The New York Times recently reported that new evidence has emerged showing that Infuse – a bone growth protein commonly used in spinal fusion surgeries and produced by Medtronic – may be no better than its alternative in relieving back pain and discomfort. The report contradicts claims to the contrary made by Medtronic and suggests that Infuse may, in fact, pose health risks to patients. Medtronic is the nation’s largest medical device producer.
Infuse was first sold in 2002; starting around that time, several studies, including some sponsored by Medtronic, claimed that Infuse produced superior patient results and posed little, if any, risk to patients. Many of these Infuse reports were written by researchers who received millions of dollars in consulting fees and other payments from Medtronic. These early, positive reports led to Infuse being commonly used across the country.
By 2011, Infuse was widely used but was also the subject of growing safety complaints. For example, in 2008 the FDA warned of reports of life-threatening complications when Infuse was used to fuse vertebrae in the upper portion of the spine. In the face of growing criticism, Medtronic agreed to fund an independent review of study data of Infuse to be overseen by Yale University. The resulting reviews, published on Monday, June 17, found that Infuse appeared to have no advantages over the alternative fusion method, a simple bone graft, and might pose patient risks, including the possibility of a slight added risk of cancer.
For the full New York Times article, as well as a link to the published medical study, visit http://www.nytimes.com/2013/06/18/business/infuse-a-spinal-treatment-found-no-better-than-older-remedy.html?pagewanted=1&_r=0.
If you have undergone a spinal fusion surgery in the past ten years in which Infuse was used, and are now experiencing any complications, please feel free to contact us. We are currently representing multiple individuals who have similarly been harmed by this product.