected with mobility difficulties and the need for revision surgery which has a lower chance of success because of damage caused to the surrounding tissue due to the reaction with the metal hip. If you or someone you know has experienced similar problems following hip surgery, you may be entitled to bring a compensation claim.”