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Restylane Training/Perlane®️ Injection Training Certification Course

Botox Training Austin

Introduction to Restylane Training

Restylane Injection Training Course Certification (Perlane) | Video Instructions

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. However, skin testing was necessary, because 2 – 3% of the patients had hypersensitivity reactions.

Hyaluronic Acid (HA) is the main polysaccharide in the extracellular matrix. It acts as a scaffold for collagen and elastin to bind. It also hydrates the skin, because it binds water. Skin loses elasticity and fullness due to loss of HA. Researchers were able to grow chains of the polysaccharide and cross link them. Crosslinking varied its degree of hardness, lift, duration of survival and resistance to heat and degrading enzymes. HA is now grown by a gram positive bacteria, and called NASHA (non-animal sourced hyaluronic acid) gel.

Hyaluronic acid was introduced to the US in 2003 with Restylane. Restylane® has an HA concentration of 20 mg/mL with a gel bead size of 250 μmol and 100 000 units per mL and an estimated 0.5–1.0% cross-linking. Perlane® contains 20 mg/mL of HA with a larger gel bead size of 1000 μmol and 10 000 units per mL, and less than 1% cross-linking.

Other fillers followed that contains polylactic acid, calcium hydroxylapatite, and etc. In addition to volume replacement, these fillers stimulate host response and endogenous collagen production.

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
  • Typically it does not migrate nor calcify
  • Cost-effective
  • Safe

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. Hyaluronic Acid decreases with age. This is also why it is an ideal dermal filler agent with good bio-compatibility.

In the injectable form it is a polysaccharide compound.  It stabilizes in the tissue by cross-linking which increases tissue residency.  Unmodified Hyaluronic Acid has half life of 24 – 48 hours.  Other medical uses of uncross-linked Hyaluronic Acid include injections in to joints or formulations on topical products.  Hyaluronic Acid binds water after injection and increases the tissue volume.  Cross-linked Hyaluronic Acid also induced fibroblasts to produce endogenous collagen.

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.

Restylane-L is indicated for mid-to-deep dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Restylane-L is indicated for submucosal implantation for lip augmentation in patients over the age of 21.

The concentration of Restylane is 20mg/mL. Restylane is implanted in the mid to deep dermis.

Restylane-L combines Restylane with lidocaine, which can help reduce discomfort during and after treatment. In clinical studies 72% of patients reported significantly less pain during treatment with Restylane-L vs. Restylane. Patients continued to experience less discomfort for up to one hour after treatment.

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.

Perlane-L is indicated for implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds.

The concentration of Perlane is 20mg/mL. The difference between Restylane and Perlane is that Perlane has a larger gel particle size than Restylane. Perlane is implanted into the deep dermis. Therefore, Perlane is a better choice for more severe facial wrinkles that benefit from a deeper injection into the skin. By combining lidocaine with Perlane, Perlane-L helps reduce discomfort during and after treatment. In clinical studies 95% of patients reported significantly less pain during treatment with Perlane-L vs. Perlane. Patients continued to experience less discomfort for up to one hour after treatment.

In clinical trials, Restylane persists in the skin for about 6 months. Perlane persists in the skin for at least 6 months in a majority of patients. Clinical studies show no significant safety profile difference between Restylane and Perlane. Both products are biocompatible with the body’s natural hyaluronic acid and no allergy testing is required.

For your hands-on Restylane training or Perlane training day, we recommend that you buy the “L” version that contains the lidocaine, which greatly improves patient satisfaction.

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 POINT NO. OF RESTYLANE PATIENTS NO. OF RESTYLANE PTS. MAINTAINING ≥ 1 UNIT IMPROVEMENT OF NLF ON WSRS NO. OF PERLANE PATIENTS NO. OF PERLANE PTS. MAINTAINING ≥ 1 UNIT IMPROVEMENT OF NLF ON WSRS
6 weeks 136 113 (83%)1 136 121 (89%)1
12 weeks 140 108 (77%)1 141 122 (87%)1
24 weeks 140 103 (74%)1 138 87 (63%)1

All p-values < 0.0001 based on t-test compared to baseline condition.

At 12 weeks, 7/19 (37%) subjects were rated as improved on their GAIS assessment by the Blinded Evaluator. At 12 weeks, all (100%) subjects rated themselves as improved on their GAIS assessment.

PARAMETER N N SUBJECTS WITH LIP IMPROVEMENT PERCENT 90% CL P-VALUE1
Lip Improvement Using the Blinded Evaluator’s Assessment1 20 19 7 37% (0.19, 0.58) 0.820
Lip Improvement Using the Treating Investigator’s Assessment 20 19 19 100% (0.85, 1.00) < 0.001
Lip Improvement Using the Subject’s Assessment 20 17 17 100% (0.84, 1.00) < 0.001

Due to the protocol deviation, the live blinded evaluator’s assessment was a photo assessment.

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.
  4. Assess the patient’s need for appropriate anesthetic treatment for managing comfort, i.e., topical anesthetic, local or nerve block.
  5. The patient’s face should be washed with soap and water and dried with a clean towel. Cleanse the area to be treated with alcohol or another suitable antiseptic solution.
  6. Sterile gloves are recommended while injecting.
  7. Before injecting, press rod carefully until a small droplet is visible at the tip of the needle.
  8. Restylane is administered using a thin gauge needle (29 G x ½”). The needle is inserted at an approximate angle of 30° parallel to the length of the wrinkle, fold, or lip. For nasolabial folds, Restylane should be injected into the mid-to-deep dermis. For lip augmentation, Restylane should be injected into the submucosal layer, care should be taken to avoid intramuscular injection. If Restylane is injected too superficially this may result in visible lumps and/or bluish discoloration.
  9. Perlane is administered using a thin gauge needle (27 G TW x ½” or 29 G TW x ½”). The needle is inserted at an approximate angle of 30° parallel to the length of the wrinkle or fold. Perlane should be injected into the deep dermis to superficial layer of the subcutis.
  10. Inject Restylane applying even pressure on the plunger rod. 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.
  11. Only correct to 100% of the desired volume effect. Do not overcorrect. With cutaneous deformities the best results are obtained if the defect can be manually stretched to the point where it is eliminated. 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.
  12. Typical usage for each treatment session is specific to the site as well as wrinkle severity. In a prospective study of midface wrinkle correction, the median total dose was 3.0 mL. Based on U.S. clinical studies, the maximum recommended dose per treatment is 6.0 mL for the nasolabial folds and 1.5 mL per lip per treatment.
  13. Dissection of the sub-epidermal plane with lateral movement of the needle, rapid flows ( > 0.3 mL/min), rapid injection or high volumes may result in an increase in short-term episodes of bruising, swelling, redness, pain, or tenderness at the injection site.
  14. When the injection is completed, the treated site should be gently massaged so that it conforms to the contour of the surrounding tissues. If an overcorrection has occurred, massage the area firmly between your fingers or against an underlying area to obtain optimal results.
  15. If so called “blanching” is observed, i.e., the overlying skin turns a whitish color, the injection should be stopped immediately and the area massaged until it returns to a normal color.
  16. If the wrinkles or lips need further treatment, the same procedure should be repeated until a satisfactory result is obtained. Additional treatment with Restylane may be necessary to achieve the desired correction.
  17. If the treated area is swollen directly after the injection, an ice pack can be applied on the site for a short period. Ice should be used with caution if the area is still numb from anesthetic to avoid thermal injury.
  18. Patients may have mild to moderate injection site reactions, which typically resolve in less than 7 days in the nasolabial folds and less than 14 days in the lip.

HOW SUPPLIED

  1. Restylane is supplied in a disposable glass syringe with a Luer-Lok fitting. Restylane-L is co-packed with sterilized needle(s) as indicated on the carton (29 G x ½”).
  2. Perlane is supplied in a disposable glass syringe with a Luer-Lok fitting. Perlane-L is co-packed with sterilized needle(s) as indicated on the carton, either 27 G Thin Wall (TW) x ½” or 29 G TW x ½.”
  3. A patient record label is a part of the syringe label. Remove it by pulling the flap marked with three small arrows. This label is to be attached to patient records to ensure traceability of the product.
  4. The contents of the syringe are sterile.
  5. The volume in each syringe and needle gauge is as stated on the syringe label and on the carton.

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); syncope; gastroenteritis; upper respiratory or influenza-like illness; bronchitis; sinusitis; pharyngitis; otitis; viral infection; cystitis; diverticulitis; injuries; lacerations; back pain; rheumatoid arthritis; and various medical conditions such as chest pain, depression, pneumonia, renal stones, urinary incontinence, and uterine fibroids.

Serious adverse events have been rarely reported. The only serious adverse events occurring in a frequency of 5 times or greater were abnormal sensitivity (hypersensitivity), injury to blood supply (vascular accidents), local tissue damage (necrosis) and infection/abscess. Hypersensitivity reactions have occurred immediately following implantation and up to 3 weeks and some required hospitalization.

Reported symptoms included swelling (including severe swelling of lips and face); redness; itching on chest and back; puffy, burning, watery, and itchy eyes; shortness of breath; headache; nausea and vomiting. Treatments used included steroids, diphenhydramine, unspecified intravenous medication, oxygen and various creams. Most hypersensitivity events have resolved within 1 to 14 days with or without treatment. Bruising and skin turning white as a result of injury to blood supply (blanching) have occurred immediately following injection with some cases resulting in necrosis. As a result of the necrosis some patients experienced scarring and dark spots on the skin.

Moderate to severe infection/abscess formations have occurred with an onset ranging from 3 days to one week post injection with approximately one month to resolution. Symptoms included swelling, redness, pain and hard nodules. Some patients required hospitalization for incision and drainage and intravenous (IV) antibiotic therapy. Culture results for the reports of infection or abscess varied. Treatment included various antibiotics and steroids in some cases.

Adverse events that have occurred at the injection sites include: discoloration, bruising, swelling, lumps/bumps, redness, pain, scarring, numbness/tingling, necrosis, and low blood supply due to blockage of a blood vessel (ischemia). Additional events include: bacterial infections, fainting (vasovagal reactions), herpetic eruptions, dilated small blood vessels (broken capillaries), and inflammatory reactions (swelling, redness, tenderness, hardness and acneform papules).

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.

Injection site reactions (e.g., swelling, redness, tenderness, or pain) to Restylane have been observed as consisting mainly of short-term minor or moderate inflammatory symptoms starting early after treatment and with less than 7 days duration in the nasolabial folds and less than 14 days duration in the lips. Rare post-market reports of immediate post-injection reactions included extreme swelling of lips, the whole face and symptoms of hypersensitivity such as anaphylactic shock.

Restylane must not be implanted into blood vessels. Localized superficial necrosis and scarring may occur after injection in or near dermal vessels, such as in the lips, nose, or glabellar area. It is thought to result from the injury, obstruction, or compromise of blood vessels.

Delayed onset inflammatory papules have been reported following the use of dermal fillers. Inflammatory papules that may occur rarely should be considered and treated as a soft tissue infection.

Injections of greater than 1.5 mL per lip (upper or lower) per treatment session significantly increases the occurrence of the total of moderate and severe injection site reactions. If a volume of more than 3 mL is needed to achieve optimal correction, a follow-up treatment session is recommended.

In a meta-analysis of all Restylane Pre-market Approval Studies (that included 42 patients under the age of 36 and 820 over the age of 35), the incidence of swelling was higher in younger patients (28%) compared to older patients (18%) and incidence of contusion was higher in older patients (28%) compared to younger patients (14%). The majority of these events were mild in severity.

Along with all of the videos and printed materials that we provide for this Restylane training course, we will also provide you with all the consent forms and pre and post care instructions.

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. 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.

