INFUSE is a product containing bone morphogenic protein (BMP), specifically, rhBMP or rhBMP-2, that is distributed by Medtronic. It is used in spinal fusion surgery involving replacement of damaged or diseased disk tissue. An INFUSE bone graft maintains the space previously occupied by the removed disk, as new bone tissue grows around it.INFUSE was approved in 2002 by the Food and Drug Administration (FDA) for treatment of sufferers of degenerative disk disease. The Center for Devices and Radiological Health (CDRH) of the FDA specified in its approval notification that the device was to be implanted in the lumbar spine (lower back) by way of an anterior open or laparoscopic approach.
Serious Complications Impact Patients
Meanwhile, Medtronic, the manufacturer, began reporting that research studies had showed that it could also be effectively implanted through a posterior approach. What Medtronic did not reveal was that doctors had reported serious complications after INFUSE implantation through a posterior opening. Furthermore, surgeons were using INFUSE for cervical (neck) fusion surgery, and patients reported distressing complications, including difficulty breathing.
Off-label use of INFUSE has been associated with many negative outcomes for patients, including nerve damage and a need for additional costly medical procedures. If you underwent lumbar spinal fusion surgery or cervical spinal fusion surgery and experienced complications, you may wonder if your surgeon used Medtronic’s INFUSE bone graft product. Your hospital bills may or may not have outlined the charges in this much detail. You may need to assert your right to find out from your orthopedic surgeon exactly what products were used in your bone graft surgery.
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Free Initial Consultation With an Infuse Bone Graft Class-Action Lawyer
For patients still struggling with complications caused by off-label use of Medtronic’s INFUSE, lawyers at Bailey, Javins & Carter, L.C., offer valuable information and assistance. We can help you join in on an INFUSE bone graft class action. Lawyers at our firm can advise you on how to recover compensation through an INFUSE lawsuit. Our plaintiffs’ attorneys have a great deal of experience handling medical malpractice and defective product cases in West Virginia. Contact our firm to schedule a free initial consultation with one of our plaintiffs’ attorneys in Charleston, Logan or Summersville.