Bones grafts are pieces of bone or bone substitute that can replace damaged or diseased bone in a number of joints and bones in human’s body. Medtronic’s INFUSE Bone Graft is a medical device developed as an alternative to traditional bone graft procedures and uses synthetic, concentrated proteins for use in spinal fusion surgeries. These synthetic proteins are mixed with collagen from cows and injected into the spine to alleviate pain and to stimulate new bone growth in the spine. The Medtronic system was granted limited approval by the U.S. Food and Drug Administration (FDA) in 2002 to be used only during surgery on the lower spine.
INFUSE Bone Grafts are risky, however, and can severely impact patient’s health. Common side effects associated with INFUSE Bone Grafts include: • Inflammatory reactions • Back and leg pain • Radiculitis (pain that spreads through the spinal nerves) • Implant displacement • Retrograde ejaculation (occurs when semen enters the bladder) • Male sterility • Infection • Osteolysis (degeneration of bone tissue) • Ectopic bone formation (unwanted bone in the spinal canal)
In 2011, Dr. Eugene J. Carragee and his colleagues published an editorial in The Spine Journal revealing that a number of Medtronic-sponsored studies failed to disclose possible side effects associated with a protein component of the INFUSE Bone Graft system. It also revealed that a number of the researchers in these studies received between $1 million and $23 million a year from Medtronic in royalties and consulting fees. A number of studies released by Medtronic-sponsored doctors promoted several “off-label,” or unapproved, uses of the product. Medtronic was sued by its own shareholders for making misleading claims about the INFUSE Bone Grafts in a lawsuit settled in 2012. U.S. Senate concluded that Medtronic had manipulated research studies and secretly paid doctors to write favorable articles about their bone protein devices.
It is estimated that several thousand people have been injured by the defective product and Medtronic’s deceptive advertising. INFUSE has been linked to infection, bone and nerve injury, sterility, urinary problems and possibly even an increased cancer risk. Hundreds of lawsuits, including INFUSE bone graft claims, have been filed against Medtronic in state and federal courts. Medtronic has offices in Tempe, Ariz., and many of the lawsuits have been filed in that state. The device maker has moved several cases, which were initially filed in Arizona state court, to the U.S. District Court for the District of Arizona.
Thousands of patients and their families are considering filing claims against Medtronic over injuries, the company’s questionable business practices in promoting INFUSE, as well as allegations that the company hid reports of adverse effects from the medical community. Patients who underwent procedures with INFUSE Bone Graft and have experienced painful side effects may have legal options.
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