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BMP infuse used in cervical surgery...

Cath111CCath111 Posts: 3,702
edited 06/11/2012 - 8:26 AM in Back Surgery and Neck Surgery
I got my Operative/Procedure Report yesterday and in the description of the procedure, it says.."She also understood the off-label use of bone morphogenic protein infused and its advantages for a 3-level fusion."

Although I'm almost three months out with no complications, I find this disconcerting for a couple of reasons - one is that it's not true that I understood - I was never told. The other is that I've read that BMP should not be used and is not FDA approved for cervical fusion, but the surgeon can "get around" this approval by using "off-label." :?

Anybody else know if they've had off-label BMP used in their ACDF?


  • That warning about bmp and the cervical spine was put out by the FDA in July. It was used on me in June. I have spoken to my surgeon at link about the use of it after the warning was released. He said they can get around it and he will continue to use it with surgeries that may have complications of non-fusion. Since I already had psuedoarthorsis(sp) it was clearly warranted. He also told me that many surgeons won't use in the cervical spine now with the warning. Apparently it will absorb in the body rather quickly. The warning was put out due to increased swelling with the use of it. In the cervical spine there is no room for extra swelling. The way i understood it they give steriods in high dose to off set the swelling so as not to interfere with the breathing. Now i for one was not given them and dealt with the extreme swelling to the point that it was interfering with my breathing. Multi-level fusions have a higher rate of non-fusion so i suspect that is why you surgeon used it. You are well passed the danger zone of the use of the product at this point from my understanding. I was told that if there is any overgrowth it should be seen with in the first two weeks after surgery which is a complication of BMP. The revision surgery for a non-fusion is a posterior surgery and is a much more difficult recovery and has more risk associated with it as well. Your surgeon should have made you aware that is what they were using from the get go. I hope this has helped you some. Take care.
  • Thanks tamtam. I figured I was past the time when it would cause swelling, but I had understood that it was never used in cervical ACDF. My bad, I should have researched this a little better before I had it done. Thanks again!
  • I would be uncomfortable with my doctor using something without telling me... Especially when it isn't FDA approved... I think that if they need to use it, they need to use it, but being what it is, they need to make their patients aware. Even if it's better for your situation, you still have the right to be informed of how you're being treated, and have the right to refuse it and go elsewhere. Ya know?

    I'm glad to hear you aren't having any complications, though.
  • Hello Cath,

    That bit of doctors going "off label" really bugs me, especially when you are not told in writing. Of course, how many times have I had a full page of writing in front of me to sign regarding some procedure, and it is rush rush rush. So I just ask the guy what this is about and get a sentence or two, upon which I stupidly sign. GRRRrrrr

    Cath, I REALLY hope all continues to go well with and for you.

    Just a thought - How about us requesting the Admin to ask one of their doctors to write an article regarding the "off label" use of BMP, and this D%&@# off label stuff in general that doctors apparently routinely use? Your thoughts.

    You know, considering the malpractice issues, one would think that doctors doing this "off label" stuff wouldn't touch it with a 100 foot pole.

  • Yes, RichT, that's a good idea. Before my surgery, I thought that I had done a thorough research of everything involved with my pending ACDF but was wholly unaware of the existence of BMP. It would be nice if future surgical candidates had that information available to them via SH. This site is where I did 95% of my research.

    Lo, you're absolutely right on the money. When I was scheduled to meet with my surgeon, I expected a long talk with him regarding all aspects of surgery. Of course, I didn't know what to ask because it was all so new to me (and scary)and my mind was going in circles. But my surgeon was sort of an in-an-out kinda guy - I knew he was a wizard of a surgeon, but it seemed to me that he was uncomfortable sitting down face to face and having a long discussion about it.

    I have to say, however, that if he had told me up front, I would have consented to the procedure. That's how much I trust my surgeon. And it's quite possible, like RichT said, that I had a mortgage-sized stack of documents in front of me that said off-label BMP would be used and I didn't see it. We all know how we get like deer in the headlights when we're told that they have to cut open your body, shove stuff aside, drill out your disks, replace them, screw a plate onto your spine and then put us all back together again. Just a tad daunting.

