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-   -   no off-label Prodisc / U.S. usage (me venting) (https://www.adrsupport.org/forums/showthread.php?t=5530)

David 10-02-2006 01:01 PM

<rant>

Grrrrrrr...........
(not the words I really want)

I finally make the call to Dr. Y to try and schedule 1 level Prodisc + 1 level Prodisc off-label, and I find out that Synthes is not "allowing" off-label Prodisc usage for 'an indefinite amount of time'.

Meaning, of course, had I made this call 6 months ago, I would already have been operated and, done, and fine. But...because I am stupid enough to have waited, I get screwed all over again (don't get me wrong, I am not blaming Dr. Y).

I guess this doesn't leave me with much options, other than Dr. B once again, which was (probably) the cheapest solution to begin with. What is the coordinator's email address again???

</rant>

David

chasswen 10-02-2006 01:42 PM

sorry to hear that after waiting so long.
patient-affairs@pro-spine.com
theres a good place to start anita should pick right up on it..
chuck

ans 10-02-2006 02:02 PM

Have you discussed fusion at L5-S1 and Pro-Disc on the higher level? The reason is that when I spoke to Dr. Regan, he didn't think that was such a bad idea.

David 10-02-2006 02:15 PM

Quote:

Have you discussed fusion at L5-S1 and Pro-Disc on the higher level? The reason is that when I spoke to Dr. Regan, he didn't think that was such a bad idea.
Actually, yes. About 5 minutes ago, I just had that very conversation with Dr. Y about that.

I gave him and his surgical coordinator the go ahead to try and schedule me for Prodisc @L4-L5 and fusion @L5-S1.

In my opinion (after years of medical school...NOT!), it remains to be seen if ADR will put 'extra' stress on a lower fusion level, but some studies have indicated that the loss in range of motion for fusion @L5-S1 isn't noticeable.

Therefore, it is definitely worth the shot.

David

David 10-03-2006 03:52 AM

To respond to my previous post (since I didn't sleep last night and made it to work over an hour earlier than normal), I guess I am giving Dr. Y one last option before I offically 'give up' and go the Germany route.

I know that Germany has the best surgeons available for the most reasonable cost, yet something (inside me) that I am still unable to identify seems to be holding me back.

To be honest, I think that I have about 3 possible scenarios:

1. Insurance covers Prodisc/Fusion 100%: Then I have a tough decision to make.
2. Insurance won't cover Prodisc/Fusion at all: Easy decision to make.
3. (Highly likely) Insurance will cover Fusion, but not Prodisc: this would probably mean around $12k in costs for me, which is significantly less than around $40k for Dr. B.

Ultimately, I guess the question is whether or not I would be better off with L4-L5 Prodisc & L5-S1 Fusion, or L4-L5 Prodisc and L5-S1 Prodisc? Some of the studies I have read tend to indicate that ADR @ L5-S1 doesn't seem to offer much advantages over Fusion, which is the primary reason why I am even considering it. Even though I have known for the last two years that I have wanted ADR over Fusion, I guess I (maybe?) should be realistic and at least consider the option (?!)

David

chasswen 10-03-2006 04:44 AM

well david
one problem with the fusion is healing time its much greater.and the possbily of a non fusionhttp://adrsupport.org/groupee_common...icon_frown.gif
althou you are correct in maken the statement about there not being much movement at s1-l5. the other question is and i didnt think much about it before is how much disc height have you lost? as i was bone to bone and i have had god awefull leg pain since about 5 days after surgery it just keeps going day after day its now been going on 9 weeks postop.
but is getting better. thank god.now my room mate in germany was larry he is 26 and didnt have much lost and at 6 weeks postop he only has muscle pain from PT. and i was running cirles arround him in the hospital as apossed to now where im praying to be able to return to work at 12 weeks. you have a tough call. but if you go to dr b cost diff isnt going to be much diff from two adr or adr and a fusion. the charge for the device was 4500 euro.
good luck to you in which ever route you take.
chuck

chasswen 10-03-2006 04:49 AM

david
your films dont appear to show to much disc height lose so you should fair well. http://adrsupport.org/groupee_common...icon_smile.gif
chuck

David 10-03-2006 05:37 AM

Quote:

david
your films dont appear to show to much disc height lose so you should fair well.
You make some excellent points, and thanks for taking a look and offering some advice.

