of the most problematic devices, according to the Times,
is the ASR system sold by Johnson & Johnson subsidiary DePuy and recalled in 2010. ASR devices "accounted for 75 percent of the complaints reviewed" by the Times.
(Another DePuy device, the all-metal version of the Pinnacle system, was the subject of "some 200 complaints" reviewed by the Times,
"as well as 400 additional complaints that noted metal-related problems in Pinnacle patients.") Under FDA rules, "many all-metal devices were sold without testing in patients or without a requirement that producers track their performance. But in an unusual intervention, the [FDA] in May ordered producers to study how frequently the devices were failing and to examine the threat to patients. Now, researchers say, producers face substantial hurdles in recruiting the hundreds of patients needed to conduct sound studies because of the lack of patient registries."
Because of the effectiveness of other countries' registries, there are at least two efforts to create similar institutions in the United States. The American Academy of Orthopaedic Surgeons is initiating a pilot program, the American Joint Replacement Registry (AJRR), in 15 hospitals to track recipients' basic information and data on their doctors and implants. The AJRR is privately funded, however, and its primary purpose will be to serve manufacturers and doctors. The federal government is also creating a registry, the National Orthopaedic Outcome Registry (NOOR). Its scope is much smaller than AJRR: It will survey six hospitals that frequently host artificial implant surgeries. But NOOR will gather more data on the recipients' post-surgery experiences.
"These projects are not without their obstacles, though," comments Rochelle Rottenstein, principal of the Rottenstein Law Group. "One is that manufacturers don't want their revenues reduced as a result of criticism of their products. And surgeons don't want to be grade
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|SOURCE The Rottenstein Law Group LLP|
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