The practice of off-label use of the Medtronic Infuse bone graft device is dangerous for patients. Off-label refers to using a medical device for purposes not approved by the FDA (Food and Drug Administration). The FDA approved this device for specific uses that did not include the neck or backside areas.
Risks Associated with Medtronic Infuse
The FDA issued a public health warning in 2008 to surgeons following reports of life-threatening complications. When used on the cervical spine or neck, the Medtronic Infuse bone graft device may cause throat and neck tissues to swell. This can lead to compressed airways or neurological structures in the patient’s neck.
Nearly 38 reports of complications were associated with the off-label usage of the Medtronic Infuse device at the time of the warning. Further, patients also reported difficulty with speaking, breathing and swallowing.
The Infuse bone graft device contains an artificial protein. Tissue surrounding the area where the device is inserted may become inflamed. When the device is inserted improperly, bone growth may occur outside the original surgical site.
There are additional links between Medtronic Infuse and male sterility. Some men may experience inverse ejaculation after receiving a bone graft procedure from the device.
Why are There Lawsuits over Medtronic Infuse Usage?
Lawsuits have been filed against the makers of Medtronic Infuse, alleging the illegal promotion of the product for off-label purposes. These allegations focus on the financial ties between surgeons and researchers at Medtronic.
Surgeons promoted using the harmful protein in a variety of unapproved settings, which have led to complications and risks. Patients have received additional medical treatment, some resulting in emergency surgery procedures.
Doctors and surgeons are permitted to use professional judgment in using medical devices approved by the FDA. However, it becomes illegal when the manufacturer promotes additional uses without FDA approval.
As a result, the Finance Committee of the U.S. Senate began investigating the surgeons paid by Medtronic to use the Infuse bone graft device. The company had to submit financial records and other documents related to the interactions between surgeons and researchers at Medtronic. The goal of the investigation was to determine whether surgeons did not report complications from the off-label usage practices.
If so, this would support a study that suggests the links to complications revealed during clinical trials. This presents a conflict of interest if compensated surgeons were aware of these findings yet chose to promote the product usage as safe.
Two months after the investigation began, Medtronic volunteered an independent review by researchers from Yale University of the Medtronic Infuse bone graft device. Over a six month period, the Yale researchers will review patient data from the clinical trials and the reports received by the FDA.