Patient consultation is a crucial skill that will be taught during your hands-on Restylane training day.

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

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.
  6. Superficial injection may cause a bluish hue to the skin, call Tyndall effect. This can either be massaged deeper, squeezed out, or dissolved with Hyaluronidase.
  7. When fanning, do not completely remove the needle from the skin, angle the syringe (fanning) and reinsert the needle to the end of the hub.
  8. Direction of the angling depends on the shape of the fold.
  9. If blanching occurs, then stop the injection. You may be injecting into or near a blood vessel. Massage the area until the skin returns to a normal color.
  10. One should always feel the resistance of the dermis as one is injecting. If the injection has too much or too little resistance, then you are likely in the wrong plane.
  11. Wrinkle should be visibly lifted and filled by the end of the treatment.

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.

Reassure the patient that the lump will likely go away. Arrange for a follow up in a week. If the lump is still apparent at the follow up appointment, then use Hyaluronidase. It can be difficult to judge the symmetry of your product placement immediately after the injection due to localized swelling and bruising.

This is true, especially in the lips. If you notice asymmetry and you feel that you have placed the products evenly, then it is best to invite the patient back in 1 week for re-evaluation. Any mild to moderate swelling due to localized swelling, internal bruising, and/or product placement should resolve in a few days. Offer your patient an ice pack to minimize swelling and bleeding.

Nasolabial Folds

Correction of the nasolabial fold is the most common site for correction with NASHA™ fillers. Malar fat pad moves medially and inferiorly due to loss of collagen and skin elasticity and cause the nasolabial folds or laugh lines. The Nasolabial fold is the visible line or groove from the lateral edges of the nose to corners of the mouth. Heavy cheeks due to aging or obesity may increase the depth of the lines. Depending on the age, the fold may be superficial or deep. Therefore, older patients may benefit from Perlane®.

For shallow to medium folds, use linear threading with fanning to correct the folds.  Start from the inferior position and insert the needle superiorly.  Inject 0.05mL to 0.1mL per injection.

Fanning is recommended up by the nose and possibly throughout depending on the level of correction visualized.  Concentrate your fanning on the upper Y-shaped area below the naris and lateral to the ala.  There is less movement of the facial muscles in this area and correction persists well.  In this position, the nasal artery runs near, so we recommend that you pull back on the syringe plunger to make sure that no flash of blood is seen if you feel that the injection may be too deep.  Also, injecting slowly low amount of volume will also prevent intra-arterial injection.

Further down the fold towards the oral commissure, the duration of correction is shorter due to increase muscle movement.  Correction may be more challenging due to the lack of underlying bone and the sagging tissue from the area of the cheekbones.

After you are finished with your injection, place a glove thumb on top of the fold and one or two fingers on the inside of the mouth.  Gently mold along the injection site to feel for nodules or bumps.  HA fillers are malleable and can be molded.

You may see multiple fine lines lateral to the nasolabial fold.  Resist the urge to inject them as they are typically due to dynamic movement.  While at rest, the lines may appear diminished, with movement, implanted fillers may be visible as cords on the patient’s face.

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.  The injection may extend down into the melomental fold in older patients.  You may ask your patients to open their mouth slightly to aid your injection.  Augmentation in the mouth corners typically does not last as long as in other areas.  Inject 0.05mL to 0.1mL per injection.

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.

MMF may look like a single line when looking at the face straight on.  A more three dimensional observation, by looking up towards the nose superiorly, may demonstrate a deeper groove or delta.  Techniques such as linear threading or serial puncture may be inadequate for more advance folds.  A scaffolding-like structure may have to be formed using fanning or cross-hatching technique.

Inject into the deep dermis vertically from inferior to superior direction.  Horizontal injections should be placed from medial to lateral direction to avoid injecting the facial vein which can be found lateral to the MMF.  Layering may be required for deep MMF.  MMFs benefit from thicker fillers, such as Perlane.  Inject along the fold 0.05mL to 0.1mL per injection.  Avoid inadvertent injections into the lip as this may cause unwanted lip enhancement or lumping in the lower lips.  Remember that while most patients can tolerate injection into the nasolabial folds, MMF injection tend to be more painful.

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.

Lips are the most challenging of all the areas to fill properly.  Issues to address include to following: proportional lip relative to the face, proportional upper and lower lip fullness, sharp, well defined vermilion borders, distinct Cupid’s Bow peak and philtral columns, and upturned oral commissure.  Typically, the lower lip is fuller than the upper lip. The ideal ratio of upper lip to lower lip is 1 : 1.6, based on the Fibonacci proportion.

There are two distinct goals typically depending on the patient’s age.

Younger individuals typically want to enhance the size and shape of the lips.  A young patient with naturally fuller lip forms may be more technically challenging.  Some may bring in photos requesting specific outcomes.  It is important to ask if the patient desires fuller lips or a completely different shape.  Lip volume enhancement increases the height of the vermilion border and increases lip circumferentially.  This may cause a “duck lip” appearance.  Small volume injections are always recommended for first time treatments.  Even a small volume of filler (0.1 – 0.3mL) can make a difference in appearance of the lips.

Older individuals typically want to correct or restore their lips back to where they were rather than to increase their size.  Detailed consultation is required for older patients as they may not want eversion of the lips or not want their lips to look “fake”.   Patients with lipstick bleeding may require additional treatments such as laser resurfacing or chemical peel.  Determine the patient’s goal for the correction.

Most patients feel moderate amount of pain during the injection.  HA products with lidocaine help reduce discomfort.  Nerve blocks and topical anesthesia cream are other ways to minimize pain. If you perform any nerve blocks, then it is important to work quickly after these as the numbing can distort the position of the patient’s lips. We recommend using the threading technique to minimize the number of punctures.

Injecting along the vermilion border and wet – dry junction will enhance the volume of the lips.

To increase the size of the lips, insert the needle 1-2mm away from the vermillion border towards the mucosa border to evert the lips.  Injecting near the vermilion border increases size, shape, lift and contour.  This will give the lips a “ski jump” like appearance where the vermillion border will curve outwards.  Injections at the vermilion borders should be done with caution, as too much filler here can give your patients a “duck-like” appearance to the lips.  Start with 0.05ml per injection and increase the amount depending on the level of correction desired.  Injection can start from the lateral edge or the medial peak of the Cupid’s Bow of the upper lip.

Typically, injections near the vermilion border should be done prior to injections near the wet-dry border.  To increase the volume of the lips, insert the needle 3-5mm away from the vermillion border near the wet-dry border to plump up the lips.  This will not evert the lip edges.  Start with 0.05ml per injection and increase the amount depending on the level of correction desired. However, DO NOT inject the wet-dry border as this can cause vascular necrosis.

To increase the philtral column, insert the needle at the junction of the Cupid’s bow and philtral column, and advance superiorly.  Try to inject a slightly greater amount of filler inferiorly to create a natural contour of the column.  Inject 0.025 to 0.05ml per column.

Vertical lip lines, or smoker’s or lipstick lines vary from fine lines to deeper grooves and injection technique will vary.  Injection can be directly into the lines, perpendicular to the lines, or along the vermilion border.  Treat this area conservatively and use very small amounts so that the area above the vermilion border does not become swollen.

Lips are the focal point of the lower face.  Therefore, mistakes are more apparent.  Due to its high vascular tissue, mistakes are more likely to produce adverse events than other areas.  Immediate, short-term swelling is common.  Bruising is frequent.  This may cause the injector to overcorrect one area in response to edema or hematoma.  If the patients lips are symmetric prior to inject, then insure that equal amount of filler is implanted to maintain symmetry.

Asymmetric lips obviously require different amounts to create symmetry.  Application of an ice pack after the injection can diminish these immediate complications.  Extravasation into small bumps may be visible during the injection.  Massage these lumps and guide the product into the desired location.  We recommend a conservative treatment with small volume injections for first time treatments.

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.

Complication can be divided into early and delayed in time of occurrence, and minor and major in severity.

Early minor complications include bruising, pain, edema and erythema.  These can occur immediately or within hours and resolve within a week.  Most patients will develop at least one of these local injection site reactions, so it is important to discuss this with them.  Pretreatment with anesthetic or ice prior to treatment is recommended to minimize pain in site that contains high sensory innervation, such as the lips.  Avoiding anticoagulants and supplements that are not medically necessary will minimize post injection ecchymosis.  Some use homeopathic ointment called Arnica in reducing ecchymosis.  Helenalin, an extract of Arnica, has shown to have anti-inflammatory effects, although clinical studies are not conclusive.

Other early minor complications of asymmetry, lumpiness, or bluish discoloration are typically due to injection technique.  Incorrect filler placement can cause nodules or papules.  When the filler is implanted too superficially, a bluish hue is visible (Tyndall effect).  Such reactions can be treated with manual massage, aspiration, incision and drainage, or hyaluronidase.

A rare early major complication is an anaphylaxis due to an immediate hypersensitivity reaction.  It is estimated that 1 in 10,000 individuals with HA report a mild to severe hypersensitivity reaction.  In 2005, a patient developed angioedema-type of reaction 1 hour after Restylane injection into the lips.  This patient responded to corticosteroid injection with complete resolution.  It is always recommended that you should have a protocol in your office should any such emergency should arise.

Cellulitis is a complication seen with any injection procedure.  Common bacterial causes are Staphylococcus and Streptococcus.  Lesions should be cultured and treated with antibiotics.  The use of chlorhexidine will minimize the risk of infection.

Trauma from the injection can trigger a recurrent herpetic lesion.  Prophylactic antiviral treatment is recommended when injecting the lips.  Also, injection should be avoided during an active herpes outbreak.

Inflammatory nodules can occur if bacteria is injected with the filler, and the HA encapsulates the bacteria within the skin.  These inflammatory nodules will be red and painful.  Incision and drainage should be performed, with cultures, and antibiotic, such as clarithromycin should be started for at least 2 – 6 weeks.  The use of steroid can worsen the situation.  Patients with diabetes, immunocompromised, chronic sinusitis, or chronic dental problems should be treated with care.

Delayed major complication is the formation of granulomas which can occur 6 months after the injection.  HA fillers are rarely linked to granuloma formation, but it has been reported in 0.1% of the patients who are typically injected with permanent or semi-permanent fillers.  The body mounts a foreign body reaction with fibrosis occurring at the injection site.  This can be treated with steroid injections, surgical excision, or hyaluronidase.

Delayed hypersensitivity reaction can also occur.  In 2009, a case report was described a patient who developed acute facial angioedema with urticarial 3 weeks after Restylane in her nasolabial folds.

The most severe, delayed complication is tissue necrosis, due to direct blockage of a vessel, compression near the vessel, or injury to the vessel.  This has been reported in 0.09% of the patients who received collagen injections.  The patient will experience delayed capillary refill and pain, followed by a mottled pattern of purple discoloration, and ulceration due to necrosis.  This can occur in the glabellar area due to blockage of the supratrochlear or supraorbital artery and the alar or nasal area due to the blockage of nasal arteries.  This can also occur along facial and angular artery.  A thorough understanding of the facial anatomy is recommended to prevent this complication.  Steps such as aspiration, slow anterograde injection, constant needle motion, using small particle size fillers, superficial use, avoiding injection near vessels, and blunt tip cannulas can help reduce the risk of intravascular injection.  This can be treated with massage, heat application, nitroglycerin paste (1/2 inch of 2% nitroglycerin) to vasodilate the area, and hyaluronidase to remove the filler.  When nitroglycerin is used topically, the patient should be warned of the potential side effects, such as headache, bradycardia, and hypotension.

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.

