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Ensuring Your Biologics Clinician is Up-to-Date: What You Should Know Part 3
Posted February 6, 2024
In the rapidly evolving field of biologic treatments, it's vital for patients to be aware of the regulatory landscape. Since June 2021, the FDA has set guidelines to ensure the safety and efficacy of biologic products.
Here's what you need to know:
- Illegal Biologic Products:
Be cautious if you are offered anything other than PRP, BMAC, M-fat, or Prolotherapy (Dextrose in Water). The FDA prohibits the use of certain products, including but not limited to exosomes—extracellular vesicles—and birth products—amniotic fluid/products, umbilical cord blood/products, and Warton's Jelly—unless part of an FDA-approved Investigation New Drug (IND) study.
If your clinician suggests any of the illegal products mentioned above or fails to adhere to the outlined key points in this article series, it might be prudent to explore other providers for your biologic treatments.
Stay informed, ask questions, and prioritize your health when considering biologic interventions for spine and sports medicine.