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Thread: FDA Approval

  1. #1
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    FDA Approval

    I thought the FDA was analogous to NICE in UK.

    However I have read that the FDA does not actually approve surgical procedure but only the 'devices' used in such procedures.


    I think NICE actually approves the surgery also.

    Can anyone clarify for me?

  2. #2
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    Burdle, The FDA will approve of something like Infuse kits (BMP), but only if trained in its usage, and particular procedure. If used in any other procedure that's not recommended or approved, its considered "off label". Surgeons are allowed to do "off label" procedures before the FDA gives a green light. (Tethering is a good example)(Magec is a good example) Surgeons need to be trusted that they are doing what they feel will benefit a patient, should something go wrong and end up in a courtroom, its mainly about intent. I signed a few waivers stating that I was informed of discussed complications of my procedure.

    So, a product approved with stipulations, but no control over its usage. BMP is approved for ALIF surgery only in scoliosis surgery. Not for posterior procedures.

    Its a good idea to know if you are having an off label procedure.

    Agreements and confidentiality between MHRA -FDA
    https://www.fda.gov/InternationalPro.../ucm100084.htm

    Its a mountain of material.

    Ed
    49 yr old male, now 59, the new 55...
    Pre surgery curves C12,T70,L70
    ALIF/PLIF 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

  3. #3
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    Thanks Ed,

    In UK we have NATIONAL INSTITUTE OF CLINICAL EXCELLENCE. But this body 'regulates' procedures. The remit is are they 'cost effective'- it is a different perspective

    I guess from an FDA point of view you cant do a procedure if there are no devices that have been approved for it ( notwithstanding 'off-label). In UK Tethering is not on the table because of NICE but it is the procedure itself. However if/when it is approved it will have to be with the use of certain devices. I need to find out how devices get approved in UK

  4. #4
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    Quote Originally Posted by titaniumed View Post
    Burdle, The FDA will approve of something like Infuse kits (BMP), but only if trained in its usage, and particular procedure. If used in any other procedure that's not recommended or approved, its considered "off label". Surgeons are allowed to do "off label" procedures before the FDA gives a green light. (Tethering is a good example)(Magec is a good example) Surgeons need to be trusted that they are doing what they feel will benefit a patient, should something go wrong and end up in a courtroom, its mainly about intent. I signed a few waivers stating that I was informed of discussed complications of my procedure.

    So, a product approved with stipulations, but no control over its usage. BMP is approved for ALIF surgery only in scoliosis surgery. Not for posterior procedures.

    Its a good idea to know if you are having an off label procedure.

    Agreements and confidentiality between MHRA -FDA
    https://www.fda.gov/InternationalPro.../ucm100084.htm

    Its a mountain of material.

    Ed
    I have resurrected this because I am unclear still - does a procedure have to be approved by the FDA as well? Can you have a procedure approved like VBT with the actual device being off-label? If so what difference would it make for the device to become approved?

  5. #5
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    Burdle, The articles below should help explain

    https://www.shahfacialplastics.com/a...e-fda-approved

    SRS VBT in peds and adults
    https://www.srs.org/about-srs/qualit...inal-deformity

    Any use of tethers in the US is considered experimental. There is no data confirming safety in adults.

    They mention a paucity or scarcity of information.

    I have 2 long posts written for you on the other webinar thread since you present a good argument about gold standard. But I am still sick with the flu, and I keep thinking about a pin head of virus being able to make 20,000 people sick.

    But I don't have any pins in the house. (smiley face)


    Ed
    49 yr old male, now 59, the new 55...
    Pre surgery curves C12,T70,L70
    ALIF/PLIF 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

  6. #6
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    Feel better soon - flu is horrid when you have orthopaedic issues

  7. #7
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    A tethering patient was on Good Morning America today.

    http://abcnews.go.com/GMA/Culture/da...ry?id=53273524
    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

  8. #8
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    Wow Linda! Check it out. She had the same curves and shape as me! Its not everyday I see x-rays that look like mine...

    At 1:40, look at her x-ray and then look at mine below in 1993. (I was 35 then)

    I am so very happy for her and so glad to see this.... She is going to skip out on some incredibly painful years.....

    I wish she would post here so we can follow along.....

    Ed
    Attached Images Attached Images
    49 yr old male, now 59, the new 55...
    Pre surgery curves C12,T70,L70
    ALIF/PLIF 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

  9. #9
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    How terrific

    Quote Originally Posted by LindaRacine View Post
    A tethering patient was on Good Morning America today.

    http://abcnews.go.com/GMA/Culture/da...ry?id=53273524
    This is so awesome. I spent a year in a cast at the age of 14. Then went through 4 more revisions. The young people are so lucky to not go through what Iíve been through.

  10. #10
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    Quote Originally Posted by titaniumed View Post
    She is going to skip out on some incredibly painful years.....

    Ed
    Hopefully, but we don't know what, if any, long-term complications we'll see.
    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

  11. #11
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    Quote Originally Posted by LindaRacine View Post
    Hopefully, but we don't know what, if any, long-term complications we'll see.
    VBT is not a one stop - it is perfectly possible to have fusion at a later stage if necessary. It is now being performed in UK for self-funders. It is a less invasive operation and contrary to what you might read it does not have lung issues afterwards or issues with broken tethers or blood loss. The long-term compliactions are that it might not work for everyone but patients are entitles to have the knowledge.

