Infuse Bone Graft Medical Device
The Medtronic Infuse bone graft is a genetically engineered liquid protein that helps the body to grow its own bone. It includes a bioengineered protein manufactured by Wyeth, called bone morphogenetic protein (BMP).
How is Infuse used? The Infuse bone implant is surgically placed between spinal vertebrae soaked in a sponge-like material and enclosed in a metal cage. BMP causes bone growth that replaces damaged disks by filling the gaps between vertebrae. Infuse is meant to eliminate the painful procedure of harvesting bone from elsewhere in the body.
In 2002, the FDA improved Infuse for the lower lumbar spine.
The FDA has only approved the Infuse bone stimulator for use in the lower lumbar spine, as Medtronic has not provided data establishing that it is safe and effective in other areas of the spine. However, since it was introduced in 2002, the medical device has been widely used off-label in the cervical spine.
The FDA has received at least 280 reports of Infuse bone graft side effects, and about 75% of the reports involved off-label use, particularly in the cervical spine. The close proximity of the cervical spine to airway structures has led to serious complications, many requiring emergency medical treatment.
Life-threatening cervical bone graft complications typically occur within 2 to 14 days after surgery. Some patients require insertion of feeding tubes, tracheotomies, anti-inflammatory drugs, and additional surgery to drain the implant site. Some patients are less fortunate; they suffocate to death.
Have you or a loved one suffered serious repercussions from the off label use of Infuse Bone Graft medical device? Has a loved one died? Talk to us to find out if you are eligible to file an Infuse lawsuit. Pain and suffering is avoidable and death is not optional.
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