Medtronic INFUSE Bone Graft
INFUSE is a type of bone graft manufactured by Medtronic Inc., the industry leader for bone graft products. In 2011 alone, Medtronic’s INFUSE bone grafts accounted for 44 percent of the total U.S. bone graft market – a total $900 million in INFUSE sales. Even more, Medtronic’s blockbuster product claims 90 percent of the national bone morphogenetic protein (BMP) market; BMP bone grafts are one of the most popular types of graft, which also include allograft bone, bone substitutes, cell-based matrices, and demineralized bone products.
Bone grafts are essentially bone substitutes or replacements, and may be crafted from a patient’s existing bone, animal bone, or synthetic products. INFUSE products are utilized in spinal fusion surgery, traumatic tibial fractures, and two dental procedures, sinus augmentation and localized alveolar ridge augmentation.
Despite high sales, these products have been linked to INFUSE bone graft problems including:
- Bone and nerve injuries
- Male sterility
- Urinary problems
- Increased risk of cancer
Manufacture Medtronic has been accused of downplaying these risks – including unethically influencing medical reports – to the general public and the medical community. The resulting INFUSE lawsuits allege deceptive marketing practices and other unethical behavior that made patients vulnerable to serious injuries.
What are bone grafts?
Bone grafts are used to replace, augment, or repair bone damage. In the United States, an estimated 84 percent of all bone grafts are used during spinal fusion surgery, a procedure to repair back damage and related pain. The surgery costs about $34,000, and U.S. surgeons perform approximately 432,000 spinal fusions every year. INFUSE Bone Grafts are one of the most popular products used in this type of surgery, and tack about $2,500-$5,000 onto the already costly procedure.
There are two basic types: natural bone grafts, which are derived from real bone, and bone substitutes, which utilize manufactured materials to reproduce bone-like substances.
Natural Bone Grafts:
- Autogenous bone grafts: Also known as autografts, this type of graft is derived from a patient’s own bones, typically from the tibia, hip, jaw, chin, or skull.
- Allogeneic bone grafts: Also called allografts, these grafts are harvested from other humans (usually cadavers).
- Xenogenic bone grafts: These bone grafts are derived from non-human animal bone, often bovine (cow) bones.
Bone Graft Substitutes:
- Demineralized Bone Matrix (DBM) and Demineralized Freeze-Dried Bone Allograft (DFDBA): This bone graft substitute is derived from processed allograft bone. Typically, it is comprised of extracted collagen, proteins, and growth factors.
- Ceramic bone grafts: Ceramics can also be used in bone grafting, providing a porous (mesh-like) surface to allow for bone growth.
- Graft composites: This type of graft combines the benefits of several types of bone graft to form a composite product. For example, one popular composite blends collagen and ceramic.
- Bone Morphogenetic Proteins (BMP): These grafts utilized manufactured versions of naturally occurring proteins. Medtronic’s INFUSE bone graft is a BMP graft.
What are INFUSE bone grafts?
INFUSE Bone Grafts are a synthetic product made from bone morphogenetic proteins (rhBMP-2) – manufactured versions of naturally occurring proteins, which are usually tasked to regulate bone formation and healing. An INFUSE Bone Graft blends rhBMP-2 with cow collagen, which is then injected into the patient to alleviate pain and perform other functions.
The demand for synthetic bone grafts arose because bone harvesting can be risky. In autografts – bone taken from the patient’s body – harvesting can cause infection, pelvic fracture, bruising and pain. Donated bone, either from other humans or animals, carries the risk of disease and infection. It is also difficult to control bone quality. BMP, on the other hand, is synthetically produced, making it easier to control and monitor. But it is expensive ($2,500-$5,000 extra per surgery), and carries its own set of serious and possibly life-threatening risks.
Editorial reveals unethical behavior
In 2011, The Spine Journal published a study headed by Dr. Eugene J. Carragee and several other colleagues. The article revealed that Medtronic had funded several INFUSE studies, and that researchers for those studies had received $1 to $23 million yearly in so-called consulting fees. Immediately following the editorial, the U.S. Senate launched an inquiry into Medtronic’s behavior.
Sen. Max Baucus (D-Montana) commented, “Medtronic’s actions violate the trust patients have in their medical care.” Medtronic “vigorously disagreed” with the report.
Side effects of INFUSE bone grafts
INFUSE bone grafts received FDA approval in 2002, and feedback and data is limited. However, preliminary studies have associated the product with severe complications. Dr. Carragee asserted that the incidence of complications is 10 to 50 percent greater than originally reported.
INFUSE side effects may include:
- Serious infection
- Male sterility
- Retrograde ejaculation (semen reversing and entering the bladder)
- Increased cancer risk
- Osteolysis, or bone loss and tissue degeneration
- Persistent pain, usually in the back or legs
- Implant displacement
- Radiculitis, a type of spinal nerve pain
- Ectopic bone formation (unwanted bone growth along the spinal canal)
Medtronic INFUSE lawsuits
Due to the popularity of INFUSE bone grafts, it is possible that thousands of Americans have been injured by the medical products since 2002. For years, many of the injured had no idea that their symptoms were caused by a defective bone graft. But Dr. Carragee’s 2011 report helped both surgeons and patients now understand the warning signs.
Many patients who have suffered INFUSE bone graft problems have already started to fight back. Take April Cabana, a 34-year-old woman who lived a happy life until, she claims, an INFUSE bone graft left her with back pain so severe, she was forced to stop working and go on disability. Or an unnamed surgeon who herself had to stop working, due to severe and permanent injuries allegedly caused by an INFUSE bone graft.
INFUSE lawsuit actions not only allege complications from the bone graft, but also deceptive marketing and the unethical practices in which Medtronic allegedly engaged.
- The Spine Journal, A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lesson learned, http://www.spine.org/Documents/TSJJune2011_Carragee_etal_CriticalRev.pdf
- Medtronic, Addressing Safety Concerns with INFUSE® Bone Graft, https://www.infusebonegraft.com/pdf/Just%20The%20Facts%20Safety%20Reprint.pdf
- CBS News, Report: Medtronic influenced studies on InFuse bone grafts, http://www.cbsnews.com/8301-204_162-57540533/report-medtronic-influenced-studies-on-infuse-bone-grafts/
- FDA, InFUSE™ Bone Graft/LT-CAGE™ Lumbar Tapered Fusion Device - P000058, http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm083423.htm
- FDA Public Health Notification: Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion, http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062000.htm