    In one way, I'm kind of impressed that surgeons would use the off-label stuff with the malpractice issues. It tells me that they think BMP is worth the risk, especially for patients that would have a more difficult time fusing. They must be pretty sure of themselves to use it and perhaps these surgeons are ahead of the curve on the proper surgical technique it takes to be successful.

  • Hello Cath,

    Okay, I will contact SH and encourage them to have a doctor write a good no nonsense article about "off label" and especially about the BMP off label issue.

    "But my surgeon was sort of an in-an-out kinda guy" GRRRRrrr, that's how most of the spinal surgeons have treated me, and THE reason I am still looking. I'm getting serious about when the next doc walks in I'm going to lock the door so he can't get out until I've really drilled him or her.

    "We all know how we get like deer in the headlights when we're told that they have to cut open your body, shove stuff aside, drill out your disks, replace them, screw a plate onto your spine and then put us all back together again." I like that "like deer". An interesting way to look at it. :)

    "They must be pretty sure of themselves to use it" WELLLllll, perhaps, howver, most docs still think that they are a God (which some are slowly realizing they are NOT!!!)

    Take care.

  • Oh, don't get me started on BMP again!!! image:)" alt=">:)" height="20" />

  • I've had 2 thorough discussions about BMP with my surgeon and he's actually using it "on label." Because I have shown reluctance, he's offered to not use it and presented other options. He will not use it off label but he is also conservative in many ways.

    I've followed the articles in the WSJ about the lawsuits against Medtronic and off label use. They scare the heck out of me and are what prompted the surgeon discussions to begin with... Cath, I am glad you are not having any complications but scary indeed. Keep us posted on how you are doing. And great advise from the others, thank you Rich for being proactive about getting an article up on BMP. Fantastic idea.
  • Hello Ernurse,

    Thanks for the link. That may be a nice warning, and a proper alert to doctors, HOWEVER, is that all they are doing? Is FDA getting their butts in gear and taking the doctors who went "off-label" to court? Back in the old days FDA sure the heck would have.

  • Hello Melissa,

    "I've followed the articles in the WSJ about the lawsuits against Medtronic and off label use." Okay, what is WSJ? I(we) need to read the articles you have read to be better informed.

    "Don't Be So Quick To Trust" - SUPERB words of wisdom!!!!

    Thank you for your kind words. I have sent an E-mail to SH as a first step.

  • WSJ - Wall Street Journal. Apologies for the acronym. I live with a finance guy.

    The first article I saw was in reference to the on label / off label use and the whistleblowing by former Medtronic employees. Here is an article with reference to it, its not still available on WSJ online that I can find:

    This is interesting: "While doctors are permitted to use approved medical devices in any way they see fit, it is illegal for manufactures like Medtronic to actively promote such uses." In other words, they CAN go off label... legally it would seem...

    The second article relating to cervical spine and the wrongful death lawsuit is in this article:
  • Hello, many of us have bmp used off-label. I had it as well in my posterior fusion, both TLIF and posteriorlateral application. I knew my surgeon was going to use it, but at the time I didn't realize it was off label use. The only approved use of bmp is with the Infuse/LT cage system used in ALIF.

    Doctors use off label drugs, implants, etc. all the time. By all means they should make us aware ahead of time, but I think it is somewhat the norm. How many have had BMP in a TLIF or PLIF? That is off-label use. Or how many have had a different type of cage besides the LT-cage used with BMP whether ALIF, TLIF, or PLIF? That would also be considered off-lable use. The only approved use was based on the studies performed with Infuse/LT cage system in ALIF. So I would bet most of us BMP Spineys had off label use.

    My surgeon has been using BMP since 2003, and I am sure he considers the way he uses it standard, you know, not any off the wall unusual application. Perhaps that is why he didn't make a point to mention it is off label use. Whether this is right or not is controversial. I do trust him completely, so I am not angry or anything and would have had the surgery even if I knew.

