Hi Eddie

That’s great news for you. I think the letter Dr Delamarter wrote for me made a big difference. I saw Dr Delamarter this week and he said that every time the FDA asks a question to the study it takes 30 more days and they seem to only ask one question at a time. The last question was about the pores coating. He sounded very frustrated by the process but said they should hear back from the FDA within the next week. Lets hope they have run out of questions.

Hi Everyone,
Just an FYI... In Yesterday's Hollywood Reporter (the weekly edition August 8-14th) The Spine Center at Century City Doctor's Hospital took out a 1/2 page ad. In the ad, they announce that the "ProDisc Artificial Disk Receives FDA Approval."

It says, and I quote "...Our elite team of spine specialists helped develop this state of the art therapy, and includes the only surgeons in the Los Angeles Area currently qualified to conduct the ProDisc Artificial Replacement Procedure..." They also claim that they are contracted with most major insurance companies so the patient fees are comparable to most other L.A. hospitals.

Just wanted to pass this information along for all of you who have been waiting. I realize that they are not the FDA but I have to think that they wouldn't have taken out a 1/2 page ad advertising its approval and their qualifications of performing the procedure if it wasn't actually available.

While that does sound like a good deal, the standard joke that goes through my head is:

I won't believe that Prodisc has U.S. approval until I hear it from the head of the FDA*


David


* - If you have been watching the news, you would notice that there is currently no head of the FDA, due to various medical / political reasons.

Sineshine,

Yaaa that would be Dr Delamarter office formerly know as the Spine Institute. They are now contracting with the Century City Doctor’s Hospital and calling themselves The Spine Center at Century City Doctor's Hospital. This info was giving to me by the x-ray technician when I was asking when they were going to get digital x-rays and he said they spent the money on this contract instead.

As we have discussed before they are publicizing that ProDisc is approved or should they say an approvable device. Like David said lets hear it from the FDA themselves who ever is in charge...

My calls to California just now confirmed that the Prodisc is NOT approved as of yet. California shouldn't have it any faster than NJ.
In Fact, NJ should get approved 3 hours faster so NYAaaaah!

As far as I know, from what was told to me by the research department at The Spine Institute, Santa Monica, California, the Prodisc was approved on June 6, 2006. We are only waiting for the official approval letter from them. Spine Institute says, September. (this year)

Any rumors today?

Maybe tomorrow...

I have been waiting for the Prodisc since Feb/06 . My Dr's office told me they expect word from FDA on or about 8/16 for Sept. surgeries. I am cautiously optimistic.

Now it really makes no diff to me when Prodisc is approved here as my OSS put in for the Charite hybrid surgery (Dr.Bae asked for Prodisc hybrid surgery) and all WC reviewing docs are denying even a fusion for me by ACOEM guidelines let alone disc replacement.

I just receieved notice today that my case has gone to a doctor (don't know if it's Neuro, Ortho, Plastic surgeon or other) in Rancho Santa Fe (SD Co.) to review and the only reason he would need to do a physical on me is if he disagrees with the surgery~ so probably I will have an exam because I can't imagine this dr. agreeing to the surgery after seeing 6 or so full paged denials from WC.

What a waste of CA. WC funds. I've have roughly 6 consultations for ADR/ADR hybrid surgery in 3 years, UR processed requests for surgery as many times (and denials) not to mention just approvals for appts. and all the in between stuff with Nurse Case Managers, the shots (ESIs) and whatever.

A bunch of extra $$ in terms of the UR process tho for WC to be wasting and the State of CA. Imagine if they do this for me, they are doing it for other cases. How is this saving money for the state? How is this helping employees get back to work?

I want to get a Cost Analysis of all costs re my case/referrals/processing authorizations thru UR since first being sent for the ADR consultations and see how much $ WC has put into this for the GOV.

Then compare it to at least the cost of proposed surgery and possibly some projected recovery treatment plan with ESIs and meds (Neurontin) that were mentioned by Dr.Bae at the Spine Center (due to possible reactivation of nerve pain as with prior spine surgery).

I still hope Prodisc FDA approval comes quickly enough for those waiting~ and surgeries will begin to be scheduled and PERFORMED! Best to all waiting!

Maria,

I’m sure they could have paid for your surgery and then some by now. I think you should sew the paints off them for causing possible permanent nerve damage for not authorizing your surgery. It just makes me so made I want to use every 4 letter word I know do her goes #^$% (^%$ *(&$ #$%^ you get the picture.