In March 2014, Medtronic indicated that the number of lawsuits over Infuse are likely to continue to grow significantly, and the manufacturer has indicated that it intends to defend its product in court. However, Medtronic has been accused of illegally promoting the device for non-approved uses, with a vast majority of sales for Infuse involving applications that were never approved by the FDA. The FDA approved Infuse recombinant human bone morphogenetic protein (rhBMP-2) for limited use during spinal fusion procedures where the lumbar spine is approached through the front and the product is applied to an absorbable collagen sponge that is placed within an “LT-Cage” that is implanted to encourage bone growth and fuse the gaps between the vertebrae. Over a six month period, the Yale researchers will review patient data from the clinical trials and the reports received by the FDA.Medtronic Infuse is a newer type of bio-engineered bone graft product that has been promoted as an alternative to traditional spinal fusions, where bone is harvested from another area of the body or used from a cadaver. Two months after the investigation began, Medtronic volunteered an independent review by researchers from Yale University of the Medtronic Infuse bone graft device.
This presents a conflict of interest if compensated surgeons were aware of these findings yet chose to promote the product usage as safe. If so, this would support a study that suggests the links to complications revealed during clinical trials. The goal of the investigation was to determine whether surgeons did not report complications from the off-label usage practices. The company had to submit financial records and other documents related to the interactions between surgeons and researchers at Medtronic. Senate began investigating the surgeons paid by Medtronic to use the Infuse bone graft device. However, it becomes illegal when the manufacturer promotes additional uses without FDA approval.Īs a result, the Finance Committee of the U.S.
#MEDTRONIC INFUSE PROFESSIONAL#
Patients have received additional medical treatment, some resulting in emergency surgery procedures.ĭoctors and surgeons are permitted to use professional judgment in using medical devices approved by the FDA. Surgeons promoted using the harmful protein in a variety of unapproved settings, which have led to complications and risks. These allegations focus on the financial ties between surgeons and researchers at Medtronic. Lawsuits have been filed against the makers of Medtronic Infuse, alleging the illegal promotion of the product for off-label purposes.
Why are There Lawsuits over Medtronic Infuse Usage? Some men may experience inverse ejaculation after receiving a bone graft procedure from the device.
There are additional links between Medtronic Infuse and male sterility. When the device is inserted improperly, bone growth may occur outside the original surgical site. Tissue surrounding the area where the device is inserted may become inflamed. The Infuse bone graft device contains an artificial protein. Further, patients also reported difficulty with speaking, breathing and swallowing. Nearly 38 reports of complications were associated with the off-label usage of the Medtronic Infuse device at the time of the warning. This can lead to compressed airways or neurological structures in the patient’s neck. When used on the cervical spine or neck, the Medtronic Infuse bone graft device may cause throat and neck tissues to swell. The FDA issued a public health warning in 2008 to surgeons following reports of life-threatening complications. The FDA approved this device for specific uses that did not include the neck or backside areas. Off-label refers to using a medical device for purposes not approved by the FDA (Food and Drug Administration). The practice of off-label use of the Medtronic Infuse bone graft device is dangerous for patients.
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