Over 1,000 people have filed Medtronic Infuse bone graft lawsuits against Medtronic. The device used in spinal fusion surgery has allegedly led to severe complications following off-label use, which, according to Medtronic Infuse bone graft lawsuits, was encouraged by Medtronic.

The Infuse bone graft has been used in over 100,000 spinal fusion surgeries per year. Many patients may not be aware that they are using the Infuse bone graft for an off-label procedure and may experience severe Infuse bone graft complications such as pain, nerve damage, and even death.

The Medtronic Infuse bone graft a synthetic protein called rhBMP-2 (recombinant human bone morphogenetic protein). It encourages bone growth and provides an alternative to bone grafting, which can be painful and dangerous.

The U.S. Food & Drug Administration (FDA) approved the Infuse bone graft in 2002 for anterior approach lumbar fusion (the lower area of the spine). It was later approved for tibia repairs, certain dental procedures, and some facial surgeries.

Infuse Bone Graft Complications

The FDA began to receive reports of Medtronic Infuse bone graft complications in 2004. In 2008, the FDA issued a warning about off-label use. Infuse bone graft studies have also suggested that the Medtronic Infuse could lead to serious complications and may contain a carcinogen.

Many patients had undergone surgery in the cervical spine. The FDA has not approved the Medtronic Infuse bone graft for use in the cervical spine, stating that safety and effectiveness of the Infuse bone graft in the cervical spine “have not been demonstrated.”

The agency stated that a reason danger exists in the cervical spine may have to do with “the anatomical proximity of the cervical spine to the airway structures,” according to the FDA Medtronic Infuse bone graft warning.

Medtronic has been accused of concealing Infuse bone graft complications from the public, which has led to thousands of reported complications that could have been avoided had patients been adequately informed.

Already, millions of dollars have been paid in Infuse bone graft settlements. Two of these settlements followed whistleblower lawsuits, which means an employee of Medtronic came forward with important information concerning Infuse bone graft complications and safety.

Medtronic Infuse bone graft complications may include:

• Difficulty breathing, speaking and swallowing
• Chronic pain requiring daily medication to manage
• Excessive bone growth
• Nerve damage
• Male sterility and other uro-genital injuries
• Death

Infuse bone graft complications are most likely to happen within two weeks of undergoing spinal fusion surgery. Victims of Medtronic Infuse bone graft side effects may be entitled to compensation for medical bills associated with complication from treatments, as well as other bills.