Smith & Nephew is voluntarily removing some components of its BIRMINGHAM HIP Resurfacing (BHR) System for the reason that performance of smaller iterations is causing concern.
Smith & Nephew’s normal post-market surveillance has yielded data suggesting that revision rates in some patient groups, exceed the current benchmark established by the UK National Institute for Health and Care Excellence (NICE). The specific patient groups include males requiring smaller femoral head components (46mm or smaller) and all women. Smith & Nephew has concluded that certain patient groups may be at a greater risk of revision surgery than previously believed, and is therefore removing small sizes and updating the IFU to contraindicate the BHR for women.
The company says its BHR continues to deliver performance in line with the best total hip replacements in male patients under 65 requiring femoral head components 50mm in diameter and larger.
So what happens next? Well the company is not advising proactive revisions for existing patients unless required for clinical reasons. Similarly it is not proposing patients should step outside their usual follow-up protocol. It is, however removing those smaller femoral heads and corresponding acetabular cup components for the BHR System, and issuing new Instructions for Use, reflecting recent performance data.
The company is clearly keen that we don’t panic though, pointing out that the global resurfacing market represents <0.5% of the total hip arthroplasty procedures market, the removed products having accounted for around 1% of Smith & Nephew’s global hip implant revenue in 2014, and 0.1% of Group revenues.
Andy Weymann MD, Smith & Nephew’s Chief Medical Officer, said: “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.”
Source: Smith & Nephew