Evaluation of the safety of a non-animal stabilized hyaluronic acid (NASHA -- Q-Medical, Sweden) in European countries: a retrospective study from 1997 to 2001.
BACKGROUND
In Europe, several filler devices are currently on the market for use in aesthetic dermatology and some of them cause severe, permanent, adverse reactions. Since 1996 a non-animal stabilized hyaluronic acid (NASHA) from Q-Medical, Sweden, has been introduced and is becoming a leading product in aesthetic dermatology. Hyaluronic acid has no species specificity and skin testing is not recommended before treatment.


OBJECTIVE
Our purpose was to evaluate the incidence of adverse reactions from 1997 to 2001 and the safety of NASHA after injections into the skin for aesthetic reasons.


METHODS
Surveys were sent to physicians in European countries that agreed to participate. This is a retrospective study. A total of 12 344 syringes were sold by the Q-Medical to these physicians and we evaluated the total number of patients treated to 35% of this number (4320). We separated immediate hypersensitivity reactions from delayed reactions and analysed infectious and other types of reactions.


RESULTS
From 1997 until 2001, 34 cases of hypersensitivity were reported: 16 cases of immediate hypersensitivity and 18 cases of delayed. The global risk of sensitivity is 0.8%. Since 2000, the amount of protein in the raw product has decreased and the incidence of hypersensitivity reactions is around 0.6%. As 50% of these reactions are immediate and resolved within less than 3 weeks, the risk of strong but transient, delayed reaction is around 0.3%. Four cases of abscess were reported. They were all sterile. No bacterial infection was found. Herpetic recurrence is possible after lip augmentation according to the technique of injection. No systemic reactions were reported.


CONCLUSIONS
NASHA is a very useful and safe filler product. Skin testing does not seem to be necessary.
André
P
P
157 rue de l'Université, 75007 Paris, France. pandre2@noos.fr
D001672:Biocompatible Materials / Q000008:administration & dosage / Q000009:adverse effects; D003357:Cosmetic Techniques / Q000009:adverse effects*; D003625:Data Collection; D004342:Drug Hypersensitivity / Q000209:etiology; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage / Q000009:adverse effects* / Q000031:analogs & derivatives*; D006968:Hypersensitivity, Delayed / Q000139:chemically induced; D006969:Hypersensitivity, Immediate / Q000139:chemically induced; D007239:Infections / Q000209:etiology; D007271:Injections, Intradermal / Q000009:adverse effects; D012189:Retrospective Studies; D015595:Skin Aging
D001672:Biocompatible Materials; D006820:Hyaluronic Acid; C445361:Restylane