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Published: November 17th, 2011
Off-label use of the Medtronic Infuse Bone Graft in the cervical spine has been associated with a number of serious and life-threatening complications. The U.S. Department of Justice is investigating the actions of Medtronic, Inc. and their off-label promotion of this product in violation of federal law.
MEDTRONIC INFUSE LAWSUIT STATUS: Potential legal claims are being investigated and reviewed for individuals who experienced cervical spine fusion problems involving the device.
MANUFACTURER: Medtronic, Inc.
OVERVIEW: The Medtronic Infuse bone graft is a man-made liquid bone graft that includes a biologically engineered protein called bone morphogenetic protein (BMP), made by Wyeth.
The bone stimulator is used to encourage bone growth and replace damaged spinal disks by filling the gaps between vertebrae. The Infuse is soaked in a sponge-like material and implanted between spinal vertebrae, enclosed in a metallic cage.
Since it was approved by the FDA in 2002, the Medtronic bone graft has been widely used during spinal fusions and has generated sales of over $3 billion.
While the Infuse bone graft is only approved for use in the lower lumber spine, it has been widely used off-label in the cervical spine which has been associated with life–threatening problems, such as:
- Difficulty Breathing
- Difficulty Swallowing
- Difficulty Speaking
- Swelling of the Neck
- Compression of Airways
- Nerve Damage
MEDTRONIC INFUSE CERVICAL SPINE FUSION SIDE EFFECTS: The close proximity of the cervical spine to the airway has caused a number of serious complications associated with use of the Medtronic Infuse bone graft in the cervical spine or neck fusions.
According to recent research presented by a group of North Carolina surgeons, the Medtronic Infuse cervical spine complication rate is about 59%, compared with a complication rate of 21% for bone grafts or collagen used in conventional cervical spine fusions.
The FDA issued a warning to healthcare providers in July 2008 highlighting at least 38 reports of cervical spine fusion problems with the bone morphogenetic protein in the Medtronic Infuse. The serious and life-threatening complications caused by airway compression have required a number of patients to receive respiratory support, tracheotomies, insertion of feeding tubes anti-inflammatory medications and additional surgery.
Most of the Medtronic Infuse bone stimulator complications have occurred within 2 to 14 days after surgery as the neck swells, compressing the airway and nerves.
JUSTICE DEPARTMENT MEDTRONIC INFUSE INVESTIGATION: On November 19, 2008, Medtronic disclosed that the Justice Department is probing their Infuse bone graft marketing and promotion to doctors and actions taken by the company that encouraged off-label use that has not been approved or determined to be safe by the FDA.