Medtronic Infuse Growing Concerns

McAlester, OKAlison had a Medtronic Infuse bone graft implanted several years ago and she says it caused permanent nerve damage. Valerie had a bone graft in 2003 and has recently experienced complications. Attorneys who specialize in medical device litigation say that both women may be able to file a Medtronic lawsuit.

Some plaintiffs have filed both Medtronic Infuse lawsuits and medical malpractice lawsuits, claiming they underwent medically unnecessary surgery to have a Medtronic bone graft implanted. A lawsuit was recently filed in California (David et al. v. Medtronic Inc., et al., No. BC-510542, California Superior Court, Los Angeles County, May 31, 2013) in which 37 plaintiffs allege they suffered injury as a result of spinal fusion procedures they had where the Medtronic Infuse bone graft was used off-label - i.e., in a manner that was not approved by the FDA.

“About a year after surgery, I developed leg pain: on a scale of 1-10, the pain has increased from 2 to about 9, so now I am living on painkillers,” Alison says. “A CT Scan shows nerve damage to L4 and L5, which are two of the levels fused with the Medtronic Infuse. Now I am facing spinal cord implant surgery because I am told there is nothing to be done to alleviate the pain. My surgeon told me that Medtronic was used, but he denies that it has anything to do with my nerve damage. Maybe he read about the Medtronic lawsuits and is afraid of medical malpractice lawsuit too.”

Valerie says that her infuse graft worked for several years but it is failing now and she has constant back pain. “I have also lost about two inches in height (I was 5' 11") since getting extensive back surgery,” she says. “Back in 2003 my surgeon told me that I could either have the implant or wait and get nerve damage, and that is irreparable. So I didn’t have a choice, but it is ironic that the Medtronic Infuse graft could actually cause the nerve damage.”

Before she had the surgery Valerie was very active - and she was only 45 years old. She has since moved to a desk job. Her problems started with intermittent back pain that is now constant.

“I went back to the Oklahoma Spine and Brain Institute for more x-rays and a CT Scan,” Valerie says. “The space between the vertebrae is narrowing again. The doctors didn’t do any nerve testing at the time but my surgeon said that not a lot can be done about it. I don’t know if the graft failed or what has gone wrong. I got a second and third opinion and they only said that ‘these things do happen’ and they reminded me that I had a great deal of surgery. Now I cannot lift anything heavy including my 20-lb grandson. I can’t lean forward for any period of time either. Short of morphine I will always have this pain - and the painkillers are also causing problems. What a mess this implant has caused.

“I just started to explore the reason why this has all happened. My next step is to get my medical records and release them to an attorney. I would hate to think that after all I have been through this implant has failed because the product was defective.”