Tuesday, April 11, 2006

Concerned about Surgiwrap

I have gone through their whole site regarding this product and I am very concerned as they do not use the word "Adhesion" or "Adhesion Barrier" at all.

In their literature regarding "Surgiwrap" they go out of their way to not use it in my opinion. They prefer to market this product as "preventing soft tissue attachment" Huh?

Very interesting. I am sure they have their reasons.

Oh, wait I see the word adhesion here ( not in their information website of the product) in a
press release to shareholders hmmmm.......

How effective was this product in FDA clinical trials?
Oh, I see....

"Is SurgiWrap® FDA approved?
SurgiWrap® and its supportive data has been reviewed and cleared for
sale in the U.S. by the FDA.
This clearance for sale means that the FDA has found SurgiWrap®
to be safe and effective in all soft tissues of the pelvic, and abdominal
cavities by determining SurgiWrap® to be substantially equivalent
to existing "like" products previously cleared by FDA."

See their " Scientific Papers" instead...hmmm....

Watch a short clip (irony) of a surgeon attaching the
product with clips ( very nasty foreign object for adhesion
sufferers to have placed in them).

Watch the "gentle tissue handling" of the film being placed
in an open abdomen.

Watch the clip of the sheet being used laproscopically.
It reminds me of my own struggles with ornery plastic wrap
at thanksgiving time.

From Home page
http://www.mastbio.com/fda.shtml

I would not want to be part of this learning curve nor do I
trust the fact that the word "Adhesion" is circumnavigated
throughout their website.
Why?

I'm no doctor, just trying to be an informed consumer.
Caveat Emptor

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