The Medtronic Infuse Bone Graft system is a cage type system implanted into the spine which containes a protein that is capable of initiating bone growth. The Medtronic Infuse Bone Graft has FDA approval to be used in the lumbar spine – or lower back. However, it has come to light that Medtronic pushed doctors to use the Infuse Bone Graft for the cervical spine – the neck – as well, without FDA approval. This non-approved use in the cervical spine has led to numerous complications including swelling of the face and neck and trouble breathing due to restriction of the airway. Others report difficulty swallowing and speaking. Unfortunately, even though the Infuse Bone Graft is not approved for use in the cervical spine, doctors receiving financial incentives from Medtronic have continued using them for cervical spine surgeries, including cervical spine fusions.
The Wall Street Journal has reported that Medtronic is being investigated becaue of the allegations that the company gave doctors numerous incentives to use the Infuse Bone Graft. Medtronic has paid out over $40 million to settle whistleblower lawsuits by former employees who alleged that Medtronic paid doctors to use the Infuse Bone Graft off-label and other spine products manufactured by Medtronic.
When implanted into the neck, the protein used by the Infuse Bone Graft can cause bone to form in teh neck, causing breathing and swallowing to be difficult, and can cause death. Doctors should stop this off-label use of the Infuse Bone Graft system and Medtronic should be held responsible for the harm it has created.