We look forward to the release of the Infuse study by Yale University. At the very least it should be quite revealing to see what an independent report on these potentially dangerous products has to say.
New York, New York (PRWEB) May 30, 2013
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, is reporting that Medtronic has revealed that a long-awaited independent review of its Infuse bone graft products will be available soon. As HealthPointCapital reported on May 23, 2013, the results of a Yale-commissioned review of Medtronic’s Infuse products will be released in June. Medtronic approached Yale University researchers after a June 2011 study published in The Spine Journal disclosed that Medtronic-paid researchers had failed to report serious potential complications from use of Infuse bone graft products in spinal surgery.
The U.S. Food and Drug Administration (FDA) approved Infuse in 2002 for use in fusing damaged vertebrae in the lower spine; Infuse was not approved for use on the upper, or cervical, spine, where it is now widely used, according to an Oct. 25, 2012 Bloomberg Businessweek report. In fact, the report added, the FDA released a July 1, 2008 notification warning that the Infuse Bone Graft had been associated with serious complications – including excessive swelling in the neck, compressed airways, difficulty breathing, problems swallowing and nerve damage – when used in cervical spinal fusions.
“We look forward to the release of the Infuse study by Yale University,” said Gary Falkowitz, Managing Attorney at Parker Waichman LLP. “At the very least it should be quite revealing to see what an independent report on these potentially dangerous products has to say.”
Only last fall, as noted by the Bloomberg Businessweek report, the U.S. Senate Finance Committee found problems with most of the initial Medtronic-supported Infuse research used to promote the product. The article noted that doctors and researchers who authored at least 11 medical journal reports about Infuse were paid about $210 million in royalties and consulting fees. Senate investigators also charged that Medtronic deliberately manipulated studies to mitigate any adverse reactions to Infuse side effects, as well as to promote off-label use.
“Medtronic’s actions violate the trust patients have in their medical care,” Senator Max Baucus, a Montana Democrat and committee chairman, said in a statement, quoted in the article. “Medical journal articles should convey an accurate picture of the risks and benefits of drugs and medical devices, but patients are at serious risk when companies distort the facts the way Medtronic has.”
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