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.
