Legal Information on the Medtronic Infuse® Bone Graft
Product Name: InFUSE® Bone Graft/LT-CAGE Lumbar Tapered Fusion Device
Manufacturer: Medtronic Sofamor Danek
Address: 1800 Pyramid Place Memphis, Tennessee 38132
Approval Date: July 2, 2002
What is it?
A device to help fuse vertebrae in the lower spine in order to treat degenerative disc disease. It differs from other, similar devices in that it uses genetically engineered protein to help build bone tissue in the fusion process, instead of using a graft of the patient’s own bone (an autograft).
The device consists of three components spilt among two parts:
• a metallic tapered spinal fusion cage (known as the LT-CAGE Lumbar Tapered Fusion Device); and
• a bone graft substitute (InFUSE� Bone Graft) which consists of a genetically-engineered human protein (rhBMP-2) along with a carrier/scaffold for the protein (manufactured from bovine [cow] Type I collagen) that is placed inside the fusion cage.
Oct. 25, 2012: Medtronic paid $210 million over 14 years in “consulting” and other fees to doctors who authored articles in medical journals that downplayed the risks associated with the Infuse Bone Graft system, according to a report from the Senate Finance Committee. The committee’s investigation determined Medtronic had a significant role in drafting, editing and shaping the content of articles that were supposed to be unbiased, resulting in an inaccurate portrayal of the product’s dangers and risks.
Did Your Spinal Fusion Surgery Have Dangerous Consequences?
Studies have linked Medtronic’s Infuse Bone Graft system to alarming and potentially fatal injuries that Medtronic allegedly spent millions trying to hide from consumers.
The dangers linked to Infuse when used off-label for spinal surgeries include:
• Uncontrolled Bone Growth
• Airway Swelling
• Nerve Damage