The Medtronic Infuse is used by surgeons to treat back pain and degenerative disc disease. Thousands of Americans receive Infuse every year to treat these conditions. What these patients may not know, however, is that Infuse has been linked to serious complications when used for cervical spinal surgeries.
Infuse is the trade name for bone morphogenetic protein, or rhBMP-2. It’s a bio-engineered bone growth protein that surgeons use to fuse two vertebrae together to strengthen the spine. Over 100,000 people each year receive Infuse treatment for spinal surgery in the U.S., including off label uses.
“Off-label” is the term for the use of a product in any manner other than its approved function. For example, Infuse is approved for anterior approach lumbar fusion surgery. The use of Infuse in the cervical region of the spine (the upper back and neck) is considered an off label use of the product.
In 2008, the FDA issued a warning about the dangers of using Infuse in cervical fusion surgeries. The warning underlined that fact that rhBMP-2 has never been approved for use in cervical spinal surgeries. The FDA cautioned against the use of Infuse in the cervical spine because of dangerous complications such as difficulty talking, eating or breathing.
When these complications occurred, medical intervention usually became necessary. Some patients required a tracheotomy, respiratory support with intubation, or second surgeries to drain the original surgery site.
If you or someone you love has experienced the dangerous complications linked to the off-label use of Infuse, then call O’Connor, Acciani & Levy for a free consultation.