Medtronic Infuse Bone Graft and Cancer Risks
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According to new medical studies, the recombinant human bone morphogenetic protein 2 (rhBMP-2), the active ingredient in the Medtronic Infuse Bone Graft, may be linked to cancer. Recent research conducted by independent doctors has found higher rates of cancer amongst patients who received the Infuse Bone Graft than patients who did not.
These findings were presented to the FDA when Medtronic sought approval for a new product called Amplify that had a higher dose of rhBMP-2 than the Infuse, whereupon the FDA rejected the product for sale in the United States. Researchers found that patients treated with Amplify were 2.5 times more likely to develop cancer within a year of their treatment than patients who had not been treated with the bioengineered bone growth protein, a risk that increased by fivefold after three years.
Infuse Cancer Risks
The high incidence of cancer found in Amplify patients has raised serious concerns regarding the health and safety of Infuse patients. A new study published in the Spine Journal, found that many patients who received off-label Infuse treatments have been treated with doses that significantly exceeds the recommended amount, often, doses that exceed the levels of rhBMP-2 found in Amplify. So far, the Infuse has been linked to cancers such as breast cancer, pancreatic cancer, or prostate cancer.
Reports of Adverse Events
In addition to cancer risks, the Spine Journal study by Dr. Carragee found that during clinical trials, 10% to 50% of Infuse patients suffered side effects such as cancer, male sterility, pain, infections, and inflammation. By 2008, enough reports of adverse events had been filed with the FDA to trigger a warning to be issued against off-label Infuse use in the cervical spine. While off-label use in general was linked with higher rates of complication, patients treated in the neck were at danger of suffering respiratory failure and faced greater risk of fatality.
Infuse Bone Graft Victims’ Rights
A number of patients have filed product liability claims against Medtronic for the dangerous side effects that they were not sufficiently warned of. The lawsuits injured patients have filed allege that Medtronic had been aware of the dangerous side effects associated with the Infuse Bone Graft but the Medtronic-paid researchers downplayed the dangers. If you have developed cancer or suffered other severe complications after receiving an Infuse Bone Graft implant, contact a qualified Medtronic Infuse Bone Graft lawyer regarding your potential claim to compensation.
ABOUT THE AUTHOR: Mike Bomberger
For decades Mike has helped patients and consumers severely injured by products that were defective or poorly designed. If you have been injured as a result of a defective medical device, please contact us for a free consultation. Our attorneys are currently screening cases for Medtronic Infuse Bone Graft injuries.
Copyright Estey & Bomberger, LLP
More information about Estey & Bomberger, LLP
Disclaimer: While every effort has been made to ensure the accuracy of this publication, it is not intended to provide legal advice as individual situations will differ and should be discussed with an expert and/or lawyer. For specific technical or legal advice on the information provided and related topics, please contact the author.
Infuse Cancer Risks
The high incidence of cancer found in Amplify patients has raised serious concerns regarding the health and safety of Infuse patients. A new study published in the Spine Journal, found that many patients who received off-label Infuse treatments have been treated with doses that significantly exceeds the recommended amount, often, doses that exceed the levels of rhBMP-2 found in Amplify. So far, the Infuse has been linked to cancers such as breast cancer, pancreatic cancer, or prostate cancer.
Reports of Adverse Events
In addition to cancer risks, the Spine Journal study by Dr. Carragee found that during clinical trials, 10% to 50% of Infuse patients suffered side effects such as cancer, male sterility, pain, infections, and inflammation. By 2008, enough reports of adverse events had been filed with the FDA to trigger a warning to be issued against off-label Infuse use in the cervical spine. While off-label use in general was linked with higher rates of complication, patients treated in the neck were at danger of suffering respiratory failure and faced greater risk of fatality.
Infuse Bone Graft Victims’ Rights
A number of patients have filed product liability claims against Medtronic for the dangerous side effects that they were not sufficiently warned of. The lawsuits injured patients have filed allege that Medtronic had been aware of the dangerous side effects associated with the Infuse Bone Graft but the Medtronic-paid researchers downplayed the dangers. If you have developed cancer or suffered other severe complications after receiving an Infuse Bone Graft implant, contact a qualified Medtronic Infuse Bone Graft lawyer regarding your potential claim to compensation.
ABOUT THE AUTHOR: Mike Bomberger
For decades Mike has helped patients and consumers severely injured by products that were defective or poorly designed. If you have been injured as a result of a defective medical device, please contact us for a free consultation. Our attorneys are currently screening cases for Medtronic Infuse Bone Graft injuries.
Copyright Estey & Bomberger, LLP
More information about Estey & Bomberger, LLP
View all articles published by Estey & Bomberger, LLP
Disclaimer: While every effort has been made to ensure the accuracy of this publication, it is not intended to provide legal advice as individual situations will differ and should be discussed with an expert and/or lawyer. For specific technical or legal advice on the information provided and related topics, please contact the author.
