Surgeons should stop using a particular combination of Johnson & Johnson (JNJ) and Stryker (SYK) Corp. metal hip devices because of “unacceptably high” rates of follow-up operations, British regulators said.
Patients with a combination of Mitch TRH cup/heads made by Finsbury Orthopaedics, a unit of J&J, and Accolade femoral stems made by Stryker, should be closely monitored, the U.K.’s Medicines and Healthcare products Regulatory Agency said in a statement on its website. After four years, 10.7 percent of patients with the product combination required a second operation, according to a patient registry.
Metal hips have come under scrutiny by regulators as researchers have highlighted some devices’s increased failure rates and higher risk of exposure to toxic materials. The U.S. Food and Drug Administration will meet June 27 to discuss safety concerns about devices made by manufacturers including J&J, Zimmer Holdings Inc. (ZMH) and Smith & Nephew Plc. (SN/)
“While this further action will not help the metal-on- metal product class, the damage to the industry in terms of ongoing sales has, in our view, largely already been done,” Tom Jones, an analyst at Berenberg Bank in London, wrote in a note to clients. “The concerns about metal-on-metal generally came to the forefront of surgeon thinking over two years ago.”
Spokespeople for J&J and Stryker were unavailable for comment outside of U.S. business hours.
Many medical devices didn’t undergo clinical testing like that required of drugs before they were used in patients, according to a February investigation by the British Medical Journal and the British Broadcasting Corp. Manufacturers have replaced plastic with metal materials over the last decade to improve movement and decrease dislocation without conducting safety studies, they said.
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