Medtronic, makers of the Infuse spine device, has been under investigation for a controversy involving Medtronic's possible cover-up of the negative side effects of Infuse. If Infuse was used as part of your treatment plan, it's a good idea to speak to a Kentucky medical malpractice lawyer about filing a Medtronic claim and the possibility of an Infuse lawsuit.
Medtronic Infuse Functions
Infuse, a bone graft designed to stimulate bone growth and used in spinal fusion surgeries, contains a genetically engineered version of recombinant human Bone Morphogenetic Protein (rhBMP), a naturally occurring protein.
It stimulates bone growth and is meant to be an alternative to certain grafting procedures, such as those in which a patient's bone is harvested and relocated to the spinal region.
The Food and Drug Administration (FDA) approved Infuse in 2002, and it has since been implanted in more than 500,000 patients. Medtronic has received millions of dollars annually for its Infuse sales.
The FDA only approved Infuse for:
- degenerative disc disease treatments;
- tibia fractures;
- sinus augmentation; and
- localized alveolar ridge augmentation.
It has not been approved for any other use, and when used in off-label procedures, Infuse may cause serious side effects.
Problems with Medtronic
Medtronic is under scrutiny from spine researchers and is causing many people around the country to file an Infuse lawsuit.
Medtronic is under fire for several reasons:
- Under-reported Risks - doctors conducting Infuse clinical trials may have been aware of the serious medical complications it can cause, yet failed to report it in medical literature.
- Financial Conflicts - Medtronic paid large sums of money to a number of prominent surgeons who were involved in Infuse clinical testing and/or authored positive medical journal articles about Infuse that omitted the serious health complications it can pose.
- Off-Label Use - the U.S. Department of Justice is investigating Medtronic's off-label marketing of Infuse, which can cause serious health complications.