By: Staff Writers | Published: August 24th, 2011
Federal health regulators have received a flood of complaints this year about complications with metal-on-metal hip replacement systems.
Since January, the FDA has received more than 5,000 adverse event reports involving metal-on-metal hip problems, according to a New York Times analysis.
Metal-on-metal hip replacement systems are a widely used type of artificial hip, which are designed to last about 15 years. However, complaints suggest that thousands of people are experiencing early failure of the hip implants within a few years of surgery, often leading to additional surgery to replace the hip.
A few years ago, metal-on-metal hip implants accounted for about one-third of the 250,000 hip replacements performed each year in the United States. However, over the past two years, concerns have increased about a risk metal hip replacement complications, resulting in use of the implants dropping to just 5% of the artificial hip market.
Recent research suggests that as the metal hip replacement parts rub against each other, microscopic particles of cobalt and chromium may be shed into the body, which can result in metal poisoning, also known as metallosis. This may result in soft tissue damage, inflammatory reactions, bone loss, genetic damage, asceptic fibrosis, local necrosis or other problems that may lead to the need for a risky hip revision surgery.
In May 2011, the FDA requested artificial hip manufacturers to provide more data on problems with metal poisoning and metal implants.
It is generally believed that only about 1% to 10% of all complications associated with medical devices are ever reported to the FDA. Therefore, it is likely that the reports identified by the New York Times involving problems with metal-on-metal hip replacements only represent a small portion of the actual injuries suffered.
Problems with DePuy’s ASR hip replacement systems accounted for about 75% of the metal-on-metal hip complications reported to the FDA this year.
A DePuy ASR hip recall was issued last August, involving more than 90,000 components sold throughout the world. There have been about 7,500 reports of DePuy ASR hip complications since 2007.
More than 1,000 people have already filed a DePuy ASR hip replacement lawsuit as a result of complications caused by the recalled system. DePuy Orthopaedics also faces a growing number of DePuy Pinnacle hip lawsuits filed as a result of problems associated with their other metal-on-metal artificial hip implant. Although a DePuy Pinnacle hip recall has not been issued, lawsuits allege that the older system features similar design defects that increase the risk of early loosening or failure.