Hyaluronidase is diluted with saline in 1:1 ratio.  Skin testing is mandatory when using hyaluronidase.  Inject 3 – 5 units intradermally.  A wheal formation within 5 minutes and persisting for 20 -30 minutes with localized itching is a positive skin test.  Total of 10 – 30 units should be injected per 2 X 2 cm area of impending necrosis.

Please check the package insert for any Hyaluronidase product for complete instructions and warnings and contraindications.

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.

A detailed consultation is a must.  Educate your patients.  Under-promise and over-deliver.

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. However, due to continuing flow of new research and information relating to the drugs being used in this course, we recommend that you check with the manufacturer for any changes in the package inserts, warnings and precautions.

Originally published at Restylane Training Miami

Posted on

Juvederm®️ Injection Training Certification Course

Botox Training Austin

How to Inject Juvéderm®: a Beginner’s Guide(hyaluronic acid dermal filler)

What is Juvéderm®?

JUVÉDERM is a hyaluronic acid-based dermal filler designed to temporarily correct moderate to severe facial wrinkles and folds, such as nasolabial folds. It is produced using HYLACROSS technology, resulting in a smooth, gel-like consistency. Juvéderm comes in pre-filled syringes containing 0.8 mL or 1 mL of the product. The primary ingredients include hyaluronic acid (20 mg/mL) and 0.3% lidocaine for pain reduction during the injection.

JUVÉDERM works by adding volume beneath the skin’s surface, thereby smoothing and lifting the treated areas. The effects are immediate, and the results can last up to one year, depending on the treatment area and the specific product used.

Contraindication

Juvéderm is contraindicated in the following patients:

  • Those with severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies.
  • Patients with a history of allergies to gram-positive bacterial proteins.
  • Patients with a history of allergies to lidocaine or other local anesthetics.

Safety Information

The package insert for Juvéderm indicates that the safety and effectiveness of the product have not been established in patients under 18 years of age and in pregnant or breastfeeding women. Post-marketing safety data suggest potential side effects including redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching at the injection site. These effects are usually mild to moderate and resolve within 14 days.

There is a risk of unintentional injection into blood vessels, which can lead to serious complications such as vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring. Patients must be advised to seek immediate medical attention if they experience symptoms such as changes in vision, signs of stroke, pale skin near the injection site, or unusual pain.

Injection Techniques

Proper injection techniques are crucial for achieving optimal results and minimizing risks. The package insert recommends using a 30-gauge needle for injections. Before the procedure, ensure that the treatment area is clean and free of makeup. Use an appropriate antiseptic to cleanse the skin.

Inject Juvéderm slowly and apply minimal pressure to ensure even distribution of the product. It is essential to inject the filler into the mid to deep dermis to achieve the desired correction. Avoid injecting too superficially, as this can lead to visible lumps and bumps. Massage the treated area gently to ensure even distribution and to smooth out any irregularities.

To minimize the risk of complications, avoid injecting into areas with active inflammation or infection. Additionally, be cautious when injecting near vital structures such as blood vessels and nerves.

Clinical Trials

Clinical studies of Juvéderm involved 439 patients with moderate to severe nasolabial folds. Patients received injections of Juvéderm Ultra XC and were followed for up to 24 weeks. Results showed that 88% of patients achieved optimal cosmetic results immediately after treatment, with a significant reduction in the severity of nasolabial folds. At the 24-week follow-up, 78% of patients maintained improvement from baseline. Adverse events were generally mild and transient, with the most common being injection-site reactions.

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 Juvéderm 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.

Patient consultation is a crucial skill that will be taught during your hands-on Juvéderm training day.

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

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.
  6. Superficial injection may cause a bluish hue to the skin, call Tyndall effect. This can either be massaged deeper, squeezed out, or dissolved with Hyaluronidase.
  7. When fanning, do not completely remove the needle from the skin, angle the syringe (fanning) and reinsert the needle to the end of the hub.
  8. Direction of the angling depends on the shape of the fold.
  9. If blanching occurs, then stop the injection. You may be injecting into or near a blood vessel. Massage the area until the skin returns to a normal color.
  10. One should always feel the resistance of the dermis as one is injecting. If the injection has too much or too little resistance, then you are likely in the wrong plane.
  11. Wrinkle should be visibly lifted and filled by the end of the treatment.

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.

Reassure the patient that the lump will likely go away. Arrange for a follow up in a week. If the lump is still apparent at the follow up appointment, then use Hyaluronidase. It can be difficult to judge the symmetry of your product placement immediately after the injection due to localized swelling and bruising.

This is true, especially in the lips. If you notice asymmetry and you feel that you have placed the products evenly, then it is best to invite the patient back in 1 week for re-evaluation. Any mild to moderate swelling due to localized swelling, internal bruising, and/or product placement should resolve in a few days. Offer your patient an ice pack to minimize swelling and bleeding.

Nasolabial Folds

Correction of the nasolabial fold is the most common site for correction with NASHA™ fillers. Malar fat pad moves medially and inferiorly due to loss of collagen and skin elasticity and cause the nasolabial folds or laugh lines. The Nasolabial fold is the visible line or groove from the lateral edges of the nose to corners of the mouth. Heavy cheeks due to aging or obesity may increase the depth of the lines. Depending on the age, the fold may be superficial or deep.

For shallow to medium folds, use linear threading with fanning to correct the folds.  Start from the inferior position and insert the needle superiorly.  Inject 0.05mL to 0.1mL per injection.

Fanning is recommended up by the nose and possibly throughout depending on the level of correction visualized.  Concentrate your fanning on the upper Y-shaped area below the naris and lateral to the ala.  There is less movement of the facial muscles in this area and correction persists well.  In this position, the nasal artery runs near, so we recommend that you pull back on the syringe plunger to make sure that no flash of blood is seen if you feel that the injection may be too deep.  Also, injecting slowly low amount of volume will also prevent intra-arterial injection.

Further down the fold towards the oral commissure, the duration of correction is shorter due to increase muscle movement.  Correction may be more challenging due to the lack of underlying bone and the sagging tissue from the area of the cheekbones.

After you are finished with your injection, place a glove thumb on top of the fold and one or two fingers on the inside of the mouth.  Gently mold along the injection site to feel for nodules or bumps.  HA fillers are malleable and can be molded.

You may see multiple fine lines lateral to the nasolabial fold.  Resist the urge to inject them as they are typically due to dynamic movement.  While at rest, the lines may appear diminished, with movement, implanted fillers may be visible as cords on the patient’s face.

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.  The injection may extend down into the melomental fold in older patients.  You may ask your patients to open their mouth slightly to aid your injection.  Augmentation in the mouth corners typically does not last as long as in other areas.  Inject 0.05mL to 0.1mL per injection.

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.

MMF may look like a single line when looking at the face straight on.  A more three dimensional observation, by looking up towards the nose superiorly, may demonstrate a deeper groove or delta.  Techniques such as linear threading or serial puncture may be inadequate for more advance folds.  A scaffolding-like structure may have to be formed using fanning or cross-hatching technique.

Inject into the deep dermis vertically from inferior to superior direction.  Horizontal injections should be placed from medial to lateral direction to avoid injecting the facial vein which can be found lateral to the MMF.  Layering may be required for deep MMF.  Inject along the fold 0.05mL to 0.1mL per injection.  Avoid inadvertent injections into the lip as this may cause unwanted lip enhancement or lumping in the lower lips.  Remember that while most patients can tolerate injection into the nasolabial folds, MMF injection tend to be more painful.

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.

Lips are the most challenging of all the areas to fill properly.  Issues to address include to following: proportional lip relative to the face, proportional upper and lower lip fullness, sharp, well defined vermilion borders, distinct Cupid’s Bow peak and philtral columns, and upturned oral commissure.  Typically, the lower lip is fuller than the upper lip. The ideal ratio of upper lip to lower lip is 1 : 1.6, based on the Fibonacci proportion.

There are two distinct goals typically depending on the patient’s age.

Younger individuals typically want to enhance the size and shape of the lips.  A young patient with naturally fuller lip forms may be more technically challenging.  Some may bring in photos requesting specific outcomes.  It is important to ask if the patient desires fuller lips or a completely different shape.  Lip volume enhancement increases the height of the vermilion border and increases lip circumferentially.  This may cause a “duck lip” appearance.  Small volume injections are always recommended for first time treatments.  Even a small volume of filler (0.1 – 0.3mL) can make a difference in appearance of the lips.

Older individuals typically want to correct or restore their lips back to where they were rather than to increase their size.  Detailed consultation is required for older patients as they may not want eversion of the lips or not want their lips to look “fake”.   Patients with lipstick bleeding may require additional treatments such as laser resurfacing or chemical peel.  Determine the patient’s goal for the correction.

Most patients feel moderate amount of pain during the injection.  HA products with lidocaine help reduce discomfort.  Nerve blocks and topical anesthesia cream are other ways to minimize pain. If you perform any nerve blocks, then it is important to work quickly after these as the numbing can distort the position of the patient’s lips. We recommend using the threading technique to minimize the number of punctures.

Injecting along the vermilion border and wet – dry junction will enhance the volume of the lips.

To increase the size of the lips, insert the needle 1-2mm away from the vermillion border towards the mucosa border to evert the lips.  Injecting near the vermilion border increases size, shape, lift and contour.  This will give the lips a “ski jump” like appearance where the vermillion border will curve outwards.  Injections at the vermilion borders should be done with caution, as too much filler here can give your patients a “duck-like” appearance to the lips.  Start with 0.05ml per injection and increase the amount depending on the level of correction desired.  Injection can start from the lateral edge or the medial peak of the Cupid’s Bow of the upper lip.

Typically, injections near the vermilion border should be done prior to injections near the wet-dry border.  To increase the volume of the lips, insert the needle 3-5mm away from the vermillion border near the wet-dry border to plump up the lips.  This will not evert the lip edges.  Start with 0.05ml per injection and increase the amount depending on the level of correction desired. However, DO NOT inject the wet-dry border as this can cause vascular necrosis.

To increase the philtral column, insert the needle at the junction of the Cupid’s bow and philtral column, and advance superiorly.  Try to inject a slightly greater amount of filler inferiorly to create a natural contour of the column.  Inject 0.025 to 0.05ml per column.

Vertical lip lines, or smoker’s or lipstick lines vary from fine lines to deeper grooves and injection technique will vary.  Injection can be directly into the lines, perpendicular to the lines, or along the vermilion border.  Treat this area conservatively and use very small amounts so that the area above the vermilion border does not become swollen.

Lips are the focal point of the lower face.  Therefore, mistakes are more apparent.  Due to its high vascular tissue, mistakes are more likely to produce adverse events than other areas.  Immediate, short-term swelling is common.  Bruising is frequent.  This may cause the injector to overcorrect one area in response to edema or hematoma.  If the patients lips are symmetric prior to inject, then insure that equal amount of filler is implanted to maintain symmetry.

Asymmetric lips obviously require different amounts to create symmetry.  Application of an ice pack after the injection can diminish these immediate complications.  Extravasation into small bumps may be visible during the injection.  Massage these lumps and guide the product into the desired location.  We recommend a conservative treatment with small volume injections for first time treatments.

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.

Complication can be divided into early and delayed in time of occurrence, and minor and major in severity.

Early minor complications include bruising, pain, edema and erythema.  These can occur immediately or within hours and resolve within a week.  Most patients will develop at least one of these local injection site reactions, so it is important to discuss this with them.  Pretreatment with anesthetic or ice prior to treatment is recommended to minimize pain in site that contains high sensory innervation, such as the lips.  Avoiding anticoagulants and supplements that are not medically necessary will minimize post injection ecchymosis.  Some use homeopathic ointment called Arnica in reducing ecchymosis.  Helenalin, an extract of Arnica, has shown to have anti-inflammatory effects, although clinical studies are not conclusive.

