History of Dermal Fillers

To appreciate the progress we have made, it is important to understand the history of dermal fillers as we start your Restylane training. In 1893, the first fat auto-grafting was performed by Dr. Neuber, who successfully auto-grafted fat into the infraorbital margin in a man with tuberculous ostitis. In 1980’s Dr. Fournier injected fat from liposuction surgery. Average fat survival rate was around 25%. Bovine collagen was developed in the 1970’s and Zyderm implant was FDA approved in 1983.

Hyaluronic Acid

Hyaluronic Acid has the following favorable qualities:

• Effective, long lasting and degradable
• Allergy testing is not required
• Similar to normal tissue texture
• No special storage requirement
• No need for mixing or preparation

Hyaluronic Acid is a component of the extracellular space. In your body, it maintains structure by binding water and increasing volume. It also is a source of protection and lubrication of your tissues.

Restylane and Perlane

Restylane-L is a gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE (butanediol diglycidyl ether), stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL with 0.3% lidocaine. Restylane is a similar gel compound without the 0.3% lidocaine.

Perlane-L is a sterile gel of hyaluronic acid with 0.3% lidocaine. The median particle size is between 750 and 1000 microns. Perlane is a similar gel compound without the 0.3% lidocaine.

Clinical Study

The results of the blinded evaluator assessment of NLF wrinkle severity for Restylane and control (Perlane) are presented in Table 15. In the primary effectiveness assessment at 12 weeks, 77% of the Restylane and 87% of the control patients had maintained at least a 1-point improvement over baseline.

Table 15: Blinded Evaluator Wrinkle Severity Response Scores

TIME POINTNO. OF RESTYLANE PATIENTSNO. OF RESTYLANE PTS. MAINTAINING ≥ 1 UNIT IMPROVEMENT OF NLF ON WSRSNO. OF PERLANE PATIENTSNO. OF PERLANE PTS. MAINTAINING ≥ 1 UNIT IMPROVEMENT OF NLF ON WSRS6 weeks136113 (83%)1136121 (89%)112 weeks140108 (77%)1141122 (87%)124 weeks140103 (74%)113887 (63%)1

Directions for Assembly

Use the thumb and forefinger to hold firmly around both the glass syringe barrel and the Luer-Lok adapter. Grasp the needle shield with the other hand. To facilitate proper assembly, both push and rotate firmly. We will go over the proper assembly technique on your hands-on Restylane training day, as failure can lead to leakage of Restylane.

Pre-treatment Guidelines

Prior to treatment, the patient should avoid taking aspirin, nonsteroidal anti-inflammatory medications, St. John’s Wort, or high doses of Vitamin E supplements. These agents may increase bruising and bleeding at the injection site.

Treatment Procedure

1. It is necessary to counsel the patient and discuss the appropriate indication, risks, benefits and expected responses to the treatment.
2. Advise the patient of the necessary precautions before commencing the procedure.
3. A consent form should be utilized.

Adverse Experiences

In three studies, investigators reported the following local and systemic events that were judged unrelated to treatment and occurred at an overall incidence of less than 2%, i.e., acne; arthralgia; tooth disorders (e.g., pain, infection, abscess, fracture); dermatitis (e.g., rosacea, unspecified, contact, impetigo, herpetic); unrelated injection site reactions (e.g., desquamation, rash, anesthesia); facial palsy with co-administration of botulinum toxin; headache/migraine; nausea (with or without vomiting)

WARNINGS

Defer use of Restylane at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present until the process has been controlled.

Precautions & Contraindications

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.

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.

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.

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.

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.

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.

Injection Technique

Injection

1. Insert the needle into the middle to deep dermis.
2. You may stretch the skin to aid insertion.
3. The contour of the needle should be BARELY or NOT visible depending on the type of filler and the type of wrinkle being injected.
4. If you are injecting using the threading technique, then remember to apply even pressure on plunger of the syringe while slowly pulling the needle backwards.
5. Remember to stop the injection before the needle is pulled to the skin to prevent losing material out of the skin or to prevent an injection that is too superficial.

Post Injection

No empty spaces or lumps should be felt along the injection. Correct to 100% — do no over or under-correct. Gently massage the injection site to contour the product with the surrounding tissue after your injection. When you feel lumps or bumps, a gentle massage between your fingers or over an underlying bone will typically flatten the protrusion.

Oral Commissures

Lateral commissures of the mouth may begin to turn downward as one age. Patients may complain that the corners of their mouth look sad. The goal of this treatment is to fill the folds and lift the corners of the mouth. Deep depressions here may require serial puncture technique, while linear threading is preferred for shallow, longer grooves.

Melomental Fold

Melomental fold (MMF) is the fold running inferiorly from the oral commissure towards the mandible. Loss of collagen and elasticity, gravity and boney atrophy causes the formation MMF. Prominent MMF gives the appearance of anger or sourness.

Lips

Lip volume reach full thickness by the mid-30s. They are a defining feature of beauty and youth. As we age, vermilion border thin, corners of the mouth droop, philtral ridge and cupid’s bow flatten, and fine lines appears on the lips. Upper lip typically becomes thin and elongated, while the lower lip becomes thin and roll inwards. Activity of the orbicularis oris cause radiating perioral lines. Patients often complain about bleeding lipstick lines

Complication Management

HA fillers have an impressive safety record. Despite this impressive safety record, adverse events occur when injecting HA fillers. It is important to be familiar with potential complications and management.

Hyaluronidase

Hyaluronidase is an enzyme that breaks down and hydrolyzes hyaluronic acid. Multiple reports have been documented on successful elimination of unwanted HA implantation. Hyaluronidase has been used to correct asymmetry, overcorrection, Tyndall effect and vascular occlusion. Hyaluronidase will dissolve the filler and reduce edema, which will help minimize occluded vessel pressure.

Conclusion

During the consultation phase, collection of a thorough medical history, including medications and allergies, is essential. The injector must be aware of the techniques and understand the depth of the implantation.

A minor complication in your eyes may not be minor in your patient’s eyes. As one can clearly see, using Hyaluronic Acid based fillers offers additional options in treating any complications. Early recognition, education, treatment and psychological support will minimize any potential disasters.

Dysport®️ Injection Training Course Certification

Learn more about Restylane®️/Perlane®️ Injection Training Certification.

Cosmetic Medical Training recognizes that many of the techniques and recommendations for this Dysport Certification Training text are considered off-label use. Our recommendations are based on many textbooks, published articles, seminars and practical knowledge and experience. The authors have attempted to maintain up to date knowledge and information in this training manual with the current standard of care.