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  • Adopting New Technology Too Quickly

    For those who think it's smart to roll out a medical technology before it's gone through the FDA's process....

    https://www.scoliosisclaim.com/

    Please note that I'm not saying there's anything actually wrong with MAGEC implants. I'm just saying we don't really know about these things until the patients mature a bit.
    Never argue with an idiot. They always drag you down to their level, and then they beat you with experience. --Twain
    ---------------------------------------------------------------------------------------------------------------------------------------------------
    Surgery 2/10/93 A/P fusion T4-L3
    Surgery 1/20/11 A/P fusion L2-sacrum w/pelvic fixation

  • #2
    This completely blows my mind. The only difference between traditional growing rods and MAGEC was how they are expanded. I am not grasping why there aren't class actions for traditional growing rods also.
    Last edited by Pooka1; 01-18-2018, 09:48 PM.
    Sharon, mother of identical twin girls with scoliosis

    No island of sanity.

    Question: What do you call alternative medicine that works?
    Answer: Medicine


    "We are all African."

    Comment


    • #3
      Originally posted by LindaRacine View Post
      For those who think it's smart to roll out a medical technology before it's gone through the FDA's process....
      That would be Ellipse... Anthony had a "compassionate" release from the FDA....May 2013, He was the first Magec patient. This was 4-1/2 years ago.
      https://www.rchsd.org/about-us/newsr...for-scoliosis/

      2 years ago, NuVasive bought Ellipse
      https://www.fiercebiotech.com/medica...more-deals-way

      It looks like NuVasive did a re-design......and got the FDA approval back in September.....2017

      https://www.prnewswire.com/news-rele...300514377.html

      We can only hope they ironed out the problems....Sigh....

      Ed
      49 yr old male, now 63, the new 64...
      Pre surgery curves T70,L70
      ALIF/PSA T2-Pelvis 01/29/08, 01/31/08 7" pelvic anchors BMP
      Dr Brett Menmuir St Marys Hospital Reno,Nevada

      Bending and twisting pics after full fusion
      http://www.scoliosis.org/forum/showt...on.&highlight=

      My x-rays
      http://www.scoliosis.org/forum/attac...2&d=1228779214

      http://www.scoliosis.org/forum/attac...3&d=1228779258

      Comment


      • #4
        Originally posted by Pooka1 View Post
        This completely blows my mind. The only difference between traditional growing rods and MAGEC was how they are expanded. I am not grasping why there aren't class actions for traditional growing rods also.
        There were differences in material and connection.

        It's possible that the lawsuits are baseless, though it would be pretty stupid for the law firm to advertise and enroll litigants without some proof that a class action suit will prevail. I've got a friend who works for NuVasive Spine, so I'll see what I can find out.

        --Linda
        Never argue with an idiot. They always drag you down to their level, and then they beat you with experience. --Twain
        ---------------------------------------------------------------------------------------------------------------------------------------------------
        Surgery 2/10/93 A/P fusion T4-L3
        Surgery 1/20/11 A/P fusion L2-sacrum w/pelvic fixation

        Comment


        • #5
          This is such a delicate matter for me, in defense of spinal hardware manufacturing, where would we be without innovation? Basically nothing happened for thousands of years, now its this progressive improvement, ideas that help us prevent, limit or improve on this insidious, subtle, painful disease we have to struggle with....

          My hardware saved my life. My surgeons saved my life. I will never forget.

          These poor kids, sometimes they cant wait....it is such a tough call knowing that there are odds, and things can and will happen. We are warned about this by our surgeons. The hope is that there will be improvement, that it will help.

          The overall "combined" intent is positive....when things are not black and white, which scoliosis or serious surgery never is, we need to remember this before going to court. Its hard to over-engineer spine hardware, and prove out tensile and yield strengths in specific areas using accepted bio materials. Ionization and particulates from wear is also another difficult problem.

          Spine is everyone's problem. It just is. Spine problems need to be solved in a positive manner with current and new technologies, and nothing good ever comes easy, and giving up is never an option.

          I say, Kudos to NuVasive!

          Ed
          49 yr old male, now 63, the new 64...
          Pre surgery curves T70,L70
          ALIF/PSA T2-Pelvis 01/29/08, 01/31/08 7" pelvic anchors BMP
          Dr Brett Menmuir St Marys Hospital Reno,Nevada

          Bending and twisting pics after full fusion
          http://www.scoliosis.org/forum/showt...on.&highlight=

          My x-rays
          http://www.scoliosis.org/forum/attac...2&d=1228779214

          http://www.scoliosis.org/forum/attac...3&d=1228779258

          Comment


          • #6
            Maybe if treatments paths for Scoliosis were not so awful. Maybe if groups like Setting Scoliosis Straight and SRS and SOSORT actually came though with their promises and actually got to grips with providing correct accurate information about scoliosis and did not 'lump' everyone together so that the uninformed can propagate inaccuracies and poor treatment paths and the unscrupulous can muddy the waters with quack chiropractic techniques - MAYBE if they actually did what they were supposed to do and help safeguard scoliosis patients then MAYBE desperate parents would not have to take a leap of faith and trusting their instincts have to go for growing rods and VBT hardware that has no FDA approval because they are so desperate that their children do not have a life of pain and deformity!

            I do not for one minute consider MAGEC rods or VBT instrumentation to be 'quack' but how easy is it for medical professions to point the finger while the situation is as it is now?

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