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FDA turns down Dascor, company goes out of business, still pain from DNR surgery, NOW WHAT?!

This is a discussion on FDA turns down Dascor, company goes out of business, still pain from DNR surgery, NOW WHAT?! within the Emerging Spine Surgery Technologies forums, part of the Spine Surgery Support category; I have some problems, as my title notes. Although I my pain may not hold a candle to some of ...

  1. #1
    Junior Member Johnny Vegas's Avatar
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    Default FDA turns down Dascor, company goes out of business, still pain from DNR surgery, NOW WHAT?!

    I have some problems, as my title notes. Although I my pain may not hold a candle to some of you here, I've got a good ten years in the spine problem business. I "thought" I knew it all, seen all the quacks, been through all of the phoney "tests" and "therapies." So what did I do with all of this knowledge? I had a non-FDA approved surgery through a clinical trial! My theory (and my doctor's) was that this was the latest and greatest. Now the company is out of business after the latest FDA turn down!
    Almost two years later now and I am still in pain! Yes, thank you ladies and gentlemen and no, I am not a genius. I believe I may be more of a gambler at this point. I would say I gambled and won though. My pain is %50 gone .
    I would like to find out the results of Disc Dynamics clinical trials of Dascor in the US (125 surgeries) and in Europe (300 surgeries). According to some reports, the FDA turned them down because of cancer causing agents. An ex-company rep says all is well, the company simply could not go on after spending $65 million in the last ten years and the technology will be bought by someone else. Anyone out there have any answers? Thanks for your help and support! The problem is what does the future hold?...........
    p.s. Come on down to Casino Arizona in Scottsdale and play some poker with me, I'm a dealer there!
    p.s.s. My surgery was done by Dr. Christopher Yeung, Phoenix, AZ. He is an awesome doctor, did a great job, I had no complications, and several of my friends have had great outcomes from his work on them.
    Last edited by Johnny Vegas; 04-08-2010 at 11:40 AM. Reason: needed more info, signature
    46 years old, former marathon runner
    1985 Three motorcycle accidents
    2000 Rear-ended by four drunk guys in a truck (I had to chase them down myself at 2 AM) - disc herniation, L4-5. Chiropractic, PT
    2006-2007 25 steroidal injections
    2007 IDET procedure, L4-5, unsuccessful
    2008 Dascor (disc nucleous replacement) surgery, L4-5 (clinical trial by Disc Dynamics)
    2010 Mixed results, pain %50 gone

  2. #2
    Senior Member Katie's Avatar
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    Default Re: FDA turns down Dascor, company goes out of business, still pain from DNR surgery, NOW WHAT?!

    Can you track down where the executives from this company moved to? It is common for engineers, etc to go to other companies even if the first one is still sound. They may be able to answer some of your questions.
    Severe compression of spinal cord, flaval ligament, etc. at C4/5 & 5/6.
    Herniation and compression, at L3/4 to L5/S1 plus spondylosis at the latter level. Severe allergy to most metals.
    Three level surgery in Brazil with Dr. Luiz Pimenta on March 17/2010 using non-metal appliances. L5/S1-PEEK cage, ALIF; L4/5-PEEK cage, XLIF; C5/6-NuVasive NeoDisc. Three separate approaches, two minimally invasive. Currently minor residual back pain, from SI ligament and still overdoing things . Therapy and chiropractic treatments helping immensely. Gone from being almost bedridden to near normal activities including gardening. Life is gooooood!

  3. #3
    Moderator KBear's Avatar
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    Default Re: FDA turns down Dascor, company goes out of business, still pain from DNR surgery, NOW WHAT?!

    I wouldn't be too hard on yourself. Most of these devices that are in trials in the US are already approved in other countries. I am in the Active L trial, which isn't at the FDA approval stage yet. The way I saw it was, I could go to Germany and pay for the same device or get it free in the US. You do what you have to do. 50% isn't bad for pain relief either. Good Luck!
    Kathy
    31 years old- 1/06- In wreck with 18 wheeler at 25 years old; 6/06- Head on collision on Interstate, both wrecks other drivers fault. Numerous MRI's, PT, chiropractic, acupuncture, TENS therapy, massage therapy, facet injections, epidural injections, Nerve study, Discogram, confirms pain in L4/5, IDET, decompression, Bi-lateral neurotomy L3/4/5, denied by insurance twice, in Active L clinical trial, had surgery March 17, 2009 in Miami, FL- received Active L disc at 29 years old. Pain and medication free as of October 2010!Mommy to Emma- 8 years, Ava- 6 years & had baby Eli after ADR, via c-section on March 25, 2011 , completely pain free still!

  4. #4
    Junior Member Johnny Vegas's Avatar
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    Default Thanks for your support and advice.............

    Thanks for the advice Katie, I know that Disc Dynamics was located in Minnesota. I can do some research. There is one guy on this forum who claims to have some knowledge of the trials in Europe, so I'll see what I can do. Hope you are able to ride again!....I love horses, worked at a Canterbury Downs race track in Minnesota for ten years!
    Kbear, You are right, I just did what I thought was best at the time. Although I have insurance and could've opted for the standard fusion, I also think we have to try new things to advance science and medicine for all of us. So I am a lab rat. Good luck with your trial as well.
    46 years old, former marathon runner
    1985 Three motorcycle accidents
    2000 Rear-ended by four drunk guys in a truck (I had to chase them down myself at 2 AM) - disc herniation, L4-5. Chiropractic, PT
    2006-2007 25 steroidal injections
    2007 IDET procedure, L4-5, unsuccessful
    2008 Dascor (disc nucleous replacement) surgery, L4-5 (clinical trial by Disc Dynamics)
    2010 Mixed results, pain %50 gone

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