Estey Bomberger is currently reviewing Medtronic inFUSE Bone Graft cases nationwide. If you or a loved one has experienced serious complications from a procedure involving the Medtronic INFUSE Bone Graft, contact our medical product liability attorneys immediately for a no-obligation consultation and review of your legal rights. Our staff is available 24 hours a day, seven days a week to discuss your potential case.
Medtronic INFUSE Bone Graft Approval and Warnings
The FDA approved the Medtronic INFUSE Bone Graft in 2002 to fuse vertebrae in the lower spine in order to treat degenerative disc disease. Unlike other devices that graft the patient’s own bone, the INFUSE Bone Graft uses genetically engineered protein to help build bone tissue. The device is approved to be used in the lower region of the spine (L4-S1) but has been widely used off-label in cervical (neck) surgery procedures. The FDA issued a warning on July 1, 2008, cautioning surgeons against off-label use, citing reports of potentially fatal complications when used in the cervical region of the spine.
Side Effects and Complications
In their warning, the FDA emphasized that the “safety and effectiveness of the recombinant human bone morphogenetic protein (rhBMP) have not been demonstrated” and that the use of the protein in cervical spine surgeries is not approved by the FDA. The FDA stated that serious complications could result from swelling of the neck and throat tissue, which could lead to airway construction and compression of the neurological structures. Side effects associated with INFUSE Bone Graft off-label use include:
- Uncontrolled bone growth
- Ectopic bone growth
- Inflammatory cyst formation
- Difficulty swallowing
- Difficulty speaking.
History of Off-Label Use of the Medtronic Infuse Bone Graft
By definition, “off-label use” is the use of a drug or medical device for purposes not specified in the labeling approved by the U.S. Food and Drug Administration. In certain instances, off-label use of devices has become generally accepted medical standard within the medical community. However, it is illegal to advertise medical products for off-label uses. The Wall Street Journal reported that Medtronic compensated a physician $800,000 to fabricate a study claiming positive results for the INFUSE device in a cervical surgery. Medtronic admittedly misled physicians and the public at large about the use of the Bone Graft, and failed to warn of the life-threatening side effects and complications associated with off-label use of the product.
When To Contact a Medtronic Bone Graft Lawsuit Lawyer
Your time to recover compensation is limited. If you have suffered injury, or if a loved one has died as a result of complications of receiving the Medtronic INFUSE Bone Graft, you may be entitled to substantial compensation for your injuries or loss. Damages many include money for medical care and treatment, lost earnings and wages, pain and suffering, and other damages. Estey Bomberger’s product liability lawyers have successfully handled a number of claims against Medtronic. To discuss your potential case with a Medtronic INFUSE Bone Graft lawyer, contact us today for a free and confidential consultation.