As far back as 2012, a Senate report outlined many of the same allegations found in Infuse lawsuits. These claims include allegations that Medtronic Inc., the makers of the Infuse Bone Graft System, inappropriately influenced research publications about their medical implant.

The Infuse Bone Graft System is a medical implant designed to encourage new bone growth. The Infuse Bone Graft System is approved by the U.S. Food and Drug Administration (FDA) for a number of dental and oral surgeries, but it is perhaps best known for use in spinal fusion surgery.

Spinal fusion surgery is a procedure designed to repair damage to spinal discs. Spinal discs cushion and support the spine, but injuries and aging can cause these discs to fail — painfully. Spinal fusion surgery uses new bone growth to fuse adjacent backbones together into a single bone, working around a damaged disc.

In regular spinal fusion surgeries, surgeons harvest a small amount of bone from elsewhere in the patient, usually the thick parts of the hip bone, and use this bone to join the vertebrae together. However, the Infuse Bone Graft System works differently.

The Infuse Bone Graft System uses a metal support cage to hold the bones together and a bio-engineered protein to trigger new bone growth. As the bone grows around the metal cage, the device reinforces the new spinal bone in this new type of spinal fusion surgery.

But thousands of Infuse lawsuits have alleged that the Infuse Bone Graft System is more dangerous — and that Medtronic lied about possible Infuse side effects.

Infuse lawsuits have alleged that the Infuse Bone Graft System is dangerous and that Medtronic suppressed information about these dangers. Allegedly, the Infuse Bone Graft System can cause uncontrolled bone growth.

Since the Infuse Bone Graft System is designed for use in the nerve- and muscle-rich tissues of the spine, uncontrolled bone could be a serious problem, as intruding bone could interfere with delicate nerves, causing anything from numbness to paralysis.

According to the 2012 Senate report, Medtronic exerted undue influence over researchers studying the safety of the Infuse Bone Graft System. Allegedly, Medtronic ordered researchers funded by the company to alter research papers before publication.

One alleged incident involved Medtronic officials telling researchers to remove a detailed table describing Infuse side effects from the final paper. The researchers chose to do so, and the table does not appear in the version of the research paper that was eventually published.

Also, Medtronic allegedly engaged in a large-scale clandestine marketing program, including altering research papers to both downplay Infuse side effects and to illegally promote the Infuse Bone Graft System well beyond its FDA approval. Some of these off-label uses allegedly include some that risk life-threatening side effects.

For example, the FDA’s approval for using the Infuse Bone Graft System in spinal fusion surgery only extends to using the device in lower back. Allegedly, Medtronic-backed papers have illegally promoted the device for spinal fusions in the neck, where the device can promote dangerous swelling, which can close the windpipe.

Medtronic is accused of funding research promoting these off-label uses, in which researchers did not disclose financial conflicts of interest.