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BMP-Interesting Study

ernurseeernurse Posts: 790
edited 06/11/2012 - 8:30 AM in Back Surgery and Neck Surgery
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My take on the following article: MD's are using BMP less off-label in Medicare patients than in non-Medicare patients. Off-label would be for any spine surgery other than 1 level anterior fusion(it is approved for some oral surgeries and leg surgeries.) Why would this be considering the older population might be more at risk for osteoporosis and might need BMP more than younger folks? This is concerning folks at the famous Cleveland Clinic.

My opinion? The government, especially Joint Commission, audits Medicare patients' care more than others and has the power to yank a hosptial's Medicare funding. Therefore, docs are trying to mind their P's and Q's in this population. Just my take, and anyone who knows me knows that I think BMP is pretty much the equivalent of the devil's holy water(except in rare cases.)


Study: 17% off-label use of bone graft substitute in spine

Investigator says spine industry must take a critical look at off-label use of bone-fusion proteins.

1st on the web (January 7, 2009)

TORONTO — Investigators at the Cleveland Clinic quantified on- and off-label use of a recombinant human bone morphogenetic protein for spine fusion surgery in Medicare and non-Medicare patients, estimating the product’s sales at about three times greater in 2007 than in 2003.

During those years, they saw off-label use of Infuse (recombinant human bone morphogenetic protein-2, Medtronic) decrease in Medicare-aged patients but increase for non-Medicare patients, a trend that has investigators concerned.

“We estimated that the sales of Infuse went up over $760 million” from 2003 to 2007, Isador H. Lieberman, MD, FRCSC, said.

For the retrospective analysis, investigators sought to delineate on- and off-label usage trends for Infuse and explore how they were reflected in Medicare and non-Medicare patient populations, Lieberman said at the North American Spine Society 23rd Annual Meeting, here.

Estimates used

The study, which involved several different parameters and assumptions, estimated Infuse usage from Wall Street volume estimates and other information from the product’s manufacturer and databases.

To determine Infuse usage in the Medicare population, Lieberman and colleagues analyzed data derived from the Medicare Provider Analysis Review database (MedPAR). Actual sales data for Infuse was unavailable, Lieberman noted.

For sales, “The unit figure assumes a charge of $4,500 per unit of Infuse,” he said. “Some centers may have been paying less. Some centers may have been paying more for it. We also used the assumption the annual growth rate of lumbar fusion is about 9.5% per year,” he said.

Increased sales

According to Lieberman, overall Infuse sales in those 5 years rose substantially from $204 million to $763 million as projected from published information.

For the same period, overall sales in Medicare vs. non-Medicare populations increased as well, changing in the non-Medicare sector from $149 million to $681 million. Sales for the Medicare sector increased from $54 million to $79 million, although the percentage of total units sold decreased annually in the Medicare patient population, Lieberman pointed out.

Usage trends

For on- vs. off-label Infuse use as a percentage of total sales, investigators noted an increase in on-label use among the Medicare population from about 9,200 to about 13,000 units, or 7.9% of Infuse sales. Off-label use of Infuse also increased in that group, but the percentage of total sales actually went down from 6.5% to 2.5%, Lieberman said.

On-label non-Medicare Infuse usage rose to about 127,200 units in 2007 and off-label use increased to about 24,200 in 2007 or 14.3%. During the period analyzed, 17.3% of all Infuse usage was off-label, according to Lieberman.

“I think these data really emphasize we have to critically study the off-label use of bone biologics,” he said.

For more information:

* Isador H. Lieberman, MD, FRCSC, is the chairman of the Spine Care Center at Cleveland Clinic Florida. He can be reached at, 2950 Cleveland Clinic Blvd., Weston, FL 33331; 954-659-5630; e-mail: lieberi@ccf.org. He receives royalties from Stryker, DePuy, Axiomed, Crosstrees, Trans1, Mazor, Merlot OrthopediX, he owns stock in Axiomed, Crosstrees, Trans1, Mazor and Merlot OrthopediX stock, he is a paid consultant to Axiomed, Trans1, Mazor, Merlot OrthopediX and Kyphon and he receives research support from Trans1, Mazor, Kyphon, Medtronic and Orthovita.


* Mroz TE, Yamashita T, Lieberman IH. The on- and off-label use of rhBMP-2 (Infuse) in Medicare and non-Medicare patients. #79. Presented at the North American Spine Society 23rd Annual Meeting. Oct. 15-18, 2008. Toronto.


  • medical substance that should be pulled from the market until further research and quality control of the product can be established. how many people will be permantly scarred and lives destroyed before they realize this?
  • I have been curious WHY BMP is used over autologus bone grafts?

