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Infuse Bone Graft

Originally approved for use in specific spinal and dental surgical procedures, the maker of the controversial Infuse Bone Graft device is facing increased criticism for encouraging off-label uses, downplaying the device's serious risks and paying physicians big money to promote the products.

While the device's manufacturer, the Minneapolis-based Medtronic, denies all of the claims, an increasing number of injured patients and skeptical physicians are stepping forward. They are concerned that the device is causing life-threatening side effects.

The U.S. Food and Drug Administration (FDA) approved Infuse in 2002 for surgery on the lower parts of the spine, called the lumbar and sacral regions. The device is a synthetic liquid protein used to promote bone growth. The liquid is soaked into a spongy substance, placed inside a thimble-like metal cage and then implanted into the spine. An estimated 500,000 people a year undergo spinal-fusion and disc repair surgeries to reduce back pain.

Infuse Bone Graft Problems

While Medtronic insists it follows the FDA rules that prohibit it from promoting its products for off-label use, there are no rules that force doctors paid by Medtronic to do the same thing. Investigators have found that doctors with financial ties to Medtronic have written extensive glowing reviews of Infuse off-label uses in medical journals, web sites and peer periodicals. Medical professionals say that about 80 percent of Infuse usage is for off-label purposes, including surgeries on the cervical spine in the neck area. Those off-label uses put patients at a higher risk for emergency tracheotomies, feeding tubes, male sterility, overactive bone growth and a variety of cancers, including stomach, ovarian, lung, laryngeal and pancreatic, just to name a few.

In 2008, the U.S. Department of Justice launched an investigation to review Medtronic's involvement in off-label use after nearly 300 side effects were reported to the FDA.

After the Justice Department closed its case without levying any charges, a group of spine specialists questioned Medtronic's research into the device. In 2011, The Spine Journal, a prominent medical periodical, devoted its entire June issue to problems with the device, saying that doctors were paid huge sums to overstate Infuse's benefits and downplay the complications. These revelations caused the U.S. Senate Finance Committee to launch a continuing investigation.

Infuse Bone Graft Lawsuits

With the growing number of questions about Infuse's side effects and safety, Medtronic has already been taken to court. In March 2012, the company paid $85 million to resolve a claim that it did not reveal to its shareholders that nearly 86 percent of the device's sales came from the off-label use of Infuse.

At the same time, patients have been turning to the court system to help pay for medical treatments that resulted from this faulty device.

Infuse Lawsuits: have your claim evaluated

If you or a loved one had surgery using the Infuse Bone Graft device, the time to act is now. With a growing amount of medical evidence implicating Infuse in cases of cancer, male sterility, nerve damage and death, patients are encouraged to take charge of their health and financial well-being. With our no-cost, no-obligation review of your case, we can decide how to progress for your best outcome.