New York, New York (PRWEB) October 26, 2012
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, is continuing to evaluate Medtronic Infuse cases alleging that the bone growth product caused serious injuries. The device, which was introduced to the US market in 2002, has become controversial in recent years amidst allegations that Medtronic paid researchers to hide serious complications associated with Infuse. Infuse has also stirred safety concerns with regards to its off-label use.
According to Businessweek on October 25, 2012, the United States Senate Finance Committee released a report showing that Medtronic manipulated at least 11 medical journals to promote Infuse. The report also indicated that the company had substantial financial ties with the authors of the studies, and had paid researchers a total of $210 million in consulting fees and royalties. The company-sponsored studies failed to mention serious side effects associated with Infuse, including male sterility, infection and leg and back pain.
Medtronic Infuse is typically used for spinal fusion surgeries in patients who have degenerative disc disease. In a traditional bone graft, a piece of bone is taken from the patient’s pelvis and inserted into the spine. Infuse, however, uses an artificial protein known as recombinant human Bone Morphogenetic Protein (rhBMP-2). It is approved for use on the lower regions of the spine, from L4 to S1, in procedure that are performed through the front of the body (anterior). Using Infuse in any other manner constitutes an “off-label” use.
The majority of procedures involving Infuse are off-label, meaning that most patients who receive the treatment are not formally approved for it, reported Businessweek. Medtronic has had safety issues concerning the off-label use of Infuse, particularly in surgeries involving the cervical spine (neck). In 2008, the U.S. Food and Drug Administration (FDA) warned about “life-threatening complications” associated with such use, including swelling of the neck and throat, difficulty breathing and swallowing. Infuse has also been used 9.2 percent of children’s spinal fusion surgeries, according to an article in MedPage Today. This unapproved use is “worrisome” because the controversial device has already been associated with serious complications in adults.
Parker Waichman LLP is currently offering free legal consultations to victims of Medtronic Infuse Bone Graft Injuries. If you or a loved one suffered a serious complication or injury after receiving Medtronic Infuse, please contact their office by visiting the firm's Medtronic Infuse injury page at yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney