September 27, 2012 — Smith & Nephew, the medical device company that manufactures the Birmingham metal-on-metal hip implant, has published an “Urgent Field Safety Notice” after finding the Birmingham hip implant is associated with a higher rate of failure and revision surgery than is acceptable in the United Kingdom. The average rate of revision exceeds the 1% benchmark created by the U.K.’s National Institute for Health and Clinical Excellence (NICE).
Researchers have found that the metal-on-metal hip implant is associated with a 1.29% failure rate, according to the National Joint Registry of England and Wales. A separate analysis of data from the Australian Orthopaedic Association’s National Joint Replacement Registry linked the Birmingham to a 1.12% failure rate.
It is difficult for researchers in the United States to determine the failure rate of the Birmingham, because the U.S. Food and Drug Administration (FDA) lacks a tracking system for medical devices. The FDA only keeps a database of voluntarily-submitted adverse event reports.
Smith & Nephew is also reminding healthcare professionals about several factors that increase the risk of hip implant failure and revision surgery. The risk of failure increase for patients who receive smaller component sizes (less than 46-mm), patients who require implantation at a high abduction angle, patients with osteonecrosis (bone death) in the hip, or other problems in their hip. Women of childbearing age and people who are severely obese have a higher risk of hip implant failure.
The company warns that patients who absolutely should not get a Birmingham hip implant include those with osteoporosis (bone loss), metabolic disorders such as kidney failure, muscle atrophy/weakness, lack of bone or soft tissue in the hip area, infection anywhere in the body, or a pre-existing metal sensitivity.
The safety communication warns about the risk of serious health complications. Metal-on-metal hip implants are facing heightened scrutiny by regulators around the world. The products can shed particles of metal into the body, which increases the risk of pain, inflammation, metal poisoning, and severe irritation of surrounding tissues and bone. This can cause the formation of soft-tissue lesions, pseudo-tumors, and fluid collections. Patients may require revisions surgery to remove, replace, or repair the implant.