Bone Morphogenetic Proteins Including InFuse on the Decline Amid Reports of Serious Complications and Adverse Events

When bone morphogenetic proteins (BMPs) such as InFuse were approved in 2002, they were considered a less painful method for spinal problems including severe back pain. But by the end of 2008, it became clear that BMP use was on the decline thanks, in part, to reports of life-threatening and life-altering adverse events that flooded into the U.S. Food and Drug Administration (FDA).

The use of Infuse rose dramatically from 2002 until 2008. A recent study published in The Spine Journal found that the proteins were used in 45.2 percent of lumbar and 13.5 percent of cervical fusions. When federal health regulators started receiving an increasing number of adverse events and complicatin reports, the agency issued a Public Health Notification in July 2008. For the new study, researchers examined how these safety concerns impacted the use of InFuse and BMPs in elective spine surgery.

Scientists 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; by the end of 2012, InFuse was used in only 25 percent of lumbar fusions. Researchers also observed 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.

Morbidity, blood loss, longer operating times and limited tissue graft available prompted surgeons to begin looking into alternative fusion procedures such as BMPs. As the use of InFuse increased, surgeons returned to the original studies on the device to reevaluate donor-site morbidity, revision rates, adverse events and patient-reported outcomes. Pivotal trials that eventually lead to InFuse’s approval have been accused of design flaws and industry influence, The Spine Journal reported.

In 2012, a U.S. Senate Finance Committee investigation found 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.’’ When the committee reanalyzed patient-level data and a meta-analysis of the industry-sponsored FDA trials that led to InFuse’s approval in 2002, it determined InFuse provided no advantage over iliac crest bone grafts and the device’s risks were understated in journal publications, according to The Spine Journal.

InFuse was viewed as a safer, less-painful alternative to grafting tissue from a patient’s own hip, but in 2008, amid a growing pile of adverse event reports, the opposite became clear. Many of the reports cited life-threatening complications including bone and nerve injury, male infertility, infection, urinary problems, and cancer.

The post Bone Morphogenetic Proteins Including InFuse on the Decline Amid Reports of Serious Complications and Adverse Events appeared first on Parker Waichman -

from Parker Waichman http://www.yourlawyer.com/blog/bone-morphogenetic-proteins-including-infuse-on-the-decline-amid-reports-of-serious-complications-and-adverse-events/