William, age 48, injured his neck about 10 years ago when he was in the military. “A VA doctor said they could do a bone graft from my hip but he knew of a product that had not been FDA approved that could get approved through the military’s insurance company,” says William. “He told me it had some protein to stimulate bone growth - he more or less sold me on this Medtronic bone graft.”
The Medtronic Infuse bone graft was, in actuality, approved by the FDA in 2002. However, its approval was solely for the treatment of degenerative disc disease as part of a single-level, anterior lumbar interbody fusion.
The FDA had not approved the Medtronic Infuse implant for other procedures in other areas - such as the surgery William had undergone.
Recently, a lawsuit related to this issue, David et al. v. Medtronic Inc., et al., No. BC-510542, complaint filed in California Superior Court, Los Angeles County, May 31, 2013, saw 37 plaintiffs alleging injury occurring as a result of spinal fusion procedures in which the Medtronic Infuse bone graft was used off-label - i.e., in a manner that was not approved by the FDA.
For William, two discs were replaced but the swallowing issue became so bad that he had another surgery in 2009 - some muscle in his throat was removed to treat the swallowing problem. “It’s like they are correcting symptoms but not looking at the cause, and I believe the cause is this Medtronic device,” William explains.
“Now my stomach fills up with air and gas - you can imagine how this feels. It hasn’t been fun. I can’t sit down at a restaurant and eat normal food - if something causes gas, I am in pain for several days. My wife thinks I am choking all the time and my kids get scared when they see this. Most days I have to take painkillers and last night I had to take a strong narcotic, so I’m not functioning well today. I’ve gone to ER a few times because the pain is so bad, but I’m afraid to get anything else done.
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"Before I had this Medtronic bone graft surgery, I was pretty active - I ran marathons and raced bikes. Now I can’t do anything and I’ve gained 30 lbs. I also lose sensation in my arms and the back of my legs and sometimes the pain is unbearable.
“Just yesterday morning it took a few hours for the feeling to come back to my hands after I woke up. Sometimes while I’m driving I will lose sensation in my fingers and that is scary. This Medtronic bone graft is one big mess. They try to fix one thing and it makes something else go wrong. Maybe an experienced attorney can at least help me with some compensation.”