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The Big File All issues not easily categorized in the above forums are here. Comments on general health, diet, "getting comfortable," and more are here. |
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#1
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I have been watching the FDA site for the Prodisc approval and have been keeping track of the advisory committee calendar. They have finally posted the calendar for 2006 and the Orthopaedic and Rehabilitation Devices panel does not have a tentative meeting date until July of 2006. What is it with these people!! How can they distance themselves from the fact that people are in extreme pain and on disability waiting for the approval of a device that can change their lives! I know that the dates are only tentative but with this panel's record who knows when they might meet again. Now I guess that we have to hope that approval comes without that meeting which I have read could happen. Sorry about the frustration I have allowed to show in this post but I didn't want to put all my hope into waiting for the approval before the panel's meeting.
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#2
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Thanks for the bad news.
I blame the Europeans for their lazy research that cannot be used in a meta-data analysis; it's way too general. Do we know how ADR's in a decade fare vs. fusion which we know sucks? Oh well... Allan
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Severe, extensive DDD, considered inoperable by Dr. Regan, Lauressen, & some guy at UCLA. Severe foraminal stenosis (guess they can't operate!) and some spinal cord compression that Lauryssen would fix if gets outta hand. |
#3
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i think the target date is still feb 2006 for prodisc
approval.activ-l trials r suppose to start may 06 and it has to be 90 days after prodisc approval. chuck at least i pray its feb |
#4
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Last night I spoke to another doctor who will be participating in the Activ-L trial. This disc is getting a lot of interest. Yes, the study is written with ProDisc as the control, so the Activ-L trial must wait for ProDisc approval.
It is possible that the ProDisc could be approved without a panel discussion. So, we are still stuck in the "could be tomorrow... could be another year" phase of our vigil. Mark |
#5
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I'm going to remain hopeful..
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#6
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Alikin
I can't find ProDisc information on the FDA website. Do you have an address? Thanks, Tom |
#7
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Geeze! Does this mean that a Maverick in 2006 is just a pipe dream? I'm not waiting though another year of this horrible pain! At that point I'll be ready to go to court to get my disc approved by W.C.
As Denny Crane would say: "Lock & load!" Boy would Denny Crane be a fun lawyer to take to Spine Court! Hey why dont we do a class action against the FDA for incompetency? mmglobal: War�s over, man. The FDA dropped the big one. Eddie G.: Over? Did you say �over"? Nothing is over until we decide it is! Was it over when the Germans bombed Pearl Harbor? Hell no! mmglobal: Germans? ans: Forget it, he�s rolling. Eddie G.: And it ain�t over now. �Cause when the goin� gets tough� [thinks hard] Eddie G.: the tough get goin�! Who�s with me? Let�s go! [runs out, alone; then returns] Eddie G: What the f**k happened to the Spineys I used to know? Where�s the spirit? Where�s the guts, huh? �Ooh, we�re afraid to go with you Eddie G, we might get in trouble.� Well just kiss my *ss from now on! Not me! I�m not gonna take this. The FDA, it�s a dead goverment agancy! FDA, INEPT! mmglobal: Dead! Eddie G's right. Psychotic, but absolutely right. We gotta take these bastards. Now we could do it with conventional weapons that could take years and cost millions of lives. No, I think we have to go all out. I think that this situation absolutely requires a really futile and stupid gesture be done on somebody�s part. Eddie G.: We�re just the guys to do it. Harrison: Let�s do it. Eddie G.: LET�S DO IT! (Lawyers all over America are throwing away their Viagra)
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12/16/03 Work Accident Herniation and DDD at L4-L5 4/1/05 Discectomy Epidurals and facet injections 5/15/06 Discogram confirmed L4-L5 DDD also an asymptomatic L5-S1 tear 10/24/06 L4-L5 Prodisc surgery with Dr. Goldstein CAT scans & X-Rays show ossification Trigger Point Injections, Medial Branch Blocks, Acupuncture, Weekly Deep Tissue Massage 10/27/08 Discogram (positive L5-S1 tear) 11/25/08 L5-S1 fusion with Dr. Goldstein FAILED BACK SYNDROME Liberty Mutual WC |
#8
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Now that was funny.
I always liked "when the going gets weird, the weird turn pro". I have to be hopeful b/c fusion is not an option according to Regan. We need good statistics, not anecdotes.
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Severe, extensive DDD, considered inoperable by Dr. Regan, Lauressen, & some guy at UCLA. Severe foraminal stenosis (guess they can't operate!) and some spinal cord compression that Lauryssen would fix if gets outta hand. |
#9
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Eddie... don't bogart those drugs!
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#10
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ROFL mark
chuck |
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