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Infuse® Bone Graft Lawsuit Update: New Studies Reveal Increased Risk of Cancer and Male Infertility

During spinal surgeries, doctors traditionally used graft material taken from another part of the patient’s body and inserted it into the space between two vertebrae to promote bone growth, improve stability, and relieve back pain. In 2002, Medtronic began marketing the Infuse® Bone Graft as a better alternative to traditional bone removal and grafting. Rather than using bone tissue, the Infuse® Bone Graft uses a genetically engineered protein that is inserted into a tiny area between the vertebrae to stimulate bone growth. The FDA approved the Infuse® Bone Graft that same year for use in lower back surgeries. However, trouble emerged as patients began complaining that the device led to unwanted bone growth, inflammatory reactions, severe arm and leg pain, and possibly cancer. According to one report, researchers began alleging that Medtronic was encouraging doctors to use the Infuse® Bone Graft in ways that the FDA had not approved (“off-label” procedures), such as neck surgery.

In an article published in The Spine Journal, a panel of experts reviewed 13 Medtronic-funded Infuse® Bone Graft studies and revealed that the researchers failed to report potentially serious side effects associated with the Infuse® Bone Graft. Specifically, the study found that the authors reported 10 to 50 times fewer complications with the Infuse® Bone Graft than those found in FDA reports. The article also described how some of the researchers and co-authors of the studies earned millions of dollars from Medtronic. According to an October 2012 report, the U.S. Senate Finance Committee found that “the company deliberately obscured evidence of adverse events and promoted off-label use of the product and paid out millions to the doctors who co-wrote positive studies.”

On June 18, 2013, two independent studies overseen by Yale University were published in the journal Annals of Internal Medicine. The first study can be found here and the second study can be found here. These studies found the Infuse® Bone Graft to be no more effective than a traditional bone graft and its use carried an increased risk of developing cancer, infection, inappropriate bone growth, and male infertility. Despite these results, Medtronic’s Infuse® Bone Graft remains on the market. Even before these results became public, Infuse® Bone Graft lawsuits were being filed by patients alleging serious injuries suffered as a result of the device – and more claims against Medtronic continue to be filed.

 

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