The Afssaps recalls that wrinkle fillers must bear the CE marking and be accompanied by at least one user manual.
According to Afssaps, the risks associated with the injection of wrinkle fillers may vary depending on the individual. Thus, patients can be victims of redness, edema, bruising, allergies and pigmentation. These risks must imperatively be recorded in the instructions for use in order to inform patients.
Afssaps insists on the fact that “slowly absorbable” or “non-absorbable” products can cause other, rarer risks, such as granulomas and necrosis. Although they only constitute a frequency of 0.1 to 1% of patients treated, these risks can occur from a few days to several years after the injection of the product and become permanent.
Faced with these dangers, the French Agency advises against the use of non-absorbable injectable products for aesthetic purposes because of an “uncontrolled risk of serious undesirable effects”.
Afssaps also invites the patients concerned by these injections to request and keep the characteristics of the product (s) concerned, namely the trade name, the name of the manufacturer, or the batch number, as well as the name of the doctor and the location. in which the injection was performed.
Source: www.afssaps.fr
