Medtronic Infuse Bone Graft Off-Label Adds Anger to Injury

Seattle, WAWhen Eileen found out that her surgeon used a Medtronic Infuse Bone Graft off-label, she was angry, to say the least. "There was never a discussion that this medical device was even used off-label," she says. "I am now told there is nothing they can do for the pain and I should have a Spinal Cord Implant."

Eileen (not her real name) underwent two surgeries in 2009 and she was told by her surgeon only that "synthetic bone" was used. "About one year after the lateral and posterior surgery, I developed severe leg pain," she explains. "An electromyogram test shows nerve damage to L4 and L5, which are two of the levels fused with the Medtronic graft.

"When I read the Wall Street Journal (July 2011) report that surgeons who conducted clinical trials to test this device didn't report serious complications in their research papers, I asked my surgeon if that is what he used on me. He confirmed that I had a Medtronic bone graft but he also denies that it has anything to do with my pain, which I believe is nerve damage."

Due to being in so much pain, Eileen, who just turned 69 and is supposedly set to enjoy her "Golden Years," says she is now pretty much housebound. She is going ahead with a spinal cord implant and hopeful that it will give some relief. "I want my life back," she says. "I've been active all my life; I love to travel and belong to many clubs, including a swim club, but all this has stopped due to the pain."

Eileen's surgery and subsequent complications are eerily similar to that of a Florida physical therapist who filed a lawsuit last September 2011 against Medtronic. Unfortunately, and a great cause of concern to Eileen, the therapist's revision surgeries haven't helped.

Jennifer English had Medtronic's Infuse Bone Graft implanted in August 2007 during a posterior-approach lumbar spine surgery, which is, according to the FDA, an off-label procedure. English alleges she developed uncontrolled bone growth in her spine, compressing nerves and leading to chronic and ongoing severe pain, caused by the Infuse bone graft. As of last September, she underwent two revision surgeries to remove the excess bone, but the surgeries did not remove continuous and severe pain.

According to the lawsuit, "Medtronic fraudulently misrepresented the risks and benefits of Infuse and improperly promoted and marketed Infuse for non-FDA-approved uses…When Infuse is implanted in off-label surgeries, medical research shows that it can cause uncontrolled bone growth into or around the spinal cord, often leading to intractable pain and difficult and dangerous revision surgeries to remove unwanted bone."

The FDA approved the Medtronic Infuse for anterior approach lumbar fusion only—all other surgeries are considered off-label, including use in the cervical spine (the part of the spine that runs from the head to shoulders). The Infuse was never approved by the FDA for use in either lateral or posterior approach lumbar fusion surgeries.

According to Medtronic's annual report, net sales for its spinal division were $3.4 billion in fiscal 2011. Revenues for its biologics division were $884 million in 2011.