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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