Bad news - FDA

Alikin:

Yes. Just to be clear, Dr. Z. did say to me that he would be able to do three levels off-label, and that I should wait for the FDA. I just don't know how long of a wait to expect from insurance companies.

Tom

[letteski]

Marria,

Where does you OSS get his information is he a part of the ProDisc study, does he go to conferences on a regular bases and keep up on the latest technology? Because if he did he would know the ProDisc lumbar arm of the study was written as a multilevel study. Why would he believe it would take so long for approval if the study started at the same time? (unlike the Charite) It just doesn�t make sense to me. I would seek another opinion I think he just wants your business and you know he can only do a 1 level Charite for you.

Just my .02

[Mariaa]

WC is Worker's comp
SSD is Social Security Disability

From what I hear, with off label use, Utilization Review can deny multi level ADR authorization even if device is FDA approved. Device has to be approved for multiple level use, and there has to be adequate study data to back up having this surgery done in terms of better outcome than multi level fusion.

This is just from what I'm gathering from my specific WC insurance carrier.

Paulette, Re my OSS.. I've gotten other opinions already last year with Dr.B and Dr.Regan re whether ADR was still possible vs. fusion at L5S1 ~ they both thought so. This year ?? Tho I'm not one to rush into a fusion unless it was necessary (not an option in terms of surgery) and/or was the ONLY option.

My OSS was/is not involved in the Prodisc study. One source he has said to have gotten info from was a collegue at TBI. He seems up to date with the studies I've brought before him. However, he's the person signing my SSD/LTD paperwork for the last 5 years as I've been seeing him on a regular basis (remember I don't drive far and he has an excellent reputation here in my city so I chose to see him over the years tho I chose not to have surgery with anyone "yet").

The last thing I was told by WC was if I want to see someone else, I have to make that person my treating doctor, and transfer all records there.

I would just want to make sure if I was going to take that step, I could physically get there (wherever there is) and that this person, surgeon would be of like mind as myself in terms of treatment options.

I'm waiting to see if Feb. brings any luck with the FDA approval of Prodisc or not... and continuing to ready myself with "Evidence Based Medicine" (studies)for why multi level ADR would be better for me than fusion and ADR or fusion alone..