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Infuse bone graft

melto9mmelto9 Posts: 75
edited 06/11/2012 - 8:28 AM in Back Surgery and Neck Surgery
I have had the LT cage procedure with pedicle screws and INFUSE bone graft. If it had not been for these forums I would have thought my problems were just normal results of having a fusion. I kept wondering why I still have to take pain meds every day for over 2 years, since when I had a cervical fusion with bone out of my hip was a piece of cake.I have been reading about people who are having to have revisions because of too much bone growth and scar tissue. The FDA has not warned Dr.'s about using this in the lumbar ( only cervical),because people are just now realizing that's their problem. If it's not reported to the FDA then they have no way of knowing about it. Please, anyone who is still having pain- get checked out with a spect ct scan and report it to the FDA if you find too much bone growth etc.When they use your own bone this cannot happen. I worry about all the new patients who will go through this pain. I am not saying that everyone has these results, but I think it's enough for the FDA to take a look at and stop until they know more. They even hinted that when tested on rats that it could have a carcinogenic connection.


  • but all meds have risks and the carciogenic one was not statiscally significant.
    Persoannly, I am at the end of my rope and the surgery was hoped to give me some life back, but tis so rubbish in pain all the time, these added risks aere not too much of an issue for "me" - I simply want some pain-less (lower) days.
    Is this too much to ask?

    I hoped 10 years out of my surgery...or more...

    Melto9, have you had extra bone growth confirmed?
    Are they going to remove it?

  • I go next week to get my scan, but I feel positive I do. I cannot stand for over 30 minutes without being in pain. I will let you know, but there are so many others this has happened to. I just want people to be aware and not go through what these people have been through. Some people have had good results- it just helps to ask a lot of questions.I have read of so many on here having revisions and scar tissue wrapped around the spinal cord. If I had it to do over I would just choose my own bone. You can never go wrong with your natural bone, and I feel it's worth that small extra pain.

  • Right now, its only approved for use by the FDA for the ALIF procedure. However, we all know there are tons of successful procedures where its used "off label" each year" i.e. TLIF, PLIF etc. Lots of folks here can testify to that. There are some cases where there has been bone overgrowth. I am curious as to how many of those have been "on label" versus "off label."

    I'm not saying its wrong to use it off label (heck, I've been on anti-seizure medications "off label" for nerve pain for months - you do what works!) but this issue has come up. I'm speaking to lumbar fusions only, cervical is a whole other story.
  • Hi itsalongwalk, you are right about a lot of products having risks. Unfortunately my Dr. did not mention that I could have too much bone growth. In his defence, I think he really believed in the product, even if Medtronic has been sued for paying 400 million to dr.s and sending them on expensive vacations. I just think if a Dr. has a financial relationship with a company they should inform you( like that would happen). Good luck to you.
  • It so unfortunate that BMP complications have happened to some of you---- in my case, There were no options left- my first fusion of L5/S1, we used my own bone- I didn't fuse in a years time- So, had revision, including the L4/L5 b/c of a torn disc that occured during recover.....had to use BMP, since my own bone didn't work, no way cadaver would of held.....my doc used it on label, knew of the "off label" problems, and I hope the cages stay where they should,and the bone stays where it should! Plate used and screws on cage into the level above and below.

    Sometimes, we have no choice when we are out of options, and it stinks that we have to choose options that might have adverse effects! darned if we do , and darned if we dont... I am not adding anything to this discussion I guess, just feel bad for everyones pain, and selfishly, hope that i can avoid it.....
  • Many times bmp induced bone growth cannot be confirmed without direct visualtion(surgery.) This is because the hardware causes so much artifact(interference) on CTs or MRIs that they cannot be read accurately. So to ask if the bone growth has been confirmed prior to surgery is difficult. Prior to surgery, patient history and selective nerve root injection helps direct the physician to that potential diagnosis.
  • Is selective nerve root injection the same as a discogram? I am clueless as to which test to ask for next week.
  • See some CSP's posts for what a selective nerve root injection is. It's something like an epidural, only needle enters a little off to the side of the spine and the numbing medicine is injected directly into the sleeve of the nerve root. If 100% relief of nerve pain, than for sure that nerve level is the problem. This test is done just like an epidural should be done using fluroscopy xray to guide the doc.

    CTs are great to show loose hardware, etc, and a good start. A nerve root injection is specific to a a nerve root level on a particular side. This could mean compression from bone or bad scar tissue. The intervetionalist should be able to tell if it is scar tissue or bone. Big hint-when they start pulling out progressively larger needles and try to bore through an opening in the bone, that mean bone is growing around the nerve root. But, it could mean that there is scar tissue there or something else.

    Typical presentation of bmp induced bone growth is return of leg pain or worsening of leg pain about 5 weeks postop without another injury or increased activity to explain it.

    Lots of doc like the nerve root injections before CTs sometimes, I had my first surgery based upon the injection alone, no CT. Other side surgery done based on CT and injection.

    I can tell you what I asked for and what my doc did, but your doc my have totally different ways of working it up. I think the most important thing is that he listens and believes and is working it up.

