Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Thursday, April 26, 2012

Consumer Reports Investigates Safety of Implanted Medical Devices


Is your implanted medical device safe?
Mar 28, 2012 6:05 AM

You might assume so, but many implanted devices, including artificial joints and surgical mesh, were never clinically tested on humans before being put on the market, according to a new Consumer Reports investigation. Worse still, if anything goes wrong, you might not hear about it—and may even have a hard time finding out what device you got.
Case in point: the DePuy ASR XL metal-on-metal hip replacement, which was implanted in 93,000 people worldwide before it was finally taken off the market in 2010 because it was failing at an unacceptably high rate.
One recipient of the DePuy hip, Susy Mansfield, 61, of Peterborough, N.H., who shared her story with our Safe Patient Project, said didn't know anything about the recall until she read a news item in the Boston Globe some five months later. The only evidence that she had a DePuy hip was a small card she was given to to help her through airport security that had that brand name on it.
But she told us that repeated calls to her surgeon's office to find out what exact device she had received met with resistance and no information, until she finally threatened to send a lawyer to get it. She recently had surgery to replace the hip with a safer model. You can hear and read more about her experience on National Public Radio's Shots blog.
"I would be happy to a sign a statement allowing my name and contact information to be given to the manufacturer so they could contact me in the event of a recall or product problem," Mansfield says.
We agree. Consumer Reports' advocacy arm, Consumers Union, is fighting to make the device industry safer for patients . One of our recommendations is that every implanted device should have a "unique identifier," similar to a serial number, to enable patients to hear quickly about recalls or other safety issues.
For details, read our report on Dangerous Medical Devices.
—Nancy Metcalf, Senior Program Editor

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