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Bone Morphogenetic Protien (BMP) vs Graphs

AnonymousUserAAnonymousUser Posts: 49,900
edited 06/11/2012 - 8:23 AM in Back Surgery and Neck Surgery
I am faced with a dilemma that someone may have an opnion or experience with and could give me some feed back on.

I was diagnosed last month by a NS with cervical spinal stenosis at several levels, the worst being at the C6-7 level. He advised me to have anterior cervical fusion surgery soon and listed my condition as critical. I do not have faith in this NS since I learned later that he has been disciplined twice in other states. I have tried to find another NS or Ortho/Spine Dr to get a second opinion. After locating some other Dr's and scheduling appointments, I have learned that they use Bone Morphogenetic Protien (BMP) for fusion. After more reasearch, I have learned that the Dr's that I have selected are being sued by whisleblowers for off-label use of BMP. It has been discovered to cause life threatening problems, post-op. Several articles have been written by the Wall Street Jounal ref this problem. The Dr's being sued have alledgedly received large payments from the company that produces or sells BMP. Irregardless of the correctness of this report, I do not want to take on any additional risk by using this product in surgery. Cervical fusion is risky enough with conventional procedures. The use of BMP is suppose to stimulate bone growth and lessen the recovery time.

Has anyone had any experience with BMP? If so, what have been your results.

What to do?
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Comments

  • I Have done alot of reading on the BMP lately, i was researching for someone else. I did read some in the wall street journal, If I were you I would keep looking for a diff. N.S. that you have faith in.
    what state are you in? PM me if you would.. patsy
  • hiya delta.....i see patsy has ladybug has posted...........she actually did some research for me[thankyou dear patsy!]..i have sent u a pm ok.........there does seem to be alot of people talking about this bmp stuff.........if i can get a surgeon to take it out i will but i have to find the money first.... :))( :))(
  • My surgeon used graffs-I am doing fantastic! HE also used "bone putty" (according to the OR report). Anyone know what that is? Is that BMP?
  • Hi Shay, I just got my op report yesterday. I had my own bone, BMP(Infuse), and something called Connexus which is allograph, human demeneralized bone. I have heard it referred to as bone putty in some of the articles I read. Perhaps it is similar to what you have. Creepy that it comes from cadaver, but it is superprocessed and sterilized etc. My surgeon just fluffed off my concern saying, well it is cadaver origin, but it is sooo processed, not really. I'll post the link, Sue

    http://www.isotis.com/prod_accell_connexus.php
  • Yesterday, I was just researching the INFUSE product used in my L4-5 fusion and I read several articles about this controversy with using it for C-spine as it is not approved for use that way. Very scarey reactions they are seeing with swelling and airway problems requiring tracheostomy. I would think it best to find a surgeon who will used approved products for cervical surgery. Rather deal with a hip donner site than a trach anyday. Goodluck, Sue
  • I'm just 5 weeks post-op so don't have any experience to relate right now. My surgeon used BMP and autogenous bone harvested from the partial laminectomy that was part of my procedure. He did not take any bone from my hip.

    I have been reading some scary stories about BMP, but I still trust my surgeon's decision about what he did, and that he did the best thing for me. He has been a spinal surgeon for 28 years an and I have no reason to doubt him, as my overall surgical and post-op experience has been much better than expected.

    Sure, I could still have future complications, but I have no reason to worry about such things right now. I'm maintaining my positive attitude.

    Delta, if you are extremely concerned about this, you have every right to tell your surgeon you prefer not to use BMP, or that if you will allow it, you don't want them to use it off-label. They should honor your request. If not, I would find another surgeon.

    My surgeon invented a facet bolt for use in 1 or 2 level fusions and told me he recommended them for me (they are new, approved by the FDA in 2006). However, he also told me that if I preferred that he use screws and rods, he could do that, too.

    He was willing to use whatever hardware I was most comfortable with. He even told me he recently had a patient who had agreed to the facet bolts, but changed their mind the morning of surgery. He had not problem with that and used screws and rods for that patient. I did allow him to use the facet bolts, but was very pleased that he gave me the option. I became very comfortable with my surgeon since he is obviously completely open to working within his patients' comfort levels.
  • Delta, I had the BMP with my fusion. The ortho used the bone from the laminectomy and the BMP together.
    I had L3-S1 done.

    At about 8 weeks or so I was getting more pain after coming off my meds and had a CT scanat 12 weeks. The ortho could see the fusion starting but he also said I had what is called 'osteolysis' which is where the bone ajoining the fusion and the BMP 'softens" a bit while the fusion is taking.

