Medtronic Inc.’s Infuse Bone Graft product is being used in pediatric spinal surgeries, even though it was never approved for use in children.  This is disturbing, considering that a number of Medtronic Infuse bone graft lawsuits have been filed by people who allege they sustained serious injuries when the bone growth protein was used in off-label procedures.

According to a study published earlier this month in the Journal of the American Medical Association, some one in ten U.S. children undergoing spine fusion surgery are receiving a  bone growth protein like Medtronic’s Infuse.  Also known as bone morphogenetic protein-2 or BMP-2, Medtronic Infuse Bone Graft is used to accelerate bone formation.  However, according to a Reuters report, the product has a troubled history, and known Medtronic Infuse side effects include increased cancer risk, sterility in men, infections, bone dissolution and worsened back and leg pain.  It’s not clear if kids face the same risks from Medtronic Infuse, but the lead author of the study told Reuters that there is concern about the ways such proteins might interact with a child’s still-developing skeleton.  There is also little evidence that products like Infuse provide any added benefits for children.

In 2008, the U.S. Food & Drug Administration (FDA) warned that Infuse Bone Graft had been associated with serious complications when used off-label in cervical spine fusions, including excessive swelling in the neck, compressed airways, difficulty breathing, problems swallowing and nerve damage.  It is legal for doctors to use medical products in procedures not approved by the FDA, but drug and device makers are not allowed to promote off-label uses.

The new study published in the Journal of the American Medical Association (JAMA) involved 4,100 hospitals where roughly 9.2% of the spinal fusion surgeons performed on patients under the age of 18 involved the use of a BMP-2 product.  The study did not differentiate which brands were used, Reuters said.  Among other things, the study revealed that procedures using products like Infuse were significantly more expensive than traditional spinal fusions – $47,136 on average when BMP-2 was used, compared to $43,126 when it was not. Most interesting, use of such products was highest at hospitals in the Midwest, where Medtronic is based, Reuters said.

While complication rates seen in either procedure were about the same, the research team did voice concerns about long-term effects.  They are currently analyzing data from another registry to see how children with BMP-2 did after they left the hospital, Reuters said.

In the past, Medtronic’s financial relationships with some doctors have raised concerns that payments from the company are behind the frequent off-label use of Infuse.  Last summer, an analysis published in The Spine Journal reported that more than a dozen Infuse clinical trials submitted to the FDA prior to its approval failed to report serious complications  in patients treated with the product.   The same paper also reported that many of the researchers involved in those studies had financial relationships with Medtronic.

Published October 22, 2012 by