Medtronic Infuse Woes Prompt Subpoena from California Attorney General (NewsInferno)
Medtronic, Inc. has disclosed that the California Attorney General issued a subpoena to the company in October as part of an investigation into its Infuse bone graft product. In its latest 10-Q filing, Medtronic said it was fully cooperating with the California probe, as well as various other investigations involving Infuse.
Medtronic’s Infuse bone graft is made from a genetically engineered material called rhBMP-2 (recombinant human Bone Morphogenetic Protein-2), which stimulates bone growth. Infuse was approved by the U.S. Food and Drug Administration (FDA) for use in one type of spine surgery called anterior approach lumbar fusion. Later, it was approved for use in two types of dental surgeries.
Since its approval, Infuse has been at the center of several controversies. Not only has the device maker been accused of downplaying the serious side effects associated with Infuse, but most recently, a prominent researcher warned that Infuse may be associated with a higher risk of developing cancer. In 2008, the FDA warned that Infuse and similar bone growth products had caused...
