The Medtronic Infuse Bone Graft System is a medical device designed for spinal repair. Developed, designed and manufactured by Medtronic, its meant to aid fusion between the vertebrae without needing the patient’s own bone to be harvested and implanted.

The U.S. Food and Drug Administration (FDA) approved Infuse for limited use in spinal fusion procedures where the lumbar spine is approached through the front. Any other use is considered “off-label.”

It’s estimated that as much as 90 percent of the Infuse bone grafts were implanted in spinal surgery patients for uses not listed on the label. This off-label usage is behind most of the Infuse bone graft lawsuits facing Medtronic, including the latest Infuse lawsuit filed by plaintiff Sylvia Domagalski. Her case concerns off-label use in a lumbar fusion procedure.

On Feb. 10, 2004, Domagalski reportedly  underwent an anterior lumbar interbody fusion. To achieve fusion, her surgeon “performed an off-label procedure by utilizing an anterior approach at multiple disc levels without the use the required LT-Cage.” Later that year, Domagalski was diagnosed with osteolysis and case migration that required costly additional medical treatment, including another surgery.

Domagalski alleges she sustained economic losses, pain and suffering. Moreover, she will continue to incur additional medical expenses as a result of the damages she has suffered as the exact nature of her injuries is still not known to date, according to her Medtronic Infuse lawsuit. Her bone graftlawsuit accuses Medtronic of fraudulent misrepresentation and fraud in the inducement, failure to warn, design defect, misrepresentation, negligence, breach of express warranty, and violation of Arizona’s consumer protection statutes. She is also seeking punitive damages.

The Infuse Bone Graft Lawsuit is Sylvia Domagalski v. Medtronic Inc., et al., in the U.S. District Court for the District of Arizona.

Infuse Bone Graft Complications

As Medtronic sells the Infuse bone graft separately, the off-label uses make up the largest part of the market, and the majority of its complications. When Infuse is used off-label, it can cause a patient severe injury, including Infuse-induced bone overgrowth and other issues that can necessitate revision surgery. Other issues can include “extreme inflammatory reactions, chronic radiculitis, retrograde ejaculation, sterility, osteolysis (bone resorption), displacement or migration of the spacer cage, pseudoarthrosis, and worse overall outcomes.”

Domagalski states that she “would not have consented to be treated with the off-label use of Infuse had she known of or been informed by Medtronic or by her spine surgeon of the true risks of the off-label use of Infuse.” According to her Infuse lawsuit, she relied on Medtronic’s case studies and reputation, which it turned out later was paid for by Medtronic.

History of the Infuse Bone Graft

Medtronic Infuse relies on bone morphogenetic proteins (BMPs). BMPs have been studied for years due to their ability to heal bone, decreasing the need for bone graft harvesting from other parts of the body. In their research, scientists isolated a specific gene from bone and tissue (rhBMP-2) to create genetically engineered cells. These cells, in turn, produce large quantities of rhBMP-2.

In 1995, Tennessee-based spinal device maker Sofamor Danek Group saw the potential of this protein and bought the exclusive rights to use it for spinal applications. In 1996, Sofamor Danek filed with the FDA for human testing. Medtronic purchased Sofamor Danek in 1999, and with it the use of rhBMP-2 liquid bone protein now known as Infuse.

On July 2, 2002, the FDA approved the Infuse Bone Graft System. A medical device containing an absorbable collagen sponge that is treated with rhBMP-2 was approved for one specific spinal fusion procedure with its LT-Cage.The initial approved labeling for Infuse indicated in bold, underlined formatting, “These components must be used as a system. The Infuse Bone Graft component must not be used without the LT-Cage Lumbar Tapered Fusion Device Component.” The labeling also specifies the manner in which both components are to be used in a fusion procedure. However, although the FDA only approved Infuse for spinal use with the LT-Cage, Medtronic sells Infuse separately and has done so since its approval in 2002.

On July 1, 2008, in light of reports of serious complications with BMP, the FDA issued a Public Health Notification to the healthcare community which strongly warned medical professionals of the serious complications that had occurred from the off-label use of Infuse and other BMP products in the cervical spine.