    When fusion was first mooted they had no idea of the long-term complications and I would maintain that the medical profession has done its dammedest to ignore any unless they need a revision. All other complications are just left to the patient to put up with.

    I would also add that the long-term goal is for mature spines achieving correction and/or halting progression.

  12. #12
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    Burdle, Linda is right about complications....you cant assume anything, even if its one stitch (that gets you infected). All surgery has risks, or even just having anesthesia with no surgery. Joan Rivers didn't have any surgery. Dodging any surgery is worth a lot of effort even if L Ron Hubbard invented Chiropractic. (Just seeing if I can knock Sharon off her chair LOL, I am hoping for joke of the month with this one...)

    Since we had the same spines, she at least had the tethering choice. I didn't have that choice so I waited. One of the things that's really hard is knowing that your going to need scoliosis surgery, but knowing that there is a good possibility that you have to do it "again" at some point, is even harder..... Most of us have to deal with this. Fused and or tethered. I just don't know if I would have made the same decision that she made. Once again, pain made both our decisions. I think Dr Lonner did a really good job on her. Her pain will probably be less for now......When she gets into the degenerative years, that will be the acid test assuming nothing goes wrong. Our fingers are crossed.

    I believe it was Dr Hibbs in 1911 that started fusing scoliosis patients, and he did have some amazing results for that time frame. He was the first scoliosis surgeon. And yes, he did have to present the concept which probably wasn't an easy thing. Same sort of thing now with tethering. New technology is always going to be scary.

    I don't think progression matters all that much since there are people with HUGE curves that don't have pain. Its the major pain that really matters. Disk herniation, stenosis and spinal cord related problems are devastating.

    She also had a few ribs removed (Costoplasty) so we can assume that she had a lot of rotation. I wonder how tethering does in this regard? She is standing up straight in the video, this balancing of her kyphosis and lordosis cant be an easy thing with 2 tethers on an "S" curve.

    Once again, amazing work on Dr Lonner's part.

    Ed
    49 yr old male, now 59, the new 55...
    Pre surgery curves C12,T70,L70
    ALIF/PLIF 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

  13. #13
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    Quote Originally Posted by titaniumed View Post
    Burdle, Linda is right about complications....you cant assume anything, even if its one stitch (that gets you infected). All surgery has risks, or even just having anesthesia with no surgery. Joan Rivers didn't have any surgery. Dodging any surgery is worth a lot of effort even if L Ron Hubbard invented Chiropractic. (Just seeing if I can knock Sharon off her chair LOL, I am hoping for joke of the month with this one...)

    Since we had the same spines, she at least had the tethering choice. I didn't have that choice so I waited. One of the things that's really hard is knowing that your going to need scoliosis surgery, but knowing that there is a good possibility that you have to do it "again" at some point, is even harder..... Most of us have to deal with this. Fused and or tethered. I just don't know if I would have made the same decision that she made. Once again, pain made both our decisions. I think Dr Lonner did a really good job on her. Her pain will probably be less for now......When she gets into the degenerative years, that will be the acid test assuming nothing goes wrong. Our fingers are crossed.

    I believe it was Dr Hibbs in 1911 that started fusing scoliosis patients, and he did have some amazing results for that time frame. He was the first scoliosis surgeon. And yes, he did have to present the concept which probably wasn't an easy thing. Same sort of thing now with tethering. New technology is always going to be scary.

    I don't think progression matters all that much since there are people with HUGE curves that don't have pain. Its the major pain that really matters. Disk herniation, stenosis and spinal cord related problems are devastating.

    She also had a few ribs removed (Costoplasty) so we can assume that she had a lot of rotation. I wonder how tethering does in this regard? She is standing up straight in the video, this balancing of her kyphosis and lordosis cant be an easy thing with 2 tethers on an "S" curve.

    Once again, amazing work on Dr Lonner's part.

    Ed
    All surgery has the potential for complications so this cannot be used as a reason not to do VBT instead of fusion It can be used as a reason not to do VBT at all but that is not the discussion here.

    Progression is the key factor for all scoliosis surgery- fusion or VBT. Since scoliosis is not considered to cause pain (not my words) and surgeons do not do surgery for 'pain alone', progression and the effect on joints/nerves etc. is the reason for doing it. It is the inability to predict progression that makes the surgical decision on the part of the surgeon and the patient that makes the decision difficult. If a curve is not causing pain and not likely to progress then no surgery required- but that is the difficult call.

    VTB surgeons also do rib work- it is called DISK Release. they mainly do it when they are working on a mature spine since the idea behind VBT is that there is growth left and so the curve will straighten with growth and the rib hump improve. With mature spines and VBT there is no growth hence the Disk release.

    I agree new technology is scary but with VBT there seems to be more to it than this. There are great surgeons performing it in US and now over Europe. It makes me wonder how much money is involved behind the reluctance towards it.

  14. #14
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    Quote Originally Posted by titaniumed View Post
    , but knowing that there is a good possibility that you have to do it "again" at some point, is even harder..... Most of us have to deal with this. Fused and or tethered. I just don't know if I would have made the same decision that she made.
    Ed
    Fusion is One and Done but the done is a nonflexible spine. VBT is the chance that you make end up with a straight flexible spine - if the worst comes to the worst fusion is still on the table. the reverse is not true. And we are talking some time later. It is not a 'good possibility' but a fall back position if ultimately needed.

    I suppose it all come down to whether you think that the optimum position is a fused spine or a working spine.

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