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FDA Advisory Panel Recommends Alternatives to Metal-on-Metal Hips

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.

July 2, 2012 – Last week, an independent advisory panel to the U.S. Food & Drug Administration (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. Over the past several years, thousands of patients implanted with metal hips have reported the devices failing and shedding toxic metallic particles into their bloodstream. While the FDA has not yet considered the possibility of removing metal-on-metal hips from the market, most of the panelists said there were few – if any – cases where they would recommend utilizing the devices.

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.

Hip Implant Recall Update 7/10/12: Michigan-based Stryker Orthopaedics is now recalling two brands of devices used in conjunction with artificial hips in hip replacement surgeries. To date, the devices in question – the Stryker Rejuvenate and ABG II Modular-Neck Stem – have been linked to at least 45 adverse event reports (AERS) submitted to the FDA by individuals who claim to have suffered severe pain and/or tissue swelling. Click here for more information.

Free Metal-on-Metal Hip Implant Lawsuit Evaluation: If you or a loved one has been injured by a metal-on-metal hip replacement device, 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?

The FDA asked its 18-member independent advisory panel to recommend new guidelines for monitoring more than 500,000 U.S. patients implanted with metal-on-metal hip replacements. The devices were originally designed to be longer-lasting alternatives to ceramic and plastic models, but new data from the U.K. and elsewhere seems to suggest that they are more likely to deteriorate, exposing recipients to cobalt, chromium, and other highly toxic metals.

Information gathered from a number of different foreign registries has shown overwhelmingly that metal-on-metal hip implants fail at a higher rate than traditional devices. To date, the FDA has received nearly 17,000 adverse event reports (AERS) involving problems with the implants, which many times require painful revision surgery to correct. The pain and inflammation reported by patients is usually caused by the shedding of microscopic metallic particles that seep into the joint, damaging the surrounding tissue and bone. The long-term complications of elevated levels of metal in the blood are still not clearly understood, though some research has indicated links to nerve damage and heart problems.

Each year, nearly a half million Americans undergo hip replacement surgery to relieve pain and restore motion inhibited by arthritis or injury. Metal-on-metal devices accounted for about one-quarter of all hip implants in 2010, down from nearly 40% in 2008. In response to a number of high-profile recalls, such as Johnson & Johnson’s recall of nearly 100,000 metal hips in 2010, more and more doctors have been seeking out safer alternatives.

During last week’s meeting, orthopedic experts stressed that patients suffering from pain and other symptoms should get periodic x-rays and blood testing for metal levels. For individuals who are not experiencing pain, annual x-rays to monitor their implants are recommended. If the FDA ultimately decides to follow the panel’s advice, the recommendations would be substantially less stringent than those already in place in other countries.

With little reliable data to go on, the FDA has asked companies like J&J, Zimmer and Biomet to conduct comprehensive follow-up studies of more than 100 metal hips currently on the market in the United States. These studies will be intended to help ‘fill in the blanks’ on a number of scientific questions, such as that of the long-term complications associated with metal particles in the bloodstream. However, industry experts contend that these studies may take a decade or longer to be completed.

“Keeping these metal-on-metal hips on the market for the next five to 10 years while research is conducted is not ethical,” said Diana Zuckerman, president of the National Research Center for Women & Families, during a public comment session at the meeting. “If the companies want to sell metal-on-metal hips, they should be required to prove their safety first.”

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 replacement device, you should contact our law firm immediately. You may be entitled to compensation by filing a metal-on-metal hip injury suit and we can help.

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