By: Austin Kirk | Published: September 26th, 2012
A warning has been issued to the Hong Kong department of health about potential problems with Smith & Nephew’s Birmingham metal-on-metal hip replacements, which 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.
Problems with Metal-on-Metal Hip Replacements Plague Many Manufacturers
The Smith & Nephew Birmingham hip is a metal-on-metal hip replacement, which features a metal femoral head that rotates within 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.
In recent years, problems with metal-on-metal hip replacements have caused substantial concerns within the medical community, as several newer designs introduced by competing medical device manufacturers have been associated with higher-than-expected failure rates.
Concerns about the safety of metal-on-metal hip replacements gained national media attention in August 2010, when a DePuy ASR hip recall was issued after it was discovered that this newer metal-on-metal implant was failing in about one out of eight patients within five years, often resulting in the need for risky revision surgery.
Both in the United States and abroad, there are a growing number of medical experts who have indicated that all metal-on-metal hip replacement systems are unsafe and should be recalled from the market. As the metal parts rub against each other, they may release microscopic shavings of metal which could increase the risk of the artificial hip failing within a few years.
In response to reports of problems and premature failures involving several different metal-on-metal hip designs, the FDA convened an advisory panel in June 2012, to evaluate the safety of the devices. After determining that there was little, if any, reason for doctors to continue using metal-on-metal hips, 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 ions in the blood if any pain or discomfort develops.
Prior to introduction of the Smith & Nephew Birmingham hip, Wright Medical filed a citizen’s petition in 2006, attempting to block the approval, arguing that there was a lack of solid data establishing the safety and efficacy of the metal-on-metal hip design.
The petition claimed that Smith & Nephew was misrepresenting the nature of the studies submitted to the FDA and using bad science. The competing medical device maker 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. It now appears this is exactly what occurred.
In addition to the Smith & Nephew Birmingham and DePuy ASR hip, hundreds of lawsuits have been filed throughout the United States on behalf of individuals who had other metal-on-metal hip systems fail, including the DePuy Pinnacle hip, Wright Medical Conserve Cup and Biomet M2A-Magnum hip.