Other early minor complications of asymmetry, lumpiness, or bluish discoloration are typically due to injection technique.  Incorrect filler placement can cause nodules or papules.  When the filler is implanted too superficially, a bluish hue is visible (Tyndall effect).  Such reactions can be treated with manual massage, aspiration, incision and drainage, or hyaluronidase.

A rare early major complication is an anaphylaxis due to an immediate hypersensitivity reaction.  It is estimated that 1 in 10,000 individuals with HA report a mild to severe hypersensitivity reaction. It is always recommended that you should have a protocol in your office should any such emergency should arise.

Cellulitis is a complication seen with any injection procedure.  Common bacterial causes are Staphylococcus and Streptococcus.  Lesions should be cultured and treated with antibiotics.  The use of chlorhexidine will minimize the risk of infection.

Trauma from the injection can trigger a recurrent herpetic lesion.  Prophylactic antiviral treatment is recommended when injecting the lips.  Also, injection should be avoided during an active herpes outbreak.

Inflammatory nodules can occur if bacteria is injected with the filler, and the HA encapsulates the bacteria within the skin.  These inflammatory nodules will be red and painful.  Incision and drainage should be performed, with cultures, and antibiotic, such as clarithromycin should be started for at least 2 – 6 weeks.  The use of steroid can worsen the situation.  Patients with diabetes, immunocompromised, chronic sinusitis, or chronic dental problems should be treated with care.

Delayed major complication is the formation of granulomas which can occur 6 months after the injection.  HA fillers are rarely linked to granuloma formation, but it has been reported in 0.1% of the patients who are typically injected with permanent or semi-permanent fillers.  The body mounts a foreign body reaction with fibrosis occurring at the injection site.  This can be treated with steroid injections, surgical excision, or hyaluronidase.

Delayed hypersensitivity reaction can also occur. 

The most severe, delayed complication is tissue necrosis, due to direct blockage of a vessel, compression near the vessel, or injury to the vessel.  This has been reported in 0.09% of the patients who received collagen injections.  The patient will experience delayed capillary refill and pain, followed by a mottled pattern of purple discoloration, and ulceration due to necrosis.  This can occur in the glabellar area due to blockage of the supratrochlear or supraorbital artery and the alar or nasal area due to the blockage of nasal arteries.  This can also occur along facial and angular artery.  A thorough understanding of the facial anatomy is recommended to prevent this complication.  Steps such as aspiration, slow anterograde injection, constant needle motion, using small particle size fillers, superficial use, avoiding injection near vessels, and blunt tip cannulas can help reduce the risk of intravascular injection.  This can be treated with massage, heat application, nitroglycerin paste (1/2 inch of 2% nitroglycerin) to vasodilate the area, and hyaluronidase to remove the filler.  When nitroglycerin is used topically, the patient should be warned of the potential side effects, such as headache, bradycardia, and hypotension.

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.

Hyaluronidase is diluted with saline in 1:1 ratio.  Skin testing is mandatory when using hyaluronidase.  Inject 3 – 5 units intradermally.  A wheal formation within 5 minutes and persisting for 20 -30 minutes with localized itching is a positive skin test.  Total of 10 – 30 units should be injected per 2 X 2 cm area of impending necrosis.

Please check the package insert for any Hyaluronidase product for complete instructions and warnings and contraindications.

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.

A detailed consultation is a must.  Educate your patients.  Under-promise and over-deliver.

Juvederm®️ Injection Training Course Certification

Learn more about Juvéderm®️ 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. However, due to continuing flow of new research and information relating to the drugs being used in this course, we recommend that you check with the manufacturer for any changes in the package inserts, warnings and precautions.

Originally published at Juvederm Training Miami

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Comprehensive Guide to Botulinum Toxin Injection Training

Botox Training Austin

The History of Botulinum Toxin

The history of Botulinum Toxin, often referred to as “botox”, is a fascinating journey that spans over several decades. This potent neurotoxin, produced by the bacterium Clostridium botulinum, has found its place in the world of cosmetic dermatology, offering a non-surgical solution to a variety of aesthetic concerns.

The discovery of Botulinum Toxin dates back to the 19th century when a German physician, Justinus Kerner, first identified it while investigating a series of food poisoning cases. Kerner coined the term “botulism” from the Latin word for sausage, “botulus,” as the affected individuals had consumed improperly prepared sausages. He was the first to recognize the paralytic symptoms of botulism and postulated the existence of a “fatty poison” that interfered with the transmission of nerve impulses.

In the early 20th century, Emile Pierre van Ermengem, a Belgian bacteriologist, isolated the bacterium we now know as Clostridium botulinum. He discovered that the bacterium produced a toxin that caused the symptoms of botulism. This marked the first step in understanding the nature of this potent neurotoxin.

The therapeutic potential of Botulinum Toxin was not realized until the mid-20th century. During the 1940s and 1950s, scientists at the United States Army’s biological warfare laboratories at Fort Detrick, Maryland, conducted extensive research on Botulinum Toxin as a potential biological weapon. Although the military applications of the toxin were never fully realized, this research paved the way for understanding the toxin’s therapeutic potential.

In the 1960s, Dr. Alan B. Scott, an ophthalmologist, began investigating the potential use of Botulinum Toxin to treat strabismus (crossed eyes), a condition that was difficult to treat surgically. His research led to the development of a purified and diluted form of the toxin that could be injected into muscles to cause temporary paralysis. In 1989, the U.S. Food and Drug Administration (FDA) approved the use of Botulinum Toxin type A (marketed as Botox) for the treatment of strabismus and blepharospasm (uncontrolled blinking).

The cosmetic applications of Botulinum Toxin were discovered somewhat serendipitously. Jean Carruthers, a Canadian ophthalmologist, noticed that her patients who received Botox treatments for eye disorders also experienced improvement in facial wrinkles. This observation led to a series of studies conducted by Jean and her husband, Alastair Carruthers, a dermatologist, which eventually led to the FDA approval of Botox for cosmetic use in 2002.

Since then, the use of Botulinum Toxin in cosmetic dermatology has skyrocketed. It is now used to treat a variety of conditions, including forehead wrinkles, crow’s feet, and frown lines. The toxin works by blocking the nerve signals to the muscles, causing them to relax and reducing the appearance of wrinkles.

The journey of Botulinum Toxin from a deadly poison to a beloved wrinkle reducer is a testament to the power of scientific research and innovation. As our understanding of this potent neurotoxin continues to grow, so too will its applications in cosmetic dermatology and beyond.

Different Botulinum Toxins

BOTOX Cosmetic (onabotulinumtoxinA): 

Indication

This drug is used in adults for temporary improvement in the appearance of moderate to severe glabellar lines (lines between the eyebrows) associated with corrugator and/or procerus muscle activity. It is also indicated for the treatment of moderate to severe lateral canthal lines (crow’s feet) associated with orbicularis oculi activity, and moderate to severe forehead lines associated with frontalis muscle activity. 

Dilution

This drug is supplied in single-dose 50 Units and 100 Units per vial. It should be reconstituted with sterile, preservative-free 0.9% Sodium Chloride Injection USP to obtain a solution at a concentration of 4 Units/0.1 mL. The reconstituted BOTOX Cosmetic should be clear, colorless, and free of particulate matter. It should be administered within 24 hours after reconstitution and stored in a refrigerator during this time period. The vials are for single-dose only.

Administration

The drug is administered intramuscularly into five sites, two each corrugator muscle and one in the procerus muscle for a total dose of 20 Units. The dosage for simultaneous treatment with lateral canthal lines is 64 Units, comprised of 20 Units for forehead lines, 20 Units for glabellar lines, and 24 Units for lateral canthal lines. The drug should be administered no closer than 1 cm above the central eyebrow to reduce the risk of ptosis.

Storage

The product is supplied as a vacuum-dried powder in single-dose vials of 50 or 100 Units. Unopened vials should be stored in a refrigerator (2° to 8°C). Reconstituted BOTOX Cosmetic should also be stored in a refrigerator and used within 24 hours.

DYSPORT (abobotulinumtoxinA): 

Indication

This drug is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adults less than 65 years of age.

Dilution

This drug is supplied as a dry powder in single-dose 300 Unit and 500 Unit vials. It should be reconstituted with preservative-free 0.9% Sodium Chloride Injection, USP using aseptic technique. The reconstituted DYSPORT should be a clear, colorless solution, free of particulate matter. It should be used for only one injection session and for only one patient. Once reconstituted, it can be stored in a refrigerator, protected from light for up to 24 hours until time of use.

Administration

The dose for the treatment of glabellar lines in adults is a total of 50 Units given intramuscularly in five equal aliquots of 10 Units each to achieve clinical effect. The drug should be administered no more frequently than every three months. To reduce the risk of ptosis, the drug should be injected at least 1 centimeter above the bony supraorbital ridge and no closer than 1 centimeter above the central eyebrow.

Storage

This is supplied as a sterile, lyophilized powder in a single-dose, glass vial. Unopened vials must be stored refrigerated (2°C to 8°C) and protected from light.

XEOMIN (incobotulinumtoxinA): 

Indication

It is indicated for temporary improvement in the appearance of moderate to severe glabellar lines with corrugator and/or procerus muscle activity.

Dilution

It should be reconstituted with only 2.5mL sterile, preservative-free 0.9% Sodium Chloride Injection, USP to obtain a solution at a concentration of 4 Units/0.1 mL. The frequency of XEOMIN treatments should be no sooner than every 12 weeks.

Administration

The drug is administered intramuscularly into five sites, two injections into medial corrugator and lateral corrugator muscles respectively, and one injection in the procerus muscle for a total dose of 20 Units. To reduce the risk of ptosis, the drug should be injected no less than 1 centimeter above the superior orbital rim.

Storage

Supplied in single-dose vials of 50, 100, or 200 Units. Unopened vials can be stored at room temperature (20°C to 25°C), in a refrigerator (2°C to 8°C), or a freezer (-20°C to -10°C). Reconstituted XEOMIN should not be used if the solution appears cloudy or contains particulate matter, and any unused solution should be discarded after 24 hours.

JEUVEAU (prabotulinumtoxinA-xvfs):

Indication

This drug is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.

Dilution

This drug is supplied in a single-dose 100 Unit vial. It should be reconstituted with only 2.5mL sterile, preservative-free 0.9% Sodium Chloride Injection, USP to obtain a solution at a concentration of 4 Units/0.1 mL. The reconstituted JEUVEAU should be clear, colorless, and free of particulate matter. It should be administered within 24 hours after reconstitution and stored in a refrigerator during this time period. The vials are for single-dose only.

Administration

The drug is administered intramuscularly into five sites, two injections into medial corrugator and lateral corrugator muscles respectively, and one injection in the procerus muscle for a total dose of 20 Units. To reduce the risk of ptosis, the drug should be injected no less than 1 centimeter above the superior orbital rim.

Storage

Supplied as a vacuum-dried powder in a single-dose vial of 100 Units. Unopened vials should be stored in a refrigerator (2° to 8°C) and protected from light.

DAXXIFY (daxibotulinumtoxinA-lanm)

Indication

This drug is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.

Dilution

This drug is supplied in single-dose 50 Unit and 100 Unit vials. It should be reconstituted with the required amount of sterile, preservative-free 0.9% Sodium Chloride Injection, USP to obtain a solution at a concentration of 8 Units/0.1 mL. The reconstituted DAXXIFY solution should be clear to slightly opalescent and colorless and free of particulate matter. It should be administered within 72 hours after reconstitution and stored in a refrigerator during this time period.

Administration

The drug is administered intramuscularly into five sites, two injections into medial corrugator and lateral corrugator muscles respectively, and one injection in the procerus muscle for a total dose of 40 Units. To reduce the risk of ptosis, the drug should be injected no less than 1 centimeter above the superior orbital rim.

