Oldream Lip Filler Instructions for Medical Professional

DEVICE DESCRIPTION

Oldream Silk Hyaluronic Acid Lip Filler is a sterile, biodegradable, non-pyrogenic, viscoelastic, clear, colorless, homogeneous gel implant. It consists of cross-linked hyaluronic acid (HA) produced by Streptococcus species of bacteria, formulated to a concentration of 24 mg/ml and 0.3% w/v lidocaine in a physiologic buffer.

INTENDED USE/INDICATIONS

Oldream® Silk injectable gel is indicated for injection into the lips for lip augmentation and perioral rhytids correction for adults over 18.

CONTRAINDICATIONS

• Oldream® Silk is contraindicated for patients with severe allergies manifested by a history of anaphylaxis or multiple severe allergies.
• Oldream® Silk contains trace amounts of Gram-positive bacterial proteins and is contraindicated for patients with allergies to such materials.
• Oldream® Silk contains lidocaine and is contraindicated for patients with allergies to such materials.

WARNINGS

• The product must not be injected into blood vessels. Introduction of Oldream® Silk injectable gel into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when using 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 For example, after insertion of the needle, and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular. Then, apply 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 or 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.

PREGAUTIONS

• Oldream® Silk injectable gel is packaged for single-patient use. Do not re-sterilize. Opened or damaged packages should not be used.
• To minimize potential complications, this product should only be used by healthcare professionals who have appropriate training, experience, and knowledge of the anatomy at and around the site of injection. Health care professionals are encouraged to discuss all aspects of 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 Oldream® Silk injectable gel per 60 kg (130 lbs) body mass per year. Injecting greater amounts has not been proven safe.
• Safety and effectiveness of treating anatomic regions other than the lips and perioral area have not been established.
• As with all transcutaneous procedures, dermal filler implantation carries infection risk. Standard precautions associated with injectable materials should be followed.
• Oldream® Silk injectable gel is used as supplied. Modification or use of the product outside the Directions for Use may adversely impact the product’s sterility, homogeneity, and performance.
• Safety during pregnancy, breast feeding, or in patients under 18 has not been established.
• The safety in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied.
• Oldream® Silk injectable gel should be used cautiously in immunosuppressive patients.
• Patients who use substances that prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may, as with any injection, experience increased bruising or bleeding at injection sites.
• After use, treatment syringes and needles are biohazards. Handle and dispose of these items in accordance with accepted medical practice and applicable local, state, and federal requirements. Oldream® Silk injectable gel is clear, colorless and particulate-free. In the event that the content of a syringe shows signs of separation and/or appears cloudy, do not use the syringe; notify Oldream Product Support at [email protected].
• If laser treatment, chemical peeling, or any other procedure. In the event that an active dermal response is considered after treatment with Oldream® Silk, there is a possible risk of eliciting an inflammatory reaction at the implant site. An inflammatory reaction is also possible if the product is administered before the skin heals completely after such a procedure.
• 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.

UNDESIRABLE EFFECTS

Patients must be informed that there are potential side effects associated with this product’s implantation, which may occur immediately or 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), they include 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 symptoms resolve without treatment.

Patients must report reactions that persist for more than one week, or any other side effect that develops, to their medical practitioner as soon as possible.

INSTRUCTIONS FOR USE

A. To Attach Needle to Syringe

STEP 1: Remove the tip cap
Hold the syringe and pull the tip cap off the syringe as shown in Figure A.

STEP 2: Insert needle
Hold the syringe body and firmly insert the needle hub (provided in the Oldream® Silk package) into the LUER-LOK® end of the syringe.

STEP 3: Tighten the needle
Tighten the needle by turning it firmly clockwise (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.

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 E.

