Hylaform® & Hylaform® Plus


A KEY COMPONENT OF BEAUTIFUL SKIN
Healthy skin has an abundance of two important substances, collagen and hyaluronic acid, that keep your skin looking smooth and supple. Collagen is a protein that provides your skin with structural support. Hyaluronic acid is a natural sugar found in all living cells that attracts and binds water, hydrating the skin and giving volume.With time, sunlight and other factors, collagen and Hyaluronic acid in your skin diminish, the skin loses structure and volume, and unwelcome lines and wrinkles appear.Now you can replace your skin’s lost hyaluronic acid using Hylaform and Hylaform Plus (hylan B gel). Hylaform and Hylaform Plus are dermal (skin) fillers made from a highly purified form of hyaluronic acid that mimics the effects of natural hyaluronic acid. When injected just below the surface of the skin, the Hylaform products add volume to the skin smoothing away unwanted lines and wrinkles.Hylaform is used to treat moderate lines and wrinkles while Hylaform Plus is used in the treatment of more pronounced wrinkles as in facial contouring.

Immediate results with fast recovery
Hylaform® and Hylaforrn®Plus provide immediate, natural-looking results. Treatment and recovery usually take as little as one hour and no pre-treatment skin test is required.

  • Immediate treatment-No pre-treatment skin test required
  • Immediate results
  • Proven safety, used in international markets for nearly a decade
  • Common side effects are mild
  • Have been used in combination with collagen-based dermal fillers like CosmoDerm® and CosmoPIast®

Hylaform® and Hylaforrn® Plus can be used to fill in the smile lines between the nose and mouth, small lines above the lip, frown lines between the eyes, and to minimize the creases that turn down the corners of the mouth.

HYLAFORM® (HYLAN B GEL)
Important Treatment Considerations for Consumers in the U.S. – Hylaform gel is injected into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds), and is generally well tolerated. The most commonly reported side effects are temporary injection site redness, bruising, swelling, pain and itching. Other side effects, such as lumps/bumps and tissue hardening have been reported rarely. Exposure of the treated area to excessive sun, UV lamp, and extreme cold weather should be minimized until any initial swelling and redness has resolved. If procedures such as laser treatment or a chemical peel are used before or after Hylaform gel treatment there is a possible risk of an inflammatory reaction at the implant site. This also applies if Hylaform gel is administered before the skin has healed completely after such a procedure. Hylaform gel should not be used in patients with known susceptibility to keloid formation, hypertrophic scarring or pigmentation disorders.

Patients using substances that can prolong bleeding may experience increased bruising or bleeding at injection sites. As with all transcutaneous procedures, Hylaform gel use carries a risk of infection and standard precautions used for injectable materials should be followed. Hylaform gel must not be injected into blood vessels; doing so may cause occlusion of the vessels and could cause infarction or embolization. Hylaform gel should be used with caution in patients on immunosuppressive therapy.

Hylaform gel is not intended for use in patients with a history of known allergy to avian (bird) proteins. The use of Hylaform gel in areas of the skin with any infection or inflammation (e.g., cysts, pimples, rashes or hives), should be postponed until the conditions have been resolved. The safety of Hylaform gel in persons younger than 18 years of age, or in pregnant or breastfeeding women has not been tested. The safety and efficacy of Hylaform gel for use in lip augmentation and regions other than nasolabial folds has not been established. The safety of injecting greater than 20 mL of Hylaform gel per 130 lbs body mass per year has not been established. Long-term safety and effectiveness of Hylaform gel beyond one year has not been investigated in clinical trials.

Hylaform® and Hylaform® Plus
(Hylan B Gel) Explained

Introduction
What is HYALURONIC ACID?
What is HYLAFORM GEL?
What are DERMAL (SKIN) FILLERS?
What is HYLAFORM GEL used for?
Where does HYLAFORM GEL come from?
How does HYLAFORM GEL work?
What is involved with HYLAFORM GEL treatment?
Do the injections hurt?
Is the product safe?
What else should I know about HYLAFORM GEL?
What are the potential concerns when using HYLAFORM?
How will my skin look and feel immediately after treatment?
When should I notify my physician?
What concerns should I have after treatment?
When may I apply make-up?
Does the correction last forever?
How often will I require treatment?
Without Touch-Up injections, how will my skin look?

