The
Medtronic Infuse Bone Graftis a bone filling material that contains a bone protein which stimulates bone growth and can be used to repair damaged spinal vertebrae. The Infuse Bone Graft consists of genetically recombinant human Bone Morphogenetic Protein (rhBMP-2) which is similar to the actual bone growth protein found in the human body. This eliminates the task of taking or grafting a bone from the hip or other areas and the patients can avoid excessive pain and lengthy recovery periods.
The US Food and Drug Administration's
approval of Medtronic's Infuse bone stimulator was only for use in spinal fusion surgeries of the lumbar spine or lower back and certain oral and dental procedures. However, it has been used for unapproved or off-label purposes based on surgeon's discretion. It is estimated that 85% of the uses of Infuse are off-label.
Safety Issues Involving the Medtronic Infuse Bone Graft Come to Light
Dr. Eugene Carragee, a Stanford University School of Medicine professor and editor-in-chief of the Spine Journal, recently pointed to evidence that some patients using the Infuse Bone Graft suffered serious health complications such as cancers (pancreatic, prostate and breast), infections, sterility in men, bone disintegration, and severe back and leg pain. In his interview to
Reuters, Dr. Carragee discussed his findings that showed BMP in Infuse leads to 2.5 times greater risk of developing cancer one year after it is used and five times increased risk after three years.
The US Senate and the Department of Justice has also raised concerns regarding the negative side effects of using Medtronic Infuse Bone Graft for spine surgery. According to the
Senate Finance Committee, the clinical trails conducted by Medtronic to test the safety and effectiveness of Infuse did not report any medial complications as a result of product usage. The Medtronic-funded internal study stated that the bone growth as a result of Infuse did not have any harmful effect on the patients. This was refuted by a comprehensive study that showed neurological impairment and other complications associated with irregular bone growth caused by the Infuse Bone Graft.
The
Senate Finance Committee also highlighted in their letter to Medtronic that one of the authors of the now debunked clinical trials received royalty payments from Medtronic in excess of several million dollars. That trial failed to report Infuse's link to higher rates of temporary or permanent sterility in men.
Medtronic Infuse Bone Graft Lawsuits
The use of Medtronic Infuse Bone Graft in the cervical spine has resulted in serious problems. Keefe Bartels is currently screening for cases in which a patient has used the Medtronic Infuse Bone Graft and later suffered any of the following:
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Sterility
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Cancer
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Hypertrophic Bone Growth, and other abnormal growth problems
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Death
If you or your family members have undergone cervical spine fusion or neck surgery and been treated with Medtronic Infuse Bone Graft, contact our competent lawyers at Keefe Bartels for a thorough evaluation on your case. All consultations are free of charge.
