An EU-funded product testing campaign to evaluate the safety of hyaluronic acid-based dermal fillers found that 13 of 17 samples passed laboratory tests. Questions over the four remaining samples indicate a need to make consumers more aware of the risks of using these products and the importance of market surveillance.
Market surveillance authorities (MSAs) in 9 countries collected 17 samples for testing. Permanent dermal fillers were excluded from the product scope.
Hyaluronic acid-based dermal fillers are injected into the skin to treat scar tissue, hydrate, replenish volume and reduce the appearance of wrinkles and fine lines. The procedures are not without risks, even when products that conform to EU standards are used.
Test results
A laboratory conducted tests for sterility, endotoxins, cytotoxicity and harmful chemicals.
All samples passed the sterility tests. Three samples failed the initial tests for endotoxins. Retesting of these samples using another method found that only one exceeded the limits defined in the testing plan. Another sample failed cytotoxicity testing.
Tests for harmful chemicals don’t indicate a simple ‘pass’ or ‘fail’, but show which samples contain substances above an analytical evaluation threshold. Substances above this threshold are usually evaluated for health risks. Four samples contained unidentified compounds. Investigation with the manufacturers showed that for two of the four samples, the substances could be identified and presented no risk. Further investigations are ongoing for the remaining two samples with unidentified compounds, in addition to those that failed cytotoxicity testing and exhibited elevated endotoxin levels.
Markings and instructions
Because of the potential concerns to consumers, complete warnings, labelling and instructions for use, as per the requirements of the Medical Device Regulation, are crucial for those who administer these products.
Four (23%) of the 17 samples did not meet the requirements for labelling, markings and instructions. Problems encountered included the absence of required information and unmet language requirements.
Manufacturers of these products are being contacted to correct these non-conformities.
EU campaign
The testing was part of the Joint Actions on Compliance of Products (JACOP), organised by the European Commission’s Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW).
MSAs across the EU jointly selected and checked the compliance of products sold on the single market with EU health, safety and environmental standards. Hyaluronic acid-based dermal fillers were one of the 16 product categories selected for testing.
“Regular market surveillance campaigns are crucial to protect consumers, but also to protect European businesses from unfair competition. The results of these tests confirm that market surveillance campaigns are necessary to enforce EU standards,” said Vanessa Capurso, policy officer at the European Commission’s Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW).
More information
Contact: jacop2024esn [dot] eu (jacop2024[at]esn[dot]eu)