The Infuse Bone Graft System is a bone-growth protein that is used in spinal fusion surgery. Unfortunately, it has been linked to severe, life-threatening side effects, including male sterility, nerve damage, and death.

One of the most common Infuse bone graft complications is excessive bone growth, which can cause severe nerve damage and other side effects.

Medtronic Inc., the bone graft maker, is currently facing Infuse lawsuits for allegedly paying researchers millions of dollars to produce research that minimized the risks of the Infuse bone graft.

What is the Medtronic Infuse Bone Graft?

The Medtronic Infuse bone graft is a bioengineered synthetic bone-growth product that the U.S. Food and Drug Administration (FDA) approved for use primarily in spinal fusion procedures, but it is approved for certain dental procedures as well. It was designed to replace similar medical devices that use an implant made of the patient’s own bone.

How Does It Work?

The Infuse Bone Graft System uses a synthetic liquid protein known as recombinant human bone morphogenetic protein, or rhBMP-2, to stimulate bone formation. It performs similarly to a naturally occurring protein found in the body (produced in small amounts) to aid in bone growth and healing.

A sponge-like carrier made from bovine Type-I collagen is used to release the protein, provide a framework for the bone to grow, and dissipate when the bone has grown. Unlike other devices that graft the patient’s own bone, the Infuse bone graft uses genetically engineered protein to help build bone tissue.

Medtronic Infuse Bone Graft FDA Approval and Warnings

The FDA approved the Medtronic Infuse bone graft in 2002 to fuse vertebrae in the lower spine in order to treat degenerative disc disease. The device is approved to be used in the lower region of the spine (L4-S1) but has been widely used off-label in cervical (neck) surgery procedures.

The FDA issued a warning in July 2008, cautioning surgeons against off-label use, citing reports of potentially fatal complications when used in the cervical region of the spine.

Infuse Bone Graft Complications

In their warning, the FDA emphasized that the “safety and effectiveness of the recombinant human bone morphogenetic protein (rhBMP) have not been demonstrated” and that the use of the protein in cervical spine surgeries is not approved by the FDA.

The FDA stated that serious complications could result from swelling of the neck and throat tissue, which could lead to airway construction and compression of the neurological structures.

Side effects associated with Infuse bone graft off-label use include:

• Uncontrolled bone growth
• Ectopic bone growth
• Inflammatory cyst formation
• Cancer
• Paralysis
• Difficulty swallowing
• Difficulty speaking

Medtronic Infuse Bone Graft Lawsuits

Medtronic is facing intense pressure regarding its Infuse Bone Graft System. The FDA has issued safety warnings and the U.S. Department of Justice (DOJ) has begun a criminal investigation. Medtronic is also accused of engaging in illegal “off-label” promotion of the Infuse Bone Graft System.

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.

Medtronic allegedly paid some doctors to use and speak favorably about the Infuse Bone Graft System, including reporting positive test results and downplaying the risks and complications of the Infuse Bone Graft System.

Many of the Infuse bone graft lawsuits involve patients who experienced excess bone growth that occurred after an off-label surgery.