In July 2013, the Annals of Internal Medicine published the results of a two year analysis of Medtronic Infuse Bone Graft data conducted by Yale University. The analysis concluded that use of the Infuse Bone Graft is no better than traditional operations for spinal surgeries but can include additional risks.
Yale University contracted with Oregon Health & Sciences University in Portland and the University of York in the U.K to analyze Medtronic data from 17 spinal studies using Infuse Bone Grafts on more than 2,000 patients.
Both universities determined that there is not a clear advantage in terms of benefits of the Infuse Bone Graft for lumbar spinal surgery. Researchers also reported links between the Infuse and serious side effects such as retrograde ejaculation, nerve pain, bone spurs and urogenital problems.
Researchers believe that previous Medtronic studies praising the effectiveness of the Infuse Bone Graft contain biased results and selective reporting. The analyses also suggests that early published data from Medtronic on the trials underreported side effects and emphasized favorable results. The FDA granted a limited approval of the Infuse Bone Graft in 2002 to be used only during surgeries on the lumbar spine region when entered through the abdomen. However, Medtronic has allegedly promoted off-label use of their bone graft product in neck and upper spine surgeries.
If you or a loved one experienced complications after receiving an Infuse Bone Graft, you may be eligible to file a lawsuit against Medtronic. For a free legal evaluation, contact the lawyers at Hissey Kientz, LLP by calling toll-free at 8-555-HELPYOU, or by filling out the free case evaluation form located on this page.