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

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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.

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Posted by

My husband had titanium rods put in his back in 2008! He was in more pain then prior to surgery for the next two years. He was 75 years old when they operated. He had all kinds of other medical problems which should have indicated he was not a surgical candidate including heart problems. Immediately following surgery he started showing signs of infection which was ignored by the surgeon. Surgery was in October and November 2008. Had signs of infection by end of November same year. Incision revision in Jan. 2009 at which time he did no tissue culture even though he told me he would. He ended up in hospital June 2009 with infection in the disks. Did four months intravenous antibiotics at home ordered by an infectious disease doctor. Within a few days of coming off antibiotics he ended up back in hospital with now infection in the bone. At this point the surgeon refused to remove rods, which was the only way to clear up infection, because he felt my husband would die on operating table. This was only a few months after original surgery. All the infection and antibiotics made him very sick and so he was throwing up constantly. So, he ended up getting cancer of the esophagus and passed away August 2010! His immune system was shot I am sure and not sure if cancer was from vomiting so much or if this to was the kind of surgery where they used The BMP-2! I will look thru records and see if that was the case. This surgery should never be used!!!! It always causes more pain and other complications. I would give anything to have not let him have the surgery and have him back!

Posted by

I was injured in 2006 and by April 2007 I had a post lateral disc fusion surgery. Before the surgery, the surgeon told me why I was in so much pain and how the surgery would alleviate that pain. But he said nothing about any complications that might arise, or that the surgery he was about to do wasn't approved by the FDA.
Since my 2007 surgery my pain has become almost unbearable, to the point that I want surgery again. ANYTHING that will stop the pain and change the way I live. As now, I barely want to move. The only time I travel anywhere is to go to my doctor's appointments, to the store or my parents house.
I can't believe this happened to me. I agreed to have surgery because I was in pain, and I trusted my doctor. Now, after reading all the facts, I realize I was just a guinea pig, who now is in danger of getting cancer.
The surgery I had didn't help me at all, and right now I'm in more pain than before....

Posted by

Continued from 1st posting. All last surgeries from the 2009 t- lift had some kinds of morphogenic bone put in to help aid in each fusion. Was told that rarely do Titanium rods break, was told because fusion didn't take in the 2009 surgery, but then wound up getting horrific infection and had 2 more surgeries to follow. To then be told that the rods breaking in Jan and Feb 2011 were becaused of failed fusion. I am fused from the tip of my tailbone up to T-7 with several failed fusions. Can somebody honestly tell me that the fusions that didn't take we're caused from this Morphagenic infuse bone graft material from Medtronics???? Now I cannot find a Dr who will touch me with a 10 foot pole due to the mess that is in my back, they do not want to be responsible for trying to go in and fix somebody else's mistake or failure. I am not and was not a guinea pig. I trusted my Dr because I had no choice and this is what I get for that faith.

Posted by

I have had 13 surgeries over the last 13 years, in July 2009 had a T-lift, 7 months later Feb 2010 spine fusion failure, 2 months later April 2010 infection, clean out surgery, 9 months later Jan 2011 right rod breaks, 1 month later left rod snaps, takes 8 more months Aug 2011 before insurance approves surgery have another spinal fusion, about 2 weeks later a rod snaps lower in spine and takes insurance till Dec 8th 2011 to approve another fusion. Spine is completely deformed, bent over like a 90 year old woman. Constant pain, numbness radiates down and through out whole spine down into legs. 51 years old and cannot sit on floor, cannot walk upright, have a pain pump to try to control some of pain, do not get over 2 to 3 hours of sleep at night. Left lung damaged in this whole process due to having pnuemonia while having August 2011 surgery. Diapragm accidentally cut during 2009 surgery......was given 3 different bone stimulators to help to try and speed up and aid in f
Spine fusing properly?????


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