Medtronic’s InFuse®, a bone growth product, has been associated with enormous controversy. Yet, despite a debacle that has involved a Senate probe, a U.S. Food and Drug Administration (FDA) warning, accusations of promoting the product off label and of minimizing information on the product’s adverse reactions, and two independent studies that found the product is not superior to traditional bone graft and is associated with serious risks, a recall has still not been implemented.
According to the FDA “defects or performance failures of marketed medical devices can pose serious risks to public health.” The agency explains that “recalls serve both to correct a defect in current and future devices and to notify users of potential risks and steps to minimize the impact of device failure or malfunction.” Although InFuse® is associated with serious risks, including cancer, the product remains on the market, continues to be touted for use in bone graft surgeries, and is considered safe because of its FDA approval.
Device recalls may be initiated by the manufacturer, voluntarily or in response to a formal agency request. The FDA may also order a mandatory recall. For the most part, medical device recalls are initiated and coordinated by the firm and are classified, monitored, and terminated by the FDA, according to the agency. Despite the various methods under which a recall can be implemented, a recall has not been put in place over Medtronic’s InFuse®.
Meanwhile, the results of two separate and independent studies revealed that InFuse® works no better than traditional bone graft and is associated with serious risks. So why is InFuse® still on the market? And why are surgeries utilizing InFuse® still being performed? Both studies—one conducted in Britain and one in the United States—were published in the Annals of Internal Medicine and followed wide criticism that prior, Medtronic-sponsored research overstated Infuse®’s benefits while understating its risks, according to The New York Times.
The FDA approved InFuse® in 2002 for use in spinal fusions, a surgical procedure commonly conducted to reduce back pain. Specifically, InFuse® was approved for lower-back procedures; however, it is typically used off label in upper cervical spine vertebrae fusions. In 2008, the FDA warned of reports of life-threatening complications associated with off label InFuse® uses.
Senate investigators charged that Medtronic deliberately manipulated studies to mitigate information on adverse reactions associated with InFuse® side effects, as well as to promote off-label use. The U.S. Senate Finance Committee also found problems with most of the initial Medtronic-supported InFuse® research used to promote the product.
A special 2011 issue of The Spine Journal was entirely focused on reports that critiqued research conducted by surgeons who were paid millions of dollars by Medtronic. The journal accused Medtronic of not reporting serious complications, including male sterility, infections, increased cancer risk, bone dissolution, and worsened back and leg pain, associated with InFuse®, according to a prior Reuters report.
It was following this publication that Medtronic agreed to two independent reviews of its trial data. The reviews were overseen by Dr. Harlan Krumholz of Yale University and the device maker agreed to release all of its InFuse®-related study data to Dr. Krumholz, providing $2.5 million to fund the reviews. The U.S. research team was located at Oregon Health & Science University and Britain’s was at the University of York.
The American team found that InFuse® was not any better than patient-harvested bone and that InFuse® was associated with an increased cancer risk after two years. The risk was low and not related to a specific cancer, according to Reuters. The British research found that InFuse® offered no clinically significant pain reduction after two years and was associated with a potential increased cancer risk, although the overall risk was considered low.
“The general, overall picture is that they failed to find a big benefit,” for InFuse®, Dr. Krumholz said. “And they found there might be some harms,” The Times reports. “I remain concerned that products like these are approved with too little study before they reach the market and too little afterward,” Krumholz said in a telephone interview with Bloomberg News.