I imagine that the recovery period for a 2 level Prodisc versus 1 level Prodisc + fusion is probably somewhat similar (although you are right 2 Prodisc would probably be a bit better). Neither is a walk in the park though.

Really a tough decision, no matter how I look at it http://adrsupport.org/groupee_common...icon_frown.gif .... At this point, I guess I will see what my insurance company says, and go from there.

David

chasswen 10-03-2006 06:03 AM

well i am a single level at l4-l5. and larry had 2 prodisc at l4-l5 and s1-l5 i believe i do have have a picture of his x-ray. larry was back to school and had pains but from PT in less then 6 weeks.
i am 9 weeks postop and my legs from my knees down in the morning feel like i had them tucked up under my butt all night.which sucks i had no idea how bad the distraction pain would be. i knew before surgery that i would hurt more durning recovery then i did pior to surgery. i though how bad could it be. well on day 5 or 6 after surgery my legs just about stopped working and it took all i had to walk about and forget about sleeping ack!! but as i said my disc pain had stopped about 3 months before surgery because the nerve had been wore away all i felt was rubbing of bones. i think you should just do it go see dr b and let him work his magic. and one thing i found is once i chose dr b i didnt worry about the surgeon any more that i would recieve the best possbile outcome. all i had to do is be there.althou after the lala pills before surgery i got sarced to death being as i never was under the knife and the first time,just happened to be spine surgery.
and fusion was out of the question as i am a smoker so that wasnt in the cards. what it came down to was i was just plain out of time when it came to this surgery. either bite the bullet and pay out of pocket or fusion was to become my only chose.
chuck

David 10-03-2006 06:31 AM

I am pretty much out of options at this point...

Either I could try and have Prodisc + Fusion here with Dr. Y, or I could go with Dr. B, whom I have almost chosen several times over (and, in retrospect, whom I should have chosen a couple of years ago).

To be honest, I wonder if the whole Prodisc + Fusion gamble is even worth the time and effort? I know that Dr. Y is an experienced surgeon and would do a great job, but I seriously doubt my insurance is going to agree to cover it.

If I have to go out of pocket for any costs, I probably should just suck it up and pay the best available (can you tell that I am just trying to talk myself into it?) http://adrsupport.org/groupee_common.../icon_wink.gif

David

chasswen 10-03-2006 06:37 AM

well im not for the fusion but its not my back.
getting to and from germany isnt a picnic either.
dont fly usair there flight 14 and 15 both need new seats in 1st class.heheh and im sure you could have yourseft talked into by the end of the day.http://adrsupport.org/groupee_common...icon_smile.gif
chuck

David 10-03-2006 06:40 AM

Quote:

....both need new seats in 1st class.heheh and im sure you could have yourseft talked into by the end of the day.Smiler
Highly likely, if not by the end of the week.

Dr. Y's surgical coordinator should be preparing the paperwork sometime soon, so I can wait a week or two and see if anything happens.

David

chasswen 10-03-2006 07:30 AM

david there is a questionair on pro spines web site you will need to fill out. if your bored of waiting
chuck

LBP 10-03-2006 08:35 AM

David,
my cobra just expired but my last attempt to get a hybrid approved (fusion at L5/S1 with Charite at L4/5) was denied. I had Pacificare which was bought out by UHC. When I pressed, they conceeded that they would approve the fusion at L5/S1 but would not approve the adr at L4/5, and did indicate that they would approve at 2 level fusion (since I pointed out that the injury to my L4/5 is the same as to L5/S1).

I am now on a state health plan for people whose Cobra has been exhausted. Was hoping to try a 2 level pro disc claim ...until I read what you wrote about no off label use being allowed http://adrsupport.org/groupee_common...icon_frown.gif May have to try the hybrid approach with pro disc with my new ins. Good luck to us!

David 10-03-2006 02:06 PM

The more I wait, the more I hope that my insurance company denies me. The instant they deny me is the instant that I re-contact Dr. B.