Storage

Supplied as a sterile lyophilized powder in single-dose vials of 50 or 100 Units. Unopened vials should be stored at room temperature (20°C to 25°C) or refrigerated (2°C to 8°C) and protected from light.

General Contraindications

Botulinum toxin drugs are contraindicated in patients with:

Known hypersensitivity to any botulinum toxin products or to any of the components in the formulation. This includes specific hypersensitivity to cow’s milk protein, which may be present in trace amounts in some formulations.

Presence of infection at the proposed injection site(s).

These contraindications apply to all the mentioned botulinum toxin drugs: BOTOX Cosmetic, DYSPORT, XEOMIN, JEUVEAU, and DAXXIFY.

Warnings and Precautions

Lack of Interchangeability between Botulinum Toxin Products

The potency units of botulinum toxin products, including BOTOX Cosmetic (onabotulinumtoxinA), DYSPORT, XEOMIN, JEUVEAU, and DAXXIFY (daxibotulinumtoxinA-lanm), are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products. Therefore, units of biological activity of these products cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method.

Spread of Toxin Effect: 

Postmarketing safety data from botulinum toxin products, including BOTOX Cosmetic, DYSPORT, XEOMIN, JEUVEAU, and DAXXIFY, suggest that botulinum toxin effects may, in some cases, be observed beyond the site of local injection. The symptoms are consistent with the mechanism of action of botulinum toxin and may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties.

These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life-threatening, and there have been reports of death related to the spread of toxin effects. Patients should be advised to seek immediate medical care if swallowing, speech, or respiratory difficulties occur. Although no serious adverse reactions of distant spread of toxin effect associated with these products have been reported in clinical studies for their specific approved indications, these reactions are possible.

Serious adverse reactions with unapproved use:

Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received botulinum toxin injections for unapproved uses. These adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of botulinum toxin products to the site of injection and/or adjacent structures. In several cases, patients had pre-existing dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of botulinum toxin products. The safety and effectiveness of botulinum toxin for unapproved uses have not been established.

Hypersensitivity Reactions:

Serious and/or immediate hypersensitivity reactions have been reported for botulinum toxin products. These reactions include anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea. If such a reaction occurs, further injection of the botulinum toxin product should be discontinued and appropriate medical therapy immediately instituted. The use of botulinum toxin products in patients with a known hypersensitivity to any botulinum neurotoxin or to any of the components in the formulation could lead to a life-threatening allergic reaction.

Cardiovascular System:

There have been reports following administration of botulinum toxins of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including pre-existing cardiovascular disease. Use caution when administering to patients with pre-existing cardiovascular disease.

Increased Risk with Pre-Existing Neuromuscular Disorders:

Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise.

Dysphagia and Breathing Difficulties:

Treatment with botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or swallowing. Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist for several months, and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised. Treatment with botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation. This may result in a critical loss of breathing capacity in patients with respiratory disorders who may have become dependent upon these accessory muscles. There have been postmarketing reports of serious breathing difficulties, including respiratory failure. Patients treated with botulinum toxin may require immediate medical attention should they develop problems with swallowing, speech or respiratory disorders. These reactions can occur within hours to weeks after injection with botulinum toxin.

Pre-existing Conditions at the Injection Site: 

Caution should be used when botulinum toxin treatment is used in the presence of inflammation at the proposed injection site(s), ptosis, or when excessive weakness or atrophy is present in the targeted muscle(s). This also applies to patients who have marked facial asymmetry, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or when subjects do not respond to 20 Units of botulinum toxin (e.g., the inability to substantially lessen glabellar lines even by physically spreading them apart). Use caution when administering to patients with surgical alterations to the facial anatomy. Do not exceed the recommended dosage and frequency of administration.

Corneal Exposure and Ulceration: 

This may require protective drops, ointment, or closure of the eye by patching or other means. Because of its anticholinergic effects, botulinum toxin should be used with caution in patients at risk of developing narrow angle glaucoma. To prevent ectropion, botulinum toxin products should not be injected into the medial lower eyelid area. Ecchymosis easily occurs in the soft tissues of the eyelid. Immediate gentle pressure at the injection site can limit that risk.

Ophthalmic Adverse Reactions: 

Dry Eye: 

Dry eye has been reported with the use of botulinum toxin products in the treatment of glabellar lines. Reduced tear production, reduced blinking, and corneal disorders may occur with use of botulinum toxins. If symptoms of dry eye (e.g., eye irritation, photophobia, or visual changes) persist, consider referring the patient to an ophthalmologist.

Spatial Disorientation and Double Vision Treated for Strabismus: 

Inducing paralysis in one or more extraocular muscles may produce spatial disorientation, or double vision.. Covering the affected eye may alleviate these symptoms.

Human Albumin and Transmission of Viral Diseases: 

The product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.

Facial Anatomy in the Treatment of Glabellar Lines: 

Caution should be exercised when administering botulinum toxin to patients with surgical alterations to the facial anatomy, excessive weakness or atrophy in the target muscle(s), marked facial asymmetry, inflammation at the injection site(s), ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or the inability to substantially lessen glabellar lines by physically spreading them apart. Do not exceed the recommended dosage and frequency of administration. In clinical trials, subjects who received a higher dose had an increased incidence of eyelid ptosis.

Intradermal Immune Reaction: 

The possibility of an immune reaction when injected intradermally is unknown. The safety of botulinum toxin for the treatment of hyperhidrosis has not been established. It is approved only for intramuscular injection.

Side Effects/ Adverse Reactions

Here is the list of major side effects taken from the Xeomin, botulinum toxin. Most botulinum toxin share similar side effect / adverse event profile. Please check your package insert for a detailed list.

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to botulinum toxin in different studies or to other products may be misleading.

Treatment with botulinum toxins may result in the formation of neutralizing antibodies that may reduce the effectiveness of subsequent treatments by inactivating the biological activity of the toxin. The critical factors for neutralizing antibody formation have not been well characterized. The results from some studies suggest that botulinum toxin injections at more frequent intervals or at higher doses may lead to a greater incidence of antibody formation. The potential for antibody formation may be minimized by injecting with the lowest effective dose given at the longest feasible intervals between injections.

Post Marketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during post-approval use of botulinum toxin products:

Death, sometimes associated with dysphagia, pneumonia, and/or other significant debility or anaphylaxis.

Adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including cardiovascular disease.

New onset or recurrent seizures, typically in patients who are predisposed to experiencing these events.

Ear and labyrinth disorders: Hypoacusis; tinnitus; vertigo.

Eye disorders: Diplopia; dry eye; lagophthalmos; strabismus; visual disturbances; vision blurred.

Gastrointestinal disorder: Abdominal pain; diarrhea; dry mouth; nausea; vomiting.

General disorders and administration site conditions: Denervation; malaise; pyrexia.

Metabolism and nutrition disorders: Anorexia.

Musculoskeletal and connective tissue disorders: Localized muscle twitching/involuntary muscle contractions; muscle atrophy; myalgia.

Nervous system disorders: Brachial plexopathy; dysarthria; facial palsy; hypoaesthesia; localized numbness; myasthenia gravis; paresthesia; peripheral neuropathy; radiculopathy; syncope.

Respiratory, thoracic and mediastinal disorders: Aspiration pneumonia; dyspnea; respiratory depression and/or respiratory failure.

Skin and subcutaneous tissue disorders: Alopecia, including madarosis; hyperhidrosis; pruritus; skin rash (including erythema multiforme, dermatitis psoriasiform, and psoriasiform eruption).

Vertigo, photophobia, influenza-like illness, amyotrophy, burning sensation, facial paresis, hypoesthesia, erythema, dry eye, and excessive granulation tissue.

Hypersensitivity reactions including anaphylaxis.

Eye swelling, eyelid edema, dysphagia, nausea, flu-like symptoms, injection site pain, injection site reaction, allergic dermatitis, localized allergic reactions like swelling, edema, erythema, pruritus or rash, herpes zoster, muscular weakness, muscle spasm, dysarthria, myalgia and hypersensitivity.

Drug Interactions

Aminoglycosides and Other Agents Interfering with Neuromuscular Transmission: Co-administration of botulinum toxin and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like compounds or tubocurarine-type muscle relaxants) should only be performed with caution as the effect of the toxin may be potentiated. If co-administered, the patient should be observed closely.

Anticholinergic Drugs: Use of anticholinergic drugs after administration of botulinum toxin may potentiate systemic anticholinergic effects such as blurred vision.

Other Botulinum Neurotoxin Products: The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.

Muscle Relaxants: Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of botulinum toxin.

Specific Populations

Pregnancy: There are no adequate data from postmarketing surveillance on the developmental risk associated with the use of botulinum toxin in pregnant women. In animal studies, administrations of botulinum toxin during pregnancy resulted in adverse effects on fetal growth (decreased fetal body weight and skeletal ossification) at clinically relevant doses, which were associated with maternal toxicity. 

Lactation: There are no data on the presence of botulinum toxin in human or animal milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for botulinum toxin and any potential adverse effects on the breastfed infant from botulinum toxin or from the underlying maternal conditions.

Pediatric Use: Safety and effectiveness in patients below the age of 18 years have not been established for botulinum toxin.

Geriatric Use: In clinical studies of botulinum toxin, the responder rates appeared to be higher for subjects younger than age 65 than for subjects 65 years or older. However, no overall differences in safety or effectiveness were observed between older and younger patients. Other clinical studies have not identified differences in responses between older and younger patients, but increased sensitivity in older patients cannot be ruled out.

Females and Males of Reproductive Potential: In rats, botulinum toxin produced adverse effects on mating behavior and fertility.

Ethnic Groups: Exploratory analyses in trials for glabellar lines in African-American subjects with Fitzpatrick skin types IV, V, or VI and in Hispanic subjects suggested that response rates at Day 30 were comparable to and no worse than the overall population.

Overdose

Excessive doses of botulinum toxin, whether it’s BOTOX Cosmetic (onabotulinumtoxinA), DYSPORT, XEOMIN, JEUVEAU (prabotulinumtoxinAxvfs), or DAXXIFY, may be expected to produce neuromuscular weakness with a variety of symptoms. Symptoms of overdose are likely not to be present immediately following injection.

Should accidental injection or oral ingestion occur, or overdose be suspected, these patients should be considered for further medical evaluation and appropriate medical therapy immediately instituted, which may include hospitalization. The person should be medically supervised for several weeks for signs and symptoms of systemic muscular weakness which could be local, or distant from the site of injection.

In the event of overdose, antitoxin raised against botulinum toxin is available from the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. However, the antitoxin will not reverse any botulinum toxin-induced effects already apparent by the time of antitoxin administration.

In the event of suspected or actual cases of botulinum toxin poisoning, please contact your local or state Health Department to process a request for antitoxin through the CDC. 

Clinical Pharmacology

Mechanism of Action 

The mechanism of action of botulinum toxin involves several steps:

  1. Binding: The botulinum toxin binds to specific surface receptors on nerve endings. This binding is facilitated by the heavy chain of the toxin molecule.
  2. Internalization: Once bound, the toxin is internalized into the nerve terminal through a process known as receptor-mediated endocytosis.
  3. Inhibition of Acetylcholine Release: Inside the nerve terminal, the toxin cleaves a pre-synaptic protein called SNAP-25. This protein is integral to the successful docking and release of acetylcholine, a neurotransmitter responsible for muscle contraction, from vesicles situated within nerve endings. The cleavage of SNAP-25 inhibits the release of acetylcholine, leading to a localized reduction in muscle activity.
  4. Muscle Response: The affected muscle undergoes partial chemical denervation, which may lead to muscle atrophy. These changes contribute to the muscle’s reduced activity and the wrinkle smoothing.

