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Date: Thu, 18 Jan 2018 11:07:56 +0800
LENZER: "So I went back to the FDA certain the company was going to get
slammed. I mean, here it is. Here's a device on the market over a decade
after it was approved, and yet, they'd never done a study looking at
deaths, nor would they release the death data. And when I brought all this
to the FDA, the FDA said, it's safe. And I said, how can you say it's safe
when we don't have death data? And their answer -- and I have it in
writing -- is we never asked the company to count the number of deaths. We
only asked them to characterize death."
This NPR interview reveals many worrisome issues, including corporate control fraud and an apparent failure to incorporate lessons learned for public safety benefit. Worth a read for anyone who has an implantable device, is contemplating implantation, or knows someone who has one. Given the "free market" regulatory structure for implantables -- in the US at least -- there is little cause for manufacturers to be concerned about selling 'high risk' devices which induce fatalities. Caveat emptor.
"DAVIES: You know, most of us ordinary patients in the world aren't going
to do research about medical devices, right? We're going to trust doctors
to know what works and what is safe. Broadly speaking, should we?
LENZER: "This is a terrific problem. I mean, I have a medical device
implanted. I'm very happy with it, but I got to confess. I didn't research
it because the truth is we are dependent on the research that comes out of
these companies. And that's where I wanted to alert the public that we
need to make some structural changes so that we can trust these devices.
As you said, we can't individually research them because we don't have the
capability to do it. Even if we read the studies that are released, we
don't know that we can trust them.
"And I'll give you two examples of just how difficult the situation is.
One of the people I talk about in the book is a man who was harmed by a
hip implant. Well, it turns out that man is also an orthopedic surgeon who
specializes in hip replacements, and yet he landed up being poisoned by
his hip implant from cobalt that leaked out of the hip and destroyed his
muscles and tissues and even caused some degree of heart damage.
"Another example is a Medtronic executive that I report on who had a
Medtronic device implanted in her spine and suffered just terribly
disabling and painful effects from that device. So even people who are
insiders and who should know don't really know."
The FDA's MAUDE (Manufacturer and User Facility Device Experience Database apparently documents only 1% of historical events attributed to implantable device incidence.
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