Infuse® Bone Graft Off-Label Uses
The term "off-label uses" of Infuse® Bone Grafts refers to uses that are not (and never were) approved by the U.S. Food and Drug Administration (FDA). The Infuse® Bone Graft has only been approved for one specific surgery, anterior-approach lumbar fusion spinal surgery (of one level of the spine between the L5 and S1 vertebrae). Medtronic, the maker of the Infuse® Bone Graft, has allegedly marketed the device for several off-label uses, even though it knew of the potential dangers.
If you or someone you love suffered injuries following an off-label procedure, you might be eligible to file an Infuse® Bone Graft lawsuit to seek compensation for your injuries. To schedule a free review of your case, contact us today.
Off-Label Use of Medtronic Infuse® Bone Graft
Pharmaceutical companies and medical device makers such as Medtronic have frequently encouraged physicians and other healthcare providers to use their products "off-label" — that is, in ways that were not approved by the FDA. It's generally against the law for the device or drug manufacturers to promote off-label uses.
Dangerous Risks Associated with Off-Label Use
Off-label uses of Infuse® Bone Grafts include:
- Procedures for vertebrae that are not among those that are approved
- Different surgeries for degenerative disc disease
- Bone graft surgery "other-than" the FDA-approved surgery
There are dangerous risks associated with these and other off-label uses of the Infuse® Bone Graft, including (but not limited to):
- acute severe neck swelling resulting in permanent injury or death
- chronic, radiating pain in the arms and/or legs
- uncontrolled bone growth from the bone graft procedure
- in male patients, uro-genital injuries
- nerve injuries resulting in severe and chronic pain
Contact an Infuse® Bone Graft Attorney
Many patients are not informed about whether they received an Infuse® Bone Graft during a surgical procedure. It's not uncommon for individuals to be "in the dark" about the medical and legal issues surrounding the drugs, devices or grafts that they have been given.
If you or someone you love suffered complications such as swelling in the neck, compressed airways, difficulty breathing or respiratory depression following surgery of the cervical spine or neck, you may be entitled to compensation. Even if you are unsure of the type of procedure or the devices that were used, you should speak with an attorney who can investigate your surgery and determine if you qualify for financial compensation.
To learn more about the complications associated with off-label uses of the Infuse® Bone Graft, please contact our attorneys today. We provide free case reviews for patients nationwide.