Hello everyone. Haven't posted in a bit. We've had a change of plans. My husband Dean was scheduled for a 2 level w/ Dr. B in Germany for 3/9/07, but we're now having surgery with Dr. Yue on 2/23/07 in CT. We were contacted by Dr. Yue recently, who informed us that he got the go-ahead a while ago from Synthes (Prodisc's manufacturer) to do two levels in the USA. The decision for us to change plans was very difficult. The entire cost of the Germany trip was significantly less expensive, Dr. B is top notch, and we had a lovely timeshare arranged in Germany as well. But we changed course because we have an 8 mth old baby and a 25 mth old which makes traveling abroad crazy, and the fact that Dr. Yue is practically in our back yard compared to Germany. We also like the Dr. Yue/ Dr. Bertagnoli connection.

We expect to be denied by our insurance company (HealthNet) and I'm going to go through the appeals process after the fact. Synthes now has material on it's website that you can use to appeal, as well as support staff available by phone.

Feb. 23rd can't get here fast enough. His hospital stay is three days. Right now we're in the process of making payment arrangements. He has to have a new MRI tomorrow and a new CT scan after that. Dean expects the tests may show that L5/S1 has gotten worse. Initially he hadn't lost much disc height at either level, so we're hoping things have not changed. The feeling of increased pain could be a combination of adjusting to his pain medication and the fact that he hasn't been able to do anything but lay around the house for a year. He used to be a physical person and his body is now shot! He is actually looking forward to all of the walking that is recommended for recovery. Dean is at the stage of getting scared about surgery but he's also mentally ready to get his life back together. We'll keep you posted on how things transpire.

http://adrsupport.org/groupee_common...icon_smile.gifKim

I don't understand what you're saying. The FDA still hasn't approved 2 levels at least nothings changes on their website. I guess if you are paying out of pocket Dr. Yue is willing to do 2 levels on your husband..which isn't as "off label" as a charite since Synthes had a 2 level arm of the prodisc clinical trials.

I just don't get what you mean by saying Synthes gave him the "go ahead" Was synthes previusly refusing to allow dr yue to do a 2 level even if you paid out of pocket? why haven't you always been able to go to Dr Yue if you were going to pay up front? Did Dr Yue actually tell you before they couldn't help you?

Are you able to clarify or explain? Are you trying to say there's something about to happen on the FDA approval front?

regardless, congrats and good luck
for those of us needing 2 levels, please share any more specifics if you have them about how to get 2 level here in the US

don't let him be scared about the surgery. Surgeons are patient and will work promptly to get the surgey done right as quickly as possible. Two level disc replacements are being performed routinely at St Mary's in san francisco, so it's not an unknown procedure in the US. It also sounds like your surgeon has a good reputation on this forum. You're lucky, many surgeons have little info published about them.

Make sure to prepare your residence for easy access when you get home. I think the worst was trying to get in and out of bed. Also turning over in bed was painful. It's very difficult to rotate your hips after the surgery. Also be prepared for the distraction pain. It's like throwing out your back in the worst possible way.

Wish you luck and make sure to post to this forum after the op when you're able to.

Hello LBP and ZorroSF- thanks for your replies. I will try to explain in more detail...
My husband has been a patient of Dr. Yue's since about June of 2006. At that time, Dr. Yue recommended a 2 level Prodisc surgery for him, but the FDA had not made a decision about Prodisc yet. In August, Prodiscs were approved for one level. Dr. Yue said we could still have a 2 level, with one disc being off label. So we'd have to pay for at least one disc. We could try to get insurance to cover surgery and one disc.

We had a pre-op appt. with Dr. Yue on 10/2/06... this was to discuss his surgery plan and go ahead to schedule a date. We went to the appt. and Dr. Yue then informed us that three days prior, he attended a meeting in I believe Seattle(?) where Synthes, the Prodisc manufacturer, made the announcement that they (not the FDA) were only going to actually allow one disc per patient. This was unexpected to Dr. Yue and other doctors in the US. Dr. Yue said we would probably have to wait another year or more for the FDA to approve two levels, so we asked him to immediately forward Dean's records to Dr. Bertagnoli in Germany.

Sometime after that (I don't know when)Dr. Yue said Synthes changed this decision. We were going full steam ahead with the Germany plan, though, so we weren't in contact with Dr. Yue any longer. That is, until Dr. Yue had to fill out some disability paperwork for my husband recently. Dr. Yue called us when he realized Dean is a two-level patient and told us that it can be done in the US. We can try to get insurance to cover surgery and one disc, but we'll be responsible for the cost of the second disc, regardless. We realize that we will probably paying the entire cost out of pocket though, since insurance companies are just not on board with ADR. The cost given to us for a two level was $70,000. (Last year, we were told by Dr. Yue that the two level would be $54,000, so things sure have changed!)

I hope this info helps you. I'll be happy to try to answer any other questions you may have.
http://adrsupport.org/groupee_common...icon_smile.gifKim

wow, that whole thing with Synthes and Dr. Yue whether or not Synthes would "allow" any dr to do 2 levels....seems strange. Oh well thanks for the clarification. I was hoping there was a scoop on FDA approval coming soon http://adrsupport.org/groupee_common...icon_frown.gif

The story that Kim tells is almost exactly the same as mine, except I was able to make it to Germany a bit earlier than Dean could.

I tried to schedule 2-level with Dr. Y around the same time, and was told by Dr. Y that Synthes 'wasn't allowing' any off-label Prodisc usage anymore, at least for the immediate future (could have been 4 months, could have been 4 years).

David

Yes, we have bonded with David over the many ups and downs of this journey, cursing the FDA and Synthes at times... http://adrsupport.org/groupee_common.../icon_wink.gif

But we're almost there, David, anxiously waiting to join you on the OTHER SIDE! http://adrsupport.org/groupee_common...on_biggrin.gif
Kim

Looking forward to the day when Dean's back feels as good (if not better) than mine! http://adrsupport.org/groupee_common.../icon_wink.gif

David