INFUSE BONE GRAFT FREE

It is legal for doctors to use approved medical devices off-label, but it is illegal for companies to market their products for unapproved uses. Off-label use occurs when a medical device or drug is utilized for purposes not specifically approved by the FDA. The complaints involve allegations that Medtronic failed to adequately warn about the risk of unwanted bone growth and actively encouraged use of the Infuse bone graft during procedures that were not only unapproved, but that the device maker knew or should have known posed an increased risk of serious injury or death. It’s also sometimes called plastic surgery, because the new tissue will look very much like your other bone structures. This is a legal process where someone (usually a doctor) creates new bone tissue in your body.

Medtronic continues to face a growing number lawsuits over Infuse bone graft side effects, which have been filed by individuals throughout the United States who experienced problems after receiving the product off-label. You may have never heard of an infuse bone graft lawsuit. In 2008, the FDA issued an alert advising doctors not to use the Medtronic Infuse in upper spinal fusion procedures, after receiving a large number of reports involving deaths and other complications that resulted from swelling of the neck and breathing difficulties. It was approved by the FDA in 2002 for use during anterior lumbar fusion surgery, but it has been widely used off-label during other types of spinal surgery, which have been found to carry a risk of inflammatory reactions, airway compressions, nerve damage and other health problems. This law firm is not associated with, sponsored by, or affiliated with the Food and Drug Administration or Medtronic, Inc.Medtronic Infuse is a bioengineered bone morphogenetic protein (BMP), which is used to encourage bone growth and replace spinal disks by filling the gaps between vertebrae. The Medtronic Infuse bone graft system is used in neck and spinal surgeries to help promote bone growth.

Infuse® is a registered trademark of Medtronic, Inc. The FDA reports most complications occurred between two and 14 days after surgery with only a few events occurring prior to the second day. difficulty swallowing (sometimes severe), breathing, or speaking.compression of the airway and/or neurological structures in the neck Medtronic Infuse is a bioengineered bone morphogenetic protein (BMP), which is used to encourage bone growth and replace spinal disks by filling the gaps.INFUSE Bone Graft should not be implanted in patients with an active infection at the operative site. The potential effects of rhBMP-2 on the human fetus have not been evaluated. INFUSE Bone Graft should not be used in pregnant women. Also known as BMP-2, Infuse contains recombinant human Bone Morphogenetic Protein (rhBMP), a genetically engineered version of a natural protein which stimulates bone growth. INFUSE Bone Graft should not be used in patients with compartment syndrome of-the affected limb. Is the Infuse bone graft system dangerous?Īfter 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. The Infuse bone graft was developed by Medtronic and approved by the Federal Drug Administration (FDA) in 2002 for use in some surgical procedures. 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. It has 3 components: recombinant human bone.

It is surgically implanted between vertebrae soaked in a sponge-like substance enclosed in a metallic cage. Infuse is a synthetic bone graft system indicated for spinal fusion available from Medtronic.

The Infuse system is a man-made liquid form of bone morphogenetic protein, or BMP. (rhBMP-2, known as dibotermin alfa) placed on an absorbable collagen sponge.

INFUSE BONE GRAFT FREE

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. INFUSE Bone Graft consists of recombinant human Bone Morphogenetic Protein-2. 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. 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 Medtronic Infuse® bone graft system is used in neck and spinal surgeries to help promote bone growth.