CE-Marked Pigments: A Higher Risk for Aesthetic Keratopigmentation?
Many CE-marked pigments were never designed for aesthetic keratopigmentation. Because of their medical classification, their benefit/risk ratio is assessed based on a therapeutic need—meaning some risk is accepted in exchange for a medical benefit.
However, for purely aesthetic procedures, safety must be absolute.
Using CE-Marked Pigments for Aesthetic Keratopigmentation Involves Risks:
- ❌ Higher risk of endothelial cell loss – Potential long-term vision impact.
- ❌ Pain and intense discoloration after MRI – Caused by unstable pigments.
- ❌ Legal and insurance concerns – Using a CE-marked medical pigment outside its intended purpose does not provide additional protection and may expose professionals to liability.
NEORIS ensures full compliance with general product safety standard, which states that aesthetic products must present zero risk to users. To meet this standard, Eurofins toxicologists have thoroughly evaluated NEORIS pigments, confirming their safety.