About a million people throughout the nation have used the Medtronic Infuse bone graft, and increasing numbers have filed lawsuits against Medtronic Inc. because of alleged bone graft complications, deceptive marketing and unethical practices.

The Medtronic Infuse bone graft is used during spinal fusion surgery to stimulate bone growth and replace damaged spinal disks. It was marketed and sold as one of the alternatives to harvesting a bone graft from the hip. The Medtronic Infuse bone graft is not approved for any other uses but it has been used off-label in cervical spine (neck) procedures.

In 2002, the FDA granted Medtronic Inc. approval for its Infuse Bone Graft, but for limited use in the lumbar spine, or lower back, and for some oral and dental procedures. The FDA also approved Medtronic Infuse bone graft for use in sinus augmentation and localized alveolar ridge augmentation.

The Infuse bone graft contains recombinant human bone morphogenetic protein (rhBMP), which stimulates bone growth and bone formation. It is a genetically modified version of a protein that is normally found in someone’s body.

Dangerous Infuse Bone Graft Side Effects

Medical complications from the use of the Infuse Bone Graft System were identified as early as 1999, during clinical trials. Soon after clinical trials began, CT scans of patients who had received the Infuse bone graft product showed signs of excessive bone growth into the spinal canal. This is called “ectopic bone growth.”

A 2004 paper about the clinical trial said that patients did not suffer any harmful effects from this bone growth, but other doctors (who had no financial ties to Medtronic) found their patients had significant bone graft complications, including nerve damage and chronic radiating pain in the legs and arms (neuritis, radiculopathy and radiculitis). Some patients needed additional surgeries to remove bone overgrowth.

Stanford University researchers later linked the Infuse bone graft with complications that cause sterility in men. Some patients experienced bone graft infection and life-threatening inflammation. In particular, some patients who underwent cervical spine surgery (for which the Infuse bone graft has not been approved) suffered extreme neck swelling resulting in permanent injury and even death. Other researchers reported that Infuse bone graft side effects included an increased risk of cancer.

FDA Medtronic Infuse Warnings

In July 2008, the FDA issued a Medtronic Infuse warning after receiving multiple reports of life-threatening bone graft complications caused by the bone protein. Medtronic allegedly promoted the use of the bone protein in unapproved settings including the upper back and neck regions.

The manufacturers also allegedly failed to warn patients and doctors about the severity of Infuse bone graft complications when used in the lower back.

Medtronic was sued by its own shareholders for allegedly making misleading claims about Infuse bone grafts in a lawsuit settled in 2012. The U.S. Senate concluded that Medtronic had manipulated research studies and secretly paid doctors to write favorable articles about their bone protein devices.

Medtronic Bone Graft Lawsuits

Medtronic allegedly marketed its Infuse Bone Graft System as appropriate for off-label uses, or uses not officially approved by the FDA. Though doctors are free to use medical devices at their own discretion, medical device manufacturers are not permitted to market their devices for unapproved and off-label uses.

Because Medtronic allegedly marketed its Infuse bone graft for uses not approved by the FDA, many patients have suffered bone graft complications and economic losses as a result.

Dozens of Medtronic Infuse lawsuits across the country are being filed as patients seek legal recourse for purported deceptive marketing practices that put them and their loved ones at needless risk for bone graft complications and injuries.