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Spine fusion and BMPs

Cath111CCath111 Posts: 3,702
edited 06/11/2012 - 8:26 AM in Back Surgery and Neck Surgery
I've been reading about Bone Morphogenetic Protein (BMP) and was wondering if any of you know if your surgeon used BMP to enhance your fusion or know of someone whose surgeon did?

From what I've been reading, BMP is pretty exciting stuff. BMP is a genetically produced protein that has the ability to stimulate a patient's own cells to make more bone. It also eliminates the need for an autograft (using your own bone), shortens the hospital stay, and lessens post-surgical pain.

In a 1997 clinical trial, BMP was used for the first time in patients undergoing spinal fusion and in all 11 patients successful fusion was achieved within 6 months from the time of surgery. In fact, 10 of the 11 patients achieved their fusions within 3 months of surgery.

In December 2001, doctors at the New Hampshire Spine Institute reported on a series of 22 patients who had undergone lumbar spinal fusion using BMP (specifically, rhBMP-2) through a laparoscopic approach. This research was done as part of a larger study sanctioned by the FDA. The average hospital stay was only 1 day, shorter than for any other reported fusion procedure. Of the 21 patients who completed the study, all of them reported improvement in back pain, leg pain and function. They all achieved a solid fusion by 6 months and all of them were able to return to work. This was the first study on spinal fusion that demonstrated a 100% success rate for both clinical and radiographic outcome.

According to SpineUniverse, with this kind of "wonder-protein", it is entirely likely that spinal fusions will soon be possible as an outpatient procedure.

BMP has received clearance from the FDA for specific uses. According to the North American Spine Society, the FDA has approved the use of BMPs for anterior spinal fusion in the lumbar spine. I don't know how old this information is, so perhaps it has been approved for cervical fusion by now.

I'm going to do some more research, but isn't it encouraging that someday BMPs may be the standard for fusion procedures, reducing post-surgical pain and improving the effectiveness of spinal surgeries? 8>
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Comments

  • Hello Cath,

    Glad you are "moving forward" since your surgery.

    The lead surgeon at the spine institute where I go thinks very highly of BMP. Send me a PM and I'll give you their web site which contains excellent info on BMP and other new procedures and devices. There is also a spinal research foundation associated with the institute.

    At this point in time ESIs are working for me. Next Thursday I go in for another injection after a bit more than 4 months since the last injection.

    Take care, and may 2009 be all you hope it will be.

    RichT

  • On December 10, I had a two level anterior fusion of L4-S1 with instrumentation (posterior). My neurosurgeon used interbody cages with BMP. He told me this has been his standard for this type of surgery for years. In some ways it seems a little surreal that there is such a magic substance as BMP. I am certainly glad to have been able to avoid the bone harvesting procedure that some go through. I am not sure however that I would say my surgical stay was shorter (5 days) or pain less than other fusion procedures. I am very hopeful that BMP will be the magic glue that holds my vertebrae together strongly for years to come.

  • It's funny that I just discovered this and you both know about it. Geez, I'm out of touch.

    RichT, yes, I'm moving forward, slowly and painfully, but I'm moving forward. Each day is one step closer to that magical day when I don't have any more pain and don't even think about my derned neck. I'm glad the ESI's are working for you. If you don't have to be cut open, that's the best thing. I'll PM you for the info. The person who referred me to my surgeon (who I just love) told me that he added something to the donor bone, but I don't remember what he said it was and forgot to ask my surgeon. I'll ask him at my next appt. Jan 21.

    Susan, wow, the standard for years? I'm very interested to see how you progress in your healing. I'll keep my fingers crossed for ya.

    You both have a great new year and here's to a pain-free 2009!
  • My surgeon used BMP for my fusion. At my 3 month post-op appointment, there was no clear sign of fusion yet in the x-rays, but my surgeon was still pleased with my progress.

