May 17, 2013 — DePuy Orthopedics announced in a press release the discontinuation of a metal liner used in the Ultamet metal-on-metal and Complete ceramic-on-metal hip implants. The liner is designed exclusively for use with the DePuy Pinnacle hip implant, which is not affected by the discontinuation. DePuy cited declining sales of the metal-on-metal hip implants and proposed changes in regulation, and “is not related to safety or efficacy, and is not a recall.”
DePuy is currently facing more than 10,000 lawsuits involving the ASR hip implant. Thousands of people were injured when their hip implant failed within just a few years after implantation. Although metal-on-metal hip implants were originally advertised as longer-lasting, more durable implants for younger patients, their popularity has declined as researchers have linked them to higher rates of complications than plastic and ceramic hip implants.
DePuy stated that they will be discontinuing other products in an effort to “simplify and streamline” their product portfolio. The decision was also influenced by “next generation options,” and advancements in technology that have shifted physician preferences away from metal-on-metal hip implants and toward metal-on-plastic, ceramic-on-plastic, and ceramic-on-ceramic bearings.
Another factor influencing DePuy’s decision to discontinue the metal-on-metal hip implant liners was the U.S. Food and Drug Administration (FDA). The agency has proposed changes to the way metal-on-metal hip implants are approved. If the products are re-classified as “high-risk” medical devices, they will no longer be approved under the 510(k) process, which allows manufacturers of new devices to avoid conducting safety studies so long as their new product is “substantially equivalent” to an existing device.
DePuy has faced criticism for the way they tested and marketed the ASR metal-on-metal hip implant. After the ASR system failed an internal safety test in 2007, instead of re-designing the implant, DePuy re-designed the test. After it was implanted in more than 90,000 people, it was linked to a 37% five-year failure rate. Many of these individuals have filed lawsuits against DePuy.
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