S & N Field Safety Notice Issued for Certain Sub-groups of Patients

According to the Food & Drug Administration (FDA), metal-on-metal hip implants have unique risks in addition to the risks of all hip implants. The metal “ball” and socket” grinds together as the patient implanted with a metal hip system walks or runs. The implant can shed tiny particles of chromium and cobalt around the hip or particles can potentially enter into the patient’s bloodstream. Over time, additional complications like inflammation, chronic pain, decreased mobility, tissue death, and bone loss may force a patient to undergo revision surgery.

Smith & Nephew is a medical device company that manufacturers the Birmingham Hip Resurfacing (BHR) system. The BHR is a metal-on-metal hip system, also the first metal hip implant to be approved in the United States. Other manufacturers have mimicked the BHR hip system, and currently faced with thousands of metal hip implant lawsuits.

In January 2015, Smith & Nephew released an urgent field safety notice for its BHR system. The field safety corrective action was undertaken as certain sub-groups have been identified to be at increased risk of adverse outcomes if fitted with the system. The safety notice informed patients that more information would be available on the company website. Patients who visited the website could not find any information or mention of the urgent field safety notice issued by the company.

It seems rather suspicious an urgent field safety notice would be issued directing patients to the company website and then, have essential information unavailable to the patient.