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Drug Injury Lawyers

Medtronic Infuse Bone Graft

Medtronic Infuse Bone Graft

The Medtronic Infuse® bone graft system is used in neck and spinal surgeries to help promote bone growth. Specifically approved by the U.S. Food and Drug Administration (FDA) in 2002 for use in anterior lumbar fusion surgery on adults (excluding pregnant women), the product has also been widely used for off-label purposes. The Infuse bone graft system has been used to treat more than 500,000 patients and has been used by more than 2,300 surgeons.

What is the Infuse bone graft system?

The Infuse system is a man-made liquid form of bone morphogenetic protein, or BMP. It is surgically implanted between vertebrae soaked in a sponge-like substance enclosed in a metallic cage. Ideally, BMP causes bone growth that fills in the gap between vertebrae to replace damaged disks; however, a number of health problems have been associated with the product.

Is the Infuse bone graft system dangerous?

After receiving a number of reports of serious complications in patients treated with the Infuse bone graft system, the FDA issued a statement, warning that off-label use of Infuse in cervical fusion procedures was unsafe.

What are the health risks?

Health risks of Infuse systems include:

compression of the airway and/or neurological structures in the neck
difficulty swallowing (sometimes severe), breathing or speaking
infection at surgical site
irregular bone growth
nerve pain or nerve damage
swelling of neck and throat tissue

The FDA reports most complications occurred between two and 14 days after surgery with only a few events occurring prior to the second day.

What should I do if I’ve been affected?

If you or someone you care about after undergoing surgery in which the Infuse bone graft system was used suffered serious health problems, contact our law firm today for a free and confidential case evaluation. We want to help.

Infuse® is a registered trademark of Medtronic, Inc.

This law firm is not associated with, sponsored by, or affiliated with the Food and Drug Administration or Medtronic, Inc.

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Have you or someone you love suffered a drug injury? Contact a Hughes & Coleman injury lawyer today! We serve clients in Bowling Green, Elizabethtown, Louisville, Murfreesboro, Nashville, Clarksville and Gallatin. Complete a Free Online Consultation Form or call us toll free at 1(800)489-6000 to contact us today.

Nashville 446 James Robertson Parkway Suite 100 Nashville, TN 37219 (800) 489-6000	Bowling Green 1256 Campbell Lane, Suite 201 Bowling Green, KY 42104 (800) 489-6000	Elizabethtown 2110 N. Dixie Ave. Suite 102 Elizabethtown, KY 42701 (800) 489-6000	Louisville 9300 Shelbyville Rd. Suite 110 Louisville, KY 40222 (800) 489-6000
Lexington 277 E. High Street, Suite 110 Lexington, KY 40504 (800) 489-6000	Murfreesboro 1501 Memorial Blvd. Murfreesboro, TN 37129 (800) 489-6000	Gallatin 1184 Nashville Pike Gallatin, TN 37066 (800) 489-6000	Clarksville 323 North Riverside Drive Suite 100 Clarksville, TN 37040 (800) 489-6000