The Medtronic Infuse is a bone-growth protein that is used in spinal fusion surgery linked to severe, life-threatening side effects, including male sterility, nerve damage, and death. One of the most common Infuse complications is excessive bone growth, which can cause severe nerve damage and other side effects.

Medtronic, the manufacturer of Infuse bone grafts, is facing lawsuits for allegedly paying researchers millions of dollars to produce research that minimized the risks of the Infuse.

The Medtronic Infuse Bone Graft System is a medical device intended to be used during lower back lumbar (spinal) surgery to stimulate bone growth and replace damaged spinal disks. It was developed as an alternative to traditional bone grafting, which involves painful bone-harvesting from other areas of the body.

The Medtronic bone graft contains recombinant human bone morphogenetic protein (rhBMP), which is a genetically engineered version of a protein that is naturally released by the body. Use of rhBMP initiates bone growth in specific areas of the spine, giving surgeons some control over where the bone re-growth occurs.

The device itself consists of a sponge-like substance, which is soaked in a biological agent. The biological agent is a synthetic liquid form of bone morphogenetic protein, or BMP. The device is implanted between vertebrae, and the BMP stimulates the bones to grow. The sponge dissolves and is absorbed into the body.

The Medtronic Infuse Bone Graft System is not approved for any other uses but it has been used off-label in cervical spine (neck) procedures.

Infuse Complications

Medtronic allegedly neglected to inform patients and doctors of serious Medtronic Infuse problems related to the product and promoted the use of the protein in a number of unapproved settings, which helped generate sales of more than $3 billion for the manufacturer.

In 2002, the U.S. Food and Drug Administration (FDA) granted Medtronic approval for its Infuse Bone Graft System, but for limited use in the lumbar spine, or lower back, and for some oral and dental procedures. Specifically, the agency approved the Infuse Bone Graft System to treat degenerative disc disease and open fractures on the tibia. The FDA also approved the Medtronic Infuse bone graft for use in sinus augmentation and localized alveolar ridge augmentation.

However, the FDA has received numerous reports of Medtronic Infuse problems associated with its use in cervical spine fusions, for which it has not received FDA approval. These Medtronic Infuse problems include difficulty swallowing, breathing and speaking, as well as chronic pain requiring daily medication to manage. When used during these unapproved procedures, Medtronic Infuse side effects may cause excessive bone growth in areas where it is not wanted, which may cause:

• Nerve damage
• Male sterility and other uro-genital injuries
• Death

Medtronic is facing intense pressure regarding its Infuse bone graft. The FDA has issued safety warnings and  investigations were launched by the U.S. Department of Justice (DOJ) and the U.S. Senate. Medtronic is also accused of engaging in illegal “off-label” promotion of the Medtronic Infuse Bone Graft System.