As with all transcutaneous procedures, lyophilized PLLA microspheres injection carries a risk of infection.
Standard precautions associated with injectable materials should be followed. As with all injectable products, universal precautions must be observed when there is a potential for contact with patient body fluids.
The injection session must be conducted with aseptic technique.
The needle for injections
Lyophilized PLLA microspheres should be injected using a 26 G sterile needle. Do not inject with needles smaller than 26 G and do not bend the needle. To maintain a uniform suspension throughout the procedure, intermittently agitate the product in the syringe. Before initial injection, expel a few drops of injectable PLLA microspheres through the attached 26 G needle to eliminate air and to check for needle blockage. If the 26 G needle becomes occluded or dull during an injection session replacement may be necessary. If clogging occurs, remove the needle, expel a small amount of product, attach a new sterile 26 G needle, then expel a few drops of lyophilized PLLA microspheres to eliminate the air and re-check for needle blockage.
The deep dermal plane
Lyophilized PLLA microspheres should be injected into the deep dermis or subcutaneous layer. In order to control the injection depth of lyophilized PLLA microspheres, stretch/pull the skin opposite to the direction of the injection to create a firm injection surface. The 26 G sterile needle, bevel up, should be introduced into the skin at an angle of approximately 30-40 degrees, until the desired skin depth is reached. A change in tissue resistance is felt when the needle crosses from the dermis into subcutaneous layer. If the needle is inserted at too shallow (small) an angle or if the needle tip is not sufficiently advanced, then the needle tip may be in the mid or superficial (papillary) dermis, the needle bevel may be visible through the skin. If product is injected too superficially the injected area will blanch immediately or shortly after injection. If this occurs,the needle should be removed and the treatment area gently massaged. In the event that the blanching does not disappear, the patient should not be re-injected.
Injecting: Threading or Tunnelling
a) Technique
When the appropriate dermal plane is reached, the needle angle should be lowered to advance the needle in that dermal plane. Prior to depositing PLLA microspheres in the skin, a reflux maneuver should be performed to assure that a blood vessel has not been entered.
Using the threading or tunnelling technique, a thin trail of lyophilized PLLA microspheres should then be deposited in the tissue plane as the needle is withdrawn. To avoid deposition in the superficial skin, deposition should be stopped before the needle bevel is visible in the skin.
b) Volume per injection
The maximum volume of lyophilized PLLA per each individual injection should be limited to 0.1 mL – 0.2 mL, spaced at a distance of 0.5 – 1 cm. Avoid overcorrection.
c) Volume per treatment area
The volume of product injected per treatment area will vary depending on the surface area to be treated. During the initial treatment sessions with, only a limited correction should be made. In contrast to other wrinkle fillers, lyophilized PLLA provides a gradual improvement of the depressed area over several weeks as the treatment effect occurs. Additional sessions may be needed to achieve full effect. The total number of injections and thus total volume of lyophilized PLLA microbeads injected will vary based on the surface area to be corrected, not on the depth or severity of the deficiency to be corrected.
Injecting: Depot
a) Technique
The depot technique is most appropriate for injections into areas of thin skin at the level of the temples. When using this technique, lyophilized PLLA microbeads is injected as a small bolus deep to the temporalis muscle. Intramuscular injection should be avoided.
b) Volume per injection
The volume of lyophilized PLLA microbeads should be reduced to approximately 0.05 mL/injection. Following each injection, the area should be massaged.
Massage during the injection session
The treatment areas should be periodically massaged during the injection session to evenly distribute the product.
Degree of correction
The depressed area should never be overcorrected (overfilled) in an injection session. Limited correction of the treatment area allows for the gradual improvement of the depressed area over several weeks as the treatment effect occurs. Typically, patients will experience some degree of edema associated with the injection procedure itself, which will give the appearance of a full correction by the end of the injection session (within about 30 minutes). The patient should be informed that the injection-related edema typically resolves in several hours to a few days, resulting in the `reappearance` of the original contour deficiency.
Post-treatment care
Immediately following an injection session with lyophilized PLLA, redness, swelling, and/or bruising may be noted in the treatment area. Refer to ADVERSE REACTIONS section fordetails. After the injection session, an ice pack (avoiding any direct contact of the ice with the skin) should be applied to the treatment area in order to reduce swelling and/or bruising.
It is important to thoroughly massage the treatment area to evenly distribute the product. The patient should periodically massage the treatment areas for five minutes, five times per day for five days after the injection session to promote a natural-looking correction.
PLLA microspheres injected may be visualized with ultrasound imaging and MRI. It is not observed with CT scans and radiography.
Edit by Bella
Rimless Industry Co.,Ltd.