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Lyophilized PLLA should only be used by health care providers with expertise in the correction of volume deficiencies after fully familiarizing themselves with the product, the product educational materials, and the entire instruction leaflet.
Lyophilized PLLA vials are for single patient and single session use only. Do not reuse or resterilize the vial. Discard immediately after use. Do not use if package or vial is opened or damaged.
Long-term safety and effectiveness of lyophilized PLLA beyond two years have not been studied in controlled clinical trials.
Lyophilized PLLA should be used in the deep dermis or subcutaneous layer. Avoid superficial injections in order to avoid the appearance of early papules or nodules at the injection site, which could be suggestive of improper injection techniques (superficial placement, excessive amount of product, incorrect reconstitution). In addition, massaging the treatment area to ensure proper distribution of the product may also minimize the appearance of papules or nodules.
Special care must be taken when using lyophilized PLLA in areas of thin skin, such as the periorbital area. An increased risk of papules and nodules in the periorbital area has been reported (see section [ADVERSE REACTIONS"). Refer to the INSTRUCTIONS FOR USE regarding injection techniques.
As with all transcutaneous procedures, lyophilized PLLA injection carries a risk of infection. Standard precautions associated with injectable materials should be followed. As with all injections, patients treated with anti-coagulants may run the risk of a hematoma or localized bleeding at the injection site.The safety of lyophilized PLLA for use during pregnancy, in breastfeeding females or in patients under 18 years has not been established. No studies of interactions of lyophilized PLLA with drugs or other substances or implants have been made.
The safety of using lyophilised PLLA in patients with susceptibility to keloid formation and hypertrophic scarring has not been established. Lyophilised PLLA should not be used in patients with known history of or susceptibility to keloid formation or hypertrophic scarring.
The patient should be informed that he or she should minimize exposure of the treatment area to excessive sun and avoid UV lamp exposure until any initial swelling and redness has resolved. If laser treatment, chemical peeling or any other procedure based on active dermal response is considered after treatment with lyophilised PLLA, there is a possible risk of eliciting an inflammatory reaction at the implant site. This also applies if lyophilised PLLA is administered before the skin has healed completely after such a procedure.
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