General information on Injectable Gel FIllers ~