Patient Not Given the Facts—Grounds for Medtronic Infuse Lawsuit?

Rocky Mount, VAIt took almost four years for Wendy to find out that her Medtronic Infuse bone graft was used off-label and it comes with risks. “If I knew that this Medtronic device was being used on me experimentally and if I knew all the potential side effects, I would have thought twice about having surgery,” says Wendy.

A recent Bloomberg report highlights two studies that were done on the Medtronic Infuse bone graft; the two independent studies suggest that the Infuse implant works no better than a graft and carries side effects including an increased risk of cancer.

Now Wendy is concerned about Medtronic Infuse cancer risk. (Patricia Caplinger, who recently filed a Medtronic lawsuit - Caplinger v. Medtronic Inc. and Medtronic Sofamor Danek USA Inc., Case # 5:2012cv00630 - also asserts that she has a significantly higher risk for cancer.)

“Since getting the Medtronic Infuse I’ve had cysts on my ovaries and had to get a hysterectomy,” says Wendy. “My doctor says the cysts aren’t cancerous but now I have two lumps on my breast. I had a mammogram and sonogram and my doctor says they are fibrous cysts - but I am freaking out. From what I have read, the Medtronic protein can cause cancer growth so it is possibly related.”

Wendy is referring to the bone morphogenetic protein (BMP-2), which promotes bone growth. Infuse is the trade name for BMP-2 that is placed inside a minute cage and implanted in the patient.

“I am a single mom and my kids depend on me so I am very worried,” says Wendy, age 42. She can no longer work as an electrician, having been deemed 100 percent disabled since having the Medtronic Infuse implant.

Wendy had spinal surgery in 2008 and says she has been in pain ever since. “I recently started going to another pain specialist who took x-rays and found two bones fused together in my spine,” she says. “My bones weren’t fused together in previous x-rays so naturally I am worried, and no wonder I am having a hard time. I am a bit unstable and have balance issues - sometimes I fall down unexpectedly.

“The last few years are getting worse. My legs feel so heavy and it’s a problem walking. My left leg barely has any reflex at all. One pain doctor thinks it is nerve damage caused by the surgery.

"I can’t do a lot of things that I used to do and I don’t even come out of the house much anymore except to go to my doctor or the grocery store. This Infuse has taken a toll on my overall health; for instance, I have also gained about 30 pounds since the surgery.”

After seeing a commercial on TV about Medtronic Infuse and its off-label use, Wendy obtained her medical records from the hospital. “I remember my surgeon telling me that this Infuse was a new procedure but he didn’t say anything about it not being approved by the FDA and he didn’t tell me about all the Medtronic side effects,” she says. “I have a list of the parts they put into my body including three bovine discs, which I didn’t know I was getting either. I figured it would be some kind of plastic device. I sure wish that I knew more about the Medtronic device before getting it.”

When a medical device such as the Medtronic Infuse is used off-label by a physician, the patient must be informed of the off-label or experimental use. The patient must also be told of the risks prior to surgery so that the patient has all the facts and can make an informed decision regarding whether or not to go ahead with the procedure.