Infuse Bone Graft Problems Documented in Numerous Studies
Infuse bone grafts, manufactured by Medtronic, have been used in the United States since they were approved by the FDA in 2002. However, since that time, numerous instances of serious side effects from the bone grafts have been reported. One of the most concerning is the relationship between the Infuse bone graft and a higher risk of many types of cancer, which has been documented in multiple recent studies.
2011 Study Points to Increased Cancer Risk
In 2011, researchers from Stanford University School of Medicine found that use of high-dose Infuse bone grafts could increase the risk for breast, prostate and pancreatic cancer. The study showed that patients with rhBMP-2 were 2.5 more likely to develop cancer over the next year than patients that did not receive a bone graft. That risk increased threefold for patients over the next three years after surgery.
While researchers did not believe the results suggested the rhBMP-2 was a carcinogen, they did label it a possible cancer promoter. In addition to various types of cancer, researchers found Infuse increased the risk for other serious side effects. These included persistent pain and infections, and a higher risk of sterility in male patients.
The lead researcher on this study, Dr. Eugene J. Carragee, also reported at the time that Medtronic had secretly funded studies on their product in the past. This unethical behavior resulted in a failure by researchers to accurately identify risks associated with Infuse in previous studies. The U.S. Senate launched an investigation into Medtronic’s practices at that time, stating, “Medtronic’s actions violate the trust patients have in their medical care.”
Stanford researchers conducted a follow-up study on Infuse in 2013 to test their initial findings. They used a randomized controlled trial of patients who underwent treatment for degenerative spine conditions using high doses of Infuse bone grafts. They discovered that 11 of the patients who received bone grafts were diagnosed with 15 new cancer events within two years after treatment. Only two patients in the control group were diagnosed with new cancer events during the same time frame.
The results calculated patients with rhBMP-2 had a cancer incidence of 3.37 per every 100 individuals. Patients that received treatment without the use of Infuse had a cancer incidence of .50 per every 100 individuals. Researchers concluded that high doses of rhBMP-2 (40 mg.) were associated with an increased risk of some types of cancer.
Benign Tumors another Risk with Infuse
A second study conducted in 2013 by Duke University researchers found Infuse increased the risk of benign tumors as well. This retrospective study looked at patients that had received Infuse over the previous two years. While this study did not detect an increased risk of cancer in patients with Infuse, researchers did find patients who received rhBMP-2 did have a significantly higher rate of benign tumors. In fact, exposure to the bone grafts resulted in a 31-percent increased risk of the formation of noncancerous tumors.
In 2008, the FDA issued a safety warning about Infuse bone grafts, stating the product had been linked to some potentially life-threatening complications. These side effects included difficulty swallowing, breathing or speaking, due to restriction of the airway. The studies released since that warning have resulted in additional concerns about Infuse, as well as growing litigation nationwide as injured Infuse patients head to court to pursue legal compensation for their medical problems.
Whitney Taylor writes for Injury Lawyer News: Read more about her here.