Precautions & Contraindications of Restylane® / Perlane®

PRECAUTIONS

  1. Restylane is packaged for single patient use. Do not resterilize. Do not use if package is opened or damaged.
  2. Based on U.S. clinical studies, patients should be limited to 6.0 mL per patient per treatment in wrinkles and folds such as nasolabial folds and to 1.5 mL per lip per treatment. The safety of injecting greater amounts has not been established.
  3. The safety or effectiveness of Restylane and Restylane-L for the treatment of anatomic regions other than nasolabial folds or lips has not been established in controlled clinical studies. Refer to the clinical studies section for more information on implantation sites that have been studied.
  4. The safety or effectiveness of Perlane and Perlane-L for the treatment of anatomic regions other than nasolabial folds has not been established in controlled clinical studies.
  5. The safety and efficacy of Restylane for lip augmentation has not been established in patients under the age of 22 years.
  6. As with all transcutaneous procedures, Restylane implantation carries a risk of infection. Standard precautions associated with injectable materials should be followed.
  7. The safety of Restylane for use during pregnancy, in breastfeeding females or in patients under 18 years has not been established.
  8. Formation of keloids may occur after dermal filler injections including Restylane.
  9. Restylane injection may cause hyperpigmentation at the injection site.
  10. The safety profile for Restylane lip augmentation in persons of color is that the incidence of adverse events was similar to the overall study population, with the exception that swelling occurred more frequently in persons of color.
  11. Restylane should be used with caution in patients on immunosuppressive therapy.
  12. Bruising or bleeding may occur at Restylane injection sites. Restylane should be used with caution in patients who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation in the preceding 3 weeks.
  13. After use, syringes and needles should be handled as potential biohazards. Disposal should be in accordance with accepted medical practice and applicable local, state and federal requirements.
  14. The safety of Restylane with concomitant dermal therapies such as epilation, UV irradiation, or laser, mechanical or chemical peeling procedures has not been evaluated in controlled clinical trials.
  15. Patients should minimize exposure of the treated area to excessive sun, UV lamp exposure and extreme cold weather at least until any initial swelling and redness has resolved.
  16. If laser treatment, chemical peeling or any other procedure based on active dermal response is considered after treatment with Restylane, there is a possible risk of eliciting an inflammatory reaction at the implant site. This also applies if Restylane-L is administered before the skin has healed completely after such a procedure.
  17. Injection of Restylane into patients with a history of previous herpetic eruption may be associated with reactivation of the herpes.
  18. Restylane is a clear, colorless gel without particulates. In the event that the content of a syringe shows signs of separation and/or appears cloudy, do not use the syringe and notify Medicis Aesthetics Inc. Glass is subject to breakage under a variety of unavoidable conditions. Care should be taken with the handling of the glass syringe and with disposing of broken glass to avoid laceration or other injury.
  19. Restylane should not be mixed with other products before implantation of the device.

CONTRAINDICATIONS

  1. Restylane is contraindicated for patients with severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies.
  2. Restylane contains trace amounts of gram positive bacterial proteins, and is contraindicated for patients with a history of allergies to such material.
  3. Restylane is contraindicated for patients with bleeding disorders.
  4. Restylane is contraindicated for implantation in anatomical spaces other than the dermis or submucosal implantation for lip augmentation.
  5. Restylane-L and Perlane-L should not be used in patients with previous hypersensitivity to local anesthetics of the amide type, such as lidocaine.

Injection Technique

Serial Puncture

This is created with multiple, closely spaced injections along a wrinkle.  It is used for superficial dermal injections and demands precise placement of the filler or gaps will be found in between the injection site.  It is undesirable due to the multiple puncture wounds it generates.  The needle is inserted bevel up.  The product is dispensed like drops along the fold.  You should massage to prevent nodule formation.

