In a recent announcement from the U.S. Food and Drug Administration (FDA), the agency warns the medical community and parents that bone grafting is not a safe procedure for children under the age of 18. The FDA warns that using synthetic bone growth materials on children who have yet to reach skeletal maturity is not approved for any reason due to the serious bone graft complications that may occur.

Some of the bone graft side effects the FDA is concerned about include excess bone growth, inhibited bone healing, and swelling. While these side effects may occur in any patient implanted with synthetic bone growth products, the FDA states that the damage will be worse if they occur in bones that are not completely formed.

Bone grafting is a major medical procedure that surgeons consider for various reasons including reconstructing bone loss after a disease or trauma, regenerating bone growth across a diseased joint, bone fracture repair, and encouraging bone growth around a hip, knee, or shoulder implant.

For now, alternative treatment options are available for pediatric patients. The medical community considers these alternatives, including using healthy bone tissue from a patient’s body and transplanting it to another location, as a safer approach. Ultimately, the FDA does not want synthetic proteins and peptides to be implanted into anyone that hasn’t reached skeletal maturity.

Medtronic Inc. is among the class of bone graft manufacturers that the FDA safety communication covers. Medtronic could be held liable if their Infuse Bone Graft System is used on pediatric patients.

Infuse Bone Graft Complications

The Infuse Bone Graft was developed as a less invasive approach to treating a damaged spine when compared to spinal fusion surgery. Medtronic’s Infuse is made of synthetic bone morphogenetic protein (rhBMP-2) as well as a spongy material made from cow collagen. The synthetic material is directly implanted into the spine and does not require a lengthy recovery time.

The FDA approved Medtronic’s Infuse Bone Graft System in 2002 to treat certain lower lumbar procedures. The bone graft system quickly became a popular alternative to spinal surgery. However, Medtronic allegedly began marketing the product for off-label use, which created some serious complications. Some of the reported Infuse bone graft complications include paralysis, ectopic bone growth, severe pain, nerve damage, airway compression, and male sterility.

Typically, Infuse bone graft complications will occur within two to 14 days post-operation. When they occur, patients require medical attention ranging from surgery to drain the area to respiratory support, tracheotomy, or anti-inflammatory medication.

Allegations have surfaced that Medtronic claimed the Infuse Bone Graft was also approved for use on the cervical area of the spine when it was not authorized to do so. This and other allegations lead to a 2011 investigation by the U.S. Senate. The investigation found that Medtronic paid doctors to write good reviews of their Infuse product and physicians were given a kickback if they used Infuse. Medtronic ultimately settled that case, but currently faces more than 1,000 Infuse bone graft lawsuits.