    It sounded scary but is actually a good sign as it means that the fusion is occuring and I just had to take a few steps back and do a bit less while my back was more fragile.

    I know there are some scary stories about BMP but then again there are scary stories about anything if you look for them.

    I would be inclined to ask your Dr what his succes rate is with BMP.

    Blessings Sara O:)

  • HI, I'm just curios, and i might be wrong but the BMP grows right? what stops it from growing when its work is done? I have been reading some on the BMP trying to understand it better. but Im just getting more confused. what if it keeps growing where it shouldn't be growing?
    sorry if this sounds like a st-p-d ? but i cant think of no other way to ask? patsy







  • Thanks Cali-I do not think that the bone putty that the report speaks of is processed cadaver bone-simply because "donor bone from a bone bank" is also listed as something they used. So it says-donor bone,bone from spine, bone from hip, and bone putty.
  • Thanks to all who have responded to my post on BMP.

    After researching BMP and the risks associated with it, I have decided not to allow it to be used in my surgery. As I stated in my original post, I do not want to add any additional risk to my surgery. One of the most disturbing things that I have learned in addition to the risks, is that some DR's or "Key Opinion Leaders" are receiving large consulting fees for promoting the use of BMP, which in my judgement is unethical. Just as in polictics, we do not trust anyone that receivies money from someone that they are supporting legislation for.

    Here is what I have learned about BMP. It is alledged that Infuse Bone Graft has been illegally marketed for uses that were not approved by regulators. It is now linked to life-threatening complications when used in an unauthorized way. Complications include difficulty in swalloing and breathing and can require tracheotomies and additional surgeries to repair. So far the FDA has received reports of 38 adverse events over a four year period. It is illegaly to use BMP in an off-label manner, meaning, used in a way that was not approved by the FDA. Anterior Cervical Fusion is an off-label procedure, along with others. In some institutions, BMP is no longer authorized for use because of the risks.

    The important issue here is that patients should make an educated and informed decision as to the procedure to be used in their surgery. Ask your Dr if they are paid consultants or have any financial connection to the company that maufactors the devise or product they are using and do your own research regarding the devise or product.

    As I said earlier, I do not want to take any andditional risk with my surgery. The surgery itself is risky enough with conventional methods. I also do not want to use a Dr who has finacial connections to the companies that manufactor the product or devise they use, that to me seems like a conflict of iterest.

    If you are interested in learning more about BMP, google "google news", Infuse Bone Graft, or Bone
    Morphogenetic Protein (BMP).

    Make an informed decision!
  • My Neurosurgeon told me that BMP in cervical fusions is NOT FDA approved. And for a reason. She said ANY BMP in the cervical area is too much. She said it's partly because the disc spaces in the cervical area are much, much smaller than in the lumbar area. That's as far as we went on that... I only asked her because I heard of people having reactions to it.

    I would definitely look for a surgeon who isn't trying to use something off label for your surgery. You shouldn't have to pay for the misjudgments of a doctor. There has to be one out there who will use grafts... I wish you the best!
  • Hi guys, i have had the bmp stuff used in my fusion from l4 to s1, do yous think if it has overgrown like a surgeon told me that it would effect my breathing ..even if not used in the cervical.............delta has anyone heard of complications with it used in lumbar fusions.........it was used on my tranverse processes.im thinking of getting it removed but i too am wondering if it will just grow back...........all this is a nightmare dealing with it all
  • Everything I read, the breathing problems were related to swelling in the cervical area. I just got my op report Friday and my surgeon used the infuse bmp in my cage and also across my transverse processes combined with bone autographs and connexus. I watched a PLIF online that did this exactly as well. Yep this is a scarey thing, worrying about bone overgrowth as I know a few Spineys have mentioned having. My new pain down right leg last week got me thinking about this and is why I went and got the op report. I am just gonna try to think positive and go from there, as it is already done, so hopefully will be okay. I think the probem is if the BMP moves around and gets away from the location they wanted it to be. I don't understand how it stays where they put it. Even the auto. bone, what keeps it from drifting around out of position. I am going to have to ask my surgeon. Good luck all with BMP, Sue
  • cali sue with me having scoloisis.it swhere u have strons side that pulls the weak side.u think that may have pulled the bmp stuff around and perhaphs thata where my problems are
  • My surgeon didnt use cages or anything, he didnt take out my discs, he just put in that bmp stuff so there would be nothing to stop it from moving about would there?
  • I don't know what keeps it in place. I am going to ask my surgeon next week. I basically had 2 types of fusion, the interbody fusion with cage, bmp, connexus, and a posteriorlateral gutter fusion with bmp, connexus, and autograph across the transverse processes. This second type is the way they used to do it before interbody fusion existed. I really didn't understand that I'd be getting this second part, or if I did I had forgotten since my initial consult was in March. Anywho, I trust my surgeon, and it is too late to worry now. Hopefully it grows where needed and nowhere else. That is what I am praying for. Good-luck, Sue
  • All this talk is making me a little on the worried side. My NS said she puts the BMP inside the cages, and screws those in, and then will just put the screws and rods in through the back... She didn't say anything about autograft or allograft. Sooo, I dunno. I guess that will be another thing I'm going to have to ask about on Thursday.
  • The three Neurosurgeons in the practice have never had a single issue with BMP, no reactions, nothing. They only use it in the lumbar region, though.. And explained to me exactly why it cannot be used in the cervical. Made sense, but I don't remember the details. Lol. My memory sucks!
  • when the Surgeon uses the BMP it is the amount of BMP used that creates the growth.
    If that were the case it could be that the proportion of BMP mixed with other 'ingredients' allograft etc that creates the fusion without excess bone growth.
    Just supposition here and I will be interesed in hearing what your Surgeon says Cali-Sue. Like you I had BMP mixed in but it is done now and no point worring about what may not be a problem.
    I know my Doc is head of research at one of our biggest hospitals and he did a lot of research on BMP and presented a paper on it just before my surgery.
    Oh and it is illegal for Drs here to use products or be sponsored by med companies unless it is a drug/med trial and the patient is informed.

