The use of BMP product?

[Doreen1]

Lenke told me he uses BMP as it was meant to be used and explained to me there have been issues with off-label use in the cervical areas. I would never allow a surgeon to use a product on me in an illegal/unethical manner.

Warmly,
Doreen

[leahdragonfly]

I think the original use was for anterior (or TLIF or XLIF, anything with a cage) lumbar interbody fusions in association with a cage. The BMP came in a sponge.

[titaniumed]

Bone morphogenetic protein-2 (BMP-2) (Infuse) has been approved for use in anterior lumbar fusion in conjunction with an LT cage. However, off-label use is seen with anterior cervical fusion, posterior lumbar interbody fusion (PLIF), and transforaminal lumbar interbody fusion (TLIF). The Federal Food and Drug Administration trial of BMP-2 in a PLIF application was halted because of a high incidence of ectopic bone forming in the neural canal (75%). The authors did not find a correlation between ectopic bone and increased leg pain. They concluded that the ectopic bone was a radiographic phenomenon and not associated with clinical findings. Complications using BMP in the cervical spine have been reported. Heretofore, there has not been a similar warning voiced for use of BMP in a lumbar PLIF or TLIF.

http://www.thespinejournalonline.com...268-9/abstract

Ed

[Confusedmom]

Based on Doreen, myself, and I think Karen & Pam, I'm pretty sure Lenke uses BMP routinely in TLIFs. I don't think the cancer risk is dependent on where it is used. The problem with cervical use, as I understand it, is that if more bone forms than expected, it can interfere with things in your neck (like windpipe and nerves!). The implication of the Stanford study is that BMP might somehow activate cells in your body to proliferate--useful in bone formation, but a problem for cancer. I was also aware of this before my surgery and spoke to Lenke about it. His take was that it's unlikely we will know in our lifetimes whether there is a link. Fused patients will get cancer, as will not fused patients. It's the second biggest killer after heart disease. But for all of us severe scolis, BMP definitely CAN help. So, it's a risk-reward thing, and I chose to take it.

Evelyn

[titaniumed]

It looks as if surgeons can do “off label” surgeries at their discretion. I wondered about this. The FDA will raise that flag when a problem arises, but its not a stop sign, it’s a warning. Surgeons that do off label surgeries need to notify patients of the risk and the facts. Surgeons that use BMP need to be adept or knowledgeable in its use. You just don’t slap this stuff on.

Evelyn, I agree with you totally on the cancer issue and the benefits of BMP for those that really need it. The amount of BMP usage in surgeries now is quite high, and the amount of complications is low. Its unfortunate that the people that suffered, had this happen.

Ed

[KathK]

Hi,

I have been following this thread with interest! Here's what I find confusing:

1. Linda seems to indicate that the use of BMP-2 in all lumbar fusions is okay - I read "okay" to mean NOT off-label
2. The literature that I have read states that all uses of BMP-2 OTHER THAN in a cage are off-label

Can someone please clarify that for me exactly what is the on-label use of BMP-2? I think that the list of on-label uses be smaller than the list of off-label uses (smiles).

FYI...I just read my operative summary and 12 mg of BMP was used at my PLIF site (L4-L5). In addition, BMP soaked sponges were placed from T9-T10 all the way down to L5-S1. I'm guessing that this is the standard practice at WashU. I am 2 years post-op and feeling fine with no indications of a non-fusion (although we never know 100%).

Kathy

[Confusedmom]

I looked this up a couple of years ago, so I don't remember the exact details. But I believe Ed or Linda or whoever said it's approved only for anterior lumbar usage is right. HOWEVER, it is my understanding that "off label" usage of approved drugs and biotech products is standard throughout medicine. Once a product has been vetted in one area, it's presumed safe in other areas. I was a health care reporter for 10 years, and I can tell you this is definitely the case for many heart and cancer drugs. So, just because something is used "off label" doesn't mean the doctor is unethical or experimenting. It's often a matter of timing--I.e. there's an FDA application for the use, but it hasn't been approved yet. Or in some cases, there might not be a big enough patient population to test all possible uses. At any rate, reputable doctors, like Dr. Lenke, don't use these things in a way that is prohibited. And in fact, even the insurance companies are aware they use it off label. So, if your insurer is covering you for BMP up and down your spine (mine did), they probably are not expecting you to come down with cancer in the next couple of years because of it. (Odd to think of something my insurance company did as reassuring for once!)

[titaniumed]

Evelyn

Good response...Lets keep this one going. I found this article about FDA regulatory status and informed consent. It answers many of our questions.

Canterbury v. Spence (1972)—The plaintiff was seriously injured after spinal surgery for a herniated disk. The surgeon had not discussed the risk of paralysis with the patient, rationalizing his decision on the basis of minimal risk and concern that discussion of paralysis would needlessly provoke anxiety that might contribute to a dangerous postponement of a needed operation. The court disagreed; its opinion said that “true consent to what happens to one's self is the informed exercise of a choice, and that entails an opportunity to evaluate knowledgeably the options available and the risks attendant upon each…. The context in which the duty of risk-disclosure arises is invariably the occasion for decision as to whether a particular treatment procedure is to be undertaken. …it is the prerogative of the patient, not the physician, to determine for himself the direction in which his interests seem to lie.”

http://www.aaos.org/news/aaosnow/may12/managing6.asp

Ed

[LindaRacine]

In this week's issue of Orthopedics This Week, it is reported that there appears to be no increase in cancer risk with BMP. Paul Anderson, MD, presented a talk at NASS earlier this month. They looked at about 468,000 Medicare patients who had spinal fusions between 2005 and 2009. The BMP-2 group actually had fewer cancers than the non BMP-2 group: "We found that exposure to BMP not only was not associated with increased cancer but that the opposite was true with a relative risk reduction in the BMP group of 6.2%."

[JenniferG]

Thanks Linda. That's good to know.

[titaniumed]

Fewer cancers! Well I like that. Linda, you made my day. (I’m smiling now!)

This thread has answered a few questions.

Ed