Re: LIFECORE RECEIVES FDA FINAL APPROVAL TO MARKET GYNECARE INTERGEL ADHESION
From: cathy:- (anonymous@medispecialty.com)
Tue Nov 20 21:37:41 2001
I really hate to bring this up, but I think that it would be good to
take a deep breath and step back and think about this a little harder.
To use a baseball analogy, this is not a "home run" of a medical advice.
It's more like a "first base and home plate umpire huddle for 5 minutes
trying to decide if the baserunner really beat the throw or not" sort of
thing. The FDA's original ruling was that the intergel didn't really
work well enough to make the "effective" standard. The ruling of the
appeals panel is that if you add a few more studies then it just kinda
"squeaks in" under the wire. Not exactly a ringing endorsement!!!
What attitude do I think I want to take? If I have some life-threatening
emergency and I MUST have abdominal surgery, then I'm going to ask for
the gel. But I'm not going to schedule an adhesiolysis with the idea
that this is a miracle cure and that I don't have to worry about it
failing. After another year or two, some people will have been forced
by circumstances to be the guinea pigs, and we'll all know a lot more
about how well this stuff REALLY works...
--
cathy :-)