As reported last month by a U.S. Senate Finance Committee report raises new concerns about the safety and effectiveness of BMP-2 also known as bone morphogenetic protein-2, widely used in spinal fusion surgery.The Black Letter …
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As reported last month by a U.S. Senate Finance Committee report raises new concerns about the safety and effectiveness of BMP-2 also known as bone morphogenetic protein-2, widely used in spinal fusion surgery.The Black Letter is an independent publication with Dr. Sam Wiesel, Professor of Orthopedic surgery at Georgetown University, as executive editor. Read the full story »
In an investigation by the U.S. Senate Committee on Finance on physician/industry relationships, scientific publishing and the marketing of Medtronic products used in spinal surgeries, The Spine Journal was singled out for its dedication to …
Medtronic paid $210 million to 13 doctors to author a series of now-repudiated positive reviews and not reveal any side effects linked to using its bone graft product, Infuse
Two courts have recently ruled that lawsuits may proceed and are not preempted where the injured patient alleges that the device manufacturer engaged in off-label promotion of medical devices, in violation of the Food Drug, …
Reuters reports, Medtronic Inc., manufacturer of controversial and allegedly dangerous Infuse bone graft, has settled a shareholder lawsuit by paying $85 million to shareholders accusing it of making misleading statements concerning its Infuse bone graft …
The Milwaukee-Wisconsin Journal Sentinel reports that Dr. Thomas Zdeblick, a spinal surgeon and chair of the University of Wisconsin’s orthopedic department, has received over $25 million in royalty payments from Medtronic since 2003.
U.S. Senators Charles Grassley, Richard Blumenthal and Herb Kohl have introduced the Medical Device Patient Safety Act, designed to give the Food and Drug Administration (FDA) tools to better monitor post-market performance of new medical …
Mercury News reports that Medtronic, Inc. has agreed to pay $23.5 million to the U.S. Justice Department to settle claims that the company paid kickbacks to doctors to implant its pacemakers and defibrillators.
Medtronic, Inc. disclosed last week that California Attorney General Kamala Harris issued a subpoena on October 14, 2011, for documents related to its Infuse bone graft product.
Medical device manufacturer Medtronic is under scrutiny for its financial ties to surgeons who researched and promoted its Infuse bone graft device. Recently a full issue of The Spine Journal was devoted to voicing the concerns of spine specialists who in an unprecedented action repudiated what they considered to be misleading and biased research on the Infuse bone graft, published by colleagues with financial ties to Medtronic. Conflict of interest created when a surgeon is financed by a medical device maker is not limited to complications from the off-label use of Medtronic’s Infuse bone graft.
In September 2011, the Milwaukee Journal Sentinel profiled Tom Engel of Milwaukee and his experience with failed back surgery syndrome. Engel has undergone two spinal surgeries, one in 2002 and another in 2004, in an effort to manage his excruciating back pain.