Medtronic Infuse: Painful and Tragic Consequences

Denver, COSince having a Medtronic Infuse bone graft six years ago, Libby was prescribed Fentanyl patches and oxycontin for severe pain. Unfortunately, one of the drugs prescribed to take away her pain, took away her son as well.

“The saddest part of all is that Joshua stole one of my Fentanyl patches a year ago, overdosed and died,” says Libby.

“Joshua was only 23 and I miss him every day of my life. He was alive when my husband and I found him - Josh was living with us at the time - but by the time we got to the hospital, we lost him, and all because I had to use pain meds for [after my surgery]. After Josh died, I stopped taking Fentanyl and oxycontin; I will never have narcotics in my house again, ever.”

Now Libby goes regularly to the pain clinic for injections to ease the pain, and help her walk. In 2005, she had a laminectomy - a common type of surgery that helps relieve spinal stenosis-related pain - on her L4 and L5 discs that had ruptured. But the surgery was unsuccessful and her surgeon suggested that she have a Medtronic Infuse bone graft.

“I was in agony from the moment I woke from surgery and that pain has never subsided,” says Libby. ”I have been with a pain management specialist ever since.

“After the surgery I went back to the surgeon three times and each time I had x-rays. He said that nothing ‘big’ was wrong and that I wasn’t completely ‘set up yet,’ so it was too early to tell if anything was amiss. I just continued on with the pain. To be honest, it is intimidating to see these specialists and not know the right questions to ask - all I can say is that I am in pain. If they don’t see another ruptured disc, they just brush it off.

“A few months ago my friend phoned and told me about Medtronic lawsuits - I couldn’t believe it! She also had a Medtronic Infuse implanted. She got her medical records from the hospital and advised me to do the same.

“Sure enough, a Medtronic bone infuse was used in my back surgery. After I Googled Medtronic bone infuse lawsuits and dug deeper, I was furious. The Medtronic lawsuits specifically stated that the Medtronic Infuse was not to be used in posterior surgery. In other words, this surgeon used it off-label on me. I am still learning this terminology, and the more I learn, the madder I get. And the more discouraged I get. I feel that I will never be OK again.”

The Medtronic Infuse bone graft was approved by the FDA in 2002, but it was approved solely for the treatment of degenerative disc disease as part of a single-level, anterior lumbar interbody fusion. According to the FDA’s “Summary of Safety and Effectiveness Data” for the Medtronic Infuse Bone Graft/LT-CAGE™ Lumbar Tapered Fusion Device, the FDA notes, “The safety and effectiveness of the InFUSE Bone Graft component with other spinal implants, implanted at locations other than the lower lumbar spine, or used in surgical techniques other than anterior open or anterior laparoscopic approaches have not been established.”

Libby goes on to say, “Before I had this surgery, I had a home-cleaning business but I had to sell it for pennies on the dollar. I used to paint wall murals, but if I got on a ladder now, I would crumple in pain. In other words, my whole life has turned upside down.

“My kids are pushing me to find an attorney. At least I could get compensated for medical bills and the pain doctor, which has cost thousands and thousands of dollars, even though I have insurance. I know the Medtronic surgery alone was $57,000. In hindsight, I wish I didn’t have insurance because then I couldn’t have afforded to get it done! How ironic. I would have found another way to deal with these blown-out discs.

“Had I known, had I done more research, I could have just gone to an anesthesiologist and gotten a nerve block. One month from now I am having another surgery where they will electronically kill the nerve, so I am hopeful that once the nerve is killed, it will kill the pain. But there is a huge risk involved - anywhere from paralysis to death.

“My health insurance stipulates that I have to go through two sets of injections first (those are very painful) before having this procedure, which I have done. I have gone through so much to get to this point…”

Libby says that after her son died she got off the narcotics: 150 micrograms of Fentanyl patches every two days and 240 mgs of oxycontin per day. Between the pain and the drugs, her family said they didn’t even know her anymore - all she lived for was the next visit to the pain clinic.

“I read Medtronic’s annual report - it makes billions of dollars per year in net sales,” Libby adds. “I’m sick and tired of these large, greedy corporations taking advantage of people, and their lack of humanity - they shouldn’t get away with this.”