    I don't think it shortened my hospital stay (surgery Monday AM, home Wednesday afternoon), which seems to be consistent with other non-BMP patients. I don't know if my pain level was less because BMP was used. My actual surgery was shorter (1.5 hours) because my surgeon used facet bolts instead of rods and screws.

    It seems that BMP can be a very good thing, if used correctly by a trained doctor. However, there are also BMP horror stories where the BMP overgrows the intended area and possibly grows bone on nerves. I think this primary happens when too much BMP is used, or BMP is otherwise misued. It also may happen when untrained doctors try to use it.
  • Holy cow,you sound like a drug rep for BMP! :)

    Seriously, BMP use is not to be taken lightly. In an ealier post, I posted the link to the FDA's website containing the package insert about BMP. You can go to the FDA's website and also read about physician's who have voluntarily reported complications from BMP.

    Whether from using too much, incorrectly applying it, or overpacking the cages, BMP has not caused me to fuse(18 months later) and has caused bone to grow on my nerve roots(I had a two level TLIF.) I attempted to cut off my leg at one point postop fusion because the pain was worse than preop. I was suicidal every day for months. Only the thought of what would happen to my children kept me from killing myself. The pain was horrible, even on max dose of Lyrica.

    On one side of my spine, the BMP induced bone growth had grown a complete boney tunnel completely comressing and flattening my nerve root. Having surgery next week on the other side and one thing will be to attack the bone growth on nerve root on that side, among other things.

    It did not shorten my hospital stay. I am not a smoker. I did not take NSAIDS. I exercised like a fiend. My postop leg pain was entirely GONE until 5 weeks postop when it began returning until it was worse than preop. This is typical of BMP induced bone growth on nerve roots. I have permanent damage now to the nerve in one leg because of this stuff. The surgeon I used for the fusion, well, he didn't believe me when I brought reseach to his attention about this possible complication. Apparently he also doesn't read the package inserts, either, since this is a well known complication. That surgeon is fellowship trained at a famous facility and is board certified.

    I went to a surgeon who had done research on BMP complications. He believed me, but thought I had bone fragments growing on my nerve roots. After surgery, he said he'd never seen BMP induced bone growth so bad before. This is the same good surgeon who is doing my 2nd clean up surgery next week. He does not use BMP.

    I am sure that properly applied, BMP can be beneficial for folks who are at risk for pseudoarthrosis(non-fusion.) However, no matter what I would never get BMP again even though I am not fused at 18 months postop.

    Return of postop leg pain at about 5 weeks which progresses in severity and does not lessen with decreased activity is one of the main symptoms of BMP induced bone growth on nerve roots.

    CANNOT be used in c-spine.

    http://www.fda.gov/cdrh/safety/070108-rhbmp.html

    I try to post every chance I get about BMP. Yeah, I know that everyone does not have complications with it, but what if you ARE that person and your surgeon tells you that you are overdoing it? That you just have to live with the return of leg pain? That you need a spinal cord stimulator when you actually have a mechanical obstruction? That you just need to see a psychologist and accept it? If I can help just one person, I want to try.

    If you are really interested, browse the FDA's website, you will find the package insert warning of this possible complication and also voluntarily reported adverse events from using BMP.




  • I'm 18 months post op using BMP and i'm so happy with it and my recovery. =D> I hope and pray that everyone is doing as well!

    Evelyn :H
    Had PLIF in 2008 and a Laminectomy. One level fusion, L4-L5.
  • I consulted four docs and they all use BMP. I wonder if it had to do with my specific problem--L5/S1. I believe they had problems with it cervically--but I have no clue what I'm talking about when it comes to some of this stuff--just guessing like most people. I've wondered at times why they didn't just put a cadaver bone in--I suppose if he had used a cadaver and the BMP, THEN the risk of overgrowth would have been present. There must be a reason why all these docs are using it. At this point in my recovery, I just have to hope.

    Chuck
  • Osteoporosis is a good reason to use BMP since osteoporosis puts you at risk for not fusing. If you are 18 months out and fused, then wonderful, those few minutes that BMP was active in your body helped stimulate bone growth in the right places.

