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Singderm Silk Intended Use

Singderm Silk lip filler is a cross-linked hyaluronic dermal filler indicated for injection into the lips for lip augmentation and for correction of perioral rhytids in adults over the age of 18 for a more youthful appearance.

Who Should Get Lip Filler?

Like other places of the face, lips also show signs of aging as people get older. This often causes lip thinning, lost shape and fine lines and superficial wrinkles around the lips. And a lip filler can be used to plump up lips and smooth out lip lines.

 

How Supplied

0.5ml or 1.0ml Singderm Silk is available.

0.5ml:  1 × syringe of Singderm Silk Lip Filler

1 × 30G×1/2 needle

1.0ml:  1 × syringe of Singderm Silk Lip Filler

       2 × 30G×1/2 needle

Benefits of Singderm Silk

Balance the lip shape

Enhanced curves and contour

Natural long-lasting results

More comfortable experience with 0.3% lido-caine

Can be easily reversed if results are unsatisfactory

How Long the Effect Will Last?

Singderm Lift can help you achieve your ideal lips and last over 6 months.

Singderm Silk, An Upgraded Version of Singderm, Specially Designed for Lips

1.      In terms of product

1.1   Singderm Silk is much softer. This can create a more natural look and will be safer. It is much less likely that your body will reject the filler.

1.2   Singderm Silk has better cohesiveness leading to a perfect shape and it is not easy to deform and shift.

1.3   The concentration of 24mg/ml is the highest concentration among the lip fillers to last longer.

2.      In terms of package

2.1   A new syringe is used

a. The syringe is made of COC material (cycloolefin polymer), non-glass, and the wall is thicker, so it is safer and not easy to be damaged during transportation, storage and usage.

b. The inner diameter is smaller, so the syringe is more slender, and the injection volume can be controlled more accurately.

c. The syringe and the Luer connector are integrated to prevent the possibility of leakage.

d. The blister is upgraded with PETG material. PETG sheet has outstanding toughness and high impact strength, and its impact strength is 3-10 times that of modified polyacrylates, and has a wide range of processing range, high mechanical strength and excellent flexibility. Compared with PVC, it has many advantages like high transparency, good gloss, easy printing and environmental protection.

2.2 The needle is upgraded to a smaller 30G needle.

a. The thinner and shorter needle can offer more comfortable experience during injection

b. The thinner and shorter needle is particularly designed for lip, the sensitive area.

Instruction 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 Silk package) into the LUER-LOK 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: If the position of the needle cap is as shown in Figure D, it is not attached correctly. Continue to tighten until the needle is seated in the proper position.


 

Warnings

• The product must not be injected into blood vessels. Introduction of Singderm Silk injectable gel 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 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 professional 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.

• Injection site responses consist mainly of short-term inflammatory symptoms starting early after treatment and lasting ≤7 days.

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 swelling, tenderness, firmness, bruising, lumps/bumps, redness, pain, discoloration, itching, and dryness. Few treatment-related AEs after initial treatment (or touch-up treatment) included chapped lips, dizziness, dry lips, general physical condition abnormal, headache, lip disorder (lumps), lip injury, oral herpes, presyncope, wound, and injection site discoloration, discomfort, edema, erythema, exfoliation, hyperaesthesia, hypoaesthesia, laceration, nodule, papule, paraesthesia, pruritus, and reaction. 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.

Shelf Life and Storage

Store at 2 °C to 30 °C. DO NOT FREEZE. Fragile.

Singderm Silk Shelf life is 24 months. Singderm Silk injectable gel has a clear appearance. In the event that a syringe contains material that is not clear, do not use the syringe