The Medtronic InFuse Bone Graft is manufactured and sold by Medtronic, Inc.  It has been approved by the FDA for use in lumbar (lower back) spine-repair surgery to promote bone growth, including Degenerative Disc Disease (DDD).  The active ingredient used in the InFuse Bone Graft is a drug known as recombinant human Bone Morphogenetic Protien (rhBMP-2), a protein released naturally by the body that promotes bone growth. 

The InFuse Bone Graft is made of titanium and acts as a “cage” that houses and releases the rhBMP, which promoted bone growth.  According to the products direction, the rhBMP should be soaked first in a collagen sponge before being placed in the case.  Ideally, rhBMP causes bone growth that fills in the gap between vertebrae to replace damaged disks.

Medtronic has disclosed and various journalists have reported that the Department of Justice is investigating Medtronic for off-label marketing of the InFuse Bone Graft for cervical spine (neck) injuries.  As of July 2008, the FDA had received 38 reports of patients who have undergone off-label cervical spine (neck) injuries where rhBMP was used and the patients suffered complications.  And, at least one lawsuit has been filed alleging that use of the InFuse Bone Graft in a cervical spine surgery resulted in the death of the patient. 

FDA Health Notification Warning Against Use of the rhBMP in Cervical Spine Fusion

On July 1, 2008, the Food and Drug Administration (FDA) issued a Public Health Notification about life-threatening complications associated with recombinant human Bone Morphogenetic Protein (rhBMP) used in cervical (neck) spine fusion.  As the FDA has warned, rhBMP has been approved only for use in limited ways in limited patient populations and it has received 38 reports of patients who have had complications rom off-label use of rhBMP.  When rhBMP is used in the cervical spine fusion, it is potentially deadly because the rhBMP can cause swelling of neck and throat tissue, which results in compression of the airway and/or neurological structures in the neck.  Some patients have also described difficulty swallowing, breathing or speaking.  Other patients have also described severe dysphagia. 

It is unclear from the FDA warning letter whether the InFuse Bone Graft was used in all 38 reported incidents.  For instance, according to the Wall Street Journal, however, at least one surgeon has testified that he has used the rhBMP outside the Infuse Bone Graft by injecting it in “the fracture line,”? suggesting that at least some of the 38 FDA reported incidents might involve use of rhBMP, independent of the InFuse Bone Graft.  Patients who have had spinal fusion surgery in the neck area who experienced allergy-like reactions, including swelling of the neck and throat tissue, within two weeks of surgery may have experienced adverse reactions from rhBMP.  By contacting a lawyer and obtaining the surgical report, the attorney should be able to identify whether rhBMP and/or the InFuse Bone Graft are at issue.  

Get The Legal Help You Deserve Today

If you or a loved one underwent spine graft surgery in the neck area and suffered an allergy like reaction, contact us today for a confidential free case evaluation to determine whether rhBMP or the InFuse Bone Graft was used in your surgery.  You may have claims against the surgeon, Medtronic and/or Wyeth for the off-lable use of rhBMP and the InFuse Bone Graft. 

Published November 17, 2011 by