    A big off-label area is medications. They are commonly used for other things than the original studies were done for. Lyrica for example is approved for use in seizures, fibromyalgia, diabetic neuropathy, and pain from shingles. So when a Spiney takes it for radiculopathy, it is being used off label. This is so common many people have no clue that the med they are taking was never studied for use in their condition.

    I think if these drugs and treatments end with a successful outcome, then no one will complain. But, when something goes wrong, these docs better watch out. Just my 2 cents.

    >:D< Cali-Sue

  • Thanks Cali-Sue - very true.

    The common thread in what I have been reading is issues with BMP and cervical spine fusion. It is clearly something that can be used with success as people here are proof :)))

    Cath's original point was that her doc noted in her paperwork that she understood that BMP was something she would have in her surgery and that she understood the off label use, but the reality is that it wasn't explained to her. I think its about communication with your surgeon as to when you are going off label (speaking as someone taking 2 anti-seizure meds for nerve pain, like most of you!) So what I've been reading about, what Rich was asking about, is exactly what you mention - when it goes wrong (in this case, with BMP).

  • Thanks for contacting them. I think it would be good to also include legitimate (ok, probably not the best word for this) use of BMP for lumbar ALIF, etc.

    Yeah, at first it really bugged me to how my surgeon just whisked in and out, but his PA is a awsome. She's been my main contact and spends as much time as I need answering questions, etc.

    I don't think I'd say "most" docs still that they're a God, maybe only half. :)

    Take care RichT and let me know what happens with the SH/BMP stuff.

  • ...I was most looking forward to your comments on this. It was your response on my last BMP post that said, in capital letters, CANNOT be used in c-spine and made me freak out over my Operation Report. :))(
  • Hello Cath and Melissa,

    I received a very positive reply back from SH regarding having a surgeon write an article about "off-label", especially regarding the BMP issue.

    I'll keep you updated.

  • You're a mover and a shaker! :P

    I look forward to the update.
  • Hello Cath,

    AHHHhhh thanks for your nice words and SH gets at least half the credit. I really needed that. I've been off of my Voltaren for several days now and the ole arthritis has really kicked in. The reason for no Voltaren is because I'm having an ESI this afternoon.

    Of course I will keep you and everyone uopdated.

    By the way, there is some very good information on the Virginia Spine Institute web site regarding the various "types" of BMP. Good info. If you need the link and "how to get there" send me a PM.

  • RichT, I'm glad I could make you smile. :D

    I'm sorry about the arthritis - it's a b---h, isn't it?

    I just wanted to say good luck on your ESI. I'll look up the Virginia Spine Institute's web page. You just sit back and wrap your sore hands around a cup of hot chocolate until you have to go to your appointment.

    Cath >:D<
  • Hello Cath,

    I have a bit of time before I leave for my ESI, so thought I'd give a bit of "guidance". Below is the link


    Okay, next go to the following link


    Click on Education. Then click on Jounal of the SRF Fall 2008. Scroll WAY DOWN to Research Notes "Bone Morphogenetic Proteins by Marcus M. Martin, Ph.D.

    Cath, I think you and others will find both of these links very informative regarding BMP.

    See you later.


    P.S. - Yep, its a b--h. lol
  • Hello Cath,

    All went well with the ESI. Only bummer is that my PM Doc is moving 1400 miles away. Man, that's a long way to go for an ESI.

    The institute where I go had better find one heck of a good doc to fill Dr K's shoes.

  • If you start walking now you should be there by Spring.
  • Hello Lo,

    Oh did you ever break me up on that one. THANKS!!!!

    I've already told my wife that if the institute does not find a doc who can fill Dr. K's shoes, I'm off flying like a bird. (I'd wear out too many shoes walking. LOL)

    Have a FANTASTIC Day Bright Eyes!!!

  • I have just recently learned that my Dr. did NOT use the cage approved for this procedure and I also had TLIF- I was not aware that the FDA didn't approve that surgery and I am beyond worried about our FDA. They are not looking out for us. I have not gone one day without pain medicine and just recently had a new MRI just to get steroid injections? I asked my Dr. how the cage looked and he said he never used the cage- grrrrr. Now they are saying that a study showed a high increase for cancer and autoimmune disorders.
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