Medtronic Infuse Bone Graft Refused to Fuse

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 LawyersandSettlements.com 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."