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Evolence
WHAT IS
EVOLENCE®COLLAGEN FILLER?
EVOLENCE®collagen dermal filler products are used to correct facial wrinkles
and folds.
EVOLENCE®is made of highly purified porcine collagen that is
crosslinked via GLYMATRIXTM technology to provide long lasting results.
WHAT IS
EVOLENCE®COLLAGEN FILLER USED FOR?
EVOLENCE®is injected into areas of facial tissue where moderate to deep facial
wrinkles and folds occur.
WHO CAN BENEFIT FROM
EVOLENCE®COLLAGEN FILLER TREATMENT?
EVOLENCE®may be appropriate for patients who want soft, supportive
foundation to fill areas where there has been natural collagen loss. Your
healthcare provider can help you determine if you are a good candidate for
EVOLENCE®treatment.
DO I NEED A SKIN TEST BEFORE USING
EVOLENCE®COLLAGEN
FILLER?
No. Skin test study showed that reactions to
EVOLENCE®are rare and, when
they do occur, mild. Skin testing is not necessary prior to treatment. However, in
case you have had an allergy to collagen product in the past (such as hives or
swelling after eating porcine products) or serious recurrent nonspecific allergic
reactions, please inform your healthcare provider before treatment.
WHAT SHOULD MY HEALTHCARE PROVIDER WARN ME ABOUT?
•
EVOLENCE®should be used with caution in patients on
immunosuppressive therapy (medication commonly prescribed for those
who have undergone an organ transplant, or are suffering from
rheumatoid arthritis, psoriasis, inflammatory bowel disease, or cancer).
• The safety and effectiveness of
EVOLENCE®for the treatment of areas
other than facial wrinkles and folds have not been established in controlled
clinical studies.
•
EVOLENCE®should be used with caution in patients with known
connective tissue disease, such as rheumatoid arthritis, scleroderma or
systemic lupus erythematosus, history of herpes.
• The safety of
EVOLENCE®in pregnant or breastfeeding women as well
as in patients under the age of 18 years has not been established.
CAN
EVOLENCE®BE USED IN SKIN OF COLOR PATIENTS?
The safety of
EVOLENCE®Collagen Filler in skin of color patients (i.e.,
individuals with skin tone of light brown to black) was studied for a limited time
only (2 weeks to 3 months, 3 to 6 months, and greater than 6 months).
EVOLENCE®should not be used in patients with known susceptibility to
abnormal scarring or local changes in skin color. The safety of
EVOLENCE®in
patients susceptible to keloid formation, hyperpigmentation and hypertrophic
scarring has not been established.
WHO SHOULD NOT USE
EVOLENCE®COLLAGEN FILLER?
• Patients with a known allergy from eating any pork collagen product
• Patients with a history of severe or multiple occurring allergies.
People with these conditions, if they use
EVOLENCE®, may have an allergic
reaction and experience swelling, redness, or pain. In rare instances, allergic
reactions to some materials can be severe and require medical assistance.
Although no such reaction has ever been observed following use of
EVOLENCE®, patients having experienced past allergic reactions to pork
products should be aware of their medical history and these risks.
HOW DOES EVOLENCE® COLLAGEN FILLER WORK?
The production of collagen in the body decreases as you get older and/or
exposed to the sun. The first visible signs of this decrease in production are the
development of wrinkles.
EVOLENCE®works by replacing and restoring
collagen in the dermal layer of the skin where it naturally exists.
EVOLENCE®will be injected with a fine needle midway or deep into your skin to help fill the
areas of lost collagen where moderate to deep facial wrinkles and folds occur.
HOW IS EVOLENCE®COLLAGEN FILLER INJECTED?
EVOLENCE®is injected beneath the wrinkle or fold into the dermal layer of the
skin using a fine needle.
DO INJECTIONS HURT?
Dermal fillers often require more than one injection during a treatment session to
obtain an optimal result. The use of a needle to inject a product like a dermal filler
can be associated with local skin discomfort. Certain areas of the face are more
sensitive than others and your healthcare provider may choose either an external
and/or local injectable anesthetic to help prevent discomfort and pain. Discuss
pain management with your healthcare provider.
ARE THE RESULTS FROM EVOLENCE® COLLAGEN FILLER IMMEDIATE?
