there needs to be assurance that you have sufficient data collected
over a reasonable period of time, sufficient post-marketing follow-up
and a better, more robust population-tracking system," says Dr.
Walter.
Additionally, clinical trials are both extremely expensive and much
more challenging for implantable devices than they are for drugs,
since, among other things, no placebos are available. The problems,
says Dr. Wall, are institutional.
"Corporations didn't want to invest the time and effort into doing
clinical trials that would show the mesh implants were safe and effec-
tive procedures," he says. "A lot of these medical devices don't have
physicians driving the process. They're engineers and marketers, and
once the products were developed, it was the marketing arms that ran
with them to maxi-
mize sales. The calcu-
lation at the end of the
day is that they'll have
more profit than liabil-
ity and they'll end up
ahead of the game."
Poor product or
poor placement?
Dr. Feagins thinks
poor surgical tech-
nique is more to blame
than a faulty product.
He estimates he's
implanted about 5,000
mesh slings to treat
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