    Cadaver bone has nothing to do with BMP complications. Just because a lot of doc use it doesn't mean it's a good thing. Lots of doctors used to use leeches to bleed people for every illness, didn't mean that was the right hting.

    Think about it-studies show it helps bone grow and surgeons want success. How does a surgeon measure success? Some might measure it by quality of life or return to work. But if a surgeon was asked, "What is your successful fusion rate?" his answer is probably based on how many of his patients fuse since that is the question. If BMP will help fusion, then they want it. It sounds like a wonder biological agent.

    Keep in mind recent scandals with one company who manufactures BMP products. Company was accused by whistleblowers of offering physicians incentives to use their products. I'm not saying doctors who use BMP are corrupt and accepted bribes, so don't start flaming. I'm just pointing out that when a new drug or biological passes FDA approval, many jump on the bandwagon and listen to the promotions from the medical companies. It IS documented in the FDA insert about the possible complications.

    My point is just to make people aware and to ask questions of their doctors. Get second opinions if your doc doesn't listen or you have complications or before you ever have surgery. Everyone has to make the right choice for themselves, I just want people to know what can happen to some of us. Like I said, if I can help even one person by sharing my story, I want to do it.

  • I just had surgery on Dec 11 and my surgeon will not do fusion with out it. First he doesnt have to use my bone from hip, less painful. It icrease the rate of fusion from 85% to 98%. He says nothing is 100 percent. He does say that his sucess rate is much better with it. It did not shorten my hospital stay or my pain. But I was never told that it would. I just have done alot of reading before my surgery and feel that anything that gives me that much better odds, why wouldnt you. He is an excellant surgeon and after 2 1/2 years and numerous doctors he is the first one that read my MRI and discovered that I had a sacral tumor. He even drove to Rochester Mn on Memorial Day Weekend to take my MRI to a former colleage at Mayo clinic to look at it becasue he was so concerned about it being cancer. I know of no other Drs that would have done that on their weekend off. So I completely trust him, he has gone over and above for me and I know he wouldnt do anything that wasnt to my benefit.
  • Agree with the others, do your homework. As with any other new medical anything, there are great stories and horror stories and everything in between. Its not approved by the FDA for anything other than lumbar, and I believe only ALIF but I may be out of date. The lawsuits I've read about against Medtronic were regarding "off label" usage (i.e. not FDA approved)

    It is not itself a bone matter that grows but rather a "matrix" that must be mixed with bone (your own or cadaver bone). I don't believe it stands on its own from what I understand from my surgeon and what I have read. But again, I'm no medical expert, don't take my word for it - do your homework ;))
  • Hello Everyone,

    WOW, what a fantastic sharing of experiences regarding BMP, both the good and the bad. This is a fine example of what a forum is all about.

    I hsve learned a lot in reading each of your posts. Your experiences, thoughts and advice.

    And thanks moderators in keeping the very valuable link which Ernurse provided.

    Happy New Year Everyone!!!

    RichT
  • Hello Ernurse,

    Thanks for the FDA link which you provided. Much appreciate.

    A question if I may - Have you informed the FDA about your adverse experience with BMP? And if so did you receive a response back from them?

    Take care. Many HUGS

    RichT
  • I am not a doctor but from other members' experiences with BMP it seems to have both positives and negatives. One of the main negatives being excess bone growth leading to significant pain issues all over again.

    Personally, I would be wary of it unless my surgeon felt that there was a specific need to use it. I don't think that there are wonder procedures, wonder drugs or wonder anything else yet to help us spine patients. However there are significant advances being made and BMP is certainly one. I think that it's like many things tho - horses for courses: Great for some cases but not necessarily suitable to all cases.

    I think that ernurse has made some good informed comments about BMP, particularly in regard to fusion success. Unfortunately, traditionally surgeons have rated the success of fusion surgery almost exclusively in regard to how well the bone has fused and NOT in regard to how well the patient is actually feeling (quality of life) after recovery from such surgery.
    Keep positive!

