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Medtronic Infuse Bone Graft Refused to Fuse

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San Diego, CASteve had a Medtronic Infuse bone graft implanted two years ago. The first two bone grafts he had previously with human bone were successful, but the Medtronic bone graft has been a total failure. "If I have to go through another, riskier surgery, I'll be getting a lawyer," he says.

Besides the graft not fusing, Steve, age 53, hasn't experienced any Medtronic bone graft complications such as difficulty swallowing. "And I don't worry about sterility at my age," he says, "but anything below the belly button is concerning because if the L3 and L4 snaps, I could lose bladder control, incontinence and, of course, paralysis—hello! I've had four other spinal fusions since 1992 but Medtronic is the only one that has screwed up."

Steve had his last surgery with the Medtronic device as an alternative to bone allografts that he had implanted before. (The Medtronic bone graft contains recombinant human Bone Morphogenetic Protein (rhBMP) that is designed to stimulate bone growth in specific areas of the spine.)

"Had I known that my surgeon was going to use this Medtronic infuse, I would have objected," says Steve. "He told me that this was less invasive than the other 'cut and paste' surgeries I had before, but the Medtronic fusion plug still hasn't fused to the bone.

"The only thing holding up my L3 and L4 is the titanium plate that was installed to hold it all in. I'm a quick healer so it's pretty strange that this bone plug never took hold.

"This Medtronic device pisses me off because I race motorcycles and one good crash could paralyze me! If it fused properly, I wouldn't be worried about racing again. And I'm pissed off about this whole off-label issue with Medtronic. I think my doctor said it was approved for large bone use such as the femur, and the FDA approved it for lumbar spine at the time I had it. But my doctor also said it hadn't been accepted for cervical spine yet because of overgrowth and complications to airways—pretty much what research on indicates.

"So, I had this artificial Medtronic bone graft infused into my lumbar and have had no noticeable side effects other than no fusion whatsoever! Strange that this artificial plug is infused with a bone growth hormone of some sort, but two years on, it hasn't worked at all.

"My surgeon wants to redo the whole thing but I don't have the time or money. He said that they want to take everything out and do it right—by not using Medtronic. But when you start taking out the screws and plates, you have to put it back into the exact same place. It's like re-drilling wood. And when I get older, this plate may just wear out. So I am pissed off at Medtronic—the only thing different about this surgery is the artificial product, this is the only time an implant has failed.

"When I found out it is being used off-label and Medtronic is paying off its doctors, that too got me angry. Why wasn't I told about this by my doctor? Medtronic probably pays the medical community to shut up—it is definitely time to get a Medtronic attorney."


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Posted by

I got vasculitous 2 weeks after my surgery.My doctors assitant says to me maybe your allergic to the bone growth hormone.The hormone last 1year.I had Vascalitous for 1 year .Yet my surgeon said there was no way it was from it.If I walked 5 minutes the blisters would start the longer I was up the more I would get until my body was covert.light yourself on fire and sting youself with a million bees.That's what it's like got kicked out of physical therapy because heart rate at 175 sitting up .They thought I was going to have a heart attack.So Labour and industry stopped paying me for not attending. Didn't get paid for three months . Almost lost my house. Oh and the 2 skin doctors in formed me it was doing the same thing to my insides had to have a kidney biopsy.I still have to see kidney specialist every 6 months due to blood in urine. So be happy they gave you a sponge they forgot to dip !!! If anyone can help with legal service for lawsuit or class action lawsuit my phone number is 206 249 2651 I live in washington state .Oh by the way a university did a study with the morphagenitic bone sponge on rate and it caused vasculitous...

Posted by

wow these stories are just like mine,I had L4L5 fusion done in jan2011 with infuse bone graft done from the back which is off label and my life hasn't been the same since. about a month after surgey my leg was so numb i couldn;t walk on my left leg and my back hurt so bad.ive had 3 surgeries to take out extra bone that has grown around my spine still no help theydid a emg test and said i had nerve damage put a dorsel colum stimulator in me and still in so much pain that all i do is lay in bed 80% of the day. now im on disability never get to go see my kids at there school functions and watch them cheer or play softball or enjoy doing things with the family on top of that im so deppressed i lay in bed and cry all the time and im not a cryier. but the sad thing is that medtronics has so many lawyers to get them out of all this trouble that nobody will see a dime for all the pain and suffering that weve gone through and worse than the pain is the time were losing not being able to do things with our kids. I do have to say that i have a great doctor that has not given up on me and is always trying to find ways to help me out he just ordered me an electric wheelchair so i can get out a little more but its just so embarrassing for a 43 year old man to be on one of those things and my kids hate me with it but they understand that it helps with the pain .thanks for listening and i hope they find something to help us one day. good luck everyone.

