There is a big difference between a hip resurfacing and a hip replacement--in how these two systems are made, how they function and the types of patients they are intended for.
Hip resurfacing is considered to be the more conservative surgical approach than a total hip replacement, providing greater benefits for physically active patients who are typically younger, male and with good bone quality. Instead of replacing the entire hip joint, hip resurfacing entails shaving and capping a small amount of the ball at the top of the femur (thigh), thus preserving more of the patient’s natural bone.
The Smith & Nephew Birmingham is a metal-on-metal hip resurfacing (BHR) system. It was approved by the FDA in 2006 and is one of the two remaining metal-on-metal hip resurfacing systems still on the market (the other is the Cormet Hip Resurfacing System).
In June of 2015, Smith & Nephew issued an urgent field safety notice which adjusted its instructions for use. This warning stated that females, patients requiring a smaller head size, males age 65 or older, those with dead bone tissue and patients with hip dysplasia are at a higher than normal risk of needing early revision surgery.
Problems with the Smith & Nephew Birmingham continued to surface. Hundreds of patients in the U.S. have filed complaints alleging they have suffered serious health complications due to metallosis. Metallosis is caused when the components of a metal-on-metal device rub against each other. Cobalt and chromium ions migrate into the surrounding tissue resulting in severe pain and bone and tissue necrosis (death). In many cases, these injuries cannot be reversed. Additional injuries include pseudotumors, fluid collections, pain and swelling, impaired function and loss of mobility.
Plaintiffs who have filed lawsuits against Smith & Nephew concerning this implant claim that it was defective and subject to early failure, and that the manufacturer knew about the defects and failed to warn doctors and patients about the risks.
Due to the larger number of product liability lawsuits alleging metal debris contamination, the cases were consolidated into a multidistrict litigation (MDL) in the state of Maryland. Though the original Birmingham Hip Resurfacing was made only for resurfacing hip surgery, Smith & Nephew later combined its components with others for use in total hip replacement surgeries. These hip replacements caused similar injuries and health problems; lawsuits covering them were added to the MDL in March 2018 which now covers some 450 lawsuits nationwide.
The complaints include:
Since then, there have been many new cases added to the growing litigation. The first bellwether trial concerning BHR resurfacing implants is scheduled to begin in April 2020.
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Medical Device Watch is sponsored by Wilentz, Goldman & Spitzer, P.A. The medical device approval process in the U.S. allows for the sale of some devices that have not been tested in clinical trials on humans. Our goal is to help people protect themselves from the physical, emotional and financial harm that can be caused by medical devices that are defective.
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