    Bruce

    ...an old timer here and ex-moderator

  • Actually, yes, I have informed the FDA of my adverse effect. I was contacted by a representative for more information and I am to contact them after this surgery next week that(among other things) is to remove bone growth from a nerve root on the opposite side from the first clean up surgery. That way I have a complete case to post.

    BTW-I had BMP-2, some surgeons are now using another version BMP-7.
  • I do think that surgeons sometimes give misleading information. Not on purpose, but because they don't understand what patients are asking. If you asked about successful fusion rate, the doctor might tell you 90%. Great, but how does the patient FEEL. I suspect some patients then think fusion surgery is a good option and then are surprised when it's not as good as it seemed it would be.
  • http://www.orthosupersite.com/view.asp?rID=31044

    “One of the more recent findings is this problem of radiculitis that does not seem to be caused by a mass effect or a mechanical pressure, but simply irritation of the nerve [root],” Sandhu said. While initial reports estimated a 20% incidence of the condition, recent research from investigators at the Rothman Institute reports up to a 23% rate of radiculitis when rhBMP-2 is used.


    Interesting study and worth looking at if you are considering fusion. Ask your doctor if the outcomes are the same at 2 years with and without BMP.



  • To BMP or not to BMP? That is the question????!!! I think the best we can do is find an experienced spine surgeon and discuss our options. The negative outcomes are very scarey. It was the first thing I thought of when I had a flare up at 5 weeks post-op. When I put on my BGS I think well, I hope I am not helping BMP to fuse around my nerves.

    So far I am doing okay with no sign of these complications. My surgeon has used BMP in hundreds of fusions since 2003 and says he has never had a patient with BMP overgrowth problems. He was very aware of the literature on the matter. He used it in my cage between L4-5 and also in the posterior-lateral fusion at this same level. He does not do iliac-crest autografts, says it is outdated. With my fusion he also used DBM (doner bone matrix). I think many of our surgeons are using BMP off label, as I only have seen literature about it being approved for use with the Infuse system with LT cage in ALIF. The BMP complications in cervical surgeries are very scarey.

    As for hospitalization length and recovery time, I think it is related to surgical technique rather than use or not of BMP. Minimally invasive, muscle damage, etc.

    Good-luck to everyone in their decisions and recoveries. >:D< Cali-Sue
  • Hello

    Bruce and Ernurse, you have raised a most important point - that doctors most likely rate success of fusion as to whether the bones do fuse, whereas most patients assume the bones will fuse and to them success means little or no pain after surgery and recovery. That certainly would be how I would look at the surgery as a patient.

    Cali-Sue - YES, it is VERY important to discuss options, AND also to have the surgeon spell out in detail all that she/he plans to do, or may have to do during surgery. Frankly I have yet to get that kind of communication exchange from any of the eight spinal surgeons I have been to.

    The more I read about fusion the more I hope I can stay away from it. To me there are just TOO many uncertainties. And the loss of motion concerns me greatly. With the good Lord willing I will stay away from the knife as long as I can, and in so doing hope the procedures and devices undergoing clinical study now will be at least somewhat superior to fusion. And yes, there is risk trying something new. As a retired researcher, to make advances requires one to take risks.

    Have a GREAT Day!!

