2 (or more) level cervical ADR in the U.S.?

melodyl · #1 (**permalink**) 03-03-2008, 11:09 PM

Prodisc C was approved by the FDA for single level cervical disc replacement surgery a couple months ago. Does anyone have any idea how long it might take for multiple levels to get FDA approval? Due to circumstances beyond my control, My Feb. 2008 ADR surgery date in Germany, with Dr. B (C5/6 and C6/7) was cancelled. If I can have the surgery here in the U.S. (paid for by insurance), I am willing to wait awhile. After living in chronic pain for the last few years....another few months would be worth the cost of paying for the surgery and travel costs myself. Mark....or anyone else who had heard anything, please share! Thanks, Melody

mmglobal · #2 (**permalink**) 03-04-2008, 01:12 AM

Hey Melody... nice to see you here, but I'm sorry to read that you have not moved forward yet.

The device is FDA approved... not the number of levels. If Synthes will let the surgeons do them... 2 and 3-level procedures can happen in the US. You'll still have the same problems with insurance reimbursement.

Will you be having discography so you'll know if it's 2 or 3 levels? I just had 3-level cervical discography and it was really fun... I highly recommend it..

If you want to go to the more experienced ProDisc surgeons in the US, you'll still have substantial travel costs. That will be great if you can get the surgery paid for.

All the best... talk to you soon,

Mark

melodyl · #3 (**permalink**) 03-04-2008, 10:35 PM

Hi Mark,
I've never heard the words "fun" and "discography" used in the same sentence! I assume you were joking! My ortho hasn't mentioned performing that particular test....maybe because I've already had a CT/myelogram done? The haven't moved ahead with my cervical surgery yet because of emergency lumbar-sacrum surgery in December. My dr. thought I should give my body 6 months to heal. The dr. seems confident re: FDA approval for the 2 level ADR surgery I need. I really hope to be able to get my insurance company to cover the surgery though...so I may have to wait until the FDA approves multiple levels for the general public. What is your best guess/estimate of what the surgery would cost in the U.S? And any idea how long it might take the FDA to approve multiple level cervical ADR for everyone? ps. Is that cute baby in the picture yours? He is adorable! Melody

mmglobal · #4 (**permalink**) 03-04-2008, 11:06 PM

That is my wonderful little granddaughter, Zoey Kate. Zoey will turn a year old when Diane (mrs. mmglobal) and I are in Bogen for her surgery.

The FDA is not standing in the way... surgeons can do multi-level prodisc-C. It's a question of reimbursement and as we've seen for so long... FDA approval does not mean that insurance will pay for it. Remember that the number of levels is not approved or disapproved. The device has been released and surgeons can use it 'off-label' if they see fit. Synthes has to be willing to allow them to do multi-level procedures. The hospital must allow it too.

I hope to hear good news soon...

All the best,

Mark

melodyl · #5 (**permalink**) 03-05-2008, 05:13 PM

Mark, Thanks for the clarification re: FDA/off label use. You have an amazing wealth of knowledge about so many issues that many of us on this site are experiencing. It is kind and generous of you to share with all of us. Hope your wife's surgery in Bogen goes well. I'll post an update re: my ADR surgery and insurance issues when I learn more. I see my ortho surgeon at the end of this month. Melody

dshobbies · #6 (**permalink**) 03-05-2008, 06:23 PM

I heard from an insider that insurance reimbursement ususally does not happen for about 5 years following FDA approval on new procedures/devices. How accurate this is????????

Also studies that prove superiority over fusion that might hasten insurance reimbursement have not been done, and those that have are inconclusive and perhaps skewed.