Infuse Bone Graft has a history of controversy, beginning with off-label usage that resulted in serious side effects. Now, surgeons involved in clinical trials for the product, along with Medtronic, Infuse's manufacturer, are currently being investigated for failing to report complications and serious side effects linked to the bone graft device.
Infuse is used as a substitute for bone in graft operations, and was originally approved by the Food and Drug Administration (FDA) for limited purposes in 2002. However, the product has been widely used by doctors for off-label purposes, which now account for 85 percent of its use. According to a warning given by the FDA in July 2008, these off-label purposes caused serious complications, such as acute severe neck swelling, that could result in death or permanent injuries.
Then, in May 2009, it was discovered that a study promoting the use of Infuse on severely injured soldiers contained false claims and overstated benefits. Dr. Timothy Kuklo, a former Army Surgeon and paid consultant for Medtronic, published the now retracted study in the Journal of Bone & Joint Surgery in August of 2008. However, he had not obtained the Army's permission and used false data.
Recently, The Spine Journal questioned the information Medtronic used to gain FDA approval for Infuse. According to the Journal, surgeons funded by Medtronic did not report a number of serious complications caused by Infuse, including:
The Spine Journal stated that in 13 clinical trials funded by Medtronic from 2000-2010, these complications occurred in 10-50% of patients using Infuse.
According to Medtronic, Infuse has been implanted in over 500,000 patients. Medtronic has commissioned researchers at Yale University to conduct an independent study on the safety of Infuse Bone Graft.