Revenues for the bone graft product, InFuse, were down for the second quarter, due to ongoing safety issues.
Medtronic’s InFuse, has long been steeped in controversy, including a Senate probe, a warning issued by a federal regulator, accusations that Medtronic was touting the device off label, findings that Medtronic downplayed risks, and recent and independent studies revealing that InFuse is no better than traditional bone graft and is associated with serious risks. Yet, Medtronic continues to market the device and has not implemented a recall, which means that InFuse remains on the market and most patients and doctors remain unaware of InFuse’s notorious history.
InFuse—a bone growth product comprised of recombinant human bone morphogenetic protein (rhBMP-2) and a sponge made from cow collagen–received U.S. Food and Drug Administration (FDA) approval in 2002 for use in spinal fusions, a surgical procedure conducted to reduce back pain. InFuse was specifically approved for lower-back procedures; however, the product is most often 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.
As we’ve written, although InFuse is associated with very serious risks, such as 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. Users of the device have no idea of the potential risks associated with InFuse. The Rockwell Group expects that Medtronic’s market share will continue to be soft, according to Seeking Alpha.
The results of two independent studies reveal that InFuse does not work any better than traditional bone graft, in which the patient’s bone is used, and is associated with serious risks. Both studies—one conducted in Britain’s University of York and one in the United States at Oregon Health & Science University—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.
Senate investigators charged that Medtronic deliberately manipulated studies to mitigate information on adverse reactions associated with InFuse side effects, as well as to promote the product’s off-label use. The U.S. Senate Finance Committee also found problems with most initial Medtronic-supported InFuse research used to promote the product.
A special 2011 issue of The Spine Journal was devoted to reports that critiqued research conducted by surgeons 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. Following this publication, Medtronic agreed to two independent reviews of its trial data, which were overseen by Dr. Harlan Krumholz of Yale University. Medtronic agreed to release all of its InFuse-related study data to Dr. Krumholz, providing $2.5 million to fund the reviews.
The American team found that InFuse was no better than patient-harvested bone and that the product was associated with increased cancer risks 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 also found the product was associated with a potential increased cancer risk; 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 recent telephone interview with Bloomberg News.
InFuse, according to Seeking Alpha, has also been associated with risks to pregnant women because of some of its active ingredients, according to a recent study that revealed that rhBMP-2 extracts antibodies capable of crossing the placenta, a threat to the developing fetus.