    Whats the benefit? I could understand diseased bone but most have some sort of healthy bone in the hip that is usable if not their own spines!
  • I think it is because BMP is easier and quicker for the surgeon to use. It does not involve a second surgery to harvest the bone, if there is not enough to use from the removed lamina, or whatever. So, assuming the BMP works as designed, it is an easier process for the patient and quicker for the surgeon. Maybe that means the surgeon can do one more surgery that day. :>

    BMP is designed to be used with cages so I imagine it is just an easier process to pack the little sponge impregnated with BMP into the cage than using bone from the iliac crest which would involve further preparation. And, finally statistics indicate that it has a slightly higher fusion rate than autograft.
  • Interesting but it seems it overgrows a lof of the time, spurs?
  • I had BMP in my cages and bone graft from my lamina. Bone grew very nicely on nerve root but fusion-none until more than 18 months later only partially on one side.

    I have heard that Medtronic claims that they have received approval from the FDA for further use in spinal surgery but have not yet seen what it is. BTW-the Medtronic whistleblower suit was dismissed(not sure if that is the right word) from court. Medtronic has agreed to disclose future monies given to physicians.
  • Personally, I found out well after my tlif surgery that BMP was used, so I tried to find out if that is "off-label", but nothing. Where can I find this info?

  • My surgeon used the bones removed during the laminectomies mixed with cadaver bone, he did not use BMP at all. I thought this was a good solution, as no second incision was necessary. At the time of surgery he also inserted a bone fusion simulator, consisting of a small battery pack )just under my skin) connected to the electrodes that were placed over the bone implants. I guess it worked, as I fused by five months (I had three-level fusion), and my recovery was remarkably easy.

  • If I could go back in time, I would insist on hip graft material(studies showing higher fusion rate with it and since I had fusion probs, well, go for the best!) and ask the surgeon about the implanted bone growth stimulator like Kin is talking about. To me, that sounds like a plan!
  • Yes, your BMP was used off-label. I stated in a recent post that Medtronics is claiming that they have recently(like this month) received approval for more spine uses of BMP. But, until now, the only FDA approved uses for rhBMP-2 for spines is for 1 level anterior fusions. It is approved for some oral surgeries and a type of leg surgery.


    This is a link to the company that sells BMP and their information on the product. Make sure you keep clicking the blue "next" box to read more. It will say it is approved for 1 level anterior fusions and also list the voluntary reporting by physicians of patients with adverse outcomes related to BMP.

    I signed a consent form for BMP for surgery but had no idea it was being used off-label on me. Many drugs and procedures are done off-label with no problems, and that's OK. It's when the surgeon does not do the proper follow up and deviates from the standard of care. If someone complains of leg symptoms within a short time(mine 5 weeks) that has returned after being pain free(or close to it) and BMP was used on or off-label, that surgeon is obligated to investigate the cause.

    I bumped a previous post of mine with links to the top of the Surgery Forum. I think that post even has the product nume in it for searching. m,You can go to the FDA's website and read the actual package insert for BMP that the surgeon sees every time he uses it. It includes a warning about growing on nerve roots. It also talks about how overpacking the cages can cause cage migration and non-fusion(pseudoarthrosis or pseudarthrosis.)

    Hope this gives you some info to help.

  • Thank you for the great info. I'm curious, was I supposed to "sign off" on the use of BMP, because I didn't that I recall, and I am curious if there are complications, if I DID or DIDN'T sign anything, is there recourse?

    I can't help but wonder if my new problems are because of the use of this product, but so far, I can't get the NS to do anything more than X-rays, and tell me that everything is in place. He doesn't seem to be concerned that I am having new problems, even though his nurse admitted that my "muscle spasms" (they are NOT muscle spasms, I'm SURE of it), have gone on longer than normal. Because the NS already discussed the fact that my recovery would be longer and harder than "normal", I think he is not giving it the attention it deserves.

    As for surgery, I was asked on the day of surgery several times if I knew what they were going to be doing, and each time I answered "a min. invasive. Transforaminal lumbar interbody fusion", I was never told I would be having any of the other things they did, and didn't know until I finally asked for the surgical notes. It's upsetting to know that the work on my back was unexpected to me, yet nobody ever said "oh, we had to do more than originally planned".....

  • No doubt BMP has its place and no doubt a lot of ppl have had success with it, but it does amaze me how widespread the off label use is, and there are a lot of sad stories out there.

    Health driven by $$$ again.
    Keep positive!