The effects of botulinum toxin are not permanent. Over time, the muscle begins to regain its strength through a process known as reinnervation. This occurs as the neuromuscular junction recovers from SNAP-25 cleavage and new nerve endings are formed. The parent nerve terminal regains function, and the collateral terminals, which had sprouted during the period of denervation, retract. This gradual recovery of muscle function ensures the safety of botulinum toxin use in cosmetic medicine, as the effects can be reversed over time.

Pharmacodynamics: 

No formal pharmacodynamic studies have been conducted with these toxins. The primary pharmacodynamic effect is due to chemical denervation of the treated muscle resulting in a measurable decrease of the compound muscle action potential, causing a localized reduction in muscle activity. The return of increased muscle tone following injection typically occurs within 3 to 4 months.

Pharmacokinetics: 

Using currently available analytical technology, it is not possible to detect these toxins in the peripheral blood following intramuscular injection at the recommended doses.

Carcinogenesis, Mutagenesis, Impairment of Fertility: 

Long term studies in animals have not been performed to evaluate carcinogenic potential of these toxins. They were negative in a battery of in vitro and in vivo genetic toxicologic assays. In fertility studies, reduced fertility was observed in males and females at high doses. 

Patient Consultation

The patient consultation is a critical component of a successful botulinum toxin treatment. It provides an opportunity to understand the patient’s concerns, set realistic expectations, and plan the treatment accordingly. 

Initial Consultation

  1. Patient History: Begin with a comprehensive history, including medical conditions, previous cosmetic procedures, allergies, and medications. This information is crucial to assess the suitability of botulinum toxin treatment and to anticipate potential complications.
  2. Informed Consent: Explain the procedure, potential risks, benefits, and alternatives to the patient. Ensure they understand the information and have the opportunity to ask questions. Obtain written consent before proceeding with the treatment.
  3. Photographic Documentation: Take standardized ‘before’ photographs from multiple angles. These photos serve as a reference for treatment planning and to evaluate the treatment outcome.

Patient Examination

  1. Patient Concerns: Provide a mirror and ask the patient to point out the areas of concern. Ask them to animate their face to illustrate their concerns better. This step helps to understand the patient’s perception of their appearance and their aesthetic goals.
  2. Facial Analysis: Conduct a thorough examination of the face, noting asymmetries, skin quality, muscle strength, and the depth and location of wrinkles. Point out any asymmetries to the patient and document them in the medical record.
  3. Glogau Wrinkle Scale: Use the Glogau Wrinkle Scale to assess the severity of wrinkles. This scale categorizes wrinkles into four types, each associated with a specific age group and recommended treatment:

    – Type 1: ‘Early Wrinkles’ (20s to 30s) – botulinum toxin is typically sufficient.

    – Type 2: ‘Wrinkles in Motion’ (30s to 40s) – botulinum toxin and possibly dermal fillers may be needed.

    – Type 3: ‘Wrinkles at Rest’ (50s & older) – botulinum toxin and dermal fillers will likely be required.

    – Type 4: ‘Only Wrinkles’ (60s or 70s) – botulinum toxin and dermal fillers may not be enough; consider facelift or laser resurfacing.

  1. Glabellar Spread Test: This test helps determine if botulinum toxin alone will soften a patient’s frown lines. Spread the glabellar wrinkles apart with your thumb and index fingers. Patients with thick skin and deep dermal folds who do not improve with manual spreading may need dermal filler injections alongside botulinum toxin.

Setting Expectations

  1. Realistic Expectations: Discuss the expected outcomes and limitations of botulinum toxin treatment. Emphasize that the typical goal is to enhance their natural beauty and not to completely change their appearance.
  2. Patient Education: Educate the patient about the procedure, post-treatment care, and the need for follow-up sessions. Explain that the effects of botulinum toxin are temporary and regular treatments are necessary to maintain the results.
  3. Treatment Plan: Based on the patient’s concerns, facial analysis, and wrinkle assessment, develop a personalized treatment plan. Discuss the plan with the patient, including the areas to be treated, the type of botulinum toxin to be used, and the estimated cost.

The patient consultation is not just about gathering information but also about building a therapeutic relationship with the patient. A well-conducted consultation can lead to high patient satisfaction and a successful treatment outcome.

Counseling

Patients should be informed that injections of botulinum toxins, such as BOTOX Cosmetic, DYSPORT, XEOMIN, JEUVEAU, and DAXXIFY, may lead to potential swallowing, speaking, or breathing difficulties, or other unusual symptoms. If such symptoms develop or existing symptoms worsen, patients or caregivers should seek immediate medical care.

Patients should also be aware that these injections may cause eye dryness, and they should report any symptoms of eye dryness, such as eye pain, eye irritation, photosensitivity, or changes in vision, to their doctor.

In addition, patients should be advised to avoid driving a car or engaging in other potentially hazardous activities if they experience loss of strength, muscle weakness, blurred vision, or drooping eyelids.

It’s important to note that these are general guidelines and the specific details may vary between the different toxins. Always refer to the specific patient counseling information for each toxin for the most accurate information.

Injecting the Glabella/Procerus and Corrugator Muscle

The glabellar region, often referred to as the ‘frown lines,’ is a common area for botulinum toxin injections. The primary muscles involved in this region are the procerus and corrugator muscles.

Muscles Involved and Action

  1. Procerus: This muscle originates from the nasal bone and inserts into the medial forehead and skin of the brow. Its action is to draw the medial brow inferiorly, contributing to the horizontal lines seen on the forehead.
  2. Corrugator: The corrugator muscle originates from the medial superciliary arch and inserts into the skin of the medial forehead. It draws the brow medially and inferiorly, leading to the formation of vertical lines between the eyebrows.

Landmarks

Identifying the correct landmarks is crucial for successful injections. Here are the key landmarks for glabellar injections:

  1. Medial Corrugator: The injection should be 1 cm above the bony orbital rim and vertical to the medial canthus.
  2. Lateral Corrugator: The injection should be 1 cm above the bony orbital rim and medial to the vertical mid-pupillary line.
  3. Procerus: The injection should be just above the crossing point of the ‘X’ formed by drawing a line from the medial eyebrow contralateral to the medial canthus.

Injection Technique

All injections for the glabella are intramuscular and perpendicular to the skin. The needle should be above the periosteum. It’s important to note that the frontalis muscle overlaps the corrugator superficially, so a superficial injection may cause paralysis of the inferior edges of the frontalis muscle. Therefore, corrugator injections should be deep intramuscular injections.

Previously, the recommendation was to inject until hitting the periosteum, then pull back several millimeters before injecting the botulinum toxin. However, this technique has been modified as it was found to increase the incidence of headaches in patients and dull the needle for subsequent injections.

The standard FDA-approved dose for glabellar lines, as per the BOTOX® Cosmetic package insert, is 20 units. However, men may require an additional 1-2 units per injection site due to typically larger muscle mass.

Complications and Solutions

The complication rate for glabellar injections is 1-3%. Potential complications include:

  1. Lid Ptosis: This can occur if the injection is too close to the orbital rim, as diffusion of the botulinum toxin may affect the levator palpebrae superioris muscle.
  2. Brow Ptosis: This can occur if the injection is placed too superficially (affecting the frontalis muscle) or too lateral to the mid-pupillary line. 

Complications can appear as soon as 48 hours or as late as 7 days post-injection and may persist for 4-8 weeks. Solutions include:

  1. Lid Ptosis: Apraclonidine 0.5% drop can be used, one drop to the affected eye three times a day. This stimulates Mueller’s muscles to minimize the ptosis. Oxymetazoline 0.1%, which has the FDA approval for lid ptosis, can also be used. 
  2. Brow Ptosis: A brow lift injection technique can be attempted. However, typically, time is required for frontalis movement to reappear to lift the brow up once again.

Injecting the Brow for a Brow Lift

Injections above near the brows that paralyzes the depressor muscles and create a “brow lift” like effect. 

Muscles Involved and Action

The primary muscles involved in a brow lift procedure using botulinum toxin are the Procerus and the Orbicularis Oculi.

Procerus

The Procerus muscle originates from the nasal bone and inserts into the medial forehead and skin of the brow. Its primary action is to draw the medial brow inferiorly, contributing to the formation of horizontal wrinkles on the bridge of the nose.

Orbicularis Oculi

The Orbicularis Oculi is a circumferential muscle group that functions like a sphincter or a purse string. It originates from the medial palpebral ligament and inserts into the lateral palpebral raphe, corrugator, frontalis, and depressor supercilii. Its action pulls the skin of the forehead, temple, and cheek toward the medial angle of the orbit, and it is also responsible for closing the eyelids.

Landmarks

The key landmarks for a brow lift procedure are the crossing point of the X formed by drawing a line from the medial eyebrow contralateral to the medial canthus for the Procerus, and the superolateral portion of the Orbicularis Oculi as it curves infralaterally lateral to the temporal fusion line for the Orbicularis Oculi.

Injection Technique

Procerus

The Procerus should receive a deep intramuscular injection, just above the periosteum. Inject 4 units of botulinum toxin to the Procerus just above the crossing point of the X formed by drawing a line from the medial eyebrow contralateral to the medial canthus.

Orbicularis Oculi

For the Orbicularis Oculi, inject 3 units subcutaneously to the superolateral portion of the muscle as it curves infralaterally lateral to the temporal fusion line. Ensure that the movement of the lateral portions of the frontalis muscles is not felt in this superolateral injection site to avoid injecting the frontalis and creating brow ptosis. The injection should be placed 1 cm outside of the bony orbital rim.

Complications and Solutions

The primary complication of a brow lift procedure is brow ptosis, or drooping of the brow. This can be minimized by injecting superior and lateral to the orbital rim. If brow ptosis does occur, it will naturally resolve as the action of the botulinum toxin diminishes over time.

Additional Pearls

– Precise injection location and depth are crucial for achieving aesthetically pleasing brow outcomes and greater duration of efficacy. 

– Avoiding the frontalis muscle during injection is key to prevent brow ptosis.

– Always consider individual patient anatomy when planning and executing the procedure.

Injecting the Horizontal Forehead Lines or Frontalis Muscle

The primary indication for injecting the frontalis muscle is to reduce the appearance of horizontal forehead lines. These lines are a result of the repetitive contraction of the frontalis muscle, which lifts the eyebrows and furrows the forehead.

Muscles Involved and Action

The frontalis muscle is a broad muscle that varies in size and shape among individuals. Some may have a narrow or broad frontalis, while others may have a tall or short frontalis. The shape can also vary, being either V-shaped or rectangle-shaped. It is important to palpate the muscle before injecting to understand its size and shape.

The frontalis muscle originates from the galea aponeurosis and inserts into the muscles of the glabellar complex. The action of the frontalis muscle is to lift the eyebrows superiorly and depress the scalp inferiorly. The fibers of the frontalis muscles are oriented vertically, while the visible wrinkles formed by the contraction of the frontalis muscle are horizontal.

Landmark

The frontalis muscle is located on the forehead and is easily palpable. The lower 2-3 cm of the frontalis muscle is used to elevate the eyebrow and injection here should be avoided. The medial portions of the frontalis muscle fibers may be more fibrous or absent and may need less injection. A key point about the frontalis is to avoid injecting near the lowest horizontal wrinkle or at least 2-3 cm above the brow.

Injection Technique

The injections are subcutaneous and are typically placed roughly 2 cm apart. Typically, 2 units of botulinum toxin are injected per site. Men may require 1-2 additional units per injection site due to typically having a larger muscle mass.

Complications and Solutions

The most common complications associated with frontalis muscle injections include brow ptosis and Spock brow.