At least I will have tried everything I can, have been backed into a corner, and have no other available options.

David

Fortitudine 10-03-2006 07:45 PM

David: Try looking on ispine - it's a new forum set up by Mark ******* for people who want the hard goods - Mark is a patient advocate who has observed dozens of spine surgeries, is friends with the top surgeons and has helped many. At any rate, he has a lending library that includes the proceedings of the main spine conferences - you might find a/some paper/s on the question you are agonizing over.

David 10-04-2006 06:11 AM

Thanks.

I have worked with Mark before, as he was the one that helped me contact Dr. Y, Dr. B, and Dr. Z about a year ago.

I tried going with Dr. Y, but his hands are pretty much tied now by the FDA and by Synthes.

I really have no other alternatives anymore. I can either do nothing, or I can go to Germany and get on with my life.

More than likely, by the end of this week, I will be forwarding Anita the last email I got from Dr. B, in order to start my visit to das Vaterland.

David

letteski 10-04-2006 05:23 PM

David,

You have been at this fare too long my vote is for Dr B and getting to the other side before more damage is done. You are worth the best and I would rather know you had 2 ProDisc riding that motorcycle then a fusion ProDisc combo. $ comes $ goes and it will always come again. Don't let $ keep you in this hell of a place you are in. My thoughs are with you on this very difficult decision.

David 10-05-2006 04:54 AM

Paulette,

Agreed 100%. I waited this year, hoping to have surgery with Dr. Y, but it just isn't going to happen.

I will be contacting Dr. B's office shortly, as soon as I can coordinate with my parents, since they will be going with me.

Looks like I will find out what Germany is like in the winter (I was in München during the summer, years ago).

David

Mariaa 10-06-2006 12:43 AM

David,
Remember me..still waiting to see if WC is going to authorize a fusion at L5S1 and ADR at L4. It's been denied already, then the CA. WCAB sent me to 2nd surgical opinion (a formal one) who actually agreed with the other surgeons re a feasible idea. Now I guess I still have another years worth of waiting to find out the next move by WC...

I'm pretty sure no matter what you hear from the insurance company that even with appeals you're still going to beat me to having some kind of surgery done!!!

take good care! Maria

David 10-06-2006 04:57 AM

Well, I sent my email to Dr. B's office yesterday, so now I play the waiting game and see how long it takes for them to get back to me with a surgery date.

David

ans 10-06-2006 10:15 AM

Speaking of off-label here's a winner.

Saw Regan today for f/u and he's suggesting fusion at L5-S1 b/c of too much damage and an ADR at L4-5 (and maybe another level, pending discogram).

I was told that a one-level fusion and one level ADR can be denied in toto by an insurance company b/c that is consided an "off-label" use (the combo procedure which is rather new here). Imagine, being denied for a traditional fusion. Just go back. Dr. B. is looking better and I must self-medicate. http://adrsupport.org/groupee_common...icon_smile.gif

chasswen 10-06-2006 10:37 AM

i have no regrets going overseas to have dr b do my surgery. once you get there things change a great deal compared to the emailing part of it and waiting and waiting.
now if i could get pass this distraction crap i would be 200% a happy camper.8 weeks of distraction crap and counting heffy price for a inch taller.lol
chuck

chasswen 10-10-2006 05:22 AM

david
have you heard anything yet from dr. b?
chuck

David 10-10-2006 06:00 AM

Yes, I have. I have gotten an updated quote on the procedure (it had been a year since my last contact via MM), and have spoken with Dr. Fenk-Mayer, briefly.

I haven't heard yet from Anita, or from the contact concerning the wire transfer, but I am in the process of getting a new MRI (been over a year), and a lumbar/bone density measurement.

My MRI is tomorrow, and I am waiting to hear back from the office concerning when my bone density measurement will be.

Once I get both, I am going to put them on my website/gallery and send the link back to Dr. Fenk-Mayer, since she specifically asked for them on Sunday afternoon. If they want 'hard copies' as well, then I can do that, but I guess I would need to know the exact physical/mailing address (no one has responded since Sunday).