B. Health Care Professional Instructions

1. Oldream® Silk injectable gel is a cross-linked, soft, smooth gel formulation that can be injected using a fine gauge (e.g., 30G) needle into the lips and perioral area to add fullness and improve the shape of the lips, and to smooth perioral rhytids.
2. Prior to treatment, the patient’s medical history should be obtained. 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” treatments may be required to achieve and maintain maximum correction.
3. The patient’s treatment goals should be characterized with regard to proper proportion of upper and lower lip, vertical height, horizontal length, vermilion fullness, contouring of the vermilion border, Cupid’s bow, and philtral columns, as well as perioral lip. rhytids and oral commissures. Pretreatment photographs are recommended.
4. Supplementary anesthesia may be used for additional pain management during and after injections.
5. After ensuring that the patient has thoroughly washed the treatment area with soap and water, the area should be swabbed with alcohol or other antiseptic. Prior to injecting, depress the plunger rod until the product flows out of the needle.
6. After the first small amount of material has been injected into the patient, wait 3 seconds to allow the lidocaine to take effect. Then proceed with the rest of the injections.
7. The injection technique may vary with regard to the angle and orientation of the bevel, the depth of injection, and the quantity administered. Tunneling technique, serial punctures. Technique, fanning technique, or a combination is used to achieve optimal results. Injecting the product too superficially may result in visible lumps and/or discoloration.
8. Inject Oldream® Silk by applying slow and even pressure to the plunger rod. It is critical that the injection be stopped before the needle is pulled out of the skin. This is to prevent material from leaking out or being placed too tightly into the skin.
   9.If the needle is blocked, do not increase the plunger rod pressure. Instead, stop the injection and replace the needle.
9. The typical volume injected into the lips and perioral area to achieve optimal correction is approximately 2.6 ml. This volume may vary depending on the goals the patient wishes to accomplish. Injection volumes into the lips and perioral area after repeated treatment tend to be lower. The typical total injection volume to achieve optimal correction is approximately 1.6 mL.
10. Correct to 100% of the desired volume effect. Do not overcorrect. The degree and duration of correction depend on the character of the defect treated. They also depend on 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.
11. If immediate blanching occurs, the injection should be stopped and the area massaged until it returns to 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 injections.
12. When injection is completed, the treated site should be gently massaged so that it conforms to the contour of the surrounding tissues. If overcorrection occurs, massage the area between your fingers or against the underlying bone/teeth to obtain optimal results.
13. With patients with 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.
14. After the initial treatment, additional touch-up treatments may be required. Necessary to achieve the desired correction level. If further treatment is needed, the same procedure should be repeated until a satisfactory result is obtained. The need for additional treatment may vary from patient to patient. It is dependent upon a variety of factors such as treatment goals, lip fullness, perioral lines severity, skin elasticity, and dermal thickness at the treatment site.
15. Patients may have mild to moderate injection site responses after treatment in the lips and perioral area, which typically resolve within 14 days. Ice may be applied for a brief period following treatment to minimize swelling and reduce pain.
16. The health care professional should instruct the patient to promptly report to her/him any evidence of problems associated with the use of Oldream® Silk.

C. Patient instructions

It is recommended that the following information be shared with patients:

• Within the first 24 hours, patients should avoid strenuous exercise, extensive sun or heat exposure, and alcoholic beverages. Exposure to any of the above may cause temporary redness, swelling, and/or itching at the injection sites.
• To report an adverse reaction, contact the Oldream Product Support Department at [email protected].

HOW SUPPLIED

Oldream® Silk injectable gel is supplied in individual treatment syringes with 30Gx1/2” needles for single-patient use and ready for injection (implantation). 1ml or 0.5ml. Oldream® Silk is available. The volume in each syringe is stated on the syringe label and carton. The syringe contents are sterile and non-pyrogenic. Do not re-sterilize. Opened or damaged packages should not be used.

STORAGE AND SHELF LIFE

• Store at 2 °C to 30 °C. DO NOT FREEZE. Fragile.
• Oldream® Silk’s shelf life is 24 months.
• Oldream® Silk injectable gel has clear appearance. If a syringe contains unclear material, do not use it;
• Notify Oldream Product Support immediately at [email protected].