Brow ptosis: This can occur when the frontalis is treated without paralyzing the active brow depressor muscles (procerus and corrugator). Ideally, glabella muscles should be injected simultaneously. Another cause of brow ptosis is when the frontalis muscle, which is hyperfunctional, supports a normally ptotic upper eyelid. To avoid complete paralysis of the frontalis muscle, it is recommended to avoid injecting near the first horizontal line or at least 2-3 cm above the brow.

Spock brow: This can occur when the lateral fibers of the frontalis muscles have not been paralyzed. The solution is to inject 1-2 units where you feel the untreated lateral fibers of the frontalis muscle when you ask your patients to lift their eyebrows. It should be noted that some patients may actually prefer the “Spock brow” look.

Additional Pearls

  1. Always palpate the frontalis muscle before injecting to understand its size and shape. This will help in determining the amount of botulinum toxin needed and the best injection sites.
  2. Always avoid injecting near the lowest horizontal wrinkle line or at least 2-3 cm above the brow to prevent brow ptosis.
  3. When treating the frontalis muscle, consider also treating the glabella muscles to prevent brow ptosis.
  4. Be aware of the possibility of a Spock brow and know how to correct it if it occurs.

Injecting the Crow’s Feet or Orbicularis Oculi

Muscles Involved and Action

The orbicularis oculi is a single, circumferential muscle group that functions like a sphincter or purse string. The muscle originates from the medial palpebral ligament and inserts into the lateral palpebral raphe, corrugator, frontalis, and depressor supercilii. Its primary action involves pulling the skin of the forehead, temple, and cheek toward the medial angle of the orbit, resulting in the closure of the eyelids.

Landmark

The landmark for the injection is 1 cm outside of the bony orbital rim or 2 cm outside of the lateral cantus. Placing the non-injecting index finger into the bony rim can help identify this landmark. The injection site should not be below the zygomatic arch to avoid diffusion into the zygomatic muscles, which can affect the smile.

Injection Technique

The injection technique for the orbicularis oculi involves subcutaneous injections, typically 1 cm apart in a slightly curving arch. Each injection typically contains 3 units of botulinum toxin. Men may require an additional 1 unit per injection site due to their typically thicker skin and stronger muscle mass.

Complications and Solutions

The most common complications include asymmetrical smile or diplopia due to migration of the toxin. To avoid this, it is crucial to inject 1 cm outside of the bony orbital rim. Excessive wrinkles underneath the lower lid may become accentuated if medial portions of the Orbicularis Oculi are left unopposed. This may require injection into the lower/medial parts of the Orbicularis Oculi or the Nasalis muscle. 

Injecting the Lower Eyelid

Botulinum toxin injections in the lower eyelid are primarily indicated for the treatment of wrinkles below the lower eyelid and narrow palpebral aperture.

Muscles Involved

The primary muscle involved in this procedure is the Orbicularis Oculi. This muscle is a circumferential muscle group that functions like a sphincter or purse string. It originates from the medial palpebral ligament and inserts into the lateral palpebral raphe, corrugator, frontalis, and depressor supercili. Its action pulls the skin of the forehead, temple, and cheek toward the medial angle of the orbit, and it is responsible for closing the eyelids.

Injection Technique

The injection technique for the lower eyelid involves a subcutaneous injection of botulinum toxin. The standard dose is 1 unit, injected 0.5 cm below the lower lid margin in line with the midpupillary line. Some individuals may require an additional unit for optimal results. It is important to avoid injections medial to the pupil to minimize the risk of complications.

Complications

The most common complication of lower eyelid injections is bruising, as this is a vascular area. Other potential complications include ectropion, where the lower lid turns outwards, and epiphora, which is excessive tear production. These complications are extremely rare but can occur.

To minimize the risk of ectropion, it is crucial to select patients appropriately. Patients with a history of lower lid ablative resurfacing or blepharoplasty may be contraindicated. Even in the absence of these contraindications, it is recommended to perform a snap test before proceeding with the injection. This test involves pulling the lower eyelid downward; a return to its normal position in less than 1 second is considered normal. Any patient with a time greater than 1 second should not be treated.

Injecting the Nasalis/Bunny Nose Lines

Muscles Involved and Action

The primary muscles involved in the formation of bunny nose lines are the Nasalis and Procerus muscles. Treatment of both the Procerus and Nasalis is necessary to diminish the horizontal and vertical lines on the bridge of the nose.

The Nasalis muscle, originating in the maxilla, is a complex structure that inserts into the aponeurosis of the Procerus and continues over the bridge of the nose onto the other side. Its primary function is to draw the skin of the nose superiorly and medially. Procerus muscle, which originates from the nasal bone, inserts into the medial forehead and skin of the brow. Its primary function is to draw the medial brow inferiorly.

Landmarks

When it comes to injecting these muscles, accurate identification of the landmarks is crucial. For the Nasalis, the injection site is anterior and medial to the nasofacial groove on the lateral nose. For the Procerus, the injection is performed just above the crossing point of the X formed by drawing a line from the medial eyebrow contralateral to the medial canthus.

Injection technique 

The Procerus requires a deep intramuscular injection, above the periosteum, with an injection of 4 units at the identified landmark. The Nasalis, on the other hand, requires a subcutaneous injection, with 2 units injected at the landmark.

Complications

One potential complication is upper lip ptosis due to diffusion into muscles lateral to the Nasalis muscle. To avoid this, ensure the injection is performed medial and anterior to the nasofacial groove, thus avoiding the levator muscles of the lip.

Injecting the Lip for a Lip Flip

Muscles Involved and Action

The primary muscle involved in the lip flip procedure is the orbicularis oris muscle. This muscle encircles the mouth and is responsible for various lip movements, including closing the lips, puckering, and other complex movements necessary for speech and facial expression. 

When botulinum toxin is injected into the orbicularis oris muscle, it causes a temporary paralysis of the muscle. This results in a slight eversion or ‘flip’ of the lip, giving the appearance of a fuller and more pronounced upper lip.

Landmark

The landmark for the lip flip procedure is the vermilion border of the upper lip. The vermilion border is the line where the pink-red lip tissue meets the surrounding skin. The injections are typically placed along this border at several points across the upper lip.

Injection Technique

The injection technique for a lip flip involves the careful placement of 1-2 units into the orbicularis oris muscle. The injections are typically administered using a fine needle, and the procedure is usually performed without anesthesia as it causes minimal discomfort. 

The injections are placed along the vermilion border of the upper lip, typically at 2-3 points on each side of the midline. The exact number and placement of injections can vary depending on the individual patient’s anatomy and desired results.

Complications and Solutions

Complications from a lip flip procedure are generally rare and mild, but can include:

– Asymmetry: This can occur if the botulinum toxin is not evenly distributed on both sides of the lip. It can be corrected in a follow-up appointment with additional injections to balance the effect.

– Difficulty with lip movements: Over-paralysis of the orbicularis oris muscle can lead to difficulty with certain lip movements, such as puckering or drinking from a straw. This is usually temporary and resolves as the effect wears off.

– Bruising or swelling at the injection site: This is a common side effect of any injection and usually resolves on its own within a few days.

Additional Pearls

– The effect of the lip flip procedure is temporary, with muscle function typically beginning to return approximately 1 to 2 months after injection due to the low dosage.

– The lip flip procedure can be a good alternative for patients who want a more pronounced upper lip but do not want or are not ready for more invasive procedures such as fillers or surgery.

– It’s important to have a thorough understanding of the patient’s anatomy and desired outcome to achieve the best results with a lip flip procedure. 

– Patient education is key. Make sure patients understand that the results are subtle and that this procedure is different from a dermal filler injection.

Injecting the Orbicularis Oris / Smoker’s Lip Lines

Muscles Involved and Action

The primary muscle involved in this procedure is the Orbicularis Oris. This muscle originates from the buccinator and fibers at the angle of the mouth, and inserts symmetrically at the vermillion border. The primary action of the Orbicularis Oris is to close the lips, which is crucial for functions such as speaking, eating, and expressing emotions.

Landmark

The Orbicularis Oris is a complex muscle that encircles the mouth. It is located directly beneath the skin and is easily palpable. The vermillion border of the lips serves as a key landmark for this muscle. The muscle extends from the corners of the mouth and wraps around the lips, meeting at the midline.

Injection Technique

The injection technique for the Orbicularis Oris involves subcutaneous symmetrical injections less than 3 mm above and below the vermillion border. Each injection should contain 1-2 units of botulinum toxin. It is important to avoid injecting more than 2 units in each lip quadrant to prevent overcorrection and potential complications. 

The mid upper lip and the corners of the mouth should be avoided during the injection process. The mid upper lip is a sensitive area, and injecting it could lead to flattening of the lip. The corners of the mouth are also crucial for facial expressions, and injecting them could lead to an asymmetrical smile or other complications.

Complications and Solutions

Potential complications of botulinum toxin injections in the Orbicularis Oris include an asymmetrical smile, difficulty with speech, and drooling. These complications can be mitigated by using a low dose of botulinum toxin and ensuring symmetrical injections. 

It is also recommended to avoid injecting individuals who rely heavily on their facial expressions for their profession, such as singers, orators, and musicians. These individuals may experience a significant impact on their ability to perform their work if any complications arise.

If a patient has a history of cold sores, it is recommended to include pretreatment with Valtrex®. The patient should take 2 grams at the time of treatment and 2 grams 12 hours later to prevent a herpes outbreak.

Additional Pearls

Patient Selection: It is crucial to select patients carefully for this procedure. Patients deep peri-oral grooves may benefit from laser resurfacing, microneedling or dermal filler injection.

Dysport: Introduction and Differences from Botox

Dysport requires an explanation, because the units are different from other botulinum toxins. All package inserts state that units are not interchangeable with other preparations of botulinum toxin products. However, most commercially available botulinum toxins use 20 units for the glabellar line. Except for Dysport. Units are a measure of the biological activity of a botulinum toxin which cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method. 

Reconstitution

Dysport is supplied as a single-use vial with 300 Units per vial. Each 300 Unit vial of Dysport is to be reconstituted with 2.5 mL of 0.9% sterile, preservative-free saline prior to injection. The concentration of the resulting solution will be 10 Units per 0.08 mL. Each 300 Unit vial of Dysport may also be reconstituted with 1.5 mL 0.9% sterile, preservative-free saline for a solution of 10 Units per 0.05 mL to be delivered. Just as a provider can dilute Botox Cosmetic with Preserved (Bacteriostatic) 0.9% Sodium Chloride, Dysport may also be diluted with the same to increase its half-life.

Unit Conversion from Botox Cosmetic to Dysport

The striking difference between Dysport and Botox Cosmetic is the amount of units injected. Botox Cosmetic requires 20 units at 4 units per injection site in treating the glabellar area, whereas Dysport requires 50 units at 10 units per injection site in treating the glabellar area. This constitutes a 1:2.5 concentration ratio. Many other users have contended that the actual ratio should be 1:3 or 1:4. These concentrations ultimately increase the amount of Dysport being injected. We recommend that you start with a 1:2.5 ratio conversion from the Botox Cosmetic unit injection recommendations offered at this course until you feel comfortable with the use of Dysport.

Comparative Studies

Studies have shown that Dysport will start working faster than Botox Cosmetic, last longer than Botox Cosmetic, and have a lower diffusion rate than Botox Cosmetic due to its high concentration. However, it’s important to note that individual patient results may vary, and it’s crucial to tailor the treatment plan to the patient’s unique needs and desired outcomes.

In conclusion, Dysport provides an effective alternative to Botox Cosmetic, with its own unique properties and considerations. As with any treatment, understanding the product and its appropriate use is key to achieving optimal results. 

