According to recently revealed information, Wright Medical tried to stop the FDA from approving the Smith & Nephew Birmingham metal-on-metal hip replacement system in 2006, citing a lack of solid data establishing the safety and efficacy of the device.
The Smith & Nephew Birmingham hip became the first metal-on-metal system approved in the United States, with other manufacturers soon following to introduce similar models, which have now been linked to an increased risk of failure and complications.
Wright Medical filed a citizen’s petition (PDF) with the FDA in 2006, asking the agency to reject the application for the Birmingham Hip Resurfacing (BHR), due to concerns over the adequacy of the clinical trials used to obtain premarket approval.
The petition claimed that Smith & Nephew was misrepresenting the nature of the studies submitted to the FDA and of using bad science. For instance, Wright medical claimed that the company’s data on BHR safety and effectiveness came from just one orthopedic surgeon.
Wright Medical suggested that if the FDA approved the Smith & Nephew Birmingham, it would open the floodgates for companies to introduce potentially unsafe metal-on-metal hip replacement systems, with minimal clinical trials and testing. It now appears this is exactly what occurred.
The FDA ignored the petition and approved the Smith & Nephew Birmingham Hip Resurfacing system later that same year. The regulatory agency then continued to approve other metal-on-metal hip replacements, many of which have now been linked to a higher-than-expected failure rate caused by the metal debris that is released from the hip replacement as the metal parts rub against each other.
Problems with Metal-on-Metal Hip Replacements May Have Been Preventable
The petition raises further questions about whether the FDA could have prevented the recent problems with metal-on-metal hip replacements, which were implanted in hundreds of thousands of people throughout the United States before doctors began to notice a high rate of failures and complications.
Metal-on-metal hip replacement systems are a type of artificial hip that use cobalt and chromium metal femoral heads, which rest in a metal acetabular cup. The design quickly grew in popularity, amid aggressive marketing by the manufacturers, which suggested that the components were stronger and more durable than traditional hip replacements.
Concerns about the safety of metal-on-metal hip replacements gained national media attention in August 2010, when a recall was issued for DePuy ASR metal-on-metal hip systems after it was discovered that about one out of eight implants failed within five years, often resulting in the need for risky revision surgery. Unfortunately, more than 93,000 of the DePuy ASR hip replacements were sold worldwide before the recall, with about 40,000 implanted in the United States.
Following additional reports of problems with other metal-on-metal hip replacements that have been introduced, the FDA convened an advisory panel last month to look at the safety issues surrounding the implants. 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.
Metal Hip Lawsuits Over Failure to Adequately Research Design
Thousand of individuals who experienced problems after receiving a metal-on-metal hip replacement are now pursuing a product liability lawsuit against the device manufacturers, alleging that they failed to adequately study the design before introducing it and marketing it as safe and effective.
More than 6,000 DePuy ASR lawsuits have been filed by individuals who received one of the recalled components, but large numbers of complaints have also been filed over issues with the DePuy Pinnacle hip, Wright Conserve hip, Biomet Magnum hip and others.
Reports have suggested that as many as half a million Americans have received an all-metal hip replacement, and a sizeable percentage of them are likely to pursue a lawsuit after their implants fail.
The first metal-on-metal hip replacement trial dates are scheduled to begin in December 2012, and estimates have suggested that the manufacturers will face billions in legal costs and settlements over metal-on-metal hip replacements.