Caution: It restricts this device to sale by or on the order of a licensed physician or properly licensed practitioner.
BEFORE USING PRODUCT, READ THE FOLLOWING INFORMATION THOROUGHLY.
1. DEVICE DESCRIPTION
Singderm® Lift is a sterile, biodegradable, non-pyrogenic, viscoelastic, clear, colorless, homogeneous gel implant. It consists of crosslinked hyaluronic acid (HA) produced by Streptococcus species of bacteria, formulated to a concentration of 24 mg/mL and 0.3% lidocaine in a physiologic buffer.
2. INTENDED USE/INDICATIONS
Singderm® Lift is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the midface in adults over the age of 18.
• Singderm® Lift is contraindicated for patients with severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies.
• Singderm® Lift contains trace amounts of Gram-positive bacterial proteins and is contraindicated for patients with a history of allergies to such material.
• Singderm® Lift contains lidocaine and is contraindicated for patients with a history of allergies to such material.
• The product must not be injected into blood vessels. Introduction of Singderm® Lift into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft tissue fillers, for example, after insertion of the needle, and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly and apply the least amount of pressure necessary. Rare but serious adverse events associated with the intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage, leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms, including changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and possibly evaluation by an appropriate health care practitioner specialist should an intravascular injection occur.
• Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled.
• Treatment site reactions consist mainly of short-term inflammatory symptoms and generally resolve within 7 days.
• Singderm® Lift is packaged for single-patient use. Do not resterilize. Do not use if package is open or damaged.
• In order to minimize the risks of potential complications, this product should only be used by health care practitioners who have appropriate training, experience, and who are knowledgeable about the anatomy at and around the site of injection.
• Health care professionals are encouraged to discuss all potential risks of soft tissue injection with their patients prior to treatment and ensure that patients are aware of signs and symptoms of potential complications.
• Generally, patients should be limited to 20 mL of any Singderm® Lift injectable gel per 60 kg (130 lbs) body mass per year. The safety of injecting greater amounts has not been established.
• The safety and effectiveness for the treatment of anatomic regions other than the mid-face have not been established in controlled clinical studies.
• As with all transcutaneous procedures, dermal filler implantation carries a risk of infection. Standard precautions associated with injectable materials should be followed.
• Singderm® Lift is to be used as supplied. Modification or use of the product outside the Directions for Use may adversely impact the sterility, homogeneity, and performance of the product.
• The safety for use during pregnancy, in breastfeeding females, and in patients with very thin skin in the mid-face region has not been established.
• The safety for use in patients under 18 years old has not been established.
• The safety in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied.
• Singderm® Lift should be used with caution in patients on immunosuppressive therapy.
• Patients who are using substances that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may, as with any injection, experience increased bruising or bleeding at treatment sites.
• Patients who experience skin injury near the site of Singderm® Lift implantation may be at a higher risk for adverse events.
• Patients may experience late onset nodules with use of dermal fillers, including Singderm® Lift.
• After use, treatment syringes and needles may be potential biohazards. Handle and dispose of these items in accordance with accepted medical practice and applicable local, state, and federal requirements.
• Singderm® Lift injectable gel is a clear, colorless gel without visible particulates. In the event that the content of a syringe shows signs of separation and/or appears cloudy, do not use the syringe; notify Singclean Product Support at 86-571-6343-1868.
• Failure to comply with the needle attachment instructions could result in needle disengagement and/or product leakage at the LUER-LOK® and needle hub connection.
6. UNDESIRABLE EFFECTS
The patients must be informed that they are potential side effects associated with implantation of this product, which may occur immediately or may be delayed. These include, but are not limited to tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching. Few treatment-related AEs after initial treatment (or touch-up treatment) included injection site mass, induration papule. Most of the symptoms resolved without any treatment.
Patients must report reactions which persist for more than one week, or any other side effect which develops, to their medical practitioner as soon as possible.
7. INSTRUCTIONS FOR USE
A. To Attach Needle to Syringe
STEP 1: Remove tip cap
Hold syringe and pull tip cap off the syringe as shown in Figure A
STEP 2: Insert needle
Hold the syringe body and firmly insert the hub of the needle (provided in the Singderm® Lift package) into the luer- lock end of the syringe.
STEP 3: Tighten the needle
Tighten the needle by turning it firmly in a clockwise direction (see Figure B) until it is seated in the proper position as shown in Figure C.
NOTE: Continue to tighten until the needle is seated in the proper position.
STEP 4: Remove the needle cap
Hold the syringe body in one hand and the needle cap in the other. Without twisting, pull in opposite directions to remove the needle cap as shown in Figure D
B. Health Care Professional Instructions
1. Singderm® Lift injectable gel is a crosslinked, robust, injectable gel formulation, injected using a 26G needle to volumize and contour the cheek for correction of mid-face volume deficit.
