Many dermal fillers look alike at first glance. One factor that is rarely discussed is what the documentation says about the cross-linking agent and its residues. This article summarises what is, and is not, documented for Lumifil.
What is BDDE?
BDDE (1,4-butanediol diglycidyl ether) is a chemical cross-linking agent used to stabilise hyaluronic acid in dermal fillers. The substance is permitted within regulatory limits. After production, residues of unreacted BDDE may remain, which is why manufacturers specify a maximum residual content.
What the documentation says about Lumifil
- According to the manufacturer's instructions for use (IFU), Lumifil's hyaluronic acid is cross-linked with BDDE. It is therefore not BDDE-free.
- The manufacturer's specification for residual unreacted BDDE is at most 2 ppm.
- BDDE has not been detected in the analysis certificates from BNC Korea that BC Nordic receives with every shipment.
- The certificates are issued by the manufacturer, not by an independent third party, and apply to the batch tested.
Questions worth asking any supplier
- What is the specification for residual BDDE, and how is it measured (method and detection limit)?
- Is there a certificate for each batch, and who issued it?
- What does the IFU say about the cross-linking agent?
Lumifil L-Lite, L-Kiss and L-Max are CE-marked medical devices for authorised healthcare professionals. Read more about Lumifil and the documentation.