    ...an old timer here and ex-moderator

  • These surgeries are expensive enough. After $100,000 a surgery is not considered cost effective. Since fusions (at least mine) was upwards of $160,000 for the surgery alone, I would think they would go with whatever had the highest success rate without complications which seems to be autologus. Allografts are just bridges from what I've read.

  • My surgeon used off-label BMP in my surgery but I didn't know about it until I got my Surgery Report. In the report it stated that "...she was aware that we were going to use off-label BMP in her surgery and was aware of the risks."

    I had no idea that they were going to use it and had no idea what BMP even was. That was news to me.

    I assumed that I gave my approval somewhere in the presurgery paperwork. I was so terribly freaked out by my surgery I must have not read everything I was signing.

    In any case, because I trust my surgeon 100% I would've approved it and I've had no problems and am fusing as expected.

  • I had problems with mine (BMP filled cages) and I am now playing a waiting game to see if ongoing pain issues settle or not. I am now 14months post my big op and 7 months post revision for a slipped cage.

    I use more medication than before my original surgery ( 2 years ago) and mobility wise my problems have shifted.

    I do think the risks need to be fully discussed BUT then again, I was so desparate to rid the original pain problems I would have done anything and taken the risks knowing or not.

  • I checked all my paperwork last night, and found NOTHING about them planning on the use of BMP. I searched the web, trying to find out if this is illegal, but from what I can see, only use on cervical patients is illegal off-label use at this point. I am so scared that BMP is the cause of my problems now, but I don't know what my reaction to the surgeon should be if it is.... do I confront him with "why didn't you tell me you were going to use BMP", or do I just walk away and find another NS?
  • Unless patients seek several opinions, I don't think they are necessarily aware of what type of instrumentation the surgeon is planning on using. Usually, unless you ask, the surgeon will just talk in more general terms about what he will do, how long the recovery will be, when you can return to work, etc. Then you sign the consent papers prior to surgery,so I'm sure many people end up with BMP without knowing it.

    What kind of "odds" were you given that prevented you from having surgery previously? Was your fusion for spondylolisthesis? Do you know what grade it was prior to surgery? It may be that the nerve is recovering from the vertebrae being put back into alignment -- this would involve some stretching of the nerve as it gets used to the new positioning. I wouldn't jump to the conclusion that your pain is a result of the use of BMP. I just don't think that many patients are having problems with it when it is used in a lumbar fusion by a spinal surgeon that has been trained in its use.
  • I am in the same situation - I just found out two days ago that my surgeon used BMP she never told me. She told me that she uses part of the spine that she removes from me - but never mentioned that she would be mixing that with BMP - let me know if you find out anything
  • Thanks Dina, I will let you know, and wish you the best in finding your own answers.

    Gwennie: I was never TOLD I could not have surgery, in fact every NS I saw pushed it on me, but I couldn't stand the odds that I may have ended up in MORE pain. My life's love of rock concerts, racketball, and rollercoasters flashed before my eyes hearing those odds. As time went on, and I found that those things were slipping away anyway, and that I was risking permanent nerve damage, I took the plunge.

    Reading a lot of info on BMP, I am constantly seeing the words informed consent, that is why I brought that up, and since I didn't join this site until right after surgery, I was unaware of many of the things that could be used by NS to accomplish their goals, so I had no basis to ask questions. If I could do this over again, I would have done a lot more research than just Googling TLIF. Live and learn, right?

    I am not "jumping to conclusions" in any way, just doing the research now that I should have done 4 months ago. I want to be informed, and know what questions to ask when I see my NS next week. I've stated before how important all this is to me here: http://www.spine-health.com/forum/back-surgery-and-neck-surgery/tests-post-op-show-bone-growth

    and how bad it is here: http://www.spine-health.com/forum/lower-back-pain/hello-ogs-or-regular-members-i-have-a-question-posting-information-a-site

    I've written walls of posts, but so far, nobody has said with certainty that they've been through something like it. Again, just trying to figure out the right thing to ask the NS so I can get answers before it's too late.

  • I hope this thread inspires people who are pre-op or considering fusion surgery to ask their surgeon specific questions about how the fusion will be performed. I'm so glad these forums exist, that is how I knew to ask... my surgeon gave me the option of harvesting my own bone, he said it can be painful. Since the intended BMP usage for my ALIF was "on label" I decided to take the risk.

    Surgeons don't volunteer this info, its up to us to educate ourselves to figure out what questions to ask. Not ideal, but at least we can learn from each other.
  • You will see a lot of BMP side effect threads here as these will be the people most inclined to post vs. those with successes.

    Not saying thats a bad thing but don't think everyone who gets BMP has these side effects based off of people on this site.
  • Has anyone looked at the research they are doing regarding using stem cell to assist the fusion in lieu of BMP?

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