-Intended Use
-Olidia® (Sterile Absorbable Poly-L-Lactic acid (PLLA) Dermal Filler) is intended for injection into the deep dermis using a syringe for the treatment of severe facial wrinkles and folds, replacement of volume defects, facial lipoatrophy,
and improvement of facial contour deformities.
-For use exclusively by licensed medical doctors with appropriate training in aesthetic procedures.
-Before treatment, patients should be informed of the indications of the product, prohibitions, and potential adverse events.
-Since the effect of the treatment gradually appears within several weeks after injection, do not overcorrect (overfill).
-Do not use the product until any inflammation or infection at the intended injection site is controlled.
-The safety of using the product has not been established in patients with susceptibility to excessive scarring (keloids), in patients with a history of herpetic eruption, during pregnancy, in breastfeeding mothers,
or in patients under the age of 18.
-Do not inject the product into patients with acute or chronic skin diseases (infection or inflammation) either at the injection site or in surrounding areas, into patients who are hypersensitive to the product and its components, or into patients
with liver malfunction or blood coagulation disorders.
-As with other injections, patients who have been administered anticoagulants may be at risk of hematoma or local bleeding at the injection site.
-Do not inject into blood vessels. Injection into blood vessels may obstruct the blood vessels or their flow and cause serious adverse effects, including tissue necrosis, loss of eyesight, and skin embolism.
-Do not inject into the vermilion areas of the lips. The safety and effectiveness of the product for lip augmentation have not been established.
-It is strongly recommended not to use the product in the periorbital areas, including the areas between the eyes, where the skin is thin and where inadvertent intravascular injection is more likely.
-Potential adverse events may include the following
-Reaction at the injection site : haemorrhage, pain, induration, swelling, tenderness, lesion, bleeding, fever
-Abnormality in the immune system : hypersensitive angioedema, skin sarcoidosis, dermatitis, severe allergic reactions including heart palpitations, hives, keloids and systemic auto-immune reaction
-Inflammation and infection : infection of the injection site including facial cellulitis, bacterial infection, abscess at the injection site
-Abnormality in skin and subcutaneous tissue : bruising, hematoma, atrophy or skin hypertrophy at the injection site, erythema at the injection site, urticaria at the injection site, telangiectasias,
papules or nodules, granuloma, scarring, skin discoloration
-General reactions : discomfort, ecchymosis, photosensitive reaction, fatigue, hair breakage, brittle nails, application site discharge, aching joints
-Most papules in the subcutaneous tissue can be sensed by palpation, but they are not visible and have no symptoms.
-After treatment, nodules including periorbital ones may be accompanied by inflammation or discoloration.
Subcutaneous nodules detected at the initial stage of injection can be minimized with adequate dilution and injection.
-Subcutaneous nodules may become apparent later (within 1 to 10 months after injection) and may last up to two years.
-It may be necessary to remove or treat nodules surgically or with intralesional corticosteroids.
-Some swelling may resolve within several hours to a few days after injection.
-After injection, redness, swelling and/or bruising may occur.
-Ice cubes or an ice pack wrapped with fabric (avoiding any direct contact of the ice with the skin) may be applied to the treatment area to reduce redness, swelling and/or bruising.
-Patients should massage the treated area for five minutes, five times a day, as directed by the healthcare professional.
-At the initial stage of injections, the original folds or wrinkles may reappear, but they may gradually diminish as the treatment effect develops.
-Additional injection treatment may be necessary after the initial treatment. Treatment effects are not permanent. Individual outcomes and duration may vary, and repeated procedures may be required to maintain results.
-If you have any concerns after treatment, consult your healthcare professional.
