Write the FDA about SaluCartilage

May 31, 2006

SaluCartilage (tough polymer plugs put in places where you have chondromalacia

lesions -- you're ready to go, no recovery time, next day) have been in use in

Europe for 4 years and in Canada for a year. I've been in contact with a doctor

in Italy who comes here to lecture on the implants. In the 4 years he's been

doing it he's only had one failure, and that was early on in his experience.

The plugs are made in the US, and are " under review " by the FDA. The FDA is

notorious for letting Europe 'experiment " on humans for 15 or 20 years (this was

confirmed by one of my docs) before they'll approve devices & procedures for use

in the US (aside: no such waiting period is imposed on drugs, as you know,

since pharmaceutical companies have some sort of in with the FDA, revolving

doors, etc.). This is a procedure that would turn those of us with

chondromalacia who are crippled, whose lifestyles have come to a halt, who are

depressed, back into the active, athletic people we used to be.

I've never been able to get an answer from the company (SaluMedica) as to when

they expect the FDA to approve SaluCartilage -- they just don't answer my

e-mails. At the Knee1 site, people's experiences have been the same. So I went

to the FDA site & filled out an inquiry and actually got an answer. Not much of

an answer, basically " wait and see " and " we can't tell you anything about any

application in progress " and " you should contact the manufacturer " .

However, recently the FDA made a statement saying that they were going to speed

up procedure/device approvals. If many of us write in

(http://www.fda.gov/comments.html, select " Medical Devices " topic, fill in form)

and ask them to get on the stick, we might get some results. Can't hurt.

SaluCartilage doesn't work on general arthritis, just on discrete chondromalacia

lesions.

I urge everyone here with discrete chondromalacia lesions, or even suspicions of

chondromalacia, to fill out that form at the FDA site. Get your friends to send

one in. The more they get, the more likely they are to get moving on it. ALL

THEY HAVE TO DO IS REVIEW THE RESULTS OF THE CLINICAL TRIALS, which are in their

hands.

It's such a simple procedure and it would restore life to so many people.

Thanks.

Ann

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