Since bone morphogenetic proteins (BMPs) were approved by the U.S. Food and Drug Administration (FDA) in 2002, the devices have been widely used in spinal fusion surgeries. A new study published in The Spine Journal, however, says that the use of BMPs – including the Medtronic’s embattled InFuse product – is declining due to safety concerns.
Until 2008, the use of InFuse in spinal fusion surgeries rapidly increased. The proteins were used in 45.2 percent of lumbar and 13.5 percent of cervical fusions. InFuse has not been approved for use in cervical fusions, and questions about the overall safety of InFuse prompted the FDA to issue a Public Health Notification in July 2008. The new study’s authors looked at how these safety concerns affected the use of InFuse in elective spine surgery, The Spine Journal reported.
Overall, researchers observed a 44.7 percent decrease in the rate of InFuse use with lumbar fusion. At its peak, InFuse was used in 45.2 percent of lumbar fusions; at its lowest point, at the end of 2012, InFuse was used in only 25 percent of lumbar fusions. Scientists also saw a 56 percent reduction in InFuse use for cervical fusion – down to 6 percent by the end of 2012, from a peak of 13.5 percent, according to The Spine Journal.
Surgeons began looking into alternative fusion procedures such as BMPs due to concerns about morbidity, blood loss, longer operating time and limited autograft (tissue graft) availability. But the increased use of InFuse had led surgeons to reanalyze original studies in order to reevaluate donor-site morbidity (prevalence), rate of revision surgery, adverse events and patient-reported outcomes. Fundamental trials that led to FDA approval of InFuse have been accused of design flaws and industry influence, The Spine Journal reported.
The U.S. Senate Finance Committee concluded in a 2012 investigation that ‘‘Medtronic was involved in drafting, editing, and shaping the content of medical journal articles authored by its physician consultants who received significant amounts of money through royalties and consulting fees from Medtronic.’’ A reanalysis of patient-level data and a meta-analysis of the industry-sponsored FDA trials independently determined that there was no advantage to using InFuse versus iliac crest bone graft and its risks were understated in journal publications, according to The Spine Journal.
InFuse is used as an alternative to grafting tissue harvested from a patient’s own hip, which can be excruciatingly painful and may require more recovery time. Medical journals initially touted InFuse surgery as having superior results, but by 2008 the FDA had received enough adverse event reports to show just the opposite. Many of the reports included life-threatening complications, including cancer.