INFUSE® Bone Graft was created to support the healing of degenerative disc disease. The bone graft contains two parts. The first part is a solution of human bone growth protein or morphogenetic protein-2. This protein is found in the human body in small dosages and is important for the healing and formation of bones. This protein is genetically engineered to utilize in Infuse Bone Graft and is necessary for the stimulation of formation and growth in bones. The second part of the bone graph is an absorbable collagen sponge. Both components of the INFUSE® Bone Graft structure are used to fill the LT-Cage Lumbar Tapered Fusion Device. This chamber is intended to restore the deteriorated disc space to its original height.
Spinal fusion is a surgical technique designated in the treatment of degenerative disc disease (DDD). This method is used after conventional treatments have failed to improve the degenerative process. Spinal fusion stabilizes the spine by fusing two adjacent vertebrae together, helping to reduce or completely remove back pains caused by degenerated discs in the patient’s spine. The specific spinal fusion the INFUSE® Bone Graft can be used in the following surgical procedures: an Anterior Lumbar Interbody Fusion procedure; laparoscopic anterior surgical approach; acute open tibial fracture with intramedullary nail; sinus augmentations; and localized alveolar ridge augmentations for defects related to extraction sockets.
The Food and Drug Administration never approved Medtronic’s INFUSE® Bone Graft for any other type of procedure other than for the treatment of spinal conditions and open fractures of the tibia. The device’s main benefits in these sanctioned procedures are enhancement of fusion rates, decreased length of some procedures and decreased post-operative hospital visits.
Using INFUSE® Bone Graft and performing other types of anterior and/or posterior spinal operations including surgery of the cervical spine; transforaminal interbody fusions; posterior lumbar interbody fusions; thoracic procedures; single or multilevel anterior fusions; or operating from the back side are considered to be off-label use. The designation of off-label use is considered utilizing a drug or medical device to treat a disorder that was not sanctioned by the Food and Drug Administration.
Using INFUSE® Bone Graft in off-label procedures can put patients at risk for significant injuries. Risks stem from the genetically engineered bone morphogenetic protein that can inflame tissue nearby the surgical site if the solution leaks or is not inserted properly. If either of these misfortunes occur, bone growth in areas outside of the designated surgical area can occur. Other serious situations can involve an inflammatory reaction, compressed airway or nerve impingement. These can lead to crippling pain, repetitive and unnecessary surgeries and, in extreme circumstances, emergency involvement to prevent death. If unnecessary bone growth occurs and another surgery is needed to remove it, the patient will be left with excruciating back or neck pain. This puts them right back where they started pre-incursion of the INFUSE® Bone Graft.
Other downfalls of using INFUSE® Bone Graft in an “off-label” manner are: problems with pregnancy including complications in fetal development; allergic reactions to titanium, bovine type I collagen or bone morphogenetic protein-2; infection; the creation or intensification of tumors; liver or kidney disease; lupus or human immunodeficiency virus (HIV/AIDS); problems with radiation, chemotherapy, or steroids if a patient is malignant; paralysis; bowel and/or bladder dysfunctions; sexual disorders including sterilization and incompetence; respiratory failure; excessive bleeding, and death. Complications are most prevalent in the anterior cervical spine; therefore, surgeons do not use it in this region anymore. Also, when doctors choose to perform off-label procedures, insurance companies such as Medicaid and Medicare refuse to pay for off-label surgeries.
Doctors determine if INFUSE® Bone Graft is a beneficial device to be used in off-label procedures because they are permitted to after the Food and Drug Administration’s approval. Congress has made it very clear that doctors are educated and practiced enough to determine how a device is used and how it can be beneficial to those that should use it. Unfortunately, in most cases, INFUSE® Bone Graft should not be utilized for off-label procedures, but only those sanctioned by the FDA.
If you or someone you know suffered painful injuries after being implanted with a Medtronic Infuse Bone Graft device, you may have valuable legal rights. We’re here to answer any questions you may have. For a free case review, please fill out our online form to the right or call our office at 1(888) 952-9757.