Intended Use/ Indications
Hylaform gel is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
DOSAGE AND ADMINISTRATION
Individualization Of Treatment
Severely indurated, sharply marginated and very superficial wrinkles may be difficult to distend and, therefore, are difficult to correct. If a defect cannot be distended because of extensive scarring or non-elastic tissue, the course of correction will be prolonged, if correction is achievable.
Touch-up implantations may be required in areas with greater motion or mechanical stress (e.g., nasolabial folds). All patients should be counseled to anticipate supplemental implantations to achieve and maintain optimal correction.
Hylaform gel is supplied in individual treatment syringes with needles, and is packaged for single patient use, ready for injection (implantation). The contents of the syringe are sterile and non-pyrogenic. The volume markings on the syringe are for reference only.
To Attach Needle To Syringe
- Peel sealed cover off the needle guard.
- Remove tip cap from syringe.
- Attach needle to syringe and twist to secure. To assure proper needle attachment, use the needles provided or 30-gauge needles with similar needle guards. Fully seat hub of needle in syringe. Do not over tighten, as this may break the needle and/or dislodge the syringe.
- Pull off the needle guard to expose needle.
Procedure To Change Needle
- Peel sealed cover off new needle guard.
- Twist used needle to disconnect it from the syringe.
- Attach new needle to syringe and twist to secure.
- Pull off the needle guard to expose needle.
To place an order, contact INAMED Corporation at (800) 624-4261.
Instructions For Use
- Hylaform gel is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). Prior to treatment with Hylaform gel, 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-up11 implantations may be required to achieve and maintain maximum correction.
- A complete medical history, including allergies, should be obtained to determine whether the patient is an appropriate candidate for Hylaform treatment.
- The patient's soft tissue deficiencies should be characterized with regard to etiology, distensibility, stress at the site, and depth of lesion. Depending on the type of skin, best results are obtained when the defect is readily distensible and correction can be visualized by manual manipulation (stretching) of the skin. Pretreatment photographs are recommended.
- Topical or injectable anesthesia may be used to manage pain during and after injection.
- 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 Hylaform gel, depress the plunger rod until the product flows out of the needle.
- Hylaform gel is administered using a thin gauge needle (30G ½”) . The injection technique with regard to the angle and orientation of the bevel, the depth of injection, and the quantity administered may vary. A linear threading technique, serial puncture injections, or a combination of the two have been used to achieve optimal results. Subderma! application should be avoided because such application may not provide optimal correction. If Hylaform gel is injected too deep, the duration of the effect will be shorter. If Hylaform gel is injected too superficially this may result in visible lumps and/or discoloration.
- Inject Hylaform gel applying even pressure on the plunger rod while slowly pulling the needle backwards. The wrinkle should be lifted and eliminated by the end of the injection. It is important that the injection is stopped just before the needle is pulled out of the skin to prevent material from leaking out or ending up too superficially in the skin.
- Only 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.
- If immediate blanching occurs, the injection should be stopped and the area massaged until it returns to a normal color.
- When injection is completed, the treated site should be gently massaged so that it conforms to the contour of the surrounding tissues. If an over correction has occurred, massage the area between your fingers or against an underlying superficial bone to obtain optima! results.
- if the wrinkle needs further treatment, the same procedure should be repeated until a satisfactory result is obtained. 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 to a touch-up session after 1-2 weeks.
- Patients may have mild to moderate injection site reactions, which typically resolve in a few days. If the treated area is swollen immediately after the injection, an ice pack can be applied to the site for a short period.
- After the initial treatment (from 1 to 2 weeks later), an additional treatment of Hylaform gel may be necessary to achieve the desired level of correction. The need for an additional treatment may vary from patient to patient and is dependent upon a variety of factors such as wrinkle severity, skin elasticity and dermal thickness at the treatment site.
- The physician should instruct the patient to promptly report to her/him any evidence of problems possibly associated with the use of Hylaform gel.
Hylaform gel should be stored at room temperature, 2°-30°C (36°-86°F). DO NOT FREEZE.
Hyiaform gel has a clear appearance. In the event that a syringe contains material that is not clear do not use the syringe and notify INAMED Corporation immediately at (800) 624-4261.
Hylaform gel is packaged for single patient use. Do not resterilize. Do not use if package is opened or damaged.
Manufactured by: Genzyme Biosurgery, 1125 Pleasant View Terrace, Ridgefield, New Jersey 07657 USA. Distributed by: INAMED Aesthetics, 5540 Ekwill Street, Santa Barbara, CA 93111 USA (800) 624-4261
Last reviewed on RxList: 7/11/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Hylaform Information
Report Problems to the Food and Drug Administration
Find out what women really need.