May 17, 2013 — The declining popularity and safety concerns surrounding metal-on-metal hip implants has led DePuy Orthopedics to discontinue the Ultamet and Complete hip implant liners. According to a press release, the metal liners are used exclusively with the Pinnacle hip implant. However, the Pinnacle is not affected, and the decision “is not related to safety or efficacy, and is not a recall.”
DePuy will re-focus their portfolio on ceramic and plastic hip implants, which have been linked to lower rates of complications than metal-on-metal hip implants. More than 10,000 people have filed ASR hip implant lawsuits against DePuy after their implant failed prematurely.
The ASR and other metal-on-metal hip implants were marketed toward younger, more active patients because they were marketed as longer-lasting than plastic or ceramic hip implants. However, researchers discovered this to be false.
DePuy stated that they will “simplify and streamline” their medical device portfolio over the next few years by discontinuing other products and re-focusing their strategy on plastic and ceramic implants. Advances in technology, physician preferences, and concerns about safety have dramatically reduced the market value of metal-on-metal hip implants.
In addition to declining market, the U.S. Food and Drug Administration (FDA) has also proposed regulatory changes that would make it more expensive for a manufacturer to approve a new metal-on-metal hip implant. Instead of “fast-track” approval under the controversial 510(k) process, which allows manufacturers to avoid safety studies, they would be required to submit Pre-Market Approval (PMA) applications, which have more rigorous requirements for safety testing.
DePuy has faced enormous criticism for not thoroughly testing the ASR metal-on-metal hip implant before it was approved. In one of the first trials involving the ASR, evidence emerged that the ASR failed DePuy’s own internal company safety tests in 2007. However, instead of improving the ASR, DePuy redesigned the test. After the ASR was marketed and implanted in 93,000 people, it was linked to a 37% five-year failure-rate.
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 hip implant, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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