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A new report suggests that medical device company Medtronic hid its spinal implant's cancer risk from the medical community.
Amplify, Medtronic's newest spinal implant, contains a genetically engineered protein that promotes bone growth. A 2009 report detailing the results of a large clinical study makes no mention of the product's significant cancer risk.
Medtronic paid the paper's authors $10 million in 2010 alone.
The company claims that there was no statistically significant spinal implant cancer risk, reports the Journal Sentinel. However, 2-3 years after the implant, a high number of patients were diagnosed with cancer.
Still, Medtronic reported this data to the Food and Drug Administration. In March, the agency denied final approval of the device, citing high cancer rates among study patients.
This suggests that the data should have been reported in the 2009 paper.
Medtronic is currently under investigation by a number of states and the U.S. Justice Department, according to the Journal Sentinel. The company is accused of systematically hiding serious complications arising from the use of its other spinal implant product, InFUSE.
The Amplify report will likely become part of those investigations.
Individuals who received an Amplify implant do not need to wait for the government to finish its investigation. Evidence indicates that Medtronic misrepresented the facts, and thus misled doctors into using the implant while it was preliminarily approved for use.
The company likely had a legal obligation to report the spinal implant's cancer risk. Patients should thus contact an attorney to discuss legal action--even if they have not been diagnosed with cancer.
Meeting with a lawyer can help you understand your options and how to best protect your rights. Visit our attorney directory to find a lawyer near you who can help.