January 21, 2015 — Recombinant bone growth proteins and synthetic peptides should not be used routinely in children due to the risk of severe complications, according to a Safety Communication from the FDA.
In October 2012, a study published in JAMA found that nearly one in ten (9.2%) spinal surgeries in children used bone-growth proteins, such as rhBMP-2.
The FDA was particularly concerned about spinal surgeries, warning:
“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, pain, or weakness.”
The FDA has already received reports of children who developed excess bone growth, fluid accumulation, inhibited bone healing, and swelling. These adverse events also occur in adults, but the FDA is more concerned about children due to their smaller size and growing bones.
For example, if the products were implanted near an open growth plate, it could affect normal skeletal development. Vital organs are also closer together in children, which increases the risk of complications from excess bone growth.
Traditional bone graft techniques in children do not have the same risks. These techniques include autograft bone (bone that comes from another part of the patient’s body) and allograft bone (“banked bone” which is transplanted bone from another person).
Despite the lack of FDA approval, bioengineered bone-growth products have gained popularity for use in children. The products contain synthetic peptides or recombinant proteins (such as rhBMP-2), which mimic the effect of natural bone-growth proteins in the body.
None of these products are FDA-approved for use in children under 18 years old. The FDA classifies them as a high-risk, Class III medical device subject to strict regulation.
Do I have a Bone Graft Lawsuit?
The Schmidt Firm, PLLC is currently accepting bone graft induced injury cases in all 50 states. If your child was injured by a bone graft using synthetic bone-growth products, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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