Recently, the FDA alerted surgeons that it has received 38 reports of serious complications associated with Infuse, a growth factor marketed by Medtronic to promote bone growth and healing after spine surgery.
What makes this news is that the complications have arisen following off label use of Infuse. The FDA approved the drug for use in lumbar spine (lower back) surgery, but the complications have followed cervical spine (neck) surgery.
The complications include difficulty breathing and swallowing, and they have at times necessitated life saving tracheotomy and repeat surgery.
Medtronic is not allowed to promote off label use of its products and Medtronic denies doing so. Physicians paid by Medtronic have no such restrictions, however.
Shortly after the FDA approved Infuse, influential surgeons such as Regis W. Haid and Gerald Rodts began lecturing about and posting on web sites their favorable results using Infuse in cervical spine surgery. They did not always disclose that they were paid by Medtronic. Some of these surgeons received royalties on sales of Infuse, a practice sure to promote off label utilization.
Not pretty, and not unusual.