    BTW-do you have any disc left after the fusion? Don't think you can have a discogram if no disc, maybe a myelogram? Don't know.
  • They removed my disk they said and put the cage and infuse bone graft in a mesh material in the middle. It took a long time to fuse. My pain was in the lower back and right leg. Now it is in my tailbone and down both legs when I stand for over 30 minutes.I just found out today that my Dr. had invented a new procedure working with Medtronic a couple of years before my surgery.
  • Isn't that a lovely conflict of interest? Is your doc one that has been named in the scuttle?
  • Melto,

    Just wanted to comment that its rare to have the bone over growth problem. I had the BMP2 used on my 2 level fusion in Aug 2007 without cages. I still have some nerve issues but they are not related to over growth of the bone. They are just the nerves being broken, that happens sometimes and its a risk associated with this type of surgery. I had my hardware removed last year and my Doc found no bone over growth nor did they find any serious scar tissue issues.

    I know of a couple of people with this issue and in my opinion it can easily be attributed to the doctors incompetence rather than the actual product itself.

    As for your problems, it may not even be the fused area that is causing your problems. When a joint is fused, additional stress is put on the joints above and below the fused area. In your case, that would be the SI Joints, hips and the l4/l5 disc. I get frequent flare ups in the SI Joint areas whenever I over do it and some of your symptoms sound like those joints could be causing you some problems.

    ERNurse is correct in that the best way to detect bone over growth is visually seeing it. Everyone that I know that has had bone over growth were confirmed during revision surgery.

    Just something to think about.

  • I have contacted someone to find out. We have had a death of a good friend and I will have to cancel my appt. this week. I noticed that Dave said below that this bone growth is rare, but if you read the FDA maude reports, it's not that rare and an artice in the WSJ is talking about the fact that a lot are showing up.Especially when done "off lable" as mine was. If you google InFuse problems I think the article will come up.My Dr. is considered the best around here and is even the Dr. for a pro football team. I am very hurt that he recieved money for a previous technique, you know that has to sway you to use their products.Definate conflict of interest.Money talks.
  • Help!

    I had L4-L5, L-5 S-1, fusion in November 2010. I thought all was going pretty good, with meds but at least it was better than before surgery and I was able to work 8 hours a day. Due to increased back pain that showed up out of no where, I had to seek help. I could no longer work but a couple of hours.

    I went to see my pain management doctor and he decided to check the pictures from the caudal injection in January 2012. He thought he could see a halo around one of the screws. He referred me to a ortho and I had the myelogram CT. Short story, the PA said all looked pretty good and that I was fusing. I was so excited, then the ortho came in and said the oppposite. He showed us where the screw was loose and where it looked like I may have a pinched nerve that was causing the pain on my right leg below my knee. Yesterday I came home to so much pain on my right knee. It was on fire. This was the first time for me. It normally was a dull pain that went thru the bone.

    He said it was only going to get worse and my only option was to have the hardware secure by going in thru the back and have six secrews secure the aree and use infusion bone graft. I asked about my own and he said that was not good at all. I asked about replacement disc, again he said that was not a good option. Most disc replacements failed.

    Because my pain is so severe they have increased my pain meds. The meds and icepacks get me thru about 2:30 after then I am crying, irritable hateful, but more med and I get thru the 8 hours. He recommends the infusion bone graft from experience using this the last ten years and the success on his patients fusing.

    One problem was getting this approved. Insurance do not want this but figured they may approve since this is my second surgery.

    I am desperate and will do anything at this point. I have scheduled my surgery for June 7, only because I have to be smoke free and my husband would not be in the state until this period.

    I pray all will go well. I really don't know if it is the product along with the type of cage or what. But it will not be necessary to go in thru the front since all is in place. The problem is in the back.

    Sorry I wrote so much. Please keep us posted. We all deserve a close to normal life. I am at the point I work, come home, walk, eat, shower sleep and back to work. Weekends are for resting and back to work. I am thankful I am able to continue working. Taking one day at a time thru the grace of God.
    11/30/2010- 360 bi level fusion L4 L5, L5 S1
    7/5/12-Revised surgery. Remv of loose hwdware, replace 6 pedicle screws and 5.5 titanium rods. Inferior laminotomy R L5 and facetectomy to deep ligamentum.
    2014 MRI indicates L3-L4 disc bulge,
  • for the info on surgeons using BMP for fusion. It was used in all my levels including both si joints. I found out from my insurance company that BMP is not covered because they told me it is still considered an experimental use for fusion. Using Bmp is very very expensive and just fusing my 4 lumbar vertebre was 38,000 dollars for the amount used and not covered. Please be sure and check with your insurance before hand. Kevin
  • Just a few major updates concerning medtronic infuse:
    Oct 2011-Amplify, which is like a high dose version of Infuse, was linked to cancer in one of Dr. Carragge's studies
    (EIC Spine Journal)
    Sept 2011-Medtronic settled with the DOJ for $23.5 million
    Mar 2012- Medtronic settled Infuse shareholder suit for $85 million

  • Well it's been a long time and I;m sure most of you know the news on INFUSE is way worse than I ever dreamed- cancer, male sterility and in some cases female infertility problems. Death when used in the cervical area. I did have to have an add on fusion and there was so much bone overgrowth that one screw had to be left in because it was embedded in 4 inches of bone. I had bone wrapped around my spinal cord- a mess. Haven't had a pain free day since. I wish I had never had it done. Needless to say I used a different Dr. but the damage was already done.
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