Prodisc and the Fda

[Mariaa]

I just got my 6th denial or so re WC for hybrid surgery with Charite at L4 and fusion at L5S1.

The 7 page attachment with reasons why I didn't qualify for this surgery was unbelievable. I mean, really, ridiculous.

I too have Lifetime Future Med but I'm telling you right now, when the insurance carrier and Utilization Review decides your number is up in terms of utlizing benefits, they design ways of torture thru not non treatment but denied/delayed treatment. All in accordance with ACOEM Guidelines~ and all the guidelines point to me not having surgery for the symptoms I have..

I'm tired of this game. Lifetime bennies are good when you can utilize them however, the new WC legislation here in CA. has really changed the ease of use of benefits as needed.

Eddie, good luck.. one thing tho I'm pretty certain I told you as well as some others in another thread that it's a DexaScan you would get to check for your Bone Mineral Density.

Also I was wondering about the connection with Rheumatoid Arthritis as that's more related to Immune Disorders and it is Osteoarthritis that is the wear and tear disease of a degenerative nature. Osteoporosis is sofening of the bone.

It's good to bring up the history of Rheumatoid Arthritis to your surgeon or doctor and I had also asked you I believe in another post if you had a Rheumatoid Factor test done, or screen for Rheumatoid Athritis yourself. Probably you have since you have a family history of it.

Good luck with your insurance company~ I hope they don't play around with you anymore and you can get the surgery done/paid for! Someone should be able to have that!!!!

[Dina]

Hi All,
Just to let all of you know that the Prodisc has been approved on June 6th. The only reason for this wait is that these doctors who will be performing the Prodisc procedures, and all of us, are waiting for the official, hardcopy approval. The last I heard, end of August, September. So, if I have waited this long, then all of you can too. Come on guys dont give up. Hang in there with me.



Injured 8-24-2000
DDD L5-S1
cervical discs C-4,5-5,6
Epidural steroid injections lumbar & cervical
x-rays, mri's, etc.
waiting for Prodisc for L5-S1, and Prodisc C for two levels on C-4,5-5,6

[David]

Not to be overly pessimistic or anything, but I have been heard this statement made many, many times over the last two years....

Now, that being said, every time it is made, I cross my fingers and hope it is true.

If you don't mind me asking, how did you come by this information?

David

[LBP]

I am extremely skeptical...because it's hard for me to believe there would not be a ton of pomp and circumstance if final approval was given...with or without the actual letter. And I don't understand why the mail would take 2 months if final approval was already granted.

I'll believe it when I see it. I am so sick of getting my hopes up. Besides, it's still probably only for a single level. AT this pace, it'll be another couple of years before a multi level gets approved.

[David]

AT this pace, it'll be another couple of years before a multi level gets approved.

...and that is my #1 biggest fear/concern. How many (years) until multi-level Prodisc is approved in the U.S.....

David

[chasswen]

Screw The FDA I'm Done By The best And Have had the most outstanding care i have ever seen in my life time.
wishing everyone the best from Bogen Germany
chuck

[Jessica]

Chuck,
I agree completely. I would have suffered for an unknown number of years waiting for the FDA to approve Prodisc for the cervical. I now am on my road to recovery and expect to be back to my old life again soon.

Jessica

[Eddie_G]

Originally posted by Dina:
Hi All,
Just to let all of you know that the Prodisc has been approved on June 6th. The only reason for this wait is that these doctors who will be performing the Prodisc procedures, and all of us, are waiting for the official, hardcopy approval. The last I heard, end of August, September. So, if I have waited this long, then all of you can too. Come on guys dont give up. Hang in there with me.

1) Where did you hear this?

2) What does this even mean? June 6???

Please don't post & run. Many of us are eagerly waiting too.
Please take time to elaborate.
Please don't procrastinate.
Because when we hear these rumours we salivate.
If you clarify this information, it would be really great.

Thanx!
Eddie G.

[Mars]

Eddie,
I know you're suffering greatly, but many of your posts are so comical that I look forward to them. Keep your sense of humor. One of these days you'll find a solution.

[Dina]

[QUOTE]Originally posted by Eddie_G:

1) Where did you hear this?

2) What does this even mean? June 6???

Please don't post & run. Many of us are eagerly waiting too. Please take time to elaborate.
Please don't procrastinate.
Because when we hear these rumours we salivate.
If you clarify this information, it would be really great.
Thanx!
Eddie G.

Well Eddie to answer your questions,

1) I heard it from my actual doctor who will be performing my prodisc procedure, and the research department there at the spine institute, and from the FDA itself.

2) June 6th means there is an approvable letter, but now we are waiting for the approval order. Which means the prodisc may not be commercially distributed until they resolve all manufacturing requirements.

FDA has determined that the Prodisc-L Total Disc Replacement PMA is approvable subject to an FDA inspection that finds the manufacturing facilities, methods and controls in compliance with the applicable requirements of the Quality System Regulations (21 CFR Part 820).
FDA will issue an approval order after the inspectional findings have been reviewed and determined to be acceptable. Commercial distribution of the
ProDisc-L Total Disc Replacement may not begin until Synthes has received an approval order.

Eddie, I dont post and run, and like myself and all of us here, I too am eagerly waiting. I believe I have been desperately waiting for this longer than you. And I feel your pain, anger, frustration, and everything else that comes along with what we all have in common here. But I would not post any rumors, or false information. Believe me. The passed six years has been hell for me, and I know you and everyone else here know that. I too have been told many times that the prodisc would be approved, and getting my hopes up for nothing. And I know that our physical injuries have not only brought us pain, but we are all suffering emotionally. I read these posts, and we are all alike in so many ways. And workers comp doesnt make it easier for us. But having a good attorney makes a difference. So please, we are all here to help and support each other. I dont come to often to read the posts, because the more I do, the more angrier and depressed I get. But when I do come, I come with news.
I hope I answered your questions.


Injured 8-24-2000
DDD L5-S1
DDD C-4,5-5,6
Epidural steroid injections lumbar & cervical
x-rays, mri's, etc.
waiting for Prodisc for L5-S1, and Prodisc C for two levels on C-4,5-5,6