Safety

Unlike other esthetic products on the market, RESTYLANE™ has undergone extensive histological and clinical studies and there is an impressive and increasing body of evidence regarding its ease of use, tolerability and effectiveness. A number of comparative studies with other implant materials are ongoing.

Anticipated side effects

After the injection, some common injection-related reactions may occur. These reactions include erythema, swelling, pain, itching, discoloration or tenderness at the implant site. Typically, resolution is spontaneous within a few days after injection into the skin, and within a week after injection into the lips. Additionally, temporary palpable lumpiness has been noted after injection in some patients.

Adverse events

Reactions thought to be of hypersensitivity nature have been reported in about one in every 2000 treatments. These have consisted of swelling and induration at the implant site, sometimes with oedema in the surrounding tissues. Redness, tenderness and, rarely, acneform papules may also occur. The reactions have started either shortly after injection or after a delay of 2 to 4 weeks and have generally described as mild to moderate, and self-limiting with an average duration of two weeks. In pronounced cases a short course of oral corticosteroids may prove effective. In addition, rare cases (less than 1 in 15,000 treatments) of granuloma formation, superficial necrosis and urticaria have been reported.

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Tolerability and Acceptability

Local tolerance to the NASHA gel is excellent, with the material becoming integrated into local tissues. Degraded material is metabolized and excreted by the same pathways as natural hyaluronic acid.

Patient acceptability is very good provided that patients are forewarned that there may be a few days of discomfort before optimal results are achieved.