Injectable Gel for Facial Wrinkles - Revitalizing Skin

Overview

Aging is an unavoidable phase of life that everyone has to pass through. With aging, numerous changes are observed in the skin texture in terms of cellularity and anatomy. There is a loss of soft tissue volume seen with increasing age. Different facial injectable gels and fillers are available for the rejuvenation of the facial skin and to fill in the wrinkles for a younger and tighter skin appearance. FDA (U.S. Food and Drug Administration) has conducted sufficient controlled clinical trials and has evaluated the safety and efficacy of various wrinkle fillers. FDA-approved fillers are injected into specific target areas in the facial region and in the hands to reduce wrinkles. The various injectable gels and fillers that are available for the reduction and removal of facial wrinkles are:

FDA-approved Filler:

• Cheek Fillers: It was approved by Food and Drug Administration (FDA) on June 2, 2006, for the treatment of mild to severe wrinkles and folds on the face. Cheek fillers is a prescription therapeutic which is sold or injected only following an appropriate prescription from any licensed healthcare provider. It is infused with Lidocaine gel for making its absorption into the tissues more smoother and comfortable for the patient. Cheek fillers are made of Hyaluronic acid which helps in hydrating and rejuvenating the skin. The effects of cheek fillers usually last for about 6 to 12 months. Hyaluronic acid is a natural sugar observed in living cells and one of the major parts of connective tissue. Hyaluronic acid keeps the skin hydrated and maintains its elasticity and volume.

Other Fillers Used:

• Calcium Hydroxylapatite: Calcium hydroxylapatite is a mineral that is widely present in body tissues like teeth and bones. These calcium hydroxylapatite particles are prepared as a gel-like suspension and used for wrinkle filling. The filler gel is injected under the skin into the wrinkle areas (face and back of the hand). These fillers are used to contour the jawline and give a fuller appearance to lips and cheeks. The effects of these fillers usually last for one to three years.

• Poly- L- Lactic Acid (PLLA): PLLA is a biocompatible, biodegradable, synthetic polymer. It is commonly used in resorbable suture materials and bone screws. These fillers are usually used to restore facial fullness and remove wrinkles in old-age patients. The effects of these fillers last for about two years. It may require multiple sessions. PLLA is an effective and long lasting filler component which is usually administered over a course of time in a series of scheduled injections.

FDA-Non Approved Dermal Fillers

The FDA has unapproved several other versions of cheek fillers (cheek fillers Ultra 2, 3, and 4) as the effectiveness and safety of these products are not yet proven. Also the use of silicone gel and liquid silicone as injections for wrinkle filling has not been approved by FDA.

Warnings and Precautions of Cheek Fillers Gel:

• Use of cheek fillers in patients with bleeding disorders or on blood thinners medication like Aspirin has not yet been established.

• According to the clinical trials use of the cheek fillers gel in regions other than mid-face has not yet been established.

• The use of injectable gel in patients who are prone to keloid formation, scarring, and skin discoloration is not yet known.

• Cheek fillers injectable gels should be used very cautiously in patients under immunosuppressive therapy.

• The safety and efficacy of the gels to be used in highly vascular areas is yet to be determined.

For Patients

What Are Facial Fillers?

Facial fillers also known as dermal fillers are gel-like solutions that are administered in the form of injection under the skin. The filler particles get absorbed in the underlying tissues and give a smoother or fuller appearance, or both. Facial fillers are the substances like collagen, hyaluronic acid, and calcium hydroxylapatite used for eliminating the fine lines on the skin and facial wrinkles. With increasing age and continuous exposure to the sun, the skin loses its elasticity and shows signs of aging like wrinkles and loss of soft tissue volume. The facial fillers help restore the elasticity of the skin and rejuvenate the skin.

Procedure of Cheek Fillers:

Cheek fillers are injected into the facial skin or nasolabial folds for over 15 minutes by the doctor. A fine needle is inserted in the area with skin creases or wrinkles and cheek fillers infused with Lignocaine gel is deposited in the area. Cheek fillers with Lidocaine gel also have anesthetic effects (numbness on the skin) on the skin treated thereby making it more comfortable for the patients.

