Before being approved by the Food & Drug Administration (FDA), medical products must go through extensive clinical trials to ensure that they are safe for use. Unfortunately, this process does not always prevent dangerous or defective medical products from entering the market and being used by doctors and surgeons across the country—especially if the product’s manufacturer has been negligent or deceptive.

Infuse Bone Graft complications and injuries
 
Infuse Bone Graft is an engineered protein that makes it possible to fuse vertebrae together without harvesting bone from a patient’s hip. But while the medical product has increased the number of spinal fusions fifteen times over in the last ten years, issues with the product have many medical professionals, doctors, and lawmakers extremely concerned.

Beginning in 2002, spinal surgery patients began reporting dangerous complications related to Infuse Bone Graft, including male sterility and retrograde ejaculation, neck swelling and breathing difficulty, and abnormal bone growth. In 2008, the FDA issued a warning to the healthcare industry that the off-label use of the product, such as use in cervical spine procedures, had not been explicitly approved and listed the complications associated with those uses.
 
Who is to blame for Infuse Bone Graft injuries?
 
Could these injuries and complications have been avoided? And why did they happen in the first place? Currently, lawmakers, injury victims, and the federal government are looking for answers. Some have reported that Infuse Bone Graft’s maker, Medtronic, Inc., was paying many of the surgeons involved in the product’s clinical trials as consultants—a conflict of interest that could have caused doctors to purposefully ignore issues with Infuse. Others claim that Medtronic has engaged in illegal off-label marketing that has led to an unknown number of patient injuries.
 
In 2011, the U.S. Department of Justice and the U.S. Senate launched investigations developing Medtronic and Infuse Bone Graft controversies. Last month, Medtronic shareholders successfully sued the company for making misleading statements about the product’s off-label usage.
 
Kentucky defective medical product attorney
 
Have you or a loved one been injured by Infuse Bone Graft? Find out who is responsible. Call the KY Infuse Bone Graft lawyers at Gray & White today and share your story. 
1 Comments
A conflict of interest that could have caused doctors to purposefully ignore issues with Infuse. Others claim that Medtronic has engaged in illegal off-label marketing that has led to an unknown number of patient injuries.
by Infuse Class Action June 1, 2012 at 08:03 AM
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