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Thread: The use of BMP product?

  1. #1
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    The use of BMP product?

    http://www.publichealthwatchdog.com/...isk-of-cancer/
    or
    http://backpainreliefsecrets.com/bac...y/#comment-727

    Medtronic Infuse Can Lead to Increased Risk of Cancer April 16, 2012

    After my surgery was put 'on hold' 2 weeks ago, I am still in the dark as Dr Bridwell's office only says that they are trying to resolve this as this is his preferred way. I asked if the other doctors in their organization also used this BMP product and the answer was yes.

    I do not know if this BMP is produced by one or more pharmaceutical company but likely not as it is a patented stuff.

    I want to get this pain out of my life but certainly prefer to keep than swap with cancer.

    Any thoughts ?
    Gardenia
    Baja California, Mexico & El Centro, Ca
    pre-surgery 75° and 89° - post ?
    Dr. Bridwell Nov 27, 2012 @Barnes Jewish @62yrs
    T11 to Sacrum Dural leak at L2 & L3 ccmail4g@gmail.com

  2. #2
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    this has been discussed before on this forum....i actually
    saw an ad on TV of lawyers who were suing over the use of
    the stuff....and wrote in forum to ask about it...
    apparently the danger lies in it being used "off label"
    for procedures it is not intended for...

    if you do a search on forum, you can probably find the
    previous thread and discussion...

    jess
    Last edited by jrnyc; 11-14-2012 at 11:56 AM.

  3. #3
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    I gotta say, this scares me. I know Dr. Lenke used a bunch of BMP on me. However, I did ask him about this issue in advance. He said that if he or his wife had to have this surgery, he would use BMP. In many ways this surgery is one where you kind of have to do all your research, learn everything you can, then say your prayers and take the plunge. There are no guarantees.
    age 44
    80* thoracolumbar; 40* thoracic
    Reduced to ~16* thoracolumbar; ~0* thoracic
    Surgery 3/14/12 with Dr. Lenke, T4 to S1 with pelvic fixation
    Not "confused" anymore, but don't know how to change my username.

  4. #4
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    Hi...

    If you find the previous thread, you'll see that I mentioned that I knew about the BMP controversy before my January 2010 revision. I chose to let my surgeons use BMP, because I feel the reward of a much higher fusion rate outweighed the risk of complications. I think I'd make the same decision today. Fusing L5-S1 used to be a real crap-shoot. While there are still non-unions reported in complication studies, I think the rate is significantly smaller than it used to be Needing revision surgery because of a non-union isn't cancer, but it's also not without morbidity.

    The jury is still out on the legal issues. Several things that one needs to know in terms of assessing the risk: 1) The cancer concern involved a product called Amplify, which uses BMP-2. I believe what most spine surgeons are using is NOT Amplify. 2) I haven't actually heard how many patients have developed cancer. For all we know, the number of cancer cases could have been 5 out of 500 (or 1%). If the actual rate is 5 times that, it would still only be 5%. 3) It's certainly possible that the Amplify product was used in smokers, as their risk of non-union is significant.

    With all that said, the studies that are under the microscope were authored by surgeons who took many millions of dollars in consulting fees from Medtronic. We can't know their motivation, but it definitely looks a bit suspicious.

    Regards,
    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

  5. #5
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    Yale Study

    Hi, It is my understanding that Yale has been hired to conduct a review of BMP Infuse. Here are some interesting links:
    http://medicine.yale.edu/core/projec...2002.06.12.pdf
    http://news.yale.edu/2011/12/05/yale...growth-product
    http://www.medicalnewstoday.com/articles/232280.php
    I have found revision surgery to be a tough decision, one that I have yet to make. For me it is a quality of life decision. My standing and walking times/distances are limited, and I'm only 53. My temporary fix was to hire someone to clean my house and use my standup time for walking. Even though Medtronics is paying Yale, I am interested in seeing the study. I believe I remember reading an article that said it was expected out later this year.

    Linda also makes a good point about needing to consider the morbidity rate of revision surgery for non union if BMP is not used. Whenever one is using a new device or new medication long term consequences are unknown. You have to make your decision on the best current information that you have. If BMP Infuse is found to increase cancer risk, that is probably very important for people with other cancer risk factors to know.

    Roxanne

  6. #6
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    thank you for all the feedback

    Well, doing research as much as I've been doing for the past 2 weeks had brought me a huge cloud of depression to a point that I could not function well. I have to admit that I have my load to support the depression without having Dr Bridwell's added on-hold as he/they were going to deal with the insurance or whatever avenues they have to use as a large medical center.

    I completely trusted his decisions before I left St Louis and I would go ahead and still do the surgery if he gets a green light. As to reseaching more and more is not healthy for me and I am not in a position to evaluate everyone's opinion or papers. I think that Dr Bridwell / Dr Lenke and associates are far well invested in the studies of this product and they will not risk their and their Universtiy's name/reputation in doing something that was questionable.

    My problem is the waiting of 2 weeks is nothing when it involves written communication and all the paper trail that this will require (for them) but for me (as you have had to wait) it seems like I am in limbo waiting for a long long time.

    It is hard to search and navigate this forum (at least for me) for forgive me if I was repeating a known concern that is very recent regarding the insurance coverage of one company.