Length of Procedure:

It usually takes around 15 to 20 minutes per clinical session. The number of sessions needed to complete the treatment is determined by the doctors based on the amount of surface with wrinkles requiring the treatment.

How Effective Are Cheek fillers in the Treatment of Facial Wrinkles?

Cheek fillers are quite effective in the remission of facial wrinkles making the facial skin fuller and younger in appearance. However, the effects of cheek fillers last for about six months.

Side Effects Associated With Cheek Fillers

Common Side Effects of Cheek Fillers:

• Redness.

• Pain and tenderness at the injection site.

• Swelling.

• Bruising of the skin.

• Bumps or rashes over the skin.

• Skin discoloration.

• Scratching or itchy skin.

• Allergic reactions at the site of injection.

• Damage to blood vessels in a few cases.

• Irregularities on the skin surface.

Serious Side Effects of Cheek Fillers:

• Loss of vision.

• Loss of sensation in treated areas.

• Occlusion of blood vessels.

• Scarring.

• Weakness in the face, arm, or legs.

• Difficulty in breathing.

• Loss of balance and coordination.

• Dizziness.

• Slurring of the speech.

Things to Inform the Doctor Before Starting the Cheek Fillers:

• Inform the doctor of any history of allergy to any drugs or their composition.

• Inform the doctor about any systemic diseases like hematological or bleeding disorders and skin diseases.

• Pregnant or breastfeeding mothers should inform the doctor about their health status.

• Inform the doctor if one is under any medications like blood thinners such as Aspirin.

Things to Inform the Doctor After Initial Session of Cheek Fillers:

• Inform the doctor about any allergies like rashes, bumps, or bruises appearing at the site of the injection.

• Inform the doctor in case there is any infection developed at the injection site.

• Inform the doctor in case there is a loss of sensation or feeling of numbness on the injection site for a longer period of time (more than 24 hours).

What Instructions Need to Be Followed After Taking Cheek Fillers Injection?

• Avoid strenuous activities till 24 hours after injection.

• Avoided excessive exposure to the heat or sun as it can result in the development of adverse reactions.

• Avoid alcohol.

• Use ice packs on the areas of injection with any redness or swelling. It helps to minimize the swelling and reduce the redness.

• Avoid any chemical substances or cosmetic products on the face for a minimum of six hours after the procedure.

• Avoid too many facial expressions for a few hours.

• Do not massage or rub the area treated.

• Avoid facial treatments and laser therapies until the entire treatment sessions are completed and until advised by your treating doctor.

• Avoid traveling by air for a minimum of two weeks after the treatment.

• Do not miss the follow-up appointment given by the doctor as it may not yield satisfactory results.

Dietary Alterations: There are no specific diet changes needed with cheek fillers. However, patients are advised not to consume alcohol till 24 hours after the injection.

For Doctors:

Composition of Cheek Fillers:

It is a dermal filler or gel implant used to reduce facial wrinkles in patients. It is composed of:

• Hyaluronic acid.

• 1,4 Butanediol diglycidyl ether (BDDE).

• Lidocaine - 0.3 percent (for pain-relieving effects).

Procedure and Site of Injection:

• Cheek fillers are injected below the subcutaneous tissue and above the bone surface in the areas affected by the wrinkles.

• It should be done carefully keeping the anatomical position of the needle in mind to prevent any damage to the underlying blood vessels.

• A 25 or 27-gauge needle is used for the injection.

• Do not re-prick or over-puncture the needle at the same site as it can increase the risk of bruising and damage to the underlying blood vessels.

• Aspirate the needle once after inserting it beneath the skin to confirm the anatomical position.

• If the needle is blocked, stop the procedure and use another needle.

• Inject around 0.1 to 0.2 ml at a time at one site and wait for three seconds to avoid the formation of lumps.

• Do not continue injecting if the blanching develops soon after injecting.