David

chasswen 10-10-2006 06:09 AM

when you get your mri ask them to also place on CD.
i had this done and there was no addition charge.
and i found USPS was the cheapest way to send the cd 2 or 3 day service was 22 bucks.
chuck

David 10-10-2006 06:17 AM

Thanks.

I will probably do both, to be on the safe side.

Pro-spine main webpage notes the following address:

Pro-Spine
Wirbelsäulen-Zentrum Spine Center
MussInanstraße 6
94327 Bogen
Germany

Does that sound about right?

David

chasswen 10-10-2006 06:22 AM

We'd recommend the documents either
* To be scanned or transferred into imaging data files (in a standard format or together with the appropriate viewing software); you are invited to use this e-mail address patient-affairs@pro-spine.com * To be compiled on a CD (formats see above, or together with a viewer) or as hard copies and then post-mailed to:
pro-spine - Dr. Bertagnoli / Dr. Fenk-Mayer Spitzwegstrasse 64 D - 93051 Regensburg Germany

chasswen 10-10-2006 06:23 AM

thats from the lumbar questionaire
chuck

David 10-10-2006 06:25 AM

Excellent! I will use that once I have my MRI CD and my bone density results.

Thanks.

David

David 10-13-2006 11:15 AM

Bone density results:

AP Spine (L1-L4)
0.952 (BMD)
-1.3 (T)
-1.3 (Z)
Osteopenic

Femoral Neck (Left)
0.735
-1.4 (T)
-1.1 (Z)
Osteopenic

Total Hip (Left)
0.936
-0.6 (T)
-0.5 (Z)
Normal

Based on my brief research, those values aren't all that great, but aren't all that bad either (although it looks like the FDA says I should n't have Prodisc implanted, if I read it correctly).

**Hopefully**, those values aren't bad enough to give Dr. B any concerns....

David

chasswen 10-13-2006 11:49 AM

david
i have been thinking about you. i glad you posted.
well there r not the best but dr b can use cortoss so i dont think those scores should matter as yopu will be seeing dr b. all thou it will be some where arround 4,000 euro more.
have you heard from pro-spine?
chuck

David 10-13-2006 11:52 AM

No, but I just got my MRI films and bone density report back today, and then immediately went to the post office and sent everything to Dr. B's office.

It should arrive there in about 3-5 days.

David

chasswen 10-13-2006 12:07 PM

very good global express 3 day service i think it was 22 bucks
chuck
ps did they put on cd for you?

David 10-13-2006 12:32 PM

Nope.

This particular MRI place doesn't do CDs (for some bizarre reason). I had to send Dr. B the actual films + bone density report.

David

chasswen 10-17-2006 05:15 AM

david
are you still out there?
did you recieve a surgery date yet?
they should have recieved your films by now.
please keep us posted.
chuck

David 10-17-2006 07:48 AM

I was just about to start a new thread, to be honest.....

My recent MRI and bone density results are in Germany (should be in their hands by today or tomorrow), and I have received a tentative surgery date of 14-NOV in Straubing.

I certainly wasn't ready for that sort of date!!, so I am scrambling with my parents to see if we can get organized enough to be ready for that date (especially the wire transfer).

Hopefully, I should know by the end of today what we are going to do!

(Deutschland über alles!)

David

chasswen 10-17-2006 09:44 AM

please keep us posted i told you if you didnt ask for a round about date they would pick one and it could be 2 weeks or a week.
i hope you can make ithttp://adrsupport.org/groupee_common...icon_smile.gif
chuck
ps www.xe.com

Mariaa 10-22-2006 05:35 PM

David,
How wonderful! See you will beat me to a surgical date! However,fortunately as you've already read elsewhere maybe WC did auth my surgery and I can have it done wherever (in the US) with whomever I want to~ whenever!

So I'm off to Fla. mid Nov. to visit my 85 y.o.father for TG before having any surgery done, and yes, that's 3 plane seats coming and going to Fla. and even a layover in Indianapolis going and Atlanta returning to LA~

Then I'll make my plans for after Dec~

Congrats on your upcoming surgical date!!! Awesome! (no idea how that translates in German)


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