READ MORE Infuse LEGAL NEWS
The lack of adverse events reported is in sharp contrast to data the FDA has, which include at least 38 reports of complications associated with recombinant human bone morphogenetic protein (rhBMP). In 2008, the FDA issued a public health warning regarding life-threatening complications associated with the product.
The article in The Spine Journal follows only days after a Senate Finance Committee initiated an inquiry into the fees doctors receive from Medtronic and whether or not those physicians reported or failed to report associated adverse events.
Launched in 2002, Medtronic’s Infuse has reportedly been used in roughly 500,000 patients who underwent spinal surgery.