We are no longer accepting INFUSE Bone Graft cases
The Medtronic INFUSE® Bone Graft is a bio-engineered protein accompanied by an absorbable collagen sponge (ACS) used to help regrow damaged bone tissue and replace damaged spinal discs. However, the system has been linked to severe, and sometimes life-threatening, injuries.
INFUSE® Bone Graft Linked to Severe Injuries
INFUSE® is approved by the U.S. Food and Drug Administration (FDA) for certain dental bone grafting procedures, shin bone fractures, degenerative disc disease, and lateral or posterior approach lumbar fusion procedures. INFUSE® is not approved by the FDA for any other use, despite the fact that Medtronic has marketed INFUSE® for off-label, or unapproved, uses to medical professionals.
According to The New York Times, the vast majority of the INFUSE® procedures involve off-label uses by doctors in spinal procedures. Medtronic INFUSE® Bone Grafts have been linked to dangerous injuries, including:
- bone dissolution
- difficulty breathing, swallowing, or speaking
- compression of the airway
- compression on the neurological structures in the neck
- permanent nerve damage
- ectopic bone growth
- inflammatory cyst formation
- male sterility
- uncontrolled bone growth
- worsened back pain
- radiating leg pain
Medtronic Faced Intense Scrutiny
In 2008, Medtronic was accused of paying $800,000 for a false study backing the off-label use of INFUSE® in cervical spine fusion procedures. That same year, the FDA issued a Public Health Notification that warned the public of life-threatening complications in cases where INFUSE® is used in surgical procedures targeting the cervical spine. Medtronic faced additional criticism in 2009, after the company admitted to paying for the fabricated study.
The company continues to face intense scrutiny regarding medical research supporting the safety of INFUSE®. In 2011, The Spine Journal, an international peer-reviewed medical journal, called research supporting widespread use of INFUSE® “biased and corrupted.” In that report, a group of spine specialists publicly repudiated the studies performed by the Medtronic-financed researchers, saying they had understated serious adverse effects connected with INFUSE®, including male sterility.
On October 25, 2012, a U.S. Senate finance inquiry, which reviewed internal Medtronic documents, found that the company paid about $210 million from 1996 to 2010 in consulting fees, royalties, and other payments to doctors involved in outside research on INFUSE®. The Senate inquiry also found that Medtronic edited published studies to play down risks associated with the INFUSE® while simultaneously trying to claim it was superior to competing products.
Cory Watson Attorneys settled their lawsuits and recovered compensation for their clients injured by Medtronic Infuse bone grafts.
*Cory Watson Attorneys is no longer accepting these cases.
INFUSE® is a trademark of Medtronic and is used here only to identify the product in question. This law firm is not associated with, sponsored by, or affiliated with the U.S. Food and Drug Administration; Medtronic; The New York Times; or The Spine Journal.