ruby2zdy
01-06-2006, 06:38 AM
Is SaluCartilage (http://www.salumedica.com/salucartinfodoc.htm) in use in AU? I know it's been approved in Europe for 4 years and in Canada for 1. If any of you have had these implants put in, I'd like to hear about your results. I'm in the US.
The US FDA is notorious for letting Europe "experiment" on humans for 15 or 20 years before they'll approve a procedure or device. As far as I'm concerned the SaluCartilage plugs have been proven in Europe. For discrete chondromalacia lesions, they drill out a hole, put the plug in, and Bob's yer uncle -- you're ready to resume your life the next day.
I was a hiking/mountain climbing athlete. I've been crippled by chondromalacia for 13 years. I'm considering a TKR just to become mobile again, but if I could just get the hindside of my kneecap fixed with the plugs, that would be so much better.
I'm asking anyone in the US, anyone who has a friend in the US with chondromalacia, anyone who'd be willing to pretend they're US citizens, any orthopedic surgeons who think the plugs are a good idea, to write to the FDA (http://www.fda.gov/comments.html -- choose "Medical Devices, Radiation-Emitting Products -- no, the plugs don't emit radiation -- that's just the FDA category) and ask them to expedite approving SaluCartilage because there are thousands of us out here whose lives have been ruined by chondromalacia lesions and who could be restored to life in merely a day. They have the trial results and are just sitting on them. You'll get a form letter back saying they'll do it in due time, you should contact the mfr (they don't answer back), etc. Address: http://www.fda.gov/comments.html
Recently the FDA stated that they were going to take measures to speed up the approval process for procedures and devices (there's an 18-yr backlog). I figure if a lot of people write in and annoy them, maybe they'll get to it before I'm forced to get a TKR.
Any help from those of you who are interested would be greatly appreciated.
The US FDA is notorious for letting Europe "experiment" on humans for 15 or 20 years before they'll approve a procedure or device. As far as I'm concerned the SaluCartilage plugs have been proven in Europe. For discrete chondromalacia lesions, they drill out a hole, put the plug in, and Bob's yer uncle -- you're ready to resume your life the next day.
I was a hiking/mountain climbing athlete. I've been crippled by chondromalacia for 13 years. I'm considering a TKR just to become mobile again, but if I could just get the hindside of my kneecap fixed with the plugs, that would be so much better.
I'm asking anyone in the US, anyone who has a friend in the US with chondromalacia, anyone who'd be willing to pretend they're US citizens, any orthopedic surgeons who think the plugs are a good idea, to write to the FDA (http://www.fda.gov/comments.html -- choose "Medical Devices, Radiation-Emitting Products -- no, the plugs don't emit radiation -- that's just the FDA category) and ask them to expedite approving SaluCartilage because there are thousands of us out here whose lives have been ruined by chondromalacia lesions and who could be restored to life in merely a day. They have the trial results and are just sitting on them. You'll get a form letter back saying they'll do it in due time, you should contact the mfr (they don't answer back), etc. Address: http://www.fda.gov/comments.html
Recently the FDA stated that they were going to take measures to speed up the approval process for procedures and devices (there's an 18-yr backlog). I figure if a lot of people write in and annoy them, maybe they'll get to it before I'm forced to get a TKR.
Any help from those of you who are interested would be greatly appreciated.