Late last week the US Food and Drug Administration announced that clinicians should avoid using certain bone graft substitutes in patients under the age of 18 because they can carry serious injury risk.
The specific bone graft substitutes in question contain recombinant proteins or synthetic peptides that mimic the bone’s natural growth. When paired with what’s known as a carrier or scaffold, these pieces work to replace or regenerate an existing bone prior to spurring new bone growth.
These types of grafts are plenty safe for patients 18 and older whose bones have stopped growing, but they’ve never been approved for patients who are still experiencing bone growth. The FDA announced that these types of bone graft substitutes should be avoided for patients who are still growing, as numerous problems can occur, including:
- Excess bone growth
- Fluid accumulation
- Inhibited bone healing
- Swelling
- Increased pressure to adjacent tissues and organs
- Related adverse events
The FDA noted that these problems also occurred in older patients from time to time, but the threat is much greater to younger patients because of their ongoing bone growth and typically smaller stature.
FDA Lists Three Options
In order to keep patients safe, the FDA listed three alternative solutions for young patients in need of a bone graft. Instead of the graft substitute containing recombinant proteins or synthetic peptides, FDA says doctors should consider:
- An autograft bone, which is harvested from another part of the patient’s body;
- An allograft bone, which is transplanted from another person’s body; or
- A bone graft substitute that is approved by the FDA for young patients which does not contain recombinant proteins or synthetic peptides.
Dr. Silverman comments
Using a one size fits all method rarely works perfectly in the healthcare field. A prescription that may work for one person may have no effect on another. A device that works well for adults may cause problems if used by children.
I’m glad the FDA is calling for more research on this device.