2. Prior to treatment, the patient’s medical history should be obtained, and the patient should be fully apprised of the indications, contraindications, warnings, precautions, treatment responses, adverse reactions, and method of administration. Patients also should be advised that supplemental “touch-up” implantations may be required to achieve and maintain maximum correction.
3. The patient’s soft-tissue deficiencies should be characterized with regard to etiology, distensibility, stress at the site, and depth of lesion. Pre-treatment photographs are recommended.
4. Topical or injectable anesthesia may be used to manage pain during and after injection.
5. After ensuring that the patient has thoroughly washed the treatment area with soap and water, the area should be prepped with alcohol or other antiseptic. Prior to injecting, depress the plunger rod until the product flows out of the needle.
6. If the needle is blocked, do not increase the pressure on the plunger rod. Instead, stop the injection and replace the needle.
7. After insertion of the needle, and just before injection, the plunger rod should be withdrawn slightly to aspirate and verify the needle is not intravascular.
8. After the first small amount of material has been injected into the patient, wait a full 3 seconds to allow the lidocaine to take effect before proceeding with the rest of the injection.
9. The injection technique for Singderm® Lift with regard to the angle and orientation of the bevel, the depth (subcutaneous and/or submuscular/supraperiosteal) of injection, and the quantity administered may vary depending on the area being treated. Injection of Singderm® Lift too superficially (intradermally), or in large volumes over a small area, may result in visible and persistent lumps and/or discoloration.
10. Singderm® Lift can be injected by a number of different techniques that depend on the treating physician’s experience and preference, and patient characteristics. Tunneling, fanning, serial puncture, crosshatching, and ferning techniques may be used with Singderm® Lift to achieve optimal results. Injection may be administered in an antegrade or retrograde fashion. Inject Singderm® Lift while applying even pressure on the plunger rod and slowly moving the needle in the subcutaneous or submuscular/supraperiosteal plane.
11. Singderm® Lift should be distributed in small aliquots (small boluses of 0.1 mL to 0.2 mL) over a large area to reduce the risk of persistent lumpiness.
12. With submuscular/supraperiosteal injection, the number of times the needle passes through the muscle should be minimized to reduce the risk of bruising. It is important to stop injecting before the needle tip reaches the level of the deep dermis to prevent material from being placed too superficially in the skin.
13. Correct to 100% of the desired volume effect. Do not overcorrect. The degree and duration of the correction depend on the character of the defect treated, the tissue stress at the implant site, the depth of the implant in the tissue, and the injection technique. Markedly indurated defects may be difficult to correct.
14. If immediate blanching occurs, the injection should be stopped and the area massaged until it returns to a normal color. Blanching may represent a vessel occlusion. If normal skin coloring does not return, do not continue with the injection. Treat in accordance with Society for Dermatologic Surgery guidelines, which include hyaluronidase injection.
15. The area of lost facial volume should be lifted by the end of the injection. When injection is completed, the treated site may be gently massaged to mold the product to the contour of the surrounding tissue and assure that it is evenly distributed and conforms to the contour of the surrounding tissues. If overcorrection occurs, massage the area between your fingers or against an underlying superficial bone to obtain optimal results.
16. With patients who have localized swelling, the degree of correction is sometimes difficult to judge at the time of treatment. In these cases, it is better to invite the patient back to the office for a touch-up treatment.
17. After the initial treatment, an additional treatment may be necessary to achieve the desired level of correction. The same procedure should be repeated until a satisfactory result is obtained. The need for an additional treatment may vary from patient to patient and is dependent upon a variety of factors such as mid-face volume deficit severity, skin elasticity, and dermal thickness at the treatment site.
18. Patients may experience treatment site responses, which typically resolve within 1 week. Ice may be applied for a brief period following treatment to minimize swelling and reduce pain.
19. The health care professional should instruct the patient to promptly report any evidence of problems possibly associated with the use of Singderm® Lift.
C. Patient Instructions
It is recommended that the following information be shared with patients:
• Within the first 24 hours, patients should avoid strenuous exercise and extensive sun or heat exposure. Exposure to any of the above may cause temporary redness, swelling, and/or itching at the treatment sites.
• If the treated area is swollen, an ice pack may be applied to the site for a short period.
• To report an adverse reaction, contact Singclean Product Support Department, http://www.singclean.net
8. HOW SUPPLIED
Singderm® Lift injectable gel is supplied in individual treatment syringes with needles as indicated on the carton. Singderm® Lift is injected with a 26G needle. 1ml or 0.5ml Singderm® Lift is available, the volume in each syringe is as stated on the syringe label and on the carton. The contents of the syringe are sterile and non-pyrogenic. Do not resterilize. Do not use if package is open or damaged.
9. STORAGE AND SHELF LIFE
Store at 2 °C to 30 °C. DO NOT FREEZE. Fragile.
Singderm® Lift Shelf life is 24 months from its manufacturing date.
Latest version 8.12.04.344 A0 Issued Date: 2021-08-23