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gardenia
08-18-2012, 07:32 PM
http://www.publichealthwatchdog.com/medtronic-infuse-can-lead-to-increased-risk-of-cancer/
or
http://backpainreliefsecrets.com/back-surgery/cancer-risks-with-spinal-fusion-surgery/#comment-727

Medtronic Infuse Can Lead to Increased Risk of Cancer April 16, 2012

After my surgery was put 'on hold' 2 weeks ago, I am still in the dark as Dr Bridwell's office only says that they are trying to resolve this as this is his preferred way. I asked if the other doctors in their organization also used this BMP product and the answer was yes.

I do not know if this BMP is produced by one or more pharmaceutical company but likely not as it is a patented stuff.

I want to get this pain out of my life but certainly prefer to keep than swap with cancer.

Any thoughts ?

jrnyc
08-18-2012, 09:04 PM
this has been discussed before on this forum....i actually
saw an ad on TV of lawyers who were suing over the use of
the stuff....and wrote in forum to ask about it...
apparently the danger lies in it being used "off label"
for procedures it is not intended for...

if you do a search on forum, you can probably find the
previous thread and discussion...

jess

Confusedmom
08-18-2012, 10:36 PM
I gotta say, this scares me. I know Dr. Lenke used a bunch of BMP on me. However, I did ask him about this issue in advance. He said that if he or his wife had to have this surgery, he would use BMP. In many ways this surgery is one where you kind of have to do all your research, learn everything you can, then say your prayers and take the plunge. There are no guarantees.

LindaRacine
08-19-2012, 02:11 AM
Hi...

If you find the previous thread, you'll see that I mentioned that I knew about the BMP controversy before my January 2010 revision. I chose to let my surgeons use BMP, because I feel the reward of a much higher fusion rate outweighed the risk of complications. I think I'd make the same decision today. Fusing L5-S1 used to be a real crap-shoot. While there are still non-unions reported in complication studies, I think the rate is significantly smaller than it used to be Needing revision surgery because of a non-union isn't cancer, but it's also not without morbidity.

The jury is still out on the legal issues. Several things that one needs to know in terms of assessing the risk: 1) The cancer concern involved a product called Amplify, which uses BMP-2. I believe what most spine surgeons are using is NOT Amplify. 2) I haven't actually heard how many patients have developed cancer. For all we know, the number of cancer cases could have been 5 out of 500 (or 1%). If the actual rate is 5 times that, it would still only be 5%. 3) It's certainly possible that the Amplify product was used in smokers, as their risk of non-union is significant.

With all that said, the studies that are under the microscope were authored by surgeons who took many millions of dollars in consulting fees from Medtronic. We can't know their motivation, but it definitely looks a bit suspicious.

Regards,
Linda

Roxanne1979
08-19-2012, 11:48 AM
Hi, It is my understanding that Yale has been hired to conduct a review of BMP Infuse. Here are some interesting links:
http://medicine.yale.edu/core/projects/yodap/117257_YODA_Project_Bozic%20BMP%20Use%2002.06.12.p df
http://news.yale.edu/2011/12/05/yale-selects-two-research-centers-review-safety-bone-growth-product
http://www.medicalnewstoday.com/articles/232280.php
I have found revision surgery to be a tough decision, one that I have yet to make. For me it is a quality of life decision. My standing and walking times/distances are limited, and I'm only 53. My temporary fix was to hire someone to clean my house and use my standup time for walking. Even though Medtronics is paying Yale, I am interested in seeing the study. I believe I remember reading an article that said it was expected out later this year.

Linda also makes a good point about needing to consider the morbidity rate of revision surgery for non union if BMP is not used. Whenever one is using a new device or new medication long term consequences are unknown. You have to make your decision on the best current information that you have. If BMP Infuse is found to increase cancer risk, that is probably very important for people with other cancer risk factors to know.

Roxanne

gardenia
08-19-2012, 11:18 PM
Well, doing research as much as I've been doing for the past 2 weeks had brought me a huge cloud of depression to a point that I could not function well. I have to admit that I have my load to support the depression without having Dr Bridwell's added on-hold as he/they were going to deal with the insurance or whatever avenues they have to use as a large medical center.

I completely trusted his decisions before I left St Louis and I would go ahead and still do the surgery if he gets a green light. As to reseaching more and more is not healthy for me and I am not in a position to evaluate everyone's opinion or papers. I think that Dr Bridwell / Dr Lenke and associates are far well invested in the studies of this product and they will not risk their and their Universtiy's name/reputation in doing something that was questionable.

