Recombinant human Bone Morphogenetic Protein (rhBMP) added to cervical spine fusion implants including Medtronic's INFUSE Bone Graft/LT-CAGEto induce new bone formation has been associated with reports of swelling of neck and throat tissue, a potentially life-threatening complication, according to FDA. Studies of patients who received the INFUSE device have also linked the protein to male sterility and increased cancer rates. The agency received 38 adverse event reports concerning rhBMP products between 2004 and 2008. Medtronic has also been accused of promoting INFUSE for off-label uses, resulting in nerve damage and paralysis.
It is estimated that 85% of surgeries using Infuse were performed off-label. Unfortunately, the off-label use of Infuse causes an over-promotion of bone growth which leads to significant nerve damage, even paralysis.”
... we strongly believe that the safety profile reported to the FDA and summarized in the product label support the safe use of rhBMP-2 for the identified indications. ”
—Omar Ishrak, Medtronic CEO
2002: Approved InFUSE Bone Graft/LT-CAGE Lumbar Tapered Fusion Device.
2008: Issued public health notification warning of "life-threatening complications associated with recombinant human bone morphogenetic protein in cervical spine fusion."
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[image courtesy of MEDTRONIC INC.]