Synthetic recombinant human Bone Morphogenetic Protein (rhBMP-2), manufactured by Medtronic under the brand INFUSE®, remains at the center of controversy following a government report and reports of new injuries associated with off-label use of the medical device.
Late last year, the U.S. Senate Finance Committee report revealed that of some 13 Medtronic-funded clinical trials, none reported side effects with use of INFUSE®. The Committee’s inquiry began in June 2011 and probed Medtronic-paid surgeons who never reported INFUSE®-related complications.
As we’ve long explained, Medtronic Infuse® was approved by the U.S. Food & Drug Administration (FDA) in 2002 to stimulate spine growth in patients suffering from lower spinal degenerative disease. The device, approved for use in one type of spinal surgery and some dental procedures, is used, for the most part, in off-label procedures. Approval for INFUSE® was based on Medtronic-funded research.
Meanwhile, the studies presented Medtronic INFUSE® in a very positive light and as a major breakthrough in spine surgery; however, the significantly manipulated information downplayed the serious complications linked to INFUSE®, overstating the bone growth product’s benefits. In truth, Medtronic employees, some from its marketing department, secretly worked with academic physician authors on 11 papers produced between 2002 and 2009, according details of the Senate report.
Although this type of so-called “ghostwriting” is not against the law, it is considered far from ethical and is largely thought of as a breach of integrity and lacking in transparency. Further, such ghostwriting places doctors and patients in a position in which they must to rely on incomplete, flawed data when making important medical decisions. In 2011, the renowned Spine Journal devoted a full issue to the matter, proving the Infuse® research wrong.
“This sounds eerily familiar to many of the transgressions we’ve read about from the pharmaceutical industry,” Dr. Harlan Krumholz, a professor of medicine at Yale University, told MedPage Today when advised of the Senate report. “It paints a picture of a company very heavily involved in the science; marketing contaminating the science; and the medical profession and researchers being complicit. It’s no wonder the public has lost confidence in the drug and device industries,” Krumholz added.
As we’ve explained, many injuries have occurred when BMP-2 was used in off-label, or unapproved procedures, which accounts for most INFUSE® procedures, some 85 percent, in fact. Medicare is considering stopping coverage of BMP-2.
New evidence is emerging that doctors may be utilizing too much water or too much BMP-2 during off-label surgical spine procedures. This means that the bone growth product, a sealant, can potentially drip onto the spinal cord or spinal nerves, leading to serious, severe injuries, including Cauda Equina Syndrome, which is caused by a significant narrowing of the spinal canal and, in which, nerve roots below the spinal cord level become severely compressed or inflamed. Although a number of causes of Cauda Equina Syndrome are known, use of Medtronic INFUSE® in off-label spinal surgery has been associated with this devastating injury. Inflammation typical with Cauda Equina Syndrome, believed to be associated with Medtronic INFUSE® procedures, is likely the result of the product coming into contact with nerves and other areas of the body.
Damage to the nerve roots due to Cauda Equina Syndrome following surgery with Medtronic INFUSE® can lead to: Pain, altered reflexes, and decreased strength and/or sensation. Cauda Equina Syndrome is considered a surgical emergency and, if left untreated, can lead to permanent loss of bowel and bladder control and leg paralysis.