Some skin and hair treatments are simply ineffective, while others are downright risky. The dangers of exosomes, which are a treatment involving injecting or topically applying cells that send messages in the body, can vary widely.
The FDA has sent warning letters to companies promoting exosome ingredients. As of May 2026, the FDA also reminded consumers about the dangers of injecting unapproved human cells and/or tissues into their bodies following a patient’s death.
While exosomes are sometimes promoted as a solution to skin and hair issues, such as anti-aging properties, reducing hair loss and more, the dangers of exosomes are worth considering before getting a treatment. Dr. Gina Maccarone, a triple board-certified cosmetic surgeon and founder of The Surgeonista in Cincinnati, Ohio, says no single exosome product has FDA approval for any therapeutic use in humans, aesthetic or otherwise. “It is considered entirely experimental.”
The Side Effects of Exosome Treatments
While you can expect typical injection or skin procedure reactions from swelling and redness to irritation at the injection site, Maccarone says, you can also see allergic or immune reactions. “The honest problem is that when a product is poorly characterized, you can’t fully predict its side effects because you don’t reliably know what’s in it,” she adds.
She also points to a lack of evidence to assure safety. “Most of the published aesthetic data comes from small, short-duration studies, and reviewers consistently point out that robust long-term safety information is lacking. That’s a significant disconnect for a product meant to send biological signals into your tissue,” she says. “We simply don’t yet have the years-long follow-up that would let me tell a patient with confidence that a given product is safe over time.”
Why Are Exosomes Controversial?
Patients need to do their research as they consider the safety versus danger of exosomes. Maccarone says since no treatments carry FDA approval, considered the “gold standard” for safety, it’s hard to be sure what is safe.
Look for transparency about the cell source, manufacturing under proper quality standards and a board-certified physician administering it, she adds. “The single strongest sign of legitimacy is that the treatment is offered within a registered clinical trial. Outside of that, understand that even a ‘reputable’ product is still not FDA-approved.”
But just because the treatment isn’t yet approved and carries safety concerns now doesn’t mean it always will. In fact, she finds the science behind the treatments promising, and anticipates there will eventually be FDA approval for some treatments.
How to Watch for Risky Signs and Red Flags
“But we’re not there yet, and the space right now is one of the most aggressively marketed and least regulated corners of aesthetic medicine, which attracts opportunists,” she says. “My advice is to stay curious but skeptical, treat ‘FDA-approved’ as a claim to verify rather than trust and remember there are other options like PRP that sit on much firmer clinical grounds.”
This article originally appeared on USA TODAY: The hidden risks of exosome treatments. Reporting by Alexandra Frost, USA TODAY / USA TODAY. USA TODAY Network via Reuters Connect.
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