According to two independent studies published in the Annals of Internal Medicine last month, Medtronic Infuse works no better than traditional bone grafts and also exposes patients to serious side effects, including an increased risk of cancer. Medtronic commissioned the studies, which were conducted in 2011 by the Oregon Health & Sciences University in Portland and the University of York in the U.K. after the product was linked to male sterility, infections and cancer.
Medtronic Infuse is a bone growth hormone designed to help bones heal after spinal surgery. According to Bloomberg News, the Infuse presents a less invasive alternative to traditional bone grafts and has been used in over a million patients. However, the researchers indicated that “there is a tremendous amount of uncertainty about the benefit it provides and how safe it is.”
Bloomberg News also reported that Medtronic Infuse generated $528 million worldwide last year, though its sales have plunged 37 percent since its peak in 2009.
Curtailing Widespread Use
Believing it carried few side effects, doctors initially used the product in a wide variety of orthopedic surgeries, including tibia fractures, facial surgery, and fusing damaged vertebrae in the lower spine. The Medtronic Infuse was also widely used in the upper, cervical spine and other areas, although it was not approved for use in these areas. Indications of serious risks to patient health, such as the recent studies showing that the Infuse bone graft is linked to an increased risk of cancer, have curtailed the product’s use. Moreover, Bloomberg News indicates that the initial research that suggested Medtronic Infuse was risk-free may have misrepresented the risks and benefits due to the researchers’ financial ties to the manufacturer.
Medtronic Infuse No Better Than Traditional Graft — And More Risky
While less invasive than a traditional bone graft, in which bone is harvested from parts of the body, the Yale review analyzing the recent studies quotes researchers as finding no clear advantage from the product that would outweigh the potential risks.
In an editorial accompanying the recent studies, doctors from the University of California, San Francisco and the University of Wisconsin advise that clinicians should carefully weigh the demonstrated and potential benefits and harms, including costs, when deciding to use new medical technology.
If you or someone you love has experienced side effects from Medtronic Infuse, you may want to speak with an attorney to learn about your rights. Free and confidential consultations with our personal injury lawyers are available by calling toll-free (866) 981-4800 or filling out the form to your right.