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Nearly 17K Metal-on-Metal Hip Implant Complaints to FDA

June 25, 2012 — According to a report posted on the Food and Drug Administration (FDA) website, there have been 16,800 adverse events associated with metal-on-metal hip implants between 2000 and 2011. Johnson & Johnson is faced with more than 6,000 ASR hip implant lawsuits, which accounted for 74% of the reports in 2011. The ASR was recalled after more than 12% of the devices failed within five years. Scrutiny regarding all metal-on-metal hip implants is increasing — several recent studies have linked the design to higher rates of corrosion, toxic metal poisoning, device failure, benign tumors, and other side effects, when compared to plastic or ceramic designs.

The most common adverse event reported was revision surgery, which involves removing or replacing the hip implant. There were 14,131 revision surgeries for metal-on-metal hip implants, and nearly 9,000 reports of pain following these surgeries. The FDA has said that the revision rate “is likely not lower” for metal-on-metal devices compared to plastic or ceramic designs. One study from England and Wales found that 6.2% of people with the devices required revision surgery within five years — three times higher than plastic or ceramic devices.

In response to the adverse event reports, the FDA may advise patients to undergo more consistent testing to help lower the high failure rate. This could involve imaging and ion testing to better determine the effect of metal on tissues, muscles, and bones surrounding the implant. Furthermore, the FDA will be meeting on June 27th and 28th to discuss whether to order manufacturers of these devices to conduct post-market surveillance to collect more data on the device safety.

The use of metal-on-metal hip implants peaked in 2006 and 2007, when about one-third of all hip replacements were this design. Now, only about 10% of hip implants are metal-on-metal. Manufacturers advertised them as ideal for younger, healthier, more active hip implant recipients, because it was thought that the metal-on-metal design would last longer than plastic or ceramic devices. Instead, after thousands of people were implanted with the devices, researchers found that the metal parts of the devices grind together when the patient walks. In some cases, this sheds toxic metal ions of chromium and cobalt into nearby bone, tissue, and muscle.

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

The Schmidt Firm, PLLC is currently accepting metal-on-metal hip implant induced injury cases in all 50 states. If you or somebody you know has been injured by a defective metal-on-metal hip implant, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Metal-on-Metal Hip Implant Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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