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FDA Warns Against Recombinant Bone Graft Use in Patients Under 18

The U.S. Food & Drug Administration (FDA) warned on Jan. 21, 2015 that bone grafts containing recombinant proteins or synthetic peptides should not be used on patients under the age of 18 because their bones may still be growing and the products may cause serious injuries. Reports of excess bone growth, fluid accumulation, inhibited bone healing and swelling have been reported in children treated with bone graft substitutes.

Free Bone Graft Lawsuit Evaluation: If you or a loved one has been injured by a bone graft, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.

What’s the Problem?

FDA is concerned about reports of serious injuries in patients under the age of 18 who have been treated with bone graft substitutes containing recombinant proteins or synthetic peptides. While these injuries are similar to those seen in adult patients, they are of more concern in minors because of their smaller size and because their bones are still growing.

When the body is still growing, vital organs and tissues are closer together than in a fully grown body. During this growth period, small changes to 1 organ or tissue can have serious effects on another. Therefore, if a recombinant bone graft is implanted into the spine of a patient under age 18, who then experiences the same amount of excess bone growth or fluid accumulation as an adult, it may cause spinal nerve injury, pain or weakness. Any product that influences bone growth could affect skeletal development by altering normal bone formation and growth, especially if used near open growth plates.

FDA classifies bone graft substitutes containing recombinant proteins or synthetic peptides as high-risk (Class III) medical devices. As such, manufacturers are required to submit a pre-market approval application which includes clinical data supporting the device’s safety and effectiveness. The agency has not evaluated the safety and effectiveness of bone graft substitutes for use in patients under the age of 18.

Minors with significant bone defects or rare bone disorders may have limited treatment options, so healthcare providers may recommend bone grafts as their best or only treatment option. However, FDA recommends that healthcare providers consider all other treatment options before using bone graft substitutes containing recombinant proteins or synthetic peptides. These options include autograft bone (bone from another part of the patient’s body), allograft bone (transplanted bone from a donor), and bone graft substitutes that do not contain recombinant proteins or synthetic peptides.

Do I have a Bone Graft Lawsuit?

The Product Liability and Defective Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in bone graft lawsuits. We are handling individual litigation nationwide and currently accepting new injury cases in all 50 states.

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