The Hidden Costs of Medtronic Infuse

Proctor, WVDavid sustained a spinal injury at work when he was 18 years old; he was too young for back surgery but managed to function with pain management - until he had back surgery with Medtronic Infuse Bone Graft. “I had pain before this Medtronic infuse but now I have the worst pain ever due to nerve damage,” says David. “I haven’t worked since the surgery and I have been on disability insurance ever since.”

David’s doctor has told him and social security administrators that David is completely disabled and will likely never be able to work again. Besides the irreparable damage to David’s livelihood (he also has a family to support), he didn’t have private health insurance, so he is collecting social security benefits.

“My neurosurgeon told me that he took out a disc and replaced it with the Medtronic bone graft,” David explains. “Three months later I got an infection and had to undergo another surgery. Altogether I have had four surgeries and now I am worried about even more nerve damage because I have shooting pain running down my legs.”

Nerve damage is an irreversible complication that is associated with the Medtronic Infuse bone graft.

David had CAT Scans and MRIs between each surgery; each time pain in his lower back and leg pain increased. “The CAT Scan shows that I have bone growth and calcification of discs that the Medtronic was supposed to fix,” he says. “Now I am told that two more vertebrae need repair but my surgeon doesn’t want to do another surgery until absolutely necessary. How much pain can I endure until I reach that point?”

As of July 2013, more than 300 lawsuits had been filed against Medtronic, and more than 900 claims are being investigated, including David’s case. In a California state court suit, 37 plaintiffs allege injury after undergoing spinal fusion procedures in which Medtronic’s Infuse bone graft product was used off label (i.e., not approved by the FDA). Some of the plaintiffs, like David, claim that the Infuse bone graft material resulted in them developing “heterotopic,” or unwanted bone growth, which resulted in pain and nerve damage.

“I take two fast-release oxycontin pills in the middle of the day and a few long-acting pills at night, and this has also taken a toll on me; being addicted to oxycontin has its own problems,” David adds. “Of course the oxy helps but I still get breakthrough pain.”

Medtronic Infuse lawsuits are also accusing Medtronic of encouraging its sales reps to promote Infuse for unapproved procedures, including posterior lumbar interfusions, posterolateral fusions and transforaminal lumbar interbody fusions, all involving surgery done from the back.

LawyersandSettlements is monitoring legal developments in the Medtronic Infuse litigation and attorneys are investigating possible Infuse bone graft cases against the company.