Treatment Failure in Botulinum Toxin Cosmetic Injection

One of the most significant challenges is treatment failure, which can be classified into primary and secondary nonresponse.

Primary Nonresponders:

Primary nonresponders are individuals who do not respond to their first BTX Cosmetic treatment. This lack of response can be attributed to several factors:

  1. Static Wrinkles: The most common reason for primary nonresponse is the presence of static wrinkles, which are not dynamic in origin. These wrinkles are usually due to photodamage or age-related changes and require the injection of a filler material. A positive spread test often indicates this.
  2. Inadequate Injection Amount: Another common cause of primary nonresponse is an inadequate amount of BTX injected. This could be due to the patient having strong muscles or the injection missing the targeted muscle.
  3. Denatured Toxin: If the BTX has denatured, it will not produce the desired effect. In such cases, contact your representative for a new vial.

Secondary Nonresponders:

Secondary nonresponders are patients who initially respond to BTX Cosmetic but lose the response on subsequent injections. The reasons for this can be:

  1. Neutralizing Antibodies: Some patients may develop neutralizing antibodies to BTX. This is a rare side effect, but it has been observed in some patients. In such cases, using a different Botulinum Toxin may yield better results.
  2. Inadequate Injection Amount: Similar to primary nonresponse, secondary nonresponse can also be due to an inadequate amount of BTX injected. This could be due to the patient having strong muscles or the injection missing the targeted muscle.

Botulinum Toxin Complications and Treatments for Complications

Localized Complications

Localized complications are those that occur in the immediate area of the injection. These can include:

– Bruising and Bleeding: This is a common complication that can occur due to the puncture of blood vessels during the injection process. It is usually minor and resolves on its own. Applying a cold compress to the area immediately after the injection can help reduce bruising and swelling. Over-the-counter pain relievers can also be used to manage any discomfort.

– Pain and Swelling: Some patients may experience pain and swelling at the injection site. This is typically transient and can be managed with over-the-counter pain relievers and cold compresses. 

– Infection: Although rare, infections can occur if the injection site is not properly cleaned before the procedure. If an infection is suspected, it should be treated promptly with antibiotics. 

Systemic Complications

Systemic complications are those that affect the entire body or multiple body systems. These can include:

– Botulism: This is a rare but serious complication that can occur if the toxin spreads beyond the injection site. Symptoms can include muscle weakness, difficulty swallowing, and respiratory problems. If suspected, immediate medical attention is required. If botulism is suspected, the patient should be hospitalized immediately. Antitoxin therapy should be initiated as soon as possible to neutralize the toxin.

– Allergic Reactions: Some patients may have an allergic reaction to the BTX. Symptoms can include hives, difficulty breathing, and swelling of the face, lips, tongue, or throat. If an allergic reaction occurs, the patient should be treated with epinephrine and antihistamines. In severe cases, hospitalization may be necessary.

Managing Lid Ptosis Complication and Treatment

Lid ptosis, or drooping of the upper eyelid, is a potential complication of botulinum toxin injections. It can occur when the toxin diffuses into the levator palpebrae superioris muscle, which is responsible for lifting the eyelid. This can lead to an undesirable aesthetic outcome and, in severe cases, can interfere with vision. 

The management of lid ptosis following botulinum toxin injection involves both preventive and corrective measures.

Preventive Measures

  1. Accurate Injection Technique: The most effective way to prevent lid ptosis is to ensure accurate injection technique. This includes proper identification of the injection site, avoiding the levator palpebrae superioris muscle, and injecting the toxin at a safe distance from the eyelid.
  2. Patient Positioning: The patient should be in an upright position during the injection and for 3-4 hours post-injection. This helps to minimize the diffusion of the toxin.
  3. Patient Instructions: Patients should be instructed to avoid rubbing or massaging the injection area for at least 24 hours post-injection to prevent the spread of the toxin.

Corrective Measures

  1. Alpha-adrenergic eye drops: In the event of lid ptosis, alpha-adrenergic eye drops such as apraclonidine 0.5% can be used. Oxymetazoline, Upneeq, 0.1% has been FDA approved for the treatment of eyelid ptosis. These drops stimulate the Müller muscle, a smooth muscle that assists in elevating the eyelid, thereby providing a temporary lift to the drooping eyelid. These drops can be used until the ptosis resolves.

Naphcon-A, Naphazoline/Pheniramine, is another over the counter option. This class of drug is known as sympathomimetic amines. There are no comparative clinical trials examining the benefits of any of the medications with each other. 

  1. Wait for Toxin to Wear Off: Botulinum toxin effects are temporary, and the ptosis will resolve naturally as the effects of the toxin wear off, typically within 4-6 weeks.

Pearls in Botulinum Toxin Cosmetic Injection

As health care providers, we are always seeking to refine our skills and improve patient outcomes. This chapter will provide you with valuable insights and pearls of wisdom for administering botulinum toxin injections for cosmetic purposes. 

The Power of Touch

The human hand is an incredible tool. Use your hands to feel the face and identify the muscles causing visible wrinkles. This tactile approach will guide you to the precise injection site. Always inject a relaxed face, not a face where the muscle is contracted. Contracted muscles can distort your landmarks and lead to less than optimal results.

Marking the Territory

Until you become proficient, use a marking pen or a white eyeliner pencil to mark your injection sites. However, be sure to place the marks below where you will inject. Injecting into a mark on the face is akin to tattooing someone. 

Landmarks: More Than Skin Deep

Many landmarks are bony, not just on the skin’s surface. Do not rely solely on surface skin landmarks as your reference. Understanding the underlying anatomy is crucial for successful injections.

Complications: Be Prepared

Complications can occur as soon as 48 hours or as late as 7 days post-injection and may persist for up to 4 – 8 weeks. Most complications are almost always temporary. In your practice, you are likely to experience a complication. Be prepared for it. Good hand holding and patient reassurance that the complication is temporary will appease most patients. In some cases, offering a money-back refund can eliminate tension and potential headaches.

Documentation: Before and After Photos

Always obtain before and after photos. This is essential documentation to resolve any complaints. It also provides a visual record of the treatment’s effectiveness.

Reinjection: Patience is Key

Reinjection should be done no earlier than one week after the first injection if the patient perceives no desired effect. Sometimes, it takes a week until a patient sees the effects. Patience is key.

Comfort Measures: EMLA and Ice Packs

Application of topical EMLA anesthetic or cold ice pack will help alleviate patient discomfort and injection fears. These simple measures can significantly improve the patient experience.

Pre and Post Injection Instructions

Please become familiar with our standard Pre and Post injection instructions. Your patients will ask you about them. Compliance with these instructions will reduce complications and improve outcomes.

Botulinum Toxin Pricing

Botulinum toxin injections are a significant investment for both the provider and the patient. Understanding the pricing structure is crucial to ensure a profitable practice and to provide clear and transparent information to patients.

Pricing Structure: Per Area, Per Syringe, or Per Unit?

There are different approaches to pricing botulinum toxin injections, and the choice often depends on the provider’s preference and the standard practice in their region. Some practices charge per area or per syringe, often using about 20 units per “area” or “syringe”. However, all manufacturers of botulinum toxin prefer the “per unit” pricing model. This approach provides patients with knowledge of the units they are receiving, promoting transparency and consistency in treatment. 

Setting Your Prices

When setting your prices, it’s recommended to research your local market. Call local competitors and inquire about their pricing. If they charge per area, ask how many units they use per area. 

As a general guide, here are some typical pricing ranges across the U.S.:

– Dermatologist/Plastic Surgeons: 150-200% higher than manufacturer purchase price

– Average pricing: 100-150% higher than manufacturer purchase price

– Competitive pricing: 75-100% higher than manufacturer purchase price

Remember, these are just guidelines. Your pricing should reflect your expertise, the quality of your service, and your local market conditions.

Legal Considerations

It’s worth noting that purchasing any botulinum toxin products from outside the U.S., such as Canada, is illegal. The FDA has strict regulations on the import of medications, and non-compliance can lead to serious legal consequences.

Additional Pearls

– Transparency is key: Always be upfront with your patients about the cost of their treatment. This includes the number of units they will receive and the total cost.

– Document everything: Keep a record of the number of units used for each patient and each treatment area. This can help you track your usage and costs, and can also be useful in case of any disputes.

– Adjust as needed: Don’t be afraid to adjust your prices as needed based on changes in your costs, market conditions, or the value you provide.

Botulinum Toxin Marketing

Marketing is a crucial aspect of any successful medical practice, and this is especially true for practices offering botulinum toxin injections. The following strategies can help you effectively market your services and attract new patients.

Understanding Your Target Market

Before you begin marketing your services, it’s important to understand who your target market is. Botulinum toxin injections are popular among women aged 35 to 50 years old, but this can vary depending on your location and the specific services you offer. Understanding your target market will allow you to tailor your marketing efforts to the needs and interests of these potential patients.

Branding and Collaboration

Improving the branding of your botulinum toxin services can significantly increase your bookings. This includes creating a professional and appealing logo, using consistent colors and fonts across all marketing materials, and developing a unique selling proposition that sets you apart from competitors.

Collaborating with influencers and local businesses can also be an effective way to drive interest in your services. This could involve partnering with a local fitness center or spa, or working with a popular local blogger or social media influencer to promote your services.

Online Marketing

Having a strong online presence is essential in today’s digital age. This includes having a professional and user-friendly website, as well as active profiles on relevant social media platforms. Search engine optimization (SEO) and pay-per-click (PPC) advertising can also be effective ways to increase your online visibility and attract new patients.

Collecting email addresses from existing patients and using email marketing campaigns can also be a powerful way to keep your services top of mind and encourage repeat bookings.

Traditional Media Advertising

While online marketing is crucial, don’t overlook the potential of traditional media advertising. This could include print ads in local newspapers or magazines, radio ads, or even television commercials. The best platforms for your practice will depend on your target market and local media landscape.

Customer Service and Experience

Providing excellent customer service is crucial for retaining patients and attracting new ones. This includes everything from the initial phone call or email inquiry, to the consultation and treatment process, to follow-up care.

Offering a unique patient experience can also set your practice apart. This could involve offering additional services, such as skincare consultations or massage, or creating a relaxing and luxurious treatment environment.

Education and Promotions

Educating potential patients about the benefits of botulinum toxin injections, and addressing common concerns or misconceptions, can help to build trust and interest in your services.

Offering promotions or discounts can also be an effective way to attract new patients. This could involve offering a discount for first-time patients, or a special promotion for existing patients who refer a friend.

Remember, marketing is not a one-time effort but an ongoing process. Regularly evaluating and adjusting your marketing strategies based on their effectiveness and changes in the market can help to ensure your practice’s success.

For more detailed strategies and tailored advice, consider consulting with our internal marketing specialist or taking advantage of resources offered by botulinum toxin manufacturers.

For more information about Comprehensive Guide to Botulinum Toxin Injection Training, contact us at email@CosmeticMedicalTraining.com or call us at (212) 470-8059.

Statement of Responsibility

Cosmetic Medical Training recognizes that many of the techniques and recommendations are for procedures that 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.  However, due to the continuing flow of new research and information relating to the drugs being used in this course, we recommend that you check with the manufacturer for any changes in the package inserts, warnings, and precautions.  All information and tools presented within this site are intended for educational purposes. We do not guarantee that the information will be completely accurate and up to date; therefore the authors will not be held responsible for any errors, omissions, or inaccuracies published.  Application of the knowledge is ultimately the responsibility of the practitioner.

The owners, authors, and any participants disclaim all liability or loss in conjunction with any content provided here. We disclaim any liability for products or services recommended including defective products or direct, indirect, special, incidental, or consequential damages, arising out of the use or the inability to use the materials/information published.

Originally published at  Botox Training Miami