Questions have surfaced related to the safety of Infuse, a bioengineered spinal bone growth product produced by Medtronic. Although Infuse was previously hailed as a major medical breakthrough in spine surgery, the product is currently being investigated by the United States Senate and the Department of Justice over omissions from its clinical trial safety results. Currently, annual sales for Infuse are approximately $700 million.
In June 2011, a leading medical publication, Spine Journal, devoted an issue to safety concerns related to the Infuse product. According to an article published in the journal, surgeons who participated in clinical trials for Infuse failed to report severe complications related to use of the product. The article alleged complications existed in 10 to 50 percent of patients who participated in 13 clinical trials funded by Medtronic over a ten year period. Those complications included cancer, infections, bone dissolution, male sterility, and increased back pain. The article also accused Medtronic researchers of failing to report known conflicts of interest, knowingly using a biased and flawed study design, and stated surgeons who participated in Medtronic clinical trials were generously compensated by the company.
In a presentation before the North American Spine Society last fall, a prominent researcher at Stanford University School of Medicine, Dr. Eugene Carragee, alleged patients who use Infuse have a 2.5 times greater risk of cancer one year later. He also stated three years later, patients have a five times greater risk of developing pancreatic, breast and prostate cancers. Dr. Carragee believes Infuse is not a carcinogen, but instead promotes cancer growth. He plans to publish his findings in the future.
In March 2011, the Food and Drug Administration (FDA) cited safety risks when the organization refused to approve Medtronic’s application for a higher dose product similar to Infuse called Amplify. The move prompted some doctors to question the safety of the lower dose product. Additionally, Infuse sales declined nearly 20 percent after the Spine Journal article was published.
Medtronic’s Infuse product was approved by the FDA for use in spinal fusion procedures as well as some dental procedures. Doctors also use the product for other unapproved purposes. Although the practice is legal, Medtronic may not market Infuse in a way that promotes off-label use of the product. An investigation into Medtronic’s marketing of Infuse is currently ongoing with the United States Department of Justice.
Medtronic Infuse has been widely used off-label during neck surgery. This unapproved use has been associated with a high number of serious and possibly fatal complications. Potential Medtronic Infuse lawsuits are being evaluated throughout the United States for problems associated with use of the product during neck and other off-label surgeries. If you or a loved one developed complications after you underwent surgery where Medtronic Infuse was used, you should speak with a qualified personal injury attorney as soon as possible.