MASSDEVICE ON CALL — A team of U.K. researchers is calling for a ban on metal-on-metal hip implants, citing studies that demonstrate that they fail more often than other artificial hips, especially when used in women.
The researchers pointed to failures of the devices, which are at the center of a high-profile Johnson & Johnson (NYSE:JNJ) recall, as evidence that the FDA needs more stringent standards for approving the devices, rather than relying on predicate devices for an assurance of safety.
"Policy makers need to appreciate that registry data alone are not a substitute for good pre-marketing studies, which should include testing of implants," Art Sedrakyan, a Cornell University associate professor who was not involved with the study, wrote in an editorial published alongside the study in the Lancet. "When failures take a long time to develop, many faulty products can enter the market."
The scientists looked at more than 31,000 metal-on-metal implant cases in the world’s largest hip replacement database, finding 6.2% of patients with all-metal artificial hips needed a 2nd operation within 5 years, Bloomberg reported.
Another recent study, published through a joint investigation by the British Medical Journal and BBC Newsnight, found the controversial implants may have exposed patients to toxic compounds and put them at risk of developing cancer, cardiomyopathy, muscle and bone destruction and changes to their DNA.
Consumer Reports takes aim at medical devices and the 510(k) pathway
Consumers Union, an advocacy arm of Consumer Reports which has been involved in recent regulatory discussions involving FDA user fees for the medical device industry and clearance status for Aptus Endosystems’ HeliFX endostapling system, wants the federal watchdog agency to require clinical testing for more medical devices, Reuters reported.
Trial lawyers protest repeal of Medicare payer board
Lobbyists for trial lawyers came out against the repeal Medicare’s independent payment advisory board when House leaders proposed tieing it to legislation that would cap medical malpractice damages, Healthwatch reported.
OptiMedica moves to Sunnyvale, California
Ophthalmic device maker OptiMedica Corp., developer of the Catalys precision laser system for cataract surgery, moved its global headquarters to a larger 55,000 square foot facility in Sunnyvale, Calif., according to a press release.
Rumors of a $350M buyout for SuperDimension Ltd.
Rumors are circulating that SuperDimension Ltd. is in the midst of a $350 million acquisition by an as-yet undisclosed buyer, Bloomberg Businessweek reported. Johnson & Johnson, Medtronic (NYSE:MDT) and Covidien (NYSE:COV) were said to have thrown their hats in the ring.