Following a 16 month investigation of the Medtronic Infuse Bone Graft, the United States Senate Finance Committee has released its report concerning the dangers of the medical device. The congressional report charges that Medtronic intentionally manipulated the research it used to promote “off-label” use of the bone graft product and minimized side effects of the device.
In addition, the report disclosed Medtronic’s payment of $210 million to doctors who wrote Medtronic-sponsored studies. A report published by The Spine Journal in 2011 found that these studies under-reported or completely omitted information regarding safety concerns about the defective medical device. The Spine Journal investigation found that the doctors who had been paid by Medtronic failed to accurately report serious side effects associated with the Infuse bone grafts.
The U. S. Food and Drug Administration approved the Medtronic Infuse Bone Graft for anterior approach lumbar spine fusion in 2002. Since that time, Infuse has been used in approximately 500,000 patients. After numerous reports of serious side effects, the FDA warned against off-label use of the Infuse Bone Graft.
Off-label use of Infuse can result in swelling in the neck and throat, blockage and compression of airways, difficulty swallowing, breathing and speaking, excessive bone growth leading to nerve damage, paralysis, osteolysis, bone loss, male sterility, and cancer.
Numerous lawsuits have been filed against Medtronic for illegal promotion of off-label use of Infuse and resulting injuries.
For more information, contact the Ohio Medtronic Infuse bone graft attorneys at Clark, Perdue & List.