ADRSupport Community  

Go Back   ADRSupport Community > General Discussion > The Big File

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.


Reply
 
Thread Tools
  #1  
Old 12-22-2005, 11:27 AM
Guest
 
Posts: n/a
Default

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.
Reply With Quote
  #2  
Old 12-22-2005, 01:58 PM
ans ans is offline
Senior Member
 
Join Date: Mar 2005
Posts: 1,596
Default

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
__________________
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.
Reply With Quote
  #3  
Old 12-22-2005, 03:46 PM
Guest
 
Posts: n/a
Default

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
Reply With Quote
  #4  
Old 12-22-2005, 05:20 PM
mmglobal mmglobal is offline
Banned
 
Join Date: Oct 2004
Posts: 882
Default

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
Reply With Quote
  #5  
Old 12-22-2005, 05:41 PM
Mariaa Mariaa is offline
Banned
 
Join Date: Nov 2004
Posts: 1,121
Default

I'm going to remain hopeful..
Reply With Quote
  #6  
Old 12-22-2005, 05:52 PM
Guest
 
Posts: n/a
Default

Alikin

I can't find ProDisc information on the FDA website.

Do you have an address?

Thanks,

Tom
Reply With Quote
  #7  
Old 12-22-2005, 08:11 PM
Eddie_G's Avatar
Eddie_G Eddie_G is offline
Senior Member
 
Join Date: Apr 2005
Posts: 238
Default

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)
__________________
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
Reply With Quote
  #8  
Old 12-22-2005, 08:57 PM
ans ans is offline
Senior Member
 
Join Date: Mar 2005
Posts: 1,596
Default

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.
__________________
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.
Reply With Quote
  #9  
Old 12-23-2005, 12:06 AM
mmglobal mmglobal is offline
Banned
 
Join Date: Oct 2004
Posts: 882
Default

Eddie... don't bogart those drugs!
Reply With Quote
  #10  
Old 12-23-2005, 11:20 AM
Guest
 
Posts: n/a
Default

ROFL mark
chuck
Reply With Quote
Reply

Bookmarks

Thread Tools

Posting Rules
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off


Similar Threads
Thread Thread Starter Forum Replies Last Post
Bad News!! Cat-mt The Big File 13 06-14-2005 01:08 AM
Big News from Aetna Harrison The Big File 5 03-18-2005 12:02 PM


All times are GMT -4. The time now is 12:09 PM.


© Copyright 2006-2017 ADRSupport.org All rights reserved.