A new study suggests that the bone growth protein, bone morphogenetic protein (BMP), is used in up to 10 percent of all pediatric spine surgeries despite the fact that it’s not approved for this use.
BMP is a relatively new alternative for doctors in select surgical situations to use this genetically-engineered protein to promote bone growth rather than grafting a portion of bone from another place on a person’s body. The bone growth material has never been approved for use in pediatric surgeries but much of the revenue BMP has generated since 2002 has been from off-label use applications of it.
Study authors however, were less concerned with the financial impact of its use on a child in a back or neck surgery but that it could be putting them at risk of suffering some serious and potentially life-threatening side effects. BMP is only approved to be used in some surgeries and few tests have ever proven that its either safe or effective in those. Most of its actual applications have been off-label varieties, meaning they’ve not been approved by the Food and Drug Administration but are chosen to be used by surgeons or patients fully aware of the risks.
The lone makers of BMP, medical device maker Medtronic, have been accused of falsifying data and wrongly influencing surgeons on the safety and effectiveness of BMP. The study that got BMP approved by the FDA in 2002 for just a few surgeries was funded by the company and is believed to be highly-influenced by an orchestrated effort to ensure the study would tout the benefits of its use while downplaying side effects.
Medtronic is also accused of hiding data that shows BMP is linked to several serious side effects like excessive bone growth, serious infections at the site of the surgery, and even some forms of cancer. Excessive bone growth can cause severe pain and in some places along the spine could have a more serious impact, like obstructing an airway and blocking a person’s ability to breathe normally.
This latest study that appears in the latest edition of the Journal of the American Medical Association warns that BMP should not be used in pediatric surgeries whatsoever until some data is produced that shows it will not lead to these same serious side effects, and potentially worse complications. On average, BMP was used in 9.2 percent of pediatric spine surgeries among a pool of several thousand examined using a national database of surgeries performed on children.