We offer a variety of resources so you and your family can make the best decision for your future outcome:
- Case evaluation – A free consultation with our skilled professionals can provide peace of mind and a plan for the future.
- Referral to one of the best national Infuse Law Firms.
Infuse Bone Graft
Introduced in 2002 by the Minnesota-based Medtronic, Infuse is a synthetic protein that was developed to grow like normal bone and approved by the U.S. Food and Drug Administration (FDA) to repair very specific lower spine problems. The liquid bone-growth agent is soaked into a tiny sponge, placed into a thimble-sized cage and surgically implanted into the lower back area to fuse spinal sections together for a repair of degenerative disc diseases. Instead of harvesting bone or using cadaver bone to make this repair, Infuse was aimed at making these fixes easier and more efficient. The device is also FDA approved for a limited number of oral surgical procedures.
Despite the FDA restrictions on the device’s applications, scores of surgeons have used it in off-label procedures, including cervical (neck) spine surgeries. Some medical experts charge that Medtronic paid a group of prominent spine surgeons to praise the off-label uses and encourage other doctors to follow suit. Today, federal drug regulators and a congressional committee are evaluating the claims and reviewing the options.
Infuse Off-Label Uses (neck and other areas)
In using the device off-label, patients have been exposed to a number of medical problems that have never been investigated through clinical trials or other means. Inserting the material into the neck area has resulted in numerous injures and deaths, the FDA said. Some patients have suffocated to death because of Infuse throat swelling and airway restrictions.
Infuse Bone Graft Complications
Medtronic is also facing charges that it altered the results of original clinical trials to make the device seem safer than it really is. Studies now show the device, when used as originally approved, is linked to radiating leg pain, nerve damage and retrograde ejaculation. It is also linked to cancer and uncontrolled bone growth.
With an estimated 100,000 patients a year undergoing on- and off-label Infuse procedures since it was introduced, the court system has been inundated with patients seeking claims. Learn if you can receive compensation by filling out our free case evaluation.