• Avoid the use of the cheek fillers gel in vascular areas as it carries the risk of embolization.

• Avoid doing the overcorrection.

Dosage and Forms:

• Cheek fillers are available in injectable gel form which is clear and colorless.

• The maximum recommended safe dose of the cheek fillers gel is 20 ml per 60 kg of body weight per year.

• Cheek fillers are buffered with 0.3 percent w/w Lidocaine.

• The dose safety for injecting more than 20 ml per 60 kg of body weight has not yet been established and can result in various side effects.

• It is recommended for single-patient use. It is advised not to resterilize the pack.

What Are the Indications of Cheek fillers Injectable Gels?

• Cheek fillers are indicated for patients above the age of 22 years and below 65 years of age. The safety and efficacy of the medication in below 22 years patients and above 65 years of age people is yet not established.

• Cheek fillers gels are indicated in patients with facial wrinkles to reduce and refine the skin contour and jawline.

• It is indicated to manage vertical lip lines, nasolabial folds, and lip borders.

• It is indicated in the treatment of wrinkles on the forehead.

• It is indicated in the management of infraorbital hollowing.

• Cheek Fillers for Cheek Augmentation: Small boluses of 0.2 to 1.2 ml over large areas are recommended for the needful results.

• Cheek Fillers for Chin Augmentation: Small boluses of 0.1 to 0.2 ml are recommended for desired results for chin augmentation procedures.

What Are the Contraindications of Cheek Fillers Injections?

Cheek fillers injectable gels are contraindicated in patients with:

• Hypersensitive Reactions: A few patients may be allergic to the medication or its compositions as it may lead to hypersensitive or anaphylactic reactions.

• Patients who are allergic to Lidocaine.

• Underlying bleeding disorders.

• In patients on blood thinners.

A thorough medical history and clinical examination of the patients should be done before starting the procedure to avoid complications and adverse effects of the medication.

Storage:

• Cheek fillers injection cartridges are stored at a room temperature of 25 degrees Celsius.

• Do not freeze the injection.

• Do not use the injection if the package is damaged.

• Discard the injection if the gel in the cartridge does not appear clear, colorless, or transparent.

Scoring for Assessment of Cheek Fillers Injections Effectiveness After Treatment:

The scoring system used for grading the effectiveness of cheek fillers during the follow-up visits of the patients such as:

• Grade 0 (None) - Wrinkles absent.

• Grade 1 (Mild) - Shallow wrinkles.

• Grade 2 (Moderate) - Moderately deep wrinkles.

• Grade 3 (Severe) - Well-defined edges with deep wrinkles. No skin overlapping is observed.

• Grade 4 (Extreme) - Very deep wrinkles with overlapping skin.

Other Specifications:

• Cheek Fillers in Pregnant and Lactating Women: The safety and efficacy of the use of any injectable gels for the treatment of facial wrinkles have yet not been established.

• Cheek Fillers in Patients Under Immunosuppressive Therapy: The efficacy and safety of the use of injectable gels in patients undergoing immunosuppressive therapy is not yet known.

Recent Advances in Injectable Gels for Facial Wrinkles

With the advent of plastic surgery and modern cosmetology, dermal or facial fillers are experiencing an astounding demand in the global market in recent years. Unlike complicated face lifting surgeries, these facial injectable gels are minimally invasive techniques which make thin lips plump, augment shallow facial contours, remove wrinkles and enhance the esthetic appearance of scar tissues.

Some of the recently developed injectable gels are as follows -

• Polyalkylimide - It is commonly used by plastic surgeons in the treatment of deeper wrinkles, depressed scars, and facial wasting due to HIV medications.

• Polymethyl-Methacrylate Microspheres (PMMA) - It is often used to reduce medium-to-deep folds and wrinkles particularly in the nasolabial folds. It is also used for treating pitted scars and for augmenting thin lips.

• Autologous Platelet-Rich Gel - It is a newly developed injectable which provides long-term fullness, shape and stability of the tissue volume. It contains bioactive particles for superior facial remodeling with better natural outcome.