History of Dermal Fillers
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 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
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.
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.
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.
- It is necessary to counsel the patient and discuss the appropriate indication, risks, benefits and expected responses to the treatment.
- Advise the patient of the necessary precautions before commencing the procedure.
- A consent form should be utilized.
- Assess the patient’s need for appropriate anesthetic treatment for managing comfort, i.e., topical anesthetic, local or nerve block.
- 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.
- Sterile gloves are recommended while injecting.
- Before injecting, press rod carefully until a small droplet is visible at the tip of the needle.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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”).
- 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.”
- 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.
- The contents of the syringe are sterile.
- The volume in each syringe and needle gauge is as stated on the syringe label and on the carton.
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).
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.
Precautions & Contraindications
- Restylane is packaged for single patient use. Do not resterilize. Do not use if package is opened or damaged.
- 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.
- 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.
- 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.
- The safety and efficacy of Restylane for lip augmentation has not been established in patients under the age of 22 years.
- As with all transcutaneous procedures, Restylane implantation carries a risk of infection. Standard precautions associated with injectable materials should be followed.
- The safety of Restylane for use during pregnancy, in breastfeeding females or in patients under 18 years has not been established.
- Formation of keloids may occur after dermal filler injections including Restylane.
- Restylane injection may cause hyperpigmentation at the injection site.
- 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.
- Restylane should be used with caution in patients on immunosuppressive therapy.
- 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.
- 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.
- 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.
- 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.
- 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.
- Injection of Restylane into patients with a history of previous herpetic eruption may be associated with reactivation of the herpes.
- 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.
- Restylane should not be mixed with other products before implantation of the device.
- Restylane is contraindicated for patients with severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies.
- Restylane contains trace amounts of gram positive bacterial proteins, and is contraindicated for patients with a history of allergies to such material.
- Restylane is contraindicated for patients with bleeding disorders.
- Restylane is contraindicated for implantation in anatomical spaces other than the dermis or submucosal implantation for lip augmentation.
- Restylane-L and Perlane-L should not be used in patients with previous hypersensitivity to local anesthetics of the amide type, such as lidocaine.
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.
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.
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.
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.
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.
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.
- Insert the needle into the middle to deep dermis.
- You may stretch the skin to aid insertion.
- The contour of the needle should be BARELY or NOT visible depending on the type of filler and the type of wrinkle being injected.
- 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.
- 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.
- 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.
- 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.
- Direction of the angling depends on the shape of the fold.
- 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.
- 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.
- Wrinkle should be visibly lifted and filled by the end of the treatment.
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.
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.
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 (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.
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.
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.
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 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.
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.
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