Another Medtronic Infuse lawsuit has been filed as a result of complications allegedly caused by the use of Medtronic’s bone replacement graft during a cervical fusion.
Medtronic has been accused of marketing the Infuse Bone Graft off-label for use in the cervical spine, even though it is only approved for use in the lumbar spine and for some dental procedures, and reports suggest that it could cause serious and potentially life-threatening injuries.
The Infuse bone replacement graft is a man-made, liquid bone stimulator that is implanted between spinal vertebrae. It contains Bone Morphogenetic Protein (BMP), which is a bioengineered protein that encourages bone growth to replace damaged spinal disks.
In what is believed to be at least the third Medtronic Infuse Bone Replacement Graft lawsuit filed in the United States, Paul Antonelli and his wife allege that use of the product during his cervical spine fusion caused him to suffer severe swelling in the neck and throat, which impacted his ability to breath and led to the an emergency tracheotomy after surgery.
The lawsuit was filed against Medtronic, Inc. and Medtroonic Sofamor Danek USA, Inc. in the U.S. District Court for the Southern District of New York.
Use of the Medtronic Infuse Bone Replacement Graft during cervical fusion surgery has been associated with a high rate of serious complications involving compression of the airway and nerves. Given the close proximity of the cervical spine to the airway, a number of patients who received the bone stimulator have experienced difficulty breathing, speaking or swallowing between 2 to 14 hours after surgery, which could lead to respiratory arrest or death.
In December 2008, a Medtronic Infuse wrongful death lawsuit was filed on behalf of a California woman, Shirley Nisbet, who died after going into a coma caused by respiratory arrest following surgery. The Infuse bone replacement lawsuit alleged that Medtronic failed to warn about the risks associated with use of the device in the neck, and claims that Medtronic actively encouraged the off-label use which has not been approved by the FDA.
According to reports on Minnesota’s Finance and Commerce, another Medtronic lawsuit was filed earlier this month by Mary Selke, a Texas woman who claims that the use of the Infuse bone graft in her neck caused her to suffer an inability to breath and swallow, requiring emergency surgery.
The U.S. Department of Justice is currently investigating Medtronic’s promotion and marketing of the Infuse bone replacement and whether federal laws have been violated by pushing use in areas of the spine which they have not established are safe or effective.
Other Medtronic lawsuits are likely to be filed in the coming months, as Infuse bone replacement lawyers are investigating and reviewing potential cases on behalf of individuals who experienced complications after use of the bone graft in the neck.