My problem is the waiting of 2 weeks is nothing when it involves written communication and all the paper trail that this will require (for them) but for me (as you have had to wait) it seems like I am in limbo waiting for a long long time.

It is hard to search and navigate this forum (at least for me) for forgive me if I was repeating a known concern that is very recent regarding the insurance coverage of one company.

Thank you so much, my friends.

gardenia

titaniumed
08-19-2012, 11:22 PM
I have been exposed to quite a bit through the years in my career, if anyone should have cancer it should be me. My usage of infuse was used in an FDA approved manner, anterior lumbar surgery. It’s the “off label” use that is causing most of the problems, mainly in the neck surgeries. I believe this “off label” use has slammed to a halt since Medtronic has informed all surgeons.

Now, I’m wondering which is more dangerous.... Dental Plaque or BMP?
http://www.drbicuspid.com/index.aspx?sec=sup&sub=orc&pag=dis&ItemID=310741

Its always something....brush your teeth! (smiley face)

It will be nice to see the results from Yale. Will we see the majority of the problems coming from non-scoli cervical applications? Off label use? How many scoli’s are in the lawsuits? Can we narrow this down?

With the element of risk involved, I must say I’m doing fine and past the 300% increased cancer risk mark of 3 years. I will be 5 years post in January with no scoli revision surgeries.

Ed

gardenia
08-20-2012, 11:06 AM
I guess people tend to remember or to grab onto the worse negative instead of taking the positive.

If they had said, non-cancer risk of 97% then it would seem a whole lot differently.

Roxanne1979
08-20-2012, 07:10 PM
Gardenia, I'm so sorry if my post was depressing, that was not my intent. After having doctors put a body cast on incorrectly, leave a sponge in me during surgery, and prescribe medication that was inappropriate for me I tend to go hog wild on research and double check everything they tell me.

I'm glad you have a doctor that you can trust and one who shows he is concerned about your safety. That alone gives you a big advantage.

Roxanne

Spring72
08-20-2012, 08:38 PM
To me the use of BMP in my surgery was a non issue.....I can't imagine going through this surgery only to face non union. From my understanding it is more of a risk to not use it. That being said, I have come to the conclusion that on the off chance I develop cancer in the future because of BMP.....I will surely be strong enough to fight it, after all I am made of some of the strongest metals on earth ;)

LindaRacine
08-20-2012, 11:29 PM
Ed...

BMP in the cervical spine is definitely off label. I hope that if anyone finds themselves in the situation where a surgeon os recommending that it be used in that fashion, they get at least one more opinion.

--Linda

titaniumed
08-21-2012, 01:19 AM
Yes. Correct.

I think if all surgeons are aware, and its used correctly, it’s a great benefit. So, for scolis, that means ALIF surgeries only, with DDD. Is this correct? So, PLIF’s, TLIF’s and XLIF’s are not approved for BMP usage.

This really narrows it down doesn’t it?

Ed

JenniferG
08-21-2012, 03:52 AM
Then the use of BMP in my surgery must have been off-label?

Doreen1
08-21-2012, 07:46 AM
Yes. Correct.

I think if all surgeons are aware, and its used correctly, it’s a great benefit. So, for scolis, that means ALIF surgeries only, with DDD. Is this correct? So, PLIF’s, TLIF’s and XLIF’s are not approved for BMP usage.

This really narrows it down doesn’t it?

Ed

Hi Ed,

I had TLIF by Lenke with BMP.

Warmly,
Doreen

jrnyc
08-21-2012, 02:34 PM
i thought it is used for posterior fusion....??????
also, what if discs are replaced with side incision...???

jess

Doreen1
08-21-2012, 03:38 PM
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
08-21-2012, 03:39 PM
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
08-21-2012, 09:29 PM
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/article/S1529-9430(07)00268-9/abstract

Ed

Confusedmom
08-21-2012, 10:46 PM
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
08-22-2012, 12:33 AM
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
08-22-2012, 10:28 AM
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
08-22-2012, 12:13 PM
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
08-22-2012, 08:46 PM
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
11-14-2012, 11:06 AM
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
11-14-2012, 01:44 PM
Thanks Linda. That's good to know.

titaniumed
11-14-2012, 07:14 PM
Fewer cancers! Well I like that. Linda, you made my day. (I’m smiling now!)

This thread has answered a few questions.

Ed