Even though the U.S. Food and Drug Administration (FDA) approved the device for a handful of medical procedures, including lower back spinal fusion, the device has been used in an array of surgeries. The most common off-label use is repairs to the cervical (neck) spinal area.
Worse yet, the company is also accused of falsifying medical trials to make it seem as though proper use of the device is safe. In fact, some studies are now pointing to an increased risk of cancer and other life-threatening diseases from normal Infuse use.
Infuse Bone Graft Injures
Infuse, a manmade human bone protein, is FDA approved for surgical patients with the most severe lower back problems, called degenerative disc disease, and only two dental bone-graft procedures. This liquid protein is placed on an absorbent material and then housed inside a thimble-sized metal cage. The device is then surgically implanted on existing bone. As it grows additional bone, it serves as scaffolding for existing skeleton. But doctors, reportedly under the advisement of Medtronic, have been using the device outside the FDA’s guidelines.
Off-label Side Effects
In 2008, the FDA warned doctors that using the device in the cervical spine area, which is considered off-label, causes severe breathing problems. This results from an increased risk of neck and throat swelling which could compress the airway. Some of the cases result in emergency tracheotomies or death. The device is known to trigger an immune response, which could cause the body to attack its own cells.
Infuse has also been linked to a variety of different cancers. While the medical community is still undecided about whether the bone-growth protein inhibits or stimulates cancer-cell growth, research shows that Infuse is linked to nearly a dozen different types of cancer, including blood, bone and uterine cancers.
Side Effects Not Disclosed
Even though Medtronic touts that the device has few, if any, severe side effects if used according to the label, new research shows that the company simply hasn’t report any problems to the FDA. The Spine Journal, a leading industry periodical, said the company paid several prominent spinal surgeons millions of dollars to coauthor 13 medical journal articles that praised the device. The periodical also says that the doctors were paid between $12 million and $16 million per study.
When the doctors for the periodical performed their own studies, they found the device is linked to increases in leg pain and numbness, infection rates, male sterility and radiating nerve pain. The approved use of this device is also linked to cancer, uncontrolled bone growth and retrograde ejaculation, a disorder that redirects semen into the bladder instead of out the urethra.
While Medtronic denies any such cozy ties or improprieties, the U.S. Senate Finance Committee is continuing an investigation.