As we’ve seen with Medtronic Infuse lawsuits, using drugs off-label can be problematic in adult surgeries. But now it may be an issue in children’s surgeries as well, according to a recent medpagetoday.com article.
Researchers have found that bone morphogenetic protein (BMP), a medical device that speeds bone growth, has been used on children undergoing spine fusion surgeries. BMP has been linked to various complications in adult surgeries, but these complications are not likely to show themselves until well after the patient has left the hospital. Because BMP is a bone-growth protein, it can take much longer for the effects to be seen as the bones heal.
Due to a lack of long-term data, the research was not conclusive regarding the types of complications that could arise from BMP, nor could it identify a direct link between the protein and post-surgery complications. But its unknown nature presents special concern when used on children. Children’s bones are still in the process of growing, so using a powerful bone-growth protein whose long-term effects are uncertain is risky, especially when it has no demonstrated positive results to make its use necessary in kids. So far, studies have not been able to prove that BMP does much good for the patient.
BMP has been the center of controversy after it was discovered that medical device maker Medtronic failed to report complications that arose after the use of its Infuse product in surgeries. Medtronic reportedly paid spine surgeons millions of dollars to write medical journal articles that downplayed possible serious effects, including increased cancer risk and male sterility.
BMP is also expensive, adding approximately $4,000 dollars to the cost of surgery. With or without insurance, surgery is already a high cost for adults. Given its possible dangers, it is an especially high cost for kids.