Yes. The natural collagen structure of
EVOLENCE®fills the space of the
depleted collagen and decreases the appearance of wrinkles, so it immediately
gives the skin a smoother appearance.
HOW MANY TREATMENTS ARE REQUIRED?
One treatment with
EVOLENCE®may be all that is required to achieve optimal
wrinkle smoothing. The decision for additional treatments with
EVOLENCE®is
left up to you and your healthcare provider. Your healthcare provider will
generally like to see you within two weeks of the first treatment to assess your
satisfaction and to measure the success of treatment.
Following your initial treatment, you and your healthcare provider will determine
when future injections are needed.
HOW LONG DOES EVOLENCE®COLLAGEN FILLER LAST?
The length of time that
EVOLENCE®lasts in the body may vary from patient to
patient. The duration may also depend on the amount of
EVOLENCE®injected
and the injected area. Information from a US clinical trial has shown that 97% of the patients maintained the effects of
EVOLENCE®for at least 6 months. Data gained from animal studies, foreign clinical studies and usage of
EVOLENCE®in other countries have demonstrated that
EVOLENCE®has lasted for up to 12 months.
WHAT CAN I EXPECT TO HAPPEN AT A TREATMENT SESSION?
- Your healthcare provider will answer any questions you have before your
treatment.
- Remove all make-up prior to your treatment.
- An antiseptic will be used to clean all of the areas to be treated.
- Local anesthetics will be used if needed.
- Small amounts of
EVOLENCE®will be injected into the skin.
- You will then receive instructions on how to care for the treated area once
you leave the office.
WHAT CAN I EXPECT AFTER TREATMENT?
Immediately after your treatment, the injection sites may be painful and red or
swollen. These site reactions are typically mild and go away with time, usually
within hours to a few days. Follow the post-treatment directions given to you by
your healthcare provider. If a side effect lasts longer than expected and is of
concern to you, contact your healthcare provider. You might have a mild to
moderate reaction at the injection site, but that should clear up in a few days.
You should follow these instructions.
- Within the first 24-48 hours you should avoid.
- Strenuous exercise
- Excessive sun, extreme heat, or extreme cold exposure
- Alcoholic beverages
Exposure to any of the above may cause temporary redness, swelling, or itching
at the injection site.
WHAT SHOULD I TELL MY HEALTHCARE PROVIDER ABOUT THE
MEDICATIONS I TAKE?
Talk with your doctor about all medications that you are taking. In addition,
discuss over-the-counter medications and natural products that you are using on
a regular basis. It is also recommended that you tell your doctor about other
fillers or procedures you have had in the past. If you are taking a blood thinner or
medications that may interfere with clotting of the blood such as aspirin,
Ibuprofen or Vitamin E products, you may be more likely to develop bruising at
the sites of injection.
No formal drug interaction studies have been done with
EVOLENCE®. Talk with
your healthcare provider about your medical history prior to deciding on a specific
treatment.
WHEN SHOULD I NOTIFY MY HEALTHCARE PROVIDER IF I HAVE
CONCERNS?
Any side effect that lasts longer than a week should be reported to your
healthcare provider. Call your healthcare provider if you are concerned about
your side effect or think that you have a complication.
HOW QUICKLY CAN I GET BACK TO MY DAILY ACTIVITIES?The majority of patients who receive
EVOLENCE®collagen filler injections
continue with their daily activities following treatment. However, during the first
24-48 hours after treatment, exposure to extremes of temperature (hot or cold) or
strong sunlight should be avoided to reduce risk of inflammation. After this time
you can go about your normal daily activities with no other treatment required.
WHEN WILL I BE ABLE TO APPLY MAKE-UP AFTER EVOLENCE®
COLLAGEN FILLER INJECTIONS?
Do not apply make-up immediately after treatment to avoid any complications
and to keep the treated area clean. You should ask your healthcare provider
when make-up may be applied after treatment.
WHAT OTHER TREATMENTS ARE AVAILABLE TO ME?There are a variety of treatments and/or dermal fillers available in the United
States. Safety and effectiveness vary. You should consult with your healthcare
provider to determine which one is right for you.
For further questions and information, or to report an adverse
reaction, please call 1-800-386-5362
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