Metal Hip Replacement Safety Concerns Focus of FDA Panel
An independent panel of expert advisors to the FDA will meet in June to review the safety of Metal-on-metal hip replacement and resurfacing systems, 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 agency indicates that the meeting is needed following numerous studies that have raised serious concerns about the risks of metal-on-metal hips, including high failure rates and a risk of metal blood poisoning caused by microscopic shavings of cobalt and chromium that are released into the body as the metal parts rub against each other.
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The committee is charged with discussing failure rates, testing for metal ion blood poisoning (known as metallosis), imaging methods, local and systemic complications, patient risk factors and considerations for follow-up after surgery. The committee will then make recommendations to the FDA on how to proceed. The agency notes that it is considering whether to make metal-on-metal hip systems “subject to more rigorous testing and premarket review requirements.”
While the recommendations of the committee are not binding on the FDA, they usually factor significantly in the any final decisions made by the agency.
There has been a steady rise in concerns over metal hip implants over the last two or three years. National registries in the U.K. and Australia were the first to sound the warning bell, as experts noticed that all-metal hip implants seemed to be failing at unusually high rates.
Doctors in the U.S. also began to sound off over the need for revision surgeries and signs that metal debris from the implants were causing problems, but medical device manufacturers have attempted to downplay and minimize the risks associated with the implants, which had grown to account for a large share of the market for artificial hips on the belief that they were stronger and more durable.
In August 2010, a DePuy ASR metal-on-metal hip recall was issued after it was discovered that about one out of eight implants failed within five years. However, more than 93,000 of the ASR components were implanted worldwide before the recall, with about 40,000 sold in the United States.
Approximately 3,500 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.
In addition, 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.
Similar 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 shed by hip replacements becomes dangerous, how much metal they actually shed and what the potential side effects of metallosis are.
Several critics have suggested that a metal-on-metal hip recall should be issued to revoke approval for the devices due to the risk of complications. However, many doctors have taken the issue into their own hands by deciding to no longer implant metal-on-metal systems.
The FDA is accepting public comment for the committee until May 9. Electronic comments can be submitted at http://www.regulations.gov. Written comments can be mailed to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm 1061, Rockville, MD 20852. Comments should be identified with Docket No. FDA-2012-N-0293.
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