Linear Treading

This is created by completely inserting the needle in the wrinkle up to the hub of the needle and injecting the product along the track as a thread as you slide out the needle.  It demands continual pressure and even distribution of the product as you remove the needle.  You must stop your injection several millimeters prior to completely removing the needle from the skin to avoid superficial placement or leaking products above the skin.  The skill of pushing the plunger of a syringe as you are pulling back syringe from the skin is a skill that may be difficult for some, but can be mastered with practice.  Linear threading may be suboptimal for some deep folds as it does not give additional structural support.

Fanning

This is created by puncturing the epidermis once, as in the linear threading technique, and before the needle is completely removed from the skin, you “fan” clockwise or counter-clockwise the needle in a fan pattern to create a triangular shape.  The additional spacing of the fanning injections depends on the size of the triangular area you want to fill.  You must avoid over injecting of the proximal end of each “fanning” as product may overlap and create lumps.  This is excellent in deep folds as it props up adjacent skin that may be hanging over the fold.

Injection techniques such as fanning, rapid injection, rapid flow rates, and higher volume caused an increased incidence of adverse reaction. Multiple punctures or deep subcutaneous injection did not affect the rate of adverse effects.

Aging Skin

Loss of subcutaneous volume, thinning of the skin, changes in bony structures, skin laxity due to loss of collagen and elastin, and downward gravitational shift of the skin and underlying tissues causes aging.  Laugh lines and marionette lines become more prominent.  The lips become thin, flat and deflate.  Vertical lines form above and below the lips.  Oral commissures turn downward.

Consultation

Good patient selection and education is paramount to a successful practice.  Many patients confuse Dysport® or Botox® Cosmetic with Dermal Fillers.  A patient may want you to inject Dysport® in the lips to make them fuller.  Educate your patients the difference between the two.

First, obtain a full medical history and physical exam to rule out any potential contraindications.

Then, ask the patients what they are interested in correcting.  Then take a look at these areas: nasolabial folds, marrionette lines, smile lines, lips, and vertical lines away from the lips.  Patient will typically ask what areas they should inject.  We also recommend that you avoid pointing out someone’s defects; but rather demonstrate on their faces, the areas that a Dermal Filler can be injected.

Are the lines too deep?  You may consider performing a stretch test of the wrinkle by stretching them with your thumb and your index finger to see if the wrinkle can be flattened.  A wrinkle that does not easily flatten or that requires your fingers to spread far apart to flatten may not be completely corrected or may require additional treatments.  Remember that not all folds can be filled to full correction due to tissue hanging over the fold or other causes, such as scar tissue.

When do they want the treatment?  If your patient’s wedding is less than a week away and she has never tried Restylane on her lips before, then this is probably not a good time to start.

Discuss the possibility of a touch up in the future and the total cost of the treatment should a touch up be required.

Ask about your patient’s pain tolerance.  Discuss the various pain control options.

Take the time to listen to your patients and educate them.  Some may have too many areas that they want treated.  Some may want you to use one syringe to fill all these areas, even though the results will be suboptimal.  Some may have areas that they want filled that you don’t see a defect in.  Set realistic goals.  Sometimes, you may be better off sending them away without a treatment to avoid disappointing them.  Dissatisfied patients rarely comes back.

Pre-Injection Checklist

Photo; Keeping a photographic record of the patient’s pre-injection feature may help avoid misdirected blame.

Evaluate for asymmetry prior to injection; This is also important to point out and note to yourself if the patient wants symmetry. You want make sure that you have enough product left in the syringe to treat each side evenly.

Clean and anesthetize the area; Use alcohol wipes liberally. Offer the patient a topical anesthetic, or ice to cool the area prior to the injection.

Use the needle provided by the vendor;

Fully seat the needle to the hub; This will decrease the possibility of needle disengagement from the syringe. A needle that is not fully attached to the syringe can result in the needle disengaging from the syringe and spilling your product on your patient’s face.

Point the eye of the needle face upwards towards the surface of the skin.

Push the plunger until the droplet appears at the tip of the needle; You want to remove the air that is inside of the needle hub. If the patient has a history of cold sores, then you should discuss with the patients about pretreatment with antiviral medication prior to any injection around the mouth.

Injection Technique

Learn more about Injection Technique of Restylane® / Perlane®.