Medtronic Infuse Bone Graft

Manufactured and sold by Medtronic, Inc., the Infuse Bone Graft has been approved for use in lower spine-repair surgery to promote bone growth. Recently Infuse has been linked to several cases of death or life-threatening complications when used in surgeries on the upper spine and neck or other unapproved procedures. It is alleged that surgeons with financial ties to Medtronic promoted the use of the protein unofficially in a number of unapproved settings, and complications have included bone growths near nerves or in areas not targeted by the therapy. This has resulted in additional medical interventions and in some cases emergency surgery. While doctors are permitted to use approved medical devices in any way they see fit, it is illegal for manufactures like Medtronic to actively promote such uses.

FDA Issues Warning

On July 1, 2008 the FDA issued a public health warning to surgeons about reports of life-threatening complications associated with the use of the Infuse Bone Graft in surgeries on the cervical spine, around the neck.

The FDA had also received at least 38 reports of complications during the past four years associated with its use in cervical spine fusions, for which it is not approved. The complications included swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Other reports describe difficulty swallowing, breathing or speaking.

View the entire FDA warning >>>

Medtronic Infuse News Archive >>>

If you or a loved one have been injured as a result of the Medtronic Infuse Bone Graft you may be entitled to compensation. Contact the Infuse Bone Graft Attorneys of Ennis & Ennis today for a free case evaluation. Our experienced Medtronic lawyers can answer any questions you may have about a potential Medtronic Infuse lawsuit.