    Thank you so much, my friends.

    gardenia
    Gardenia
    Baja California, Mexico & El Centro, Ca
    pre-surgery 75° and 89° - post ?
    Dr. Bridwell Nov 27, 2012 @Barnes Jewish @62yrs
    T11 to Sacrum Dural leak at L2 & L3 ccmail4g@gmail.com

  7. #7
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    I have been exposed to quite a bit through the years in my career, if anyone should have cancer it should be me. My usage of infuse was used in an FDA approved manner, anterior lumbar surgery. It’s the “off label” use that is causing most of the problems, mainly in the neck surgeries. I believe this “off label” use has slammed to a halt since Medtronic has informed all surgeons.

    Now, I’m wondering which is more dangerous.... Dental Plaque or BMP?
    http://www.drbicuspid.com/index.aspx...&ItemID=310741

    Its always something....brush your teeth! (smiley face)

    It will be nice to see the results from Yale. Will we see the majority of the problems coming from non-scoli cervical applications? Off label use? How many scoli’s are in the lawsuits? Can we narrow this down?

    With the element of risk involved, I must say I’m doing fine and past the 300% increased cancer risk mark of 3 years. I will be 5 years post in January with no scoli revision surgeries.

    Ed
    49 yr old male, now 60, 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

  8. #8
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    what is 1-3% versus 97-99% non problem?

    I guess people tend to remember or to grab onto the worse negative instead of taking the positive.

    If they had said, non-cancer risk of 97% then it would seem a whole lot differently.
    Gardenia
    Baja California, Mexico & El Centro, Ca
    pre-surgery 75° and 89° - post ?
    Dr. Bridwell Nov 27, 2012 @Barnes Jewish @62yrs
    T11 to Sacrum Dural leak at L2 & L3 ccmail4g@gmail.com

  9. #9
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    New York
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    Gardenia, I'm so sorry if my post was depressing, that was not my intent. After having doctors put a body cast on incorrectly, leave a sponge in me during surgery, and prescribe medication that was inappropriate for me I tend to go hog wild on research and double check everything they tell me.

    I'm glad you have a doctor that you can trust and one who shows he is concerned about your safety. That alone gives you a big advantage.

    Roxanne
    Roxanne
    Milwaukee Brace 2 years
    Fused 1976
    Fusion Repair 1979

  10. #10
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    Location
    Dubuque, Iowa
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    To me the use of BMP in my surgery was a non issue.....I can't imagine going through this surgery only to face non union. From my understanding it is more of a risk to not use it. That being said, I have come to the conclusion that on the off chance I develop cancer in the future because of BMP.....I will surely be strong enough to fight it, after all I am made of some of the strongest metals on earth
    Spring
    42 yrs old
    Milwaukee braced 1983 to 1989
    was told my curves would never progress
    at 19yrs old 1991, T30-L38
    2010, T38-L56--progression in one year 2011, T40-L67
    new diagnosis-kyphoscoliosis, DDD, Arthritis, Osteoporosis, 73 degree Kyphosis
    Surgery 1-09-12....10 hrs all posterior T4-sacrum & 2 cages
    Dr. Lenke-St. Louis Mo.
    Surgery to clean out infection 2-10-12
    Revision for broken rods 1-23-14

  11. #11
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    Northern California
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    Ed...

    BMP in the cervical spine is definitely off label. I hope that if anyone finds themselves in the situation where a surgeon os recommending that it be used in that fashion, they get at least one more opinion.

    --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

  12. #12
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    Yes. Correct.

    I think if all surgeons are aware, and its used correctly, it’s a great benefit. So, for scolis, that means ALIF surgeries only, with DDD. Is this correct? So, PLIF’s, TLIF’s and XLIF’s are not approved for BMP usage.

    This really narrows it down doesn’t it?

    Ed
    49 yr old male, now 60, 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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    Location
    Sunshine Coast, Queensland, Australia
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    Then the use of BMP in my surgery must have been off-label?
    Surgery March 3, 2009 at almost 58, now 63.
    Dr. Askin, Brisbane, Australia
    T4-Pelvis, Posterior only
    Osteotomies and Laminectomies
    Was 68 degrees, now 22 and pain free

  14. #14
    Join Date
    Jul 2011
    Posts
    535
    Quote Originally Posted by titaniumed View Post
    Yes. Correct.

    I think if all surgeons are aware, and its used correctly, it’s a great benefit. So, for scolis, that means ALIF surgeries only, with DDD. Is this correct? So, PLIF’s, TLIF’s and XLIF’s are not approved for BMP usage.

    This really narrows it down doesn’t it?

    Ed
    Hi Ed,

    I had TLIF by Lenke with BMP.

    Warmly,
    Doreen
    44 years old at time of surgery, Atlanta GA

    Pre-Surgery Thorasic: 70 degrees, Pre-Surgery Lumbar: 68 degrees, lost 4 inches of height in 2011
    Post-Surgery curves ~10 degrees, regained 4 inches of height

    Posterior T3-sacrum & TLIF surgeries on Nov 28, 2011 with Dr. Lenke, St. Louis
    2 rods, 33 screws, 2 cages, 2 connectors, living a new life I never dreamed of!

    http://thebionicachronicles.blogspot.com/

  15. #15
    Join Date
    May 2009
    Posts
    3,745
    i thought it is used for posterior fusion....??????
    also, what if discs are replaced with side incision...???

    jess

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