Bone graft surgery often involves bone morphogenic protein (BMP), an implanted material that encourages bone growth and fuses the gaps between spinal vertebrae. Instead of using natural bone, many people have been implanted with these substitute products, and too many have experienced horrible outcomes.
Now, the FDA officially is warning against their use for children.
Last month, the feds issued a safety communication to doctors advising against routine use of bone graft substitutes that contain certain proteins, like those in Medtronic Infuse, because they might cause bone growth problems for children. This product, as explained on AboutLawsuits.com, is widely used even though the FDA has approved it only for limited spinal procedures in adults. Its “off-label” use, however includes other types of spine fusion surgery that are associated with an increased risk of severe and painful complications caused by excessive bone growth, fluid accumulation, retarded healing and swelling.
“While these types of events are similar to those seen in patients over age 18,” the warning reads, “they are of more concern in patients under 18 because of their overall smaller size and because their bones are still growing.”
Three years ago, an article published in the Journal of the American Medical Association (JAMA), expressed concern about bone graft substitutes in children, indicating that nearly 1 in 10 spinal fusion surgeries relied on them despite long-term risks.
What’s possibly bad for adults, the FDA is saying, looks even worse for kids. “In a body that is still growing, vital organs and tissues are closer together than in a body that is done growing. This could potentially allow small changes from one organ/tissue to have serious effects on another,” the alert read. “For example, there is less space between the spinal cord and the bones surrounding it. If one of these products is used in the spine of a patient under age 18, who then experiences the same amount of excess bone growth or fluid accumulation as a patient over age 18, it may more easily lead to spinal nerve injury, pan, or weakness.”
If your doctor advises treating your child’s bone defect or bone disorder with a bone graft substitute, especially Medtronic Infuse, discuss your concerns and ask about other options, AboutLawsuits suggested, such as autograft bone. That involves taking bone from another part of the child’s body instead of using a substitute product. Another option to ask about is allograft bone, which is material transplanted from another person.
The FDA also recommended that doctors consider bone graft substitutes that do not contain recombinant proteins or synthetic peptides.
As we blogged regarding Medtronic Infuse, the company has vigorously promoted it since its introduction in 2002. But in 2008, the FDA warned about its risks for off-label uses after receiving many reports about serious complications and deaths.
And the company has been accused of promoting off-label use of Infuse, which is illegal. Although practitioners may use a drug or device off-label, manufacturers are not allowed to promote it for any use other than what the FDA approves. Medtronic has agreed to pay about $22 million to settle nearly 1,000 lawsuits associated with bone graft problems.
This is a dangerous device for anybody, and now, it seems, especially for kids.