A panel of expert advisors will meet in June to review the safety of Metal-on-Metal hip replacement and resurfacing systems. A scathing report is expected which could result in a range of more stringent regulatory actions.
The FDA has set June 27-28 as the date for a meeting of the Center for Devices and Radiological Health (CDRH) Orthopedic Devices Panel, which will focus on metal hip systems.
The FDA is alarmed following numerous medical studies that have raised serious concerns about the risks of metal-on-metal hips, including high failure rates and a risk of metallosis caused by microscopic particles of cobalt and chromium that are released into the body as the metal parts grind against each other.
The panel is authorized to review failure rates, testing for metallosis, imaging methods, local and systemic complications, patient risk factors and recommendations for follow-up after surgery.
The FDA is considering to make metal-on-metal hip systems “subject to more rigorous testing and premarket review requirements.”
There has been growing concerns over metal hip implants, national registries in the U.K. and Australia were the first to sound the alarm, as experts noticed that all-metal hip implants seemed to be failing at unusually high rates.
Medical device manufacturers have downplayed and minimized the risks associated with the implants, and have touted that they were stronger and more durable.
In August 2010, DePuy ASR metal-on-metal hip recall was issued after it was discovered that about one out of eight implants failed within five years. More than 93,000 of the ASR components were implanted worldwide before the recall, with about 40,000 sold in the United States.
Approximately 4,500 individuals throughout the U.S. have already filed a DePuy ASR hip lawsuit against Johnson & Johnson and DePuy, alleging that the company failed to adequately research the design of their implant or warn about the risk of metal-on-metal hip poisoning.
Hundreds of individuals are currently pursuing a DePuy Pinnacle lawsuit, after experiencing problems with the older metal-on-metal hip implant, which has also been linked to a high number of failures.
Product liability lawsuits have also been filed over problems with Wright Conserve metal hips, BioMet M2A-Magnum metal hips and other metal-on-metal hip replacements manufactured by other companies.
In May 2011, the FDA asked device manufacturers to obtain more information about the level at which the metal particles released by hip replacements becomes dangerous, how much metal they actually release and the side effects of metallosis.
Several experts have recommended that a metal-on-metal hip recall should be issued for the devices due to the risk of complications.
Shezad Malik is an Internal Medicine and Cardiology specialist, a licensed Texas Medical Doctor and Defective Medical Device and Dangerous Drug Attorney. Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.