Introduction

The way your skin looks is directly related to the way your skin is supported. As we age, the natural support layers in the skin break down resulting in the formation of wrinkles. Hylaform gel, a clear gel containing a purified form of hyaluronic acid, adds volume lost during the aging process by temporarily smoothing our facial lines and wrinkles.

Hylaform gel is injected just under the skin’s surface in order to temporarily correct wrinkles. Treatment results are immediate. Over time, the gel will break down and be naturally absorbed by your body. After the initial treatment, an additional treatment of Hylaform gel may be necessary to achieve the desired level of correction. The need for an additional treatment may vary from patient to patient. Your physician will work with you to develop a treatment program to meet your individual needs.

The materials provided are intended for educational purposes only. They are not a substitute for actual medical care. Persons requiring diagnosis or treatment, or who have specific questions related to their condition or care, are urged to discuss them with their health care provider.

What is HYALURONIC ACID?
Hyaluronic acid is a naturally occurring sugar. It is found in the human body in the skin, cartilage, joints and the eye.

The role of hyaluronic acid in skin is to deliver nutrients, hydrate the skin by holding in water, and to act as a cushioning agent.

What is HYLAFORM GEL?
Hylaform gel is a sterile, clear, colorless dermal (skin) filler gel implant made of chemically modified hyaluronic acid derived from avian (bird) source. Hyaluronic acid is a naturally occurring substance found in fluids surrounding cells and tissues. It is chemically, physically and biologically similar in the tissues of all species. Hylaform gel is made from highly purified natural hyaluronic acid that is gradually absorbed by your body through natural mechanisms.

What are DERMAL (SKIN) FILLERS?
Dermal fillers are substances that are injected just below the surface of the skin temporarily adding volume, thereby filling lines, wrinkles and folds from the inside out. Dermal fillers can temporarily restore a smoother appearance.

What is HYLAFORM GEL used for?
The gel is injected into skin tissue for correction of moderate to sever facial wrinkles and folds (such as nasolabial folds).

Where does HYLAFORM GEL come from?
The gel is produced from materials of avian (bird) origin and contains extremely small amounts of avian protein. Because of this, you should speak to your physician and you should not use Hylaform gel if you have any known allergies to avian protein.

How does HYLAFORM GEL work?
Hylaform gel is injected just beneath the skin surface, temporarily adding volume to the layers of the skin that have deteriorated due to age and other factors. The gel, when injected, is used to raise depressions in the skin, providing temporary correction of wrinkles and folds.

What is involved in HYLAFORM GEL treatment?
In general there are three steps: a consultation with your physician, a series of treatments (injections), and periodic touch up treatments, as described previously.

Do the injections hurt?
In general, injections may cause some discomfort. Hylaform gel is injected directly into the skin using a fine needle to reduce injection discomfort. Physicians may choose to anesthetize the treatment area to further minimize discomfort. Please consult your physician.

Is the product safe?
Yes for most people. The primary ingredient in Hylaform gel is hyaluronic acid which is a component of skin. The gel has undergone extensive testing including scientific clinical trials to establish safety and effectiveness. The gel has been approved for injection into the skin for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) by the U.S. Food and Drug Administration (FDA). See “Are there any reason why I should not receive Hylaform gel?” section below.

Can anyone be treated with HYLAFORM GEL?
Your physician will ask about your medical history, including allergies, to determine if you are an appropriate candidate for treatment.

Were adverse events noted during the initial treatment clinical trial?
Based on clinical studies, redness, bruising, swelling, pain, bumps, tenderness and itching may occur as a result of the injection with Hylaform gel. Most of these symptoms were mild and went away. As with all procedures that involve an injection through the skin, there is a risk of infection.

Side effects reported during the 12 weeks following treatment were categorized according to reported severity.

Are there any reasons why I should not receive HYLAFORM GEL?
Hylaform gel must not be injected into blood vessels. Doing so could cause the blood to stop flowing in that area. A blocked vessel could result in temporary discoloration of the treated area or in tissue death leading to a scab and/or scar formation.

Hylaform gel must not be injected into areas where any infection or skin eruptions such as cysts, pimples, rashes, or hives, are present.

The majority of reactions to the injection are redness, bruising, swelling, and pain that begin early after the injection and last less than 7 days.

