On March 29, 2012, the FDA announced that it is seeking expert scientific and clinical advice on the risks and benefits of metal-on-metal (MoM) hip systems. The agency will discuss the issues at a two-day expert advisory panel meeting on June 27-28, 2012.
The FDA’s request is timely because of a barrage of studies, reports, and lawsuits claiming safety issues with MoM devices such as:
- DePuy ASR
- DePuy Pinnacle
- Zimmer Durom Cup
- Smith & Nephew R3
- Wright Conserve
- Wright Profemur
- Biomet M2A-Magnum
Though the agency will not be reviewing knee implants, the Zimmer NexGen metal knee has also been reported to cause complications in numerous cases.
Patients injured by these devices, including the Zimmer NexGen knee, may be eligible to file a metal-on-metal orthopedic device lawsuit. Thousands of lawsuits already have been filed, each represented by a metal-on-metal orthopedic device lawyer.
Problems Start with DePuy ASR
The problems with MoM devices came to a head in August 2010, when DePuy Orthopaedics implemented a metal-on-metal orthopedic device recall of the DePuy ASR hip system. After the FDA approved the device in 2005, hundreds of reports of problems were submitted to the FDA, detailing problems of premature hip failure and metal toxicity.
In December 2009, the company initiated a metal-on-metal orthopedic device recall in Australia, but it wasn’t until March 2010 that they first notified U.S. doctors of the high failure rates. The U.S. metal-on-metal orthopedic device recall was announced August 26, 2010. At that time, DePuy admitted to a failure rate of 13 percent. The British Orthopaedic Association later released data indicating the failure rate was 21 percent after four years, and 49 percent after six years.
DePuy Not the Only One
After the ASR disappeared from the market, thousands of patients came forward to file a metal-on-metal orthopedic device lawsuit. Soon after, other hip implant devices designed with all-metal components were linked to reports of complications. Unlike previous designs that had paired metal with ceramic or polyethylene plastic components, these newer MoM devices contained metal ball and socket components.
The newer design was supposed to provide for longer-lasting durability, increased range of motion, and decreased risk of dislocation. Unfortunately, post-marketing reports indicated that in many instances, the devices were not living up to their promises.
Zimmer Temporarily Withdraws Durom Cup
While DePuy was wrestling with allegations of high failure rates, Zimmer, Inc. “ the manufacturer of the metal-on-metal Zimmer Durom Cup “ was investigating its MoM implant. In 2007, a prominent orthopedic surgeon, Dr. Lawrence Dorr, alerted the company to the problems he was seeing with the implant. The doctor later published a letter in 2008 to the American Association of Hip and Knee Surgeons about higher-than-expected failure rates requiring revision surgery.
Zimmer implemented what has been called a metal-on-metal orthopedic device recall in the summer of 2008, but actually the company only temporarily suspended sales to further investigate reports of problems. They re-released the product about a month later, blaming the issues on surgical error, and included new surgical instructions with the device. Since that time, thousands of patients have filed Zimmer metal-on-metal orthopedic device lawsuits.
Zimmer has also faced claims against its NexGen knee implants, which “ though not linked with metal toxicity or poisoning “ have been found to increase risk of premature loosening.
Biomet, Wright, and Smith & Nephew
In September 2001, Biomet implemented a metal-on-metal orthopedic device recall for the zirconia ceramic femoral head they were using, which proved to be defective. Years later, however, the company was again the subject of controversy when their M2A-Magnum MoM hip device was linked with premature loosening, early failure, and increased revision surgeries.
Wright Medical Technology makes the Wright Conserve family of hip implants, as well as the Wright Profemur hip implant. The Wright Conserve devices have recently been linked to serious complications like pain, instability, metal toxicity and premature failure. A metal-on-metal orthopedic device lawyer may point to the all-metal components as causing many of these problems.
Meanwhile, the Wright Profemur MoM hip implant was linked to a high failure rate of 11.2 percent in a 2009 report by the Australian National Joint Replacement Registry. Plaintiffs in a metal-on-metal orthopedic device lawsuit blame the design of the metal femoral neck, which has two parts and has been reported to fracture, degrade, and break.
Smith & Nephew announced a metal-on-metal orthopedic device recall on June 1, 2012, withdrawing a metal liner for the R3 Acetabular System from the market. After reports of high failure rates, the company stated they were unhappy with clinical results of the liner. Patients implanted with the R3 metal liner were more likely to experience infections, fractures, and dislocations than those not using all-metal devices.
FDA Requires Additional Safety Studies
On May 6, 2011, the FDA required 21 manufacturers of MoM devices to conduct post-marketing surveillance studies to further examine safety issues. The main problem with these implants is the metal ball and socket. During normal wear and tear, these components can rub against one another, potentially shedding tiny shards of cobalt and chromium into neighboring tissues and the hip joint. The metal debris can then cause tissue death, swelling, bone damage, and even metal poisoning if the metal gets into the bloodstream.
Researchers examining data from the National Joint Registry of England and Wales “ including information on more than 400,000 hip replacements between 2003 and 2011 “ determined that MoM implants failed more quickly than those with other surfaces. Overall, 6.2 percent needed revision surgery in five years “ a risk considered unacceptably high. The study authors wrote, œMetal-on-metal stemmed articulations give poor implant survival compared with other options and should not be implanted.
Filing a Metal-on-Metal Orthopedic Device Lawsuit
Thousands of lawsuits have been filed against manufacturers of MoM devices. Federal DePuy litigation concerning the recalled ASR has been centralized in Ohio. Federal Wright Conserve lawsuits were recently centralized in Georgia. Federal Zimmer Durom Cup lawsuits proceed in New Jersey, and Federal Zimmer NexGen knee lawsuits are moving forward in Illinois.
If you or a loved one has suffered complications from a metal-on-metal orthopedic device, the attorneys at Chaffin Luhana LLP may be able to help. A positive verdict in a metal-on-metal orthopedic device lawsuit could result in monetary compensation. Call today for a free and confidential case evaluation at 1-888-480-1123.