The U.S. Department of Justice has been investigating Medtronic due to allegations that the company was marketing use of the Infuse® Bone Graft for off-label uses. The company has also been accused of paying spinal surgeons to withhold information about the dangerous risks associated with using the Infuse® Bone Graft for certain off-label uses such as in the cervical spine.
Back in 2008, the U.S. Food and Drug Administration (FDA) issued a public health notification regarding the risks associated with using recombinant human Bone Morphogenetic Protein (rhBMP) products in the cervical spine.
“FDA has received at least 38 reports of complications during the last 4 years with the use of rhBMP in cervical spine fusion,” The FDA said in the notification.
The FDA said the complications involve:
- Swelling of the neck and throat tissue
- Compression of the airways
- Compression of the neurological structures in the neck
- Problems breathing, speaking and swallowing
- Severe dysphagia
For more information about the complications associated bone grafts, contact our Infuse® Bone Graft attorneys today.