    Sara O:)
  • Well, I just have to say that I am amazed at the interest in this post and the replies. I too have had several surgeries and all used bmp of some sort. Here is a link that you all may find interesting. It is of the FDA meeting in 2002 about this very subject...
    http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3828t1.htm

    Now, the thing is this; there are 3 BMP's (i think): there is BMP1, rhbmp2, and bmp7. I think that no.7 is the puddy. I have seen many different articles about all of these. What I do not understand is which one or ones are causing the problems and which ones are not? Also, if you go to that link and read (it is very lengthy but informative) it does say that one of the BMP's is FDA approved for use only with a certain 'cage' and yes, it is for a certain amount of bmp to be used in the cage. I have seen that some Dr.s use more bmp thinking it will work better but that does not seem to be the case. There have been several studies on BMP. I know it can work in some cases and not in others. If not used with the proper cage, it may just disappear and no bone form. (so i've read). I am having a different problem myself. My first fusion was a Gill decompression and transverse process fusion using BMP, my own bone and bone from a bone bank as well. My surgical notes suck from the dr. and don't state what BMP was used nor how it was prepared to place on the posterolateral part of the spine. I don't know if he used sponges to hold the BMP which I know now is not FDA approved or if he used the BMP puddy and mixed it with the crushed bone. When doing a posterolateral fusion PLF, the muscles are what hold the graft in place. It is also known as a posterolateral gutter fusion. The muscles lay in those gutters and are pried (sp) away with certain tools and the graft is laid inside the gutter then the muscle is put back in place to lay over the graft. If using sponges with bmp to lay into the posterolateral part of the spine to do a posterolateral fusion, the muscles will squeeze the bmp out of the sponges (so Ive read) and the fusion will most likely fail. I did grow a full bone on both sides but the bone did not connect at the top and bottom to attach to the vertebrae. I know that at some point there was lucency in my xrays/films and supposedly this is supposed to happen at some point while it is doing its job to form a solid bone. There are so many contridictions about this that it is confusing. Unfortunately I cannot go more into detail of all the surgeries Ive had done. I'll just leave it at that. I will say that i've learned a lot in the past several years about doctors and spine surgeries. I will tell you this..in hopes that noone else is scammed by thier dr... if you want to know the truth about your doctor, just ask for copies of the doctors notes from every visit you've had with ur dr. and see if they match what was said. Then u will know whether u can trust ur Dr. or not. Enough said. I will let u all know what else i can find on bmp and would appreciate u all to do the same for me. If an xray shows lucency early but bone is formed later, did ur body absorb the graft or was it just going thru a formation stage? If ur body does absorb the graft, will there be any bone at all? or very little or what? Does lucency on films mean there is no fusion there or can it just not see it because its too soft and not a solid bone yet?

    Hope everyone recovers well and goes on to live fully functional lives.. Unfortunately that didn't happen to me. I now suffer from FBSS and am permanently disabled. I do not wish this on anyone and I pray that all of u will heal nicely. I felt I was too young to be disabled... since age 36. Best of luck 2 u all.
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