    RichT
  • Im also dealing with a nightmare of failed two level fusion at L4,L5-S1. Along with no fusion at 22 months, the surgeon used BMP without my knowledge, now it's leaked at both levels and grown massive amounts of new bone. The overgrowth on the ct's look like heads of cauliflower, impeding the nerve roots at both levels. The only fix will be a complete revision. The new NS said the trickiest part of the procedure will be "shaving" the overgrowth off the nerve roots, without damage. Everybody needs to do some research on the complications of this stuff, before consenting.
  • Hello!
    I am post op Cervical Fusion of C-3-C7 with BMP and cages, screws and whatever else they could do for me on Oct. 23-08. It was quite simple, one night hospital stay, very little pain and outcome seems good so far. I'm not wild about my scar but I am 57 y/o. "Time to give it up."
    I also am post op as of Dec. 1st for Lumbar surgery, where they used BMP, cages, and complicated screws. L3-S1. They did the anterior approach where they entered thru my stomach and also my lower back.
    Well, I am here to tell you that I lost blood during surgery and got severly anemic. I had to be transfused after surgery. My potassium level got very low.My legs were shaking. I was so weak. My heart rate soared for unknown reasons, so I went to the Telemetry dept. for them to watch me. ( I went into hospital in excellent physical condition a 'spinner', hiker of mountains and race walker).
    They gave me the wrong IV's. They put me on Heparin- a blood thinner which I didn't need after being tranfused.(Thank God that was discovered.)
    They introduced me to solid foods way too soon and I got so sick with diahrea and stomach issues, I vomited as well. I went home to remain alive after 5 days. I got an intestinal obstruction and was vomiting and having loose stools for 2 weeks. They wanted me back in the hospital but my physician husband and my private doctor decided to take care of me from home. We were in fear of me catching a bacterial virus.Hospitals are so filthy.
    I am starting to feel normal. I walk about a half mile daily and have done so even during the obstruction where my belly was like a budda. My legs were edemic and I was bloated and just so sick.
    These are some post op issues I never thought I would have! The lumbar surgery was difficult because the stomach hurts when cut into but it wasn't That bad and the surgery was sucessful (that's the bottom line.)
    But, I was traumatized in this hospital. I felt so vulnerable and so sick post op. It has been one month exactly and I am just now getting my bowel situation and anemia under control. I was told anemia takes about 5-6 weeks to improve.I am on special vitamins and a nutritious diet.
    I wouldn't wish what I went through on anyone. Moral of my story is DON"T ADVANCE FROM LIQUID DIET TOO SOON. Stay on Jello, juices and broths even if you are starving. I didn't know any better and thought if I could eat solids, I would gain strength faster. No one explained to be about the bowel obstruction stuff. I was just the patient. Boy, am I glad I am back to almost my old self. With back brace on but no pain meds needed!
    Any questions, feel free to contact me.
  • I'm glad I didn't have that bad of an experience. I too had BPM used with my fusion. I've asked every radiologist who has looked at my films (regular x-ray, MRI and CT) to see if they can see any problems with hypergrowth. So far, the bone is staying right where it is supposed to be. But, I still have pain. I'm glad my doctor did use BMP mixed with my own bone (from the pedicles). I talked to a guy who had his bone graft from the hip and he said the hip pain was worse than the fusion pain.

    I also think any ALIF procedure does more trauma then the doctors realize. Just about everyone who has posted on here after an ALIF comments about the digestive issues they have afterwards. Unfortunatly in my case, it also led to some "male" issues.

    I hope things for you begin to look up soon!

    Keith
    Several Epidurals, L4-S1 360 ALIF, Numerous Facet Joint Injections, RFA x2
  • My own bone and some cadaver bone as well. I researched the use of BMP and weighed the pros and cons. I got my operating report and one sponge was used at each level. I was feeling pretty good about it, and still am but geez some of your posts here have scared me a bit!

    ernurse, thank you for the information you have provided. Horror movies, blood and gore, poverty and famine, I can handle. Your descriptions of possible complications is scarier than the boogey man! ;-)

    One Love,

    Stephanie
  • This is a very interesting thread. I am learning lots from reading it, and am counting my blessings that I haven't had any of these complications!

    I had a PLIF at L4-5 last January 7th, using a cage and BMP. My recovery has been uneventful. The BMP did what it was supposed to and has not grown more than needed. My doc doesn't believe in doing x-rays along the way to see if a patient is fusing unless there are issues...so I waited about 9 months and was fused at that time.

