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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  
Old 08-15-2006, 12:04 PM
David David is offline
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http://www.fda.gov/cdrh/mda/docs/p050010.html

GRRRR.... looks like one level approval only

David
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Surgery: 14-NOV-2006; Straubing, Germany (Dr. B.)
L4-S1: Prodisc
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  #2  
Old 08-15-2006, 12:46 PM
Justin Justin is offline
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Thanks David. Sorry it didn't include multilevel.

Justin
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  #3  
Old 08-15-2006, 12:59 PM
David David is offline
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One level isn't what I wanted, obviously, but I have kicked things off with Dr. Y.

To be honest, I severely doubt that UHC will cover me for ADR surgery (multi-level or one level), but it is worth a shot.

Worst case scenario is that UHC completely denies me. At this point in time, I am done waiting. If I have to go 100% out of pocket, then so be it.

David
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47 years old
Surgery: 14-NOV-2006; Straubing, Germany (Dr. B.)
L4-S1: Prodisc
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  #4  
Old 08-15-2006, 02:11 PM
Ryan Ryan is offline
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I wouldn't read too much into the single level approval. Remember, Charite was only FDA approved for single level, yet doctors immediately started doing two levels based on their "discretion".
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  #5  
Old 08-15-2006, 02:37 PM
David David is offline
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good point. I am presuming that Dr. Y is going to either ask for two level authorization, or one level approval with the other level being off-label.

Since I have UHC, I imagine I will be denied until I give up (or die trying), but I can give it a shot.

Thanks.

David
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47 years old
Surgery: 14-NOV-2006; Straubing, Germany (Dr. B.)
L4-S1: Prodisc
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  #6  
Old 08-15-2006, 03:23 PM
jf110 jf110 is offline
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If your going to pay out of pocket then go to Germany with Dr. Bertagnoli. He is an excellent surgeon using the Pro-Disc. Save you some $$$.
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  #7  
Old 08-15-2006, 05:15 PM
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Eddie_G Eddie_G is offline
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I will make an appointment for surgery tomorrow and hope to be on the operating table in a few weeks! My surgeon has to fax a letter on why he prefers the Prodisc, just like the letter I already got from my PM. I'll draft the letter myself if it will help get things done quicker.

It is usually the staff that drives me away from doctors/dentists. Unfortunately I need a good Prodisc surgeon so I have to put up with alot of needless BS while I prepare for my surgery. I HATE the telephone runaround game. I do like the fact that I can take the rail right to the World Trade Center then walk 10 minutes to my surgeons office. I don't need to drive which will be GREAT after surgery!

I see another doctor for testosterone replacement therapy. His office just moved to Jersey City (Think Beirut mixed with Baghdad crossed with South Central LA)and he promised me shorter waits, better service, blah blah blah... Well the cliental is scary, I have to get buzzed in off the street after walking through huge unlocked bars, and I have to park where crackheads and hookers don't dare tread.
He never faxes in my preauthorizations for my meds and I go back & forth between the pharmacy and his short tempered staff who keep telling me it's been taken care of when it clearly hasn't! I can't wait until November when I can change insurance. Aetna stinks! All the guys on his staff look like they're on the juice. I think I'm his only "legit" patient.

Enough derailment! 3 Cheers for the Prodisc!
Hip hip hooray!!!
Neck back hooray!!!
Back neck hooray!!!

YAY PRODISC!!!!! YEEHAWWWW!!!!! YAHOOOOO!!!!!!NYUK NYUK NYUK WOO WOO WOO WOO!!!!!!!!!!!
__________________
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
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  #8  
Old 08-15-2006, 06:28 PM
letteski letteski is offline
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YAAAAAAAAAAAAAAA ProDisc has finally made it to the big show. So get on the phone and make your arrangements to be Powered by ProDisc That is the name of my new blog that I have started to track my workouts and ADR news. This way those of you that want to see what a ProDisc can really do can come here. I have clocked in 37 miles on my mountain bike in the last week after coming home from LA where Dr Delamarter said to keep doing what I was doing. I hope this inspires all of you to work through the read tape and get yourselves a ProDisc.
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Paulette
ProDisc L5-S1 W/Dr Delamarter Aug 23, 2005
L5-S1 DDD Diagnosis 12/04
T-12 Compression Fracture 10/04
C-7 Spines Process Fracture 5/99
http://prodisc2.blogspot.com/
You are my Rock God in you I can do anything
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  #9  
Old 08-15-2006, 07:03 PM
Mariaa Mariaa is offline
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Good deal re the Prodisc FDA approval. Have to start somewhere so good that it came now. Wishing all well with their insurance approvals or appeals~
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  #10  
Old 08-15-2006, 11:23 PM
LBP LBP is offline
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anyone who sees Dr Delamarter...please keep asking about the status of FDA approving the 2 level arm of the clinical trials.

I seriously doubt my insurance will consider covering my surgery until FDA approves 2 levels and then I'm sure it will still be a battle.

Just wondering if we are still on the 6 mos timeline for the 2 level approval. Anyone with any insight or update?
__________________
Injured 9/01
Annular tears L4/5 & L5/S1
denied adr by insurance for 2 level charite as well as hybrid fusion at L5/S1 with Charite at L4/5.

New ins paid for 2 level lumbar prodisc surgery on 4/7/08 (at age 39) with Dr. Westerlund, at Core Orthop
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