The Medtronic INFUSE® Bone Graft is used to help regrow damaged bone tissue and replace damaged spinal discs. The INFUSE® Bone Graft system has been linked to severe, and sometimes life-threatening, injuries.
Medtronic INFUSE® Bone Graft is a bio engineered protein accompanied by an absorbable collagen sponge (ACS) used as an alternative to a bone graft harvested from a patient’s hip. INFUSE® is approved by the U.S. Food and Drug Administration (FDA) for the following uses:
• certain dental bone grafting procedures
• shin bone fractures
• degenerative disc disease
• 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, and, according to The New York Times, the vast majority of the INFUSE® procedures involve off-label uses by doctors in spinal procedures.
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.
Medtronic INFUSE® Bone Grafts have been linked to severe 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
Get Legal Help Today
If you or a loved one has had a surgical procedure using the Medtronic INFUSE® Bone Graft and suffered a serious injury as a result, you may be entitled to compensation. Contact VanDerGinst Law for a free consultation. Call 309-793-1234 or e-mail email@example.com.