    Since it has been almost a year since my fusion, I think you can mark me down in the "success" column. I'm glad I didn't know about all of these problems. It would have been just one more thing I would have been worrying about during recovery. /:)
  • I have significant hernations at 4 levels and am looking for relief in other places rather than an almost total lumbar fusion. Only being 25, no doctor really wants to use that as an option but I am not finding any relief. I am open for any and all suggestions from anyone. I have my 2nd discogram scheduled for January 23 in hopes that I could try an iDET procedure. If anyone is familiar with that, I would like to hear about your experience.
  • My first fusion did not use any hardware, but did use BMP. It was a failed fusion. My 2nd fusion, 3rd surgery, I had full instrumentation with a 360 PLIF and BMP and fused beautifully. Surgeon almost gave me a bone growth stimulator as well (because of the first failed fusion), but decided not to in the end and it worked fine.

    Cheri
  • Hi all. I'm new here, but thanks for all the good reading about BMP! I'm having fusion surgery at L5-S1 (Grade II Spondy) on Feb. 4th, and I'm having the WORST time deciding whether to have the bone graft from my hip or use the InFuse product!! I'm a non-smoker in pretty good shape. My doc prefers to do the graft as it's the "gold standard," but I'm terrified of the pain that supposedly results from this! He said he'd use InFuse if I preferred to go that route, but I'm not so sure about that stuff either! Before I'd even asked the doc about alternatives to the graft, I talked to a guy who told me "whatever you do, don't use BMP...the jury's still out on it!" Then that's exactly what my doc suggested in place of the graft! I've been researching but I just can't find enough evidence to sway me one way or the other! HELP!
  • Hi there! I am also new to this site and looking for information concerning BMP. I haven't found too much to sway me either but this site does have a lot of info to take to your doctor so that you can ask questions as I will do. Spine universe has info too. Depending on if you are near Maryland, perhaps look at Johns Hopkins and the University of Maryland Medical Center. Good luck with your searches and if you find anything good, please pass it along to me! Thank you.
  • I had BMP for my second level PLIF.
    Fused me in 6 months but I had problems with the spacers. One slipped into my spinal canal. Was eventually found and removed 6 months later. Was reported to be "empty" so I don't know where the BMP all went???

    I scheduled for a CT soon. I am having ongoing nerve problems and my biggest fear is the bone overgrowth story, which is quite logical in my case and would make me laugh, since I seem to have beenlessed with all the more unusual complications. :))(

    But I do I wonder how the BMP can just dissappear. Any ideas?

    Interesting thread!
  • WELL i had BMP used with my interior fusion at two levels l4 an l5. With a pro disc / artificial disc at l3 at three months fusion was about half done at six months complete fusion WITH NO OVER GROWTH .I just had a myelogram last Thursday an went to see my neuro doc today everything looks great the reason i had the Mylo was to see if i had any fragments left in the back side of my back that my DR could not get from the front But my doc told me up front that this may need to be looked at . I still have some low back pain an burning in my buttocks an down my legs. But my doc set me up for another emg he thinks the reason for my existing pain is from work comp making me go to long before the would approve the pro disc i just wish i could of had three of the pro disc installed.I have never had any pain where the pro disc was placed .Then i ask him about what i have read about the BS i have read on her about BMP an i guess some people on here have had some problems but as for me it has been great my doc said that he has never had any problems with it BUT he has heard of some untrained DR'S using to much an having problems . Just like anything you will hear of some complications from about anything that is new MY point is don't let one or two bad occurrence's stop you from using it JUST MAKE SURE THAT YOUR DR HAS USED IT BEFOER AN NO ensure im not a salesman for the people that sale BMP
  • Where was all the info on BMP when I went in? And after while I was trying to figure out what had happened to me. LOL!

    If you read my signature, you will know that my dr. suspects I had a reaction to the BMP and 2 days after my surgery he went back in and removed the BMP from inside the spine.

    We never determined if my problems were a result of a BMP reaction or something else. All I know is after the second surgery the numbness stopped progressing and I started to do better.

    I am fusing at this point. I am doing very well I think too. I am still only half way through my 'year of recovery' though.

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