Posted by

god,do i feel like a fool.i though i did my homework on the hospital,the doctor performing the surgery.after having two operations that my doctor used BMP off label in T6 and T7 i am now in permanent pain.i have been blown off by doctors and pain clinics that said i was drug seeking and that there was nothing wrong after my surgerys.its just been in the last couple of days i found out that my doctor belonged to to one of the largest group of surgions that use this product.i feel like my life is over. i can no longer work even with a bunch of oxy in my system.i am like most people in that i was not informed that the product was being used off label,i was just told that spinal surgery is a crap shot.some time it works and other times does not.what i was not told was that my chances were close to 0 that this would work and that there had been comlications with the product EVEN IN FDA APPROVED LUMBAR SURGERIES.this mess cost me a good marrige .most of my friends .the list goes on.i just hope my and everbody else's lawyers show the public what medtronic did and nail them finicialy.

Posted by

I had the enfuse surgery in Feb 2010. I immediately started having complications. I continued to lose feeling in my legs. After a full year of exstreme numbness, I went in for just a possible hardware removal. They discovered I had exstreme bone overgrowth. Now I am left with possible not being able to work the rest of my life. I am pissed that my surgeon told me nothing about the complications that was a possibility with The BMP. I am left with extreme pain in my legs and in my back.. I am unable to perform simple tasks. How could these people put my life at risk for monetary gain. Needless to say I now have a higher risk of Cancer as well. This device has left me financially and emotionally in a complete shamble. I have lost my job and my health has permently been jeperdized due to the lack of imfirmation. There is no amount of money can give me back what has been taken away from me. My career, my health, my ability to ever advance in the work force. My ability to just enjoy life. It has almost destroyed my marriage, as I am only in my early fourties. I am now left with at least 14-16 hours of the day laying in bed from the exstreme pain it has caused me just to put pressure on my legs. Why don't they take there billions of $$ that they have earned from destroying people's life and figure out a treatment to give me my life back. For anyone out there contiplating back surgery, do your research and ask questions. Back surgery is never a Guarentee but when they insert dangerous products in your spine, there is almost 100 percent Guarentee that complications will arise. MEDTRONIC
Should be shut down due to their negligence.

Posted by

I to am pissed off about the off label use. My doctor never said a word about the non FDA approval. Mine over grew causing severe nerve compression which required a revision surgery. I to would have chose not to elect with the enfuse had I been told about the dangers. He acted like it was no big deal and never discussed complications such as it can grow to much. Medtronic is a greedy corporation putting our lives at risk for their own benefits, as patients we should stand up to the company and the goverment should require them to tell us the risk and give us a choice. I am furious that I was never told anything nor gave a option. Now I have had another unnessary surgery because there product malfunctioned almost immediately following my post op period. I could have been paralized, when is it going to stop.

Posted by

Wow, I see so many complaints about the Fusion Surgery? I had a fusion done on my L3-L4-5 they made that area pretty strong but now, my other vertebra's are out of line and causing pain. I'm not allowed to complain about mine because, I was working for a Government Home Repair Program Tanif/USDA. The problem with Ohio BWC is that if you have a serious back injury and they offer back surgery to fix your problem, you have to take the first offer you are giving. If you don't take their offer, then they find you MMI ( Maximum Medical Improvement ). Then BWC will stop your workers compensation payment because, they say you're at the highest medical treatment and there's nothing else to do for you. It's sad but, thats how Ohio does it. Before I got my back surgery approved, my wife and I, was at a BWC/IC hearing in Portsmouth, Oh on March 17, 2010 and while I was in the hearing room they had their IC security guard walk-in the hearing room and pulled his gun out. The gun was pointing across the table at the employer's attorney but, while the gun was next to my attorneys head and my head ( the guard was standing behind us ) when I looked at the hearing officer he nodded his head at me to grab the gun? I will never work for another Government agency. Enough said and true.


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