The Infuse Bone Graft System has been under fire from safety concerns and marketing practices. However, a recent study suggests the device may be safe in some uses, though other studies and numerous Infuse lawsuits have alleged Infuse is dangerous.

The Infuse Bone Graft System is a medical implant designed to assist with spinal fusion surgery. In older-style spinal fusion surgery, a physician would harvest redundant bone from elsewhere in the body and use this “donor” bone to fuse two adjacent backbones together.

This procedure is designed to strengthen the spine and work around damaged spinal discs. The Infuse Bone Graft System is different in that the implant contains a bioengineered gel designed to encourage the bones to grow together without donor bone. But the Infuse Bone Graft System has been dogged by concerns regarding safety — as well as marketing practices.

New research out of Northwestern University in Chicago suggests that one of several concerns with the Infuse Bone Graft System may be unfounded. In this study, researchers pooled data from several earlier studies and found no evidence of an increased risk of cancer in patients who had the device implanted in their spines. The researchers said that on this one issue, the device might be safer than believed, though it is still not recommended for cancer patients.

However, other studies, as well as hundreds of Infuse bone graft lawsuits, focus on other alleged side effects associated with the Infuse bone graft. Many of the Infuse lawsuits allege that the Infuse Bone Graft System can cause uncontrolled bone growth. Since the spine is rich in critical nerves and musculature, this intrusive bone growth could cause large amounts of damage to sensitive tissue.

Additionally, it has been alleged that Medtronic Inc., the makers of the Infuse Bone Graft System, have engaged in an illegal, clandestine marketing campaign for the Infuse Bone Graft System.

Under federal law, a drug or medical device manufacturer is legally obligated to separately apply for U.S. Food and Drug Administration (FDA) approval for each intended use for their device or drug. Medical companies like Medtronic are legally forbidden from promoting their wares for any purpose other than those approved by the FDA.

However, physicians may use a device beyond this approval, called “off-label” use, if there is sufficient research for such a judgment call. But medical companies are strictly forbidden from marketing drugs or medical devices like the Infuse Bone Graft System for such off-label uses.

The various Infuse lawsuits against Medtronic have alleged that the medical device maker illegally marketed the device for off-label use through an elaborate, covert campaign.

Allegedly, Medtronic hired “opinion leaders,” which are typically surgeons of large orthopedic hospitals, to promote the device for off-label use. The work of opinion leaders included workshops and publishing peer-reviewed publications promoting off-label uses for the Infuse Bone Graft System.

The Infuse Bone Graft System was only approved for a very specific type of spinal fusion surgery in the lower back. If Infuse bone graft lawsuit plaintiffs can prove off-label marketing, it could greatly complicate Medtronic’s standings in these cases.

Despite the new findings, concerns, both medical and legal, remain over the Infuse Bone Graft System. Medtronic has already agreed to a $22 million payout to settle roughly 950 Infuse Bone Graft System lawsuits.