The Medtronic Infuse is a type of bone graft, which uses recombinant human Bone Morphogenetic Protein (rhBMP-2) to stimulate bone growth.

The Medtronic Infuse Bone Graft was approved by the Food and Drug Administration (FDA) in 2002 for the limited use during single-level anterior lumbar fusion surgery, as well as a treatment for tibia fractures and some oral or dental procedures.

However, several Medtronic Infuse bone graft lawsuits have been filed by individuals throughout the United States who have experienced inflammatory reactions, nerve damage or other problems following spinal fusion surgery in which the Infuse Bone Graft was used off-label.

What is the Medtronic Infuse Bone Graft?

The Infuse bone graft was developed by Medtronic Inc. as an alternative to traditional bone graft procedures, which involves either the use of bone harvested from the hip or another part of the body, or bone extracted from dead bodies. Although it was only tested and approved for use during anterior lumbar fusion, involving single level spinal fusion surgery, it has been widely used off-label in other spinal surgeries.

Infuse Bone Graft Complications

When used during these unapproved procedures, Medtronic Infuse side effects may cause bone growth in areas where it is not wanted, which may cause:

• Severe inflammatory reaction
• Airway compression or breathing problems
• Nerve impingement resulting in severe back or neck pain
• Hospitalization with treatment in ICU
• Need for a feeding tube or tracheotomy
• Additional surgery to remove excessive bone from the spinal canal
• Death

Research has also suggested that use of Medtronic Infuse Bone Graft may increase the risk of cancer as well as cause some men to become sterile.

Medtronic’s Illegal Practices

Recently, Medtronic admitted to paying a surgeon nearly $800,000. The surgeon is accused of falsifying the results of a study, which produced a favorable review of the Infuse Bone Graft, while downplaying the risks of severe Infuse Bone Graft side effects.

Medtronic is also accused of engaging in illegal “off-label” promotion of the Infuse Bone Graft. When the FDA approved the device in 2002, the federal agency only approved it for use in the lower-spine region.

However, there is evidence that the company marketed the device “off-label” for use in upper-spinal or cervical surgeries. The problem is that when the Infuse Bone Graft is used in these upper-spinal areas, there is a risk that the product can cause massive tissue swelling in the neck and throat area, leading to suffocation and death.

FDA Warning on Medtronic Off-Label Use

In the wake of at least 38 reports of Infuse Bone Graft complications, in July 2008, the FDA issued a warning concerning off-label Medtronic Infuse Bone Graft use, stating that risks were associated with the use of the bone graft on the cervical spine. The agency’s warning stated “that the safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use.”

The reports included patients who experienced severe bone graft complications and required emergency treatment, which included tracheotomies, anti-inflammatory medications, feeding tubes and second surgeries.

Infuse Bone Graft Lawsuits

Although Medtronic was aware of the risks associated with off-label use, the company engaged in widespread over-promotion of the Infuse bone graft, encouraging use during spinal fusion surgery that was never properly studies and was known to cause serious side effects.

Many bone graft lawsuits allege that Medtronic Infuse:

• Failed to adequately study the side effects of Medtronic Infuse Bone Graft
• Concealed their knowledge about the potential Medtronic Infuse Bone Graft side effects when used off-label
• Failed to adequately warn about the risk that Medtronic Infuse may result in severe damage to the nerves and spinal cord

Patients who suffered from Medtronic Infuse side effects after undergoing a cervical spine surgery with the Infuse Bone Graft may have legal recourse to recover financial compensation for damages.