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Medtronic Infuse Bone Graft
Medtronic Infuse Bone Graft is a man-made liquid bone graft that uses recombinant human Bone Morphogenetici Protein (rhBMP-2), and is used to encourage bone growth and replace damaged spinal disks.
The FDA approved the Infuse Bone Graft in 2002 for the limited use in the lumbar spine, or lower back, and for some oral and dental procedures. But, it has been reported that it has been used off-label during neck surgery/cervical (FDA review of use of the infuse bone graft). Recently, Medtronic has come under fire by the U.S. Justice Department for its marketing and promotion efforts.
POTENTIAL PROBLEMS: MEDTRONIC INFUSE BONE GRAFT
When the Infuse Bone Graft is used - off label - in neck cervical spine surgery, it may be associated with a number of serious problems, complications or injury/injuries which usually occur within 2 to 14 days following neck/cervical surgery. Some of the problems, complications or injury/injuries may be:
- Difficulty Breathing
- Difficulty Swallowing<
- Difficulty Speaking
- Compression of the Airway
- Respiratory Depression
- Nerve Damage
- Death
On July 1, 2008, the FDA alerted physicians of reports of life-threatening complications, problems or injury associated with recombinant human Bone Morphogenetic Protein (rhBMP) when used in the cervical spine and that the Medtronic Infuse Bone Graft had not been approved for use in this area and was considered an off label use of the product.
In addition, the FDA reported that it has received at least 38 reports of complications during the last 4 years with the use of rhBMP in cervical spine fusion. These complications were associated with swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck.
Some reports describe difficulty swallowing, breathing or speaking. Severe dysphagia following cervical spine fusion using rhBMP products has also been reported in the literature.
If you are suffering a side effect/injury from use of the infuse bone graft - off label - in neck cervical spine surgery, please seek and consult with your healthcare provider as soon as possible.
Please navigate to the links below to find more information on a variety of topics and what you can do to protect your legal rights or contact us.
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