Need 2 level cervical ADR - prefer USA
 

About 4 years ago, my husband had a bulging disc. Physical therapy and continuing with the exercises warded it off. Now, C5-6 is herniated and C6-7 has bone spurs and also needs replacing.

Our local neurosurgeon said he "would do it", but the hospital is in dispute about the cost of the Prodisc Cs (by $700). Our neurosurgeon appears to be 50% retired and rarely in town. Surgical nurse was supposed to call back regarding resolution of price difference a week ago (we'd gladly pay the difference). We also asked nurse how many multi levels the doc's done - no response.

We're very hopeful Texas Back (learned of them on your web site - thank-you) will come through. All images/paperwork were overnighted to them last week. Does anyone one know how many weeks/months after you contact them before the actual surgery would be? Has anyone had more than one level done at Texas Back?

Has anyone had multilevel Bryan discs? There are so many on the market. We feel fortunate if we can just find a doctor.

Thanks

Have you been to seen Dr. Garcia at Aventura orthopedic in North Miami. He did my first ADR in 2003 at l5/si and my c5/c6 2 weeks ago. He is the most experienced Dr. in Florida with ADR.

Thanks for the contact. We sent images/paperwork to TX Back... A local doc is suggesting epidural injections to see if that fixes the problem first. If it does, that would be great. Not sure how successful those are.

Having recently just completed a Prodisc-C at C6-C7, I only wish that I had done it sooner. I too live in Florida (Tampa Bay Area). I highly recommend my physician, Dr. Jim Billys in Tampa, as he has done several ADRs and from my personal experience was a true expert as it related to my case. Your other issue, however, may be the bigger problem (only my opinion here from lots of reading and investigation, so do not take my information as gospel). The current FDA indication for Cervical Arthroplasty is for single level disc only (see www.fda.gov). This is where the insurance companies come in with their reviews and decisions. I work in the medical device industry (although not spine), but understand insurance coverage and it's relationship to payments for both on and off label procedures.

Technically, a multi-level ADR is "off label" and therefore getting it covered by most carriers in the US is going to be extremely difficult. Before I would give up on this though, I would exhaust all options here by writing letters of medical necessity, as all carriers have appeals processes. They will most likely tell you that it is "experimental" and "unproven", which only means that there has yet to be a large clinical trial done in the US to gain the indication. Clearly, we all know that these procedures have been done OUS for quite some time, however there is very little clinical data substantiating the long term efficacy. This is where our medical system can be both challenging and frustrating.

On one hand, we have one of the "safest" medical systems in the world (devices that are approved in the US undergo the most rigorous clinical testing and require that they are at least as safe and effective as other products that are all ready in use), however on the other hand when it comes to getting new or expanded approvals for products, we fall behind Europe, Asia, and other parts of the world, because of this same rigorous approval process.

Another issue here is that since the current level of approval is for single level disease, it is much easier and cheaper to get new products approved the same indication. If you think about all of this from a purely economic standpoint, it becomes virtually cost prohibitive for a company with an ADR product, to undergo a large clinical study to prove both safety and efficacy for multi level cervical disk replacements in the US. A study to expand this indication in the US would most likely cost $25-50MM +. Then they would then have to wait for the outcomes to show that they were statistically at least as safe and efficacious as a fusion. Unfortunately for those of us who are patients, this is why products are approved outside the US so many years ahead of the US.

With all of that said, I have read about good results with hybrid procedures (fusion at one level and ADR at an adjacent level), which may be easier to get covered in the US by a private carrier. The other real option is to look overseas, or "cash pay" for your off-label procedure here. I know both of these sound less than desirable, however in our current medical world, I am not sure that there are really too many other options for multi-level cervical disc patients in the US today.

I wish your husband the best with his decision process and recovery. I can only say that I am 100% glad that I had my procedure done and only wish that I had done it sooner. All the best!

Kim,

Back in 2008 I saw Dr Zigler in August and was scheduled for a C6/7 ProDisc in September. If memory serves I was able to get in to see him within a week of initial contact.

I ended up not having surgery at TBI, but do know that Dr's Zigler and Blumenthal do multilevel ADRs.

Good luck, Jeff

Thank-you Jeff. I'm very happy to hear that they do multilevel. It's been almost two weeks since we've overnighted the paperwork for new patients to Texas Back. We haven't heard from them. I did leave a message on someone's machine asking when we'd hear something.

Our new local doctor, wanted him to cut back on the Gabapentin; so now, he's in a lot more pain. Steve's wanting to try a chiropractor, but I don't think it's a good move with a herniated disc. He's also considering an epidural injection. Most of these ideas stem from wanting to get rid of the pain while we wait to hear from TX Back.

Our insurance does pay for one level (I have it in writing). We will have to pay for the second level. I did the math and it's cheaper than doing it in Germany and paying for the whole thing.

I'm very relieved to hear that two of the doctors at Texas Back do multilevel. Now, if we can make contact...

Kim,

I don't know which TBI office you contacted, but Zigler and Blumenthal are at the Plano office. In fact, my 76 year old father-in-law just saw Zigler two weeks ago. From the time I called to make the appointment until the appointment was just eight days. As you've not heard back in two weeks, something's gotten dropped somewhere. I'd encourage you to consider calling them back and talking to a human.

Good luck, Jeff

Making Progress
 

We heard back from Texas Back today. Dr. Guyer says Steve is a good candidate for an ADR at C5-6 and either a fusion or ADR at C6-7. This is very encouraging since Steve's reduced the Gabapentin and the pain is up there.

Next:
-Bone Density Study...:beer:
-Results to Zelma
-Schedule surgery

Update: received results ("normal") from DXA scan. Faxed to TBI 6/27.

Hey Kim and Steve, can you provide much more detail? Hip bones? Long bones? Entire spine? Upper spine only? How were each of the vertebrae? It sounds very promising...

Thanks.