Contact the FDA about SaluCartilage plugs

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 Yahoo chondromalacia forum, 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