The Food and Drug Administration issued a public health notice on July 1, 2008, regarding the off-label use of the Medtronic Infuse bone graft that has not been FDA approved. The Infuse bone graft was approved for implantation in the lumbar spine in 2002 by the FDA. The notice was prompted after FDA received 38 reports over a four-year period of complications after the Infuse bone graft was implanted in the cervical spine.
The Infuse bone graft resembles a small cage and contains a bioengineered liquid bone protein known as recombinant human Bone Morphogenetic Protein (rhBMP) that is implanted into the spine for purposes of encouraging bone growth.
The following complications have been reported to the FDA by cervical spine patients receiving the Infuse bone graft (verbatim):
- Swelling of neck and throat tissue resulting in compression of the airway 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
Medical intervention is frequently necessary due to airway complications that manifest in two to fourteen days post-surgery and require treatment ranging from intubation to draining the surgical site with a second surgery. “Anatomical proximity of the cervical spine to airway structures in the body has contributed to the seriousness of the events reported and the need for emergency medical intervention,” per the FDA.
Medtronic, Inc., manufacturer of the Infuse bone graft, is currently being hit with numerous lawsuits tied to the off-label use of the implant for cervical spines with allegations such as:
- Concealing the risks associated with off-label use of the Infuse bone graft
- Failure to issue a warning that the surgical implant of Infuse bone graft can cause severe spinal cord and nerve damage
- Failure to report side effects associated with the surgical implant of Infuse bone graft into the back or neck
- Failure to sufficiently study rhBMP side-effects