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By: Irvin Jackson | Published: September 16th, 2013
The findings of a new study raise further concerns about the risk of problems following surgery where the Medtronic Infuse BMP bone growth product is used, suggesting that users may face an increased risk of developing tumors.
Researchers investigating the potential link between Medtronic Infuse BMP and cancer published their findings this month in the medical journal Neurosurgery. While the use of the product may not increase the risk of cancer, the study found that use of BMP during lumbar fusion surgery is associated with a significantly higher rate of benign tumors.
The increased tumor risk is just the latest concern about side effects of Medtronic Infuse BMP surgery, which has also been linked to a risk of severe and debilitating complications caused by uncontrolled bone growth, respiratory complications and other problems, particularly when the bone growth protein is used off-label during procedures that were not approved by the FDA.
The study, conducted by Duke University researchers, looked at data on more than 4,600 patients who underwent spinal surgery using Infuse, Medtronic’s recombinant human bone morphogenetic protein 2 (BMP) bone growth product. The researchers compared that data with patients who underwent similar spinal fusion surgery without Infuse, such as harvesting bone from another area of the body.
“Given the widespread use of BMP, there has been a tremendous need for better data about its effects,” lead author Dr. Nandan Lad, assistant professor in the division of neurosurgery at Duke University School of Medicine, said in a Duke University press release. “Our study is the largest to date examining the association between BMP use and cancer.”
While there was a higher rate of malignant cancer among recipients of BMP, 9.4% compared to 8.4%, the researchers say that the difference is not statistically significant. However, the researchers found that Infuse recipients were 31% more likely to develop benign, non-cancerous tumors, including tumors in the brain and nervous system.
Medtronic Infuse BMP Lawsuits Over Injuries, Problems
As more information is learned about the risk of problems associated with the bone growth protein, a growing number of Medtronic Infuse lawsuits have been brought in state and federal courts throughout the country. The complaints allege that the off-label use of the device resulted in excessive bone growth around the spine, causing plaintiffs to suffer nerve compression, paralysis, airway compression, retrograde ejaculations, urinary retention, cancer and other serious health problems.
Most of the lawsuits over Medtronic Infuse surgery pending throughout the United States allege that plaintiffs experienced problems following the “off-label” use of the product. Plaintiffs claim that Medtronic illegally promoted Infuse for such unapproved uses by influencing journal articles, making payments to opinion leaders in the industry and having sales representatives encourage such un-approved use.
Last year, a congressional investigation determined that Medtronic paid $210 million to study authors that failed to include data on Infuse complications in their reports. Those authors not only failed to disclose links to Medtronic, but the investigation also determined that Medtronic employees secretly edited and sometimes wrote parts of the studies before they were published, which encouraged the off-label use of Infuse.