The off label use of Medtronic Infuse(R) bone graft has been associated with severe side effects including in some cases, death.
Medtronic Infuse(R) Bone Graft What is It?
Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. designed and marketed the Infuse(R) Bone Graft device (“Infuse(R)”) for lumbar spine surgery. Infuse(R) is a bio-engineered bone filling material containing a bone morphogenetic protein (“BMP”), and is used as an alternative to grafting a patient’s own bone.
Infuse(R) is a genetically engineered protein -rhBMP to help fuse vertebrae in the lower (lumbar) spine in order to treat degenerative disc disease.
Side Effects including:
Excessive swelling of the neck
Difficulty swallowing, or speaking
Compression of the airway
Medtronic Infuse(R) Off Label Use
Infuse(R) Bone Graft, is only approved for a limited surgical procedure, but Medtronic allegedly illegally promoted it for a number of off-label procedures according to a pending lawsuit filed in the Superior Court of California. Case No.: BC465313
Medtronic Infuse(R) only cleared for Anterior Lumbar Surgeries
Infuse(R) was approved by the Food and Drug Administration (“FDA”) on July 2, 2002, for use only in the lower region of the spine (at levels L4 through S1) to treat degenerative disc disease, and was approved only for anterior surgeries at L4 through S1.
That meant that it was initially approved only to be used by surgeons, when the surgeons placed the cage within the vertebrae in the lumbar region of the back, and only by entrance through the abdomen.
Infuse(R) has never been approved by the FDA for use in other parts of the body or for use in any other type of procedure, and any such uses are “off-label” uses.
The Medtronic California Infuse(R) Lawsuit
The plaintiff alleges that while physicians may use FDA-approved medical devices in any way they see fit, companies are not permitted to promote off-label uses for their medical devices or to pay doctors inducements or kickbacks to promote the off-label uses or to perform procedures using the devices off-label.
FDA Adverse Event Reports
At least 280 reports of adverse events involving Infuse(R) have been made to the FDA. Approximately 75% of those reports involve off-label use.
On July 1, 2008, the FDA issued a Public Health Notification about complications from the off-label use of Infuse(R) in the neck, or cervical, area of the spine. The FDA reported that it had received 38 reports over a four year period through July 1, 2008, of complications from cervical uses of Infuse(R); and, that some reports were of life-threatening and fatal events. Some of the complications were associated with swelling of the neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck, and patients reported difficulty swallowing, breathing and speaking.
Several patients required emergency treatment, including tracheotomies and the insertion of feeding tubes. FDA Public Health Notification: Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion, issued July 1, 2008.
Dr Shezad Malik recommends that folks who have been treated with Infuse Bone Graft and experienced side effects outlined above should fill out a MedWatch Form at www.fda.gov and explore their legal rights.