November 11, 2010

Stories question medical device safety

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Journalists Shannon Brownlee and Jeanne Lenzer published an important article in the BMJ entitled, “Why the FDA can’t protect the public.”

Much of their emphasis was on medical device makers failing to properly conduct safety studies before or after marketing approval.

On the local level, another fine example of TV reporting came from Jeff Baillon of KMSP-TV in Minneapolis-St. Paul who led an investigation into problems with artificial joints. Excerpt:

“Dr. Edward Cheng is a surgeon at the University of Minnesota. He says, “If Maytag can track their washing machines, or if a car maker can track where a car goes and who the owner is, we should have the ability to track all major orthopedic implants, where they go and when they’re removed.”

But right now in this country that’s not happening. There is no mandatory system that tracks the failure rates of all joint implants. In Great Britain and Australia, doctors, hospitals and device makers are required to report to a registry whenever patients need revision surgeries to fix faulty joints.

Dr. Cheng says, “Having a registry would be a dramatic step forward in our ability to identify problems.”

Dr. Cheng says a joint registry would uncover failing products sooner meaning fewer people would be harmed. In 2006 approximately 77,000 revision surgeries were done in the United States at a cost of more than 3 billion dollars. Countries with registries have seen the need for revisions drop by as much as ten percent.”

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Gregory D. Pawelski

November 11, 2010 at 2:21 pm

Questioning medical device safety? Great post Gary! Another issue I’ve been having to deal with over the last ten years. It took me two years to get my mother’s orthoped to do a revision surgery on her right knee device, because her patella was dislocated. Finally, after an ER visit with a 103 temp and a “hot” right knee, medical personal personel ruled out MRSA, UTI, even gout and indicators lead to a revision surgery. Six months later, her patella was dislocated again! And to boot, an aspiration of the knee indicates infection. And there’s no mandatory sytem in this country to track the failure rates of all joint implants??? GEESH!!!

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