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FDA Meeting to Scrutinize Safety of Metal-on-Metal Hip Implants

A popular line of artificial hip replacement devices have been failing far sooner than expected, but it could be years before the FDA knows exactly why these problems are occurring.

June 25, 2012 – A popular line of artificial hip replacement devices implanted in a half-million Americans have been failing far sooner than expected, but it could be years before the U.S. Food & Drug Administration (FDA) knows exactly why these problems are occurring. Following thousands of patient reports of pain and swelling that sometimes requires extensive revision surgery to correct, this week the FDA is holding a two-day meeting to discuss the safety of metal-on-metal hip implants. It is a challenging but all too familiar scenario for the administration as of late: scrutinizing the safety of a device that was expected to be superior, but which may actually be far more dangerous than its predecessors.

DePuy Hip Update 1/23/13: Newly disclosed court documents have revealed that a 2011 internal investigation conducted by Johnson & Johnson on its much-troubled DePuy ASR hip implant estimated that the device would fail within five years in nearly 40% of recipients. For reasons still unclear, the company failed to make this information public while simultaneously downplaying the potential health complications associated with its metal-on-metal hip. Click here to learn more.

Metal-on-Metal Hip Implant Update 7/2/12: Last week, an independent advisory panel to the FDA agreed that there was little reason to continue using metal-on-metal hip replacement devices, seeing as there are a variety of safer alternatives widely available. While the administration has not yet considered the possibility of removing metal hips from the market, most of the panelists said there were few – if any – cases where they would recommend utilizing the devices. Click here to learn more.

Free Metal-on-Metal Hip Implant Lawsuit Evaluation: If you or a loved one has been injured by a metal-on-metal artificial hip implant, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the hip implant and we can help.

What’s the problem?

For years, the vast majority of orthopedic implants were manufactured out of plastic or ceramic. But over the past decade or so, implants made with metal stems and sockets came into fashion. The thinking was that metal devices would be more resistant to wear and less likely to fail. Unfortunately, new research gathered by surgeons in the U.K. has shown just the opposite.

In March, officials at the world’s largest artificial joint registry told doctors to stop using metal-on-metal hip replacements, after conducting a comprehensive analysis that showed they failed far more often than other types of implants. Hip replacement devices are designed to have a shelf life of 10 to 15 years, but it was found that more than 6% of patients with metal hips needed to have them replaced in less than five years. This figure is particularly shocking when compared with the mere 2% of patients with plastic or ceramic hips that needed to have their devices replaced within five years.

Yet despite these eye-opening statistics, the FDA has not made any recommendations of its own for the estimated 500,000 American patients living with metal-on-metal hip implants. Scientists from the administration say they want to analyze all available data on the subject before drawing any broad conclusions – not just information from the U.K.

“Why look at a single registry when there’s data from around the world?” said Dr. William Maisel, FDA’s chief scientist for medical devices, in an interview with the Associated Press. “This is an opportunity for us to look at all the available information so that we can have a thoughtful conversation about what clinical recommendations can be made.”

Maisel said the administration is working to gather information on a worldwide scale to determine which types of devices and groups of patients are most susceptible to problems. This week, the FDA will confer with an independent panel of experts to recommend the best practices for monitoring patients implanted with metal-on-metal hip replacement devices. The panel will consider blood tests, medical imaging, and laboratory tests.

But a growing movement within the orthopedic community has already reached its own conclusions about the beleaguered devices.

“In my personal opinion there is very little room, if any, for metal-on-metal implants because the alternatives we have on the market are likely safer and as effective,” said Dr. Art Sedrakyan, professor of public health at Weill Cornell Medical College in New York.

Between 2000 and 2011, the FDA received nearly 17,000 adverse event reports (AERS) involving metal-on-metal hips, but federal health regulators have stressed that this figure is not particularly useful. Many doctors never report problems to the administration, and the number of AERS is greatly influenced by media coverage of safety issues.

With little reliable data to go on, the FDA has asked device manufacturers like Johnson & Johnson, Zimmer, and Biomet to conduct long-term, comprehensive studies on the wide variety of metal hip implants currently on the market. The administration says the research will help answer some of the looming questions about the devices, such as that of the effects of metal particles that have been found to seep into the bloodstream as the metal implants degrade over time.

But Sedrakyan and other orthopedic experts say it could be 10 or more years before that research has been sufficiently conducted. In a commentary published last week in the New England Journal of Medicine (NEJM), Sedrakyan and two co-authors indicated that those studies must last at least eight years to gather the information the FDA is seeking. Based on current FDA records, the administration has reached agreements on the design of less than a quarter of the studies, and it’s still unclear as to whether any of the studies have actually begun yet.

Do I Have a Metal-on-Metal Hip Implant Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in metal-on-metal hip implant lawsuits. We are handling individual litigation nationwide and currently accepting new side effects cases in all 50 states.

Free Metal-on-Metal Hip Implant Lawsuit Evaluation: If you or a loved one has been injured by a metal-on-metal hip implant device, you should contact our law firm immediately. You may be entitled to compensation by filing a metal-on-metal hip implant injury suit and we can help.

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