The Medtronic Infuse® Bone Graft is used during surgery to stimulate bone growth by attracting the body's bone-building cells to the site. It consists of two parts, a genetically engineered version of a protein that the body produces (rhBMP-2) and a natural carrier for delivery.
The Medtronic Infuse® Bone Graft was approved to treat degenerative disc disease and open fractures on the tibia in 2002. It is only approved for use in the lower back (lumbar spine) and for certain oral and dental procedures.
The Medtronic Infuse® Bone Graft is not approved for use in the cervical spine. In fact, the U.S. Food and Drug Administration (FDA) warned against using it for off-label uses such as in the cervical spine due to a possible risk of complications.
In 2008, the FDA warned that use of rhBMP in the cervical spine fusion could cause serious complications such as swelling of the neck and throat tissue, resulting in compression of the airway or neurological structures in the neck.
Complications have been associated with using the Infuse® Bone Graft for off-label uses, including:
Despite complications, Medtronic has been accused of promoting use of the Infusion® Bone Graft for cervical (neck) spine fusion to make a profit. The company has also been accused of paying surgeons to use the device in off-label procedures. Some surgeons are also accused of failing to report complications during clinical trials.
Lawsuits against the company are being investigated. If you or someone you love experienced complications following spine graft surgery in the neck area, you may be entitled to compensation if the Infuse® Bone Graft was used during surgery.
To find out if you qualify to seek compensation by filing a lawsuit, contact us today. Our attorneys will review your circumstances in a free case review to determine if you have a legitimate claim.