FDA Approves Smith & Nephew’s HIP Resurfacing System
Smith & Nephew plc announced today that the US Food and Drug Administration (FDA) has approved the Birmingham Hip Resurfacing (BHR) system for use in the United States, making it the only product of its kind approved in the country. Last year the FDA’s Orthopaedic & Rehabilitation Devices Panel evaluated Smith & Nephew’s data collected in England (see these summary minutes in PDF format). Hip resurfacing is an alternative to total hip replacement for patients suffering from abnormalities of the hip such as osteoarthritis. Where hip replacement requires removing the head and neck of the femur, they are preserved with hip resurfacing (just a few millimeters of bone are shaved off) and the hip joint is relined rather than replaced. Hip resurfacing post-surgery recovery time is often shorter than for a conventional hip replacement. Downsides include a longer scar as the required incision is larger, and post-operation risks of femur fracture.
This technique was introduced about a decade ago with younger, more active patients in mind. Smith & Nephew’s product has already been used more than 60,000 times worldwide. Its competitor Zimmer - whose Durom product has not been approved in the US yet - provides good illustrations of this low-wear metal on metal technology. Edwin P. Su, MD and Assistant Professor of Orthopedic Surgery Weill Cornell Medical College wrote this useful recap.
May 10, 2006 Related topics: Product Approval & Certification, Surgery, Orthopedic