The Medtronic Infuse bone graft might be a popular choice for some patients, but experts question whether the device is worth the risks. That’s an issue particularly when the Infuse bone graft is used in procedures it has not been approved for by the U.S. Food and Drug Administration (FDA).

Infuse is approved to be used on a patient’s lower lumbar spine, but according to Infuse side effects lawsuits, surgeons have been using Infuse on the upper neck, an off-label use for the bone graft.

Numerous Infuse bone graft complication lawsuits note problems when the device is used for off-label procedures. Among the problems cited in Infuse class action lawsuits is the potential for the device to cause major complications including immobility, male infertility, and death. Several inquiries have been launched as to why the device has been used for off-label purposes so often. Medtronic, the manufacturing company, allegedly promoted the device for off-label purposes to the medical community, according to Infuse lawsuits. In addition to being approved for spinal surgery, Infuse is also approved to be used in tibia fractures and some dental procedures to repair sinus cavities.

Medtronic’s Infuse is used in approximately 100,000 spinal fusion procedures per year in the United States, and has up 44 percent of the $1.9 billion bone graft market.

Overview of Infuse Bone Graft Complications

General risks of bone grafts include nerve pain, infection, and increased risk of cancer. The FDA has reportedly received hundreds of Infuse injury and adverse event reports, citing severe back pain, leg pain, difficulty breathing, and implant failure. Many of these injuries required corrective surgery, particularly after the Infuse was originally used for an off-label purpose surgery, according to Medtronic class action lawsuits. While it is not illegal for a doctor to use a drug or product for off-label purposes, it is illegal for a company to promote those uses.

On July 1, 2008, the FDA issued a Public Health Notification to health care providers to warn against the life-threatening complications associated with Infuse off-label surgeries including swelling in the upper neck area. Those who suffered these side effects reportedly needed respiratory assistance with intubation, medication or a tracheotomy.

Most commonly, the side effects reported from using the Infuse Bone Graft for off-label purposes include:

• Inflammatory Reactions
• Back and Leg Pain
• Radiculitis (pain that spreads through the spinal nerves)
• Implant Displacement
• Retrograde Ejaculation (occurs when semen enters the bladder)
• Male Sterility
• Cancer
• Infection
• Osteolysis (degeneration of bone tissue)
• Ectopic Bone Formation (unwanted bone in the spinal canal)
• Death