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Arthroplasty Central Discuss re: 2 level lumbar disc replacement in the General Discussion forums; Does anyone have any info as to when the two level lumbar disc replacement with Prodisc will be approved by ...

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  #1  
Old 06-29-2007, 07:42 AM
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Does anyone have any info as to when the two level lumbar disc replacement with Prodisc will be approved by FDA? I think they are done with all the clinical trials. My spine surgeon said can be done through authorization from Synthes, the company that makes the disc
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DDD L4-5 &L5-S1, Bulging L4-5, Herniated L5-S1, Positive Discogram 6/07 for both, 5 ESI. Waitng for 2 level ADR, had 2 two level fusion on 9/11/07, no regrets so far!
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Old 06-29-2007, 08:06 AM
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That's the $24,000.00 (probably greater) question. I personally gave up waiting for that to happen about 8 months ago...

David
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39 years old
Surgery: 14-NOV-2006; Straubing, Germany (Dr. B.)
L4-S1: Prodisc
5 years and feeling GREAT!
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Old 06-29-2007, 08:16 AM
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So I guess it hasn't been approved. Then those people that posted having had two levels done in Texas were maybe part of a clinical trial? I hear of a lot of people who have gone to germany, I spoke with someone who went to straubing and had 3 levels done. Does anyone know of Dr. Yue in Conn, I think she saw him first. I'm new to this sight and I find it very informative, it's nice not to feel so alone all the time with "back problems"!
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DDD L4-5 &L5-S1, Bulging L4-5, Herniated L5-S1, Positive Discogram 6/07 for both, 5 ESI. Waitng for 2 level ADR, had 2 two level fusion on 9/11/07, no regrets so far!
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Old 06-29-2007, 09:05 AM
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I could be wrong here, but I believe that the people having 2 level Prodiscs (eg, TBI and Dr. Yue) are generally paying for the procedure out of pocket, and then fighting their insurance company afterwards.

I figured that if I were going to fly from Ohio to Texas (or CT), I might as well fly all the way to Germany.

By the way, feel free to let me know if you have any other questions...


David
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39 years old
Surgery: 14-NOV-2006; Straubing, Germany (Dr. B.)
L4-S1: Prodisc
5 years and feeling GREAT!
My website
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Old 06-29-2007, 09:26 AM
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So, its being done in the US if you are willing to pay out of pocket??? Do you know which doctors have the most experience with 2 level ADR? My spine surgeon has already starting filing for authorization from my insurance company and Synthes, I'm curious to see the outcome of that! By the way, which ADR did you have?
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DDD L4-5 &L5-S1, Bulging L4-5, Herniated L5-S1, Positive Discogram 6/07 for both, 5 ESI. Waitng for 2 level ADR, had 2 two level fusion on 9/11/07, no regrets so far!
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Old 06-29-2007, 09:35 AM
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I have personally dealt with Dr. Yue (CT), so I would feel comfortable with him performing the procedure (look for posts from KimDean'sWife).

I also have heard good things about the surgeons at Texas Back Institute.

For me, although I was initially hesitant about Germany, it was the best decision I have ever made in my life.

To quote KimDean'sWife: Money. Well. Spent.

(two level Prodisc)

David
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39 years old
Surgery: 14-NOV-2006; Straubing, Germany (Dr. B.)
L4-S1: Prodisc
5 years and feeling GREAT!
My website
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Old 06-29-2007, 10:00 AM
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thanks for the info. I have read postings from kimdeanswife. I've read other postings as well. Frankly, I am starting to become a bit frightened of the surgery. I've read so many good outcomes, but I am wondering if it is worth all the pain and discomfort from major surgery. I've been dealing with back problems for 20+ years, with countless opinions and treatments. I am 47 now and just feel if I wait any longer, my options for this surgery will not be as good.
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DDD L4-5 &L5-S1, Bulging L4-5, Herniated L5-S1, Positive Discogram 6/07 for both, 5 ESI. Waitng for 2 level ADR, had 2 two level fusion on 9/11/07, no regrets so far!
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Old 06-29-2007, 10:32 AM
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Stacy, you're right. Options diminish as you age. Personally, if I had 20 years of back pain like you, I'd be asking myself: why the hell would I wait any longer? (just being honest here) Facing the pain and recovery of surgery is not equal to, nor is it greater than 20 years of back pain. Ask yourself what your quality of life is, has been, and will be, for the next 40 years, if you sit and do nothing. And will you be satisfied with that?

Dr. Blumenthal @ TBI and Dr. Yue in Connecticut would be my top picks for stateside experts. The doctor in California, Dr. Delamarter, I believe, also receives rave remarks from folks on this site.

Personally, I'm partial to Dr. Bertagnoli in Germany, but honestly don't think you could go wrong w/ Blumental or Yue. Dr. Blumenthal happens to be my local spine doctor's best friend, so I hear exceptional things about him frequently.

Prepare yourself for denial by your insurance, and then if you are one of the lucky few, jump for joy! Well, don't jump. But celebrate. We are, unfortunately, a rather large club here of "denials." But, fight, fight, fight is our mantra.

Best of luck with all your decision making.
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bicycle accident 6/19/01
2 compression fractures, T12, L1;
vertibroplasty @ above levels, 9/15/01
4/06 hip labral tear repair
4/07 Lumbar ProDisc replacement by Dr. B., 3 levels; L3-6
7/2/08 ALIF of L6-S1
7/30/08 Removed bone cement.
8/7/08 Diagnosed with pulmonary embolism, double pneumonia, collapsed left lung, pleurisy, pleural effusion.
3/10/09 right SI Joint Fusion; seeing light at end of tunnel, for first time in 8 years!!
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Old 06-29-2007, 10:43 AM
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Thank-you! I needed that inspiration. It's nice to have people to communicate with that understand. This last bout with my back has been debilitating, (It usually puts me out of work for weeks @ a time because I can't drive) My oldest daughter is getting married in less that one month and I'm hoping this last ESI holds out, I still have back pain but at least I can walk now.
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DDD L4-5 &L5-S1, Bulging L4-5, Herniated L5-S1, Positive Discogram 6/07 for both, 5 ESI. Waitng for 2 level ADR, had 2 two level fusion on 9/11/07, no regrets so far!
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  #10  
Old 06-29-2007, 12:16 PM
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Stacy,
glad you are getting some relief, albeit small. Being vertical is definitely a plus! I do hope you maintain some relief for your daughter's fast approaching wedding. I have to tell you, when my son got married last November, I too was very concerned about my pain levels. Surprisingly, I had an incredible day, even danced w/ my son. And it wasn't until I fell into bed, at the end of a long day of celebration, did I feel my pain. I took my pain meds, smiled, said a soft thank-you, and drifted off to sleep.
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CindyLou
bicycle accident 6/19/01
2 compression fractures, T12, L1;
vertibroplasty @ above levels, 9/15/01
4/06 hip labral tear repair
4/07 Lumbar ProDisc replacement by Dr. B., 3 levels; L3-6
7/2/08 ALIF of L6-S1
7/30/08 Removed bone cement.
8/7/08 Diagnosed with pulmonary embolism, double pneumonia, collapsed left lung, pleurisy, pleural effusion.
3/10/09 right SI Joint Fusion; seeing light at end of tunnel, for first time in 8 years!!
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