Medtronic Infuse bone grafts are designed to encourage bone growth in spinal fusion operations. The product is a man-made protein that is soaked in a sponge and then implanted into the spine in a metal casing. Infuse has proven effective at encouraging bone growth in patients, but many have experienced severe side effects, the dangers of which may have been covered up by Medtronic themselves.
Medtronic Infuse Negligence
The widespread use of Medtronic Infuse bone drafts was due to both the product’s effectiveness and the perceived lack of serious side effects. However, more and more patients over the years began reporting infuse bone graft complications. Serious conditions such as Medtronic Infuse cancer and Medtronic Infuse sterility were potentially much more likely than what was previously thought. Now, recent reports from an investigation in Journal Sentinel/MedPage Today have suggested that the doctors who conducted clinical trials of Infuse may have been paid off by Medtronic.
Thirteen clinical trials held over the course of ten years wrote of no serious side effects from Medtronic Infuse bone grafts in their reports, yet the actual data reflected that 10% to 50% of patients experienced Medtronic infuse problems. Further investigation revealed that the doctors who conducted the trials have since received $62 million from the company for other, unrelated endeavors. The Senate Finance Committee began an investigation into this matter in late June 2011. If negligence like an intentional cover-up by Medtronic can be proved, then patients who have been injured by a Medtronic infuse bone graft may be able to recover compensation for their injuries through Infuse bone graft lawsuits.
Additionally, patients injured by Medtronic Infuse off label use may have legal recourse. Currently, the FDA has only approved Infuse for use in the lower lumbar (lower back) spine, and not for surgeries on the neck. However, many cervical (neck) spine fusion surgeries have incorporated Medtronic Infuse, despite there being no approval by the FDA for such a procedure. Medtronic may be negligent in misrepresenting the approved uses of their product, and even encouraging off label use among doctors and healthcare providers.