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Dermal Fillers

U.S. Food and Drug Administration (FDA)-approved Restylane® injectable gel is a cosmetic “filler” that contains hyaluronic acid (HA), a natural substance that is found in the body. HA gives volume and elasticity to the skin, but as the body ages, HA levels decrease, resulting in loose skin and wrinkling. When injected, Restylane gel is designed to plump the skin beneath lines and wrinkles, smoothing them out and making them less noticeable.

The most common areas for Restylane treatment are the glabellar lines (which run between the eyebrows) and the nasolabial folds (which run from the sides of the nose to the corners of the mouth). Restylane injectable gel is also FDA-approved, for those 21 and older, for enhancing the lips. According to manufacturer Medicis, results can last for up to 6 months, at which point the hyaluronic acid is reabsorbed by the body.

Benefits of Restylane Injectable Gel

When injected, Restylane gel plumps up glabellar lines and nasolabial folds, making skin appear younger and look smoother. When used for lip enhancement, it makes the lips fuller and gives them more definition.

Advantages of Restylane Injectable Gel

One significant advantage that Restylane injectable gel has over other facial fillers made with hyaluronic acid is that it contains nothing of animal origin. As a result, it does not require a potential user to undergo allergy testing, which can sometimes take weeks. Another advantage is that Restylane injections are performed in-office, usually by a dermatologist, in less than half an hour, and require little-to-no downtime for the patient.

Side Effects of Restylane Injectable Gel

The most common side effects of Restylane injectable gel are swelling, redness, pain, bruising and tenderness in and around the injection sites. They typically go away within a week. Although considered safe for most patients, Restylane injections carry a risk of infection, bleeding or allergic reaction.

$650.00-$750.00/ syringe

 
 
 
 
 
What is Revanesse® Versa™+?

Revanesse® Versa™+ is an FDA approved hyaluronic acid dermal filler that can be used to treat moderate to severe facial wrinkles and folds, including nasolabial folds in patients 22 years of age or older.

What is Revanesse® Lips™+?

Revanesse® Lips™+ is an FDA approved hyaluronic acid dermal filler that can be used for submucosal implantation for lip augmentation in patients 22 years of age or older.

Are there any reasons (contraindications) I should not receive a Revanesse® Versa™+ or Revanesse® Lips™+ injection?

You should not be treated if you:

  • Are pregnant or breastfeeding, as the safety of these products for use during pregnancy, or in women who are breastfeeding, has not been studied

  • Have a history of hypertrophic scarring or keloid formation

  • Have evidence of scars at the intended treatment sites

  • Have acne and / or other inflammatory diseases of the skin, such as rosacea, seborrheic dermatitis, and psoriasis,

  • Have allergic history including: severe allergic reactions (anaphylaxis), heightened immune responses to common allergens, especially inhaled allergens and food allergens (atopy), allergy to hyaluronic acid products, allergy to lidocaine, Streptococcal proteins or have plans to undergo administration of graded doses of allergens (desensitization therapy) during treatment with Revanesse®.

  • Have acute or chronic skin disease, such as seborrheic dermatitis or rosacea, in or near the injection sites, or any infection or unhealed wound of the face

  • Are under concomitant anticoagulant therapy, antiplatelet therapy, or have a history of bleeding disorders, clotting disorders such as hemophilia or connective tissue disorders such as systemic lupus erythematosus

If you are under the age of 22 you should not be treated with a Revanesse® dermal filler.

It’s not recommended to use Revanesse® dermal fillers in conjunction with a laser, intense pulsed light, chemical peeling or dermabrasion treatments, or with Over-the-counter (OTC) wrinkle products or prescription wrinkle treatments within 4 weeks prior to treatment, as there is a possible risk of inflammation or infection at the treatment site.

What are the risks?

The most common reported side effects are bleeding, bruising, swelling, and pain. Other risks that are less likely, but may occur, include: Acne-like skin eruptions, skin sensitivity (rash, itching, tenderness), skin infection, damage to nerves or blood vessels, skin lumpiness, scarring, skin necrosis, hyperpigmentation, reactivation of herpes infection (blisters or skin sores).

If you have an adverse reaction or side effect that persists for one week or more after treatment with a Revanesse® dermal filler, please contact your healthcare provider.

Warning: One of the risks of being injected with any dermal filler is unintentional injection into a blood vessel. These complications, which have been reported with facial injectable fillers, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin.

$550.00/ syringe

 
 
 
 
 
What is BELOTERO BALANCE® (+)?

BELOTERO BALANCE is a prescription injection that is approved to temporarily smooth out and fill in moderate to-severe nasolabial folds (the folds or wrinkles that go from the side of the nose to the corner of the mouth).

Who should not use BELOTERO BALANCE?

BELOTERO BALANCE should not be used in patients with a history of or presence of multiple or severe allergies, including those with a history of anaphylaxis. BELOTERO BALANCE should not be used in patients with allergies to gram-positive bacterial proteins..

What is the most important information I should know about BELOTERO BALANCE?

Introduction of BELOTERO BALANCE into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft tissue fillers, for example inject the product slowly and apply the least amount of pressure necessary. Rare but serious adverse events associated with the intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage, leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms, including changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and possibly evaluation by an appropriate health care practitioner specialist should an intravascular injection occur.

As with all events that involve an injection through the skin, there is a risk of infection. Laser treatments or chemical peels or any other treatments that affect the skin can increase the risk of infection. Do not use BELOTERO BALANCE if you have a skin inflammation or a skin infection. Do not use until the infection is healed.

Patients getting BELOTERO BALANCE may have an injection site reaction. These reactions can include inflammation and usually last less than seven days.

For approximately 24 hours after treatment, avoid:

  • strenuous activity

  • extensive sun or heat exposure

  • aspirin or non-steroidal anti-inflammatory drugs

  • alcoholic beverages

Exposure to any of the above can cause temporary redness, swelling, and/or itching at the injection site.

It is not known how BELOTERO BALANCE will work in areas of the face other than the smile lines. It is not known how BELOTERO BALANCE will work in women who are pregnant or breastfeeding or people who are less than 21 years of age.

What should I tell my doctor before injections with BELOTERO BALANCE?

Tell your doctor if you are taking medicines that affect blood clotting, like aspirin, an NSAID or warfarin. These medicines may put you at an increased risk of bruising or bleeding at the treatment site. Tell your doctor if you have a skin reaction like cold sores, cysts, pimples, rashes, hives, or an infection. Treatment with BELOTERO BALANCE should be delayed until the reaction goes away. Tell your doctor if you are taking medicines that affect your immune system.

What are the most common adverse events seen with BELOTERO BALANCE?

The most common adverse events seen in clinical studies with BELOTERO BALANCE were swelling, bruising, redness, hardening of the skin, pain, altered color, or itching. Other side effects that have occurred in clinical studies of BELOTERO BALANCE include headache, swelling of the side of the nose, moderate cold sore, lip numbness, and lip dryness. Side effects were often mild to moderate and often resolved within 7 days.

Information on adverse events from post-market surveillance of BELOTORO BALANCE are included in the Package Insert (PI) and Patient Information Guide (PIG) based on an assessment of seriousness and potential causal relationship to BELOTERO BALANCE. Please see the PI and PIG available on www.belotero.com for a complete list of these events.

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