The FDA has warned about serious complications connected to the off-label use of Infuse® BMP spinal implants. 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.
The FDA has issued a public health notification regarding the use of BMP spinal implant in cervical spinal fusions. In this notification the FDA linked such products to a variety of injuries including:
- Swelling of the neck and throat
- Difficulty Breathing
- Compression of the nerves
- Difficulty swallowing
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.
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.
In addition to the reports of such adverse effects, a recent issue of the Spine Journal (June, 2011) indicated numerous problems with the process in which the Medtronic® Infuse® bone graft product was approved by the FDA in the first place. The Spine Journal points to a variety of conflicts of interests between the doctors reporting to the FDA that may have gone unreported.
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.
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.
For more information about injuries caused by the Infuse® BMP spinal implant, especially if such product was used in an off-label method, please review our website for further information.
Shezad Malik is an Internal Medicine and Cardiology specialist, a licensed Texas Medical Doctor and Defective Medical Device and Dangerous Drug Attorney. Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.