Infuse Bone Graft
It has been reported that off label use of the Medtronic Infuse bone graft can potentially cause serious medical issues and complications, including difficulty speaking or swallowing, compression of the airway, nerve damage and even death.
Infuse Approval And Investigation
Infuse is the trade name for bone morphogenetic protein or BMP-2, which promotes bone growth. The BMP-2 is placed inside a small cage and then implanted in the patient.
In 2002, the Food and Drug Administration (FDA) approved Infuse for the use of stimulating spinal bone growth in patients with a degenerative disease affecting the lower spine. According to Medtronic, Infuse has been used to treat more than 500,000 patients.
On October 25, 2012, Senate Finance Committee Chairman Max Baucus (D-Mont.) and senior member Chuck Grassley (R-Iowa) released the results of their 16-month investigation into Medtronic, which revealed questionable ties between the medical technology company and the physician consultants tasked with testing and reviewing Medtronic products.
Contact Our Attorneys In Southern California
If you or someone you love has received an Infuse bone graft and is suffering from it, call our law firm at 818-991-8900 or contact our lawyers online to set up a time to talk with our team about your injuries.
July 2, 2002: FDA Approval letter to Medtronic – https://www.accessdata.fda.gov/cdrh_docs/pdf/P000058a.pdf
July 2, 2008 FDA Notice: FDA Public Health Notification: Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion – https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062000.htm
October 25, 2010: United States Committee on Finance: Baucus-Grassley Investigation into Medtronic Reveals Manipulated Studies, Close Financial Ties with Researchers – https://www.finance.senate.gov/newsroom/chairman/release/?id=b1d112cb-230f-4c2e-ae55-13550074fe86