There has been many warnings issued to health departments world wide about potential problems with Smith & Nephew’s Birmingham metal-on-metal hip replacements. These hip model and others including the R3 model, have been linked to a high failure rate according to implant registry data in Europe and Australia.
Smith & Nephew recently issued a safety notice that indicates the Birmingham hip failure rate appears to be higher than 1%, which exceeds the rate established for quality standards according to the United Kingdom’s National Institute for Health and Clinical Excellence.
According to data collected since 2010 in the National Joint Registry of England and Wales, as well as the Australian Orthopaedic Associations National Joint Replacement Registry, the rate of Smith & Nephew Birmingham hip problems that were classified as a failure were 1.29% and 1.12%, respectively.
Smith & Nephew R3 Metal Liners of the R3 Acetabular System
On June 1, 2012 Smith & Nephew Orthopaedics initiated a market withdrawal for metal liners of the R3 acetabular system due to a higher than expected number of revision surgeries associated with the use of the device in total hip replacements outside the US.
Smith & Nephew is recommending that physicians maintain their usual follow-up protocol for patients who have undergone total hip replacement or resurfacing surgery.
In the US:
The R3 metal liner is only approved for use with the Birmingham Hip Resurfacing System.
The R3 Acetabular System is a total hip replacement system component that is not cleared for use with the R3 metal liner.
Problems with Metal-on-Metal Hip Replacements
The Smith & Nephew Birmingham hip is a metal-on-metal hip replacement, which features a metal femoral head and a metal acetabular cup. Smith & Nephew introduced the Birmingham hip implant as the first of a new generation of metal-on-metal hip implant designs in the United States.
Recently, problems with metal-on-metal hip implants have caused concerns and recalls, as several newer designs by competing medical device manufacturers have been associated with higher-than-expected failure rates and metallosis.
The Smith & Nephew Birmingham was the first metal-on-metal artificial hip system approved in the United States, with other hip manufacturers soon following to introduce similar models, which have now been linked to an increased risk of failure and other complications.
Thousands of product liability lawsuits have also been brought over other metal-on-metal hip systems, including the DePuy ASR Hip, DePuy Pinnacle hip, Wright Conserve hip and Biomet M2A-Magnum hip.
In August 2010, a DePuy ASR hip recall was announced after it was discovered that this newer metal-on-metal implant was failing in about 12-15% of patients within five years, resulting in the need for risky revision surgery.
In the United States medical experts have indicated that all metal-on-metal hip replacement systems are unsafe and should be recalled from the market. As the metal parts grind against each other, they release microscopic debris of metal which increases the risk of the artificial hip failing within a few years.
FDA Investigation and Recommendations
The FDA convened an advisory panel in June 2012, to evaluate the safety of the metal hip devices. The FDA found no reason for doctors to continue using metal-on-metal hips, and the panel recommended that any individuals who received one of the implants should obtain annual x-rays to check for problems and should also receive blood tests to look for signs of chromium and cobalt blood poisoning in the blood.
Wright Medical, a competing hip manufacturer, filed a citizen’s petition in 2006, to block the approval the Smith & Nephew Birmingham hip, arguing that there was a lack of solid data establishing the safety and efficacy of the metal-on-metal hip design.
Wright Medical, claimed that Smith & Nephew was misrepresenting the studies data submitted to the FDA and using bad science. Wright Medical, argued that if the FDA approved the Smith & Nephew Birmingham metal hip, it may open the floodgates for companies to introduce potentially unsafe metal-on-metal hip replacement systems, with minimal clinical testing. And in fact this is exactly what occurred.