FDA Issues Warning Against Bone Graft Use in Children

On January 21, 2015, the U.S. Food and Drug Administration issued a bone graft warning to physicians, children with bone growth defects, and parents of children with bone growth defects. The warning pertained to the use of bone grafting in children under age 18, including a detailed explanations of the problems than can ensue for children as they reach adulthood.

Bone grafting is a highly-technical major medical procedure implemented by pediatricians, plastic surgeons, dentists, orthopedic surgeons and neurosurgeons. Very generally speaking, the process involves stimulating or implanting bone in an area where it is needed.

The four most common instances of bone grafting, including pediatric bone grafting, include:

• Bone stimulation to effectuate the healing of a fracture
• To encourage bone growth across a diseased joint, a process also known as “fusion” or “arthrodesis”
• To regenerate a bone lost as a result of disease or trauma
• To encourage healthy bone growth around the implantation of a foreign object, such as a hip, knee, or shoulder replacement

Bone grafting can occur either through the implantation of healthy bone tissue from elsewhere in the body, or through a process known as “osteoconductive stimulation.” The latter – which is under scrutiny by the FDA – involves the placement of a “scaffold” in the affected area, which is made of synthetic man-made materials and designed to encourage the “migration” of healthy bone cells to the area, ultimately resulting in the development of new bone tissue. These scaffolds also contain synthetic proteins and peptides designed to “mimic” bone growth, which has caused the FDA apprehension when used to stimulate pediatric bone growth.

FDA bone graft warning

The FDA begins its safety communication with an explanation as to the type of patient permitted to use synthetic bone growth peptides and proteins. Currently, these products are only approved for orthopedic and dental use in patients who are “skeletally mature,” – that is, done growing. By contrast, these synthetic materials are not approved for use for any reason in patients who are “skeletally immature,” – or, still growing. The FDA has determined that an appropriate marker for skeletal maturity occurs once the patient has reached age 18, and has prohibited use of these products in any orthopedic or dental patient aged 17 years or younger.

The FDA continued its explanation by highlighting several severe side effects having occurred in pediatric patients implanted with synthetic bone growth products – which are generally limited to those patients suffering from rare or incurable bone growth disorders. According to the FDA, these patients experienced the onset of “excess bone growth, fluid accumulation, inhibited bone healing, and swelling.” Admittedly, these side effects also occur in patients aged 18 and older, however the FDA’s cause for concern centers around the fact pediatric bones are not fully formed or developed, making the side effects much more potentially damaging.

Infuse bone graft problems for pediatric patients

One such synthetic bone grafting system, known as the Infuse bone graft, has caused a number of problems in patients – particular those seeking relief from severe lumbar injuries. As a member of the class of bone grafts mentioned in the FDA’s safety communication, Infuse bone grafts could face additional liability for issues arising in pediatric patients, particularly in light of the fact the FDA has not approved synthetic bone growth peptides and proteins for use in pediatric patients for any reason.

Parents looking for a solution for their child’s bone growth issues are encouraged to consider the following, safer, alternatives:

• Autograft bone grafting: Bone transplanted from the patient’s own body
• Allograft bone grafting: Bone originating from a “bone bank,” and transplanted to the patient from a donor
• FDA-approved bone graft substitutes that do not contain the synthetic proteins and peptides.

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