What else should I know about HYLAFORM GEL?
Hylaform gel is indicated for injection into the skin for correction of moderate to severe facial wrinkles and folds (such as nasalabial folds), the lines that run from the nose to the corner of the mouth).

The safety and effectiveness of Hylaform gel use longer than one year has not been evaluated in clinical trials.

As with all injections into the skin, the injection of Hylaform gel has a risk of infection.

The safety of Hylaform gel for use during pregnancy in breastfeeding females or in patients under 18 years has not been studied.

Hylaform gel should not be used in patients with a known potential for keloid formation, hypertrophic scarring (heavy scarring) or pigmentation disorders.

Hylaform gel should be used with caution in patients on immunosuppressive therapy.

Patients who are using substances that can prolong bleeding, such as aspirin, non-steriodal anti-inflammatory drugs and warfarin may, as with any injection, have increased bruising or bleeding at injection sites.

After receiving injections of Hylaform minimize exposure of the treated areas to excessive sun, UV lamp exposure, and extreme cold weather, until any swelling and redness have disappeared.

If laser treatment, chemical peeling or similar procedure is considered before or after treatment with Hylaform gel, there is a possible risk of an inflammatory reaction (such as redness, swelling) at the Hylaform injection site.

What are the potential concerns when using HYLAFORM?
It is possible for the needle to be accidentally placed through a blood vessel during injection, which could result in a temporary change in color or in tissue death in the treated area leading to a scab and/or scar formation.

How will my skin look and feel immediately after treatment?
Most people feel comfortable in resuming their normal activities following treatment. Temporary puffiness of the treated areas, however, should be expected.

As with any injection, you may notice temporary redness, slight bruising, and tenderness around the treatment sites. Like the puffiness, these are normal occurrences and all should clear up within a few days. Although the injected material is generally not visible through the skin, some people have reported that they were initially able to feel the outline of the injected material.

When should I notify my physician?
Any redness and/or visible swelling that lasts for more than a few days may indicate a reaction to the material. Be sure to report any symptoms to your physician.

What concerns should I have after treatment?
Your physician will review with you what to expect following treatment with Hylaform gel. If there is swelling or redness after the injection you should minimize your exposure to sun and UV lamp. Within the first 24 hours, patients should avoid strenuous exercise, extensive sun or heat exposure and alcoholic beverages as exposure to these may cause temporary redness and swelling at injection sites. Make-up may be applied a few hours after treatment if no complications are present (e.g., open wounds, bleeding and infection).

When may I apply make up?
Make-up may be applied a few hours after treatment if no complications are present such as open wounds, bleeding and infection.

Does the correction last forever?
No. Correction is temporary, therefore, touch-up injections as well as repeat injections are usually needed to maintain optimal correction. The need for touch-ups will be influenced by ongoing mechanical forces (such as smiling or other muscle activity) and biological changes (such as aging) that caused the original skin depressions.

A controlled clinical study was designed to evaluate the effectiveness of Hylaform gel at 12 weeks. Hylaform gel was found to be equivalent to the control material (Zyplast implant) in the correction of nasolabial folds at the end of the study using the independent review of photographs of patients who received treatment. The correction looked the best during the first 2 weeks after treatment. Photographic assessment showed that, on average, wrinkles had returned to normal after 12 weeks. However, visual assessment of correction by the investigators and masked patients during the controlled clinical study support the effectiveness of Hylaform and Zyplast at 12 weeks.
How often will I require treatment?
Everyone’s skin is different. That is why the timing of any additional treatment varies from person to person. Over time Hylaform gel will be absorbed by your body. This is why you may want ongoing treatments. If you choose not to continue with your treatment, any remaining gel is simply absorbed by your body over time and your skin gradually returns to its natural shape.

Without Touch-Up injections, how will my skin look?
Correction will reduce gradually until your skin looks like it did before treatment with Hylaform gel.

Touch-up injections will help you maintain correction of the skin surface.

 

 

BEFORE & AFTER PHOTOS

HYLAFORM & HYLAFORM PLUS
HYLAFORM & HYLAFORM PLUS images

Advanced Dermatology P.C. and The Center for Laser and Cosmetic Surgery would like to thank Hylaform® and Hylaform Plus® for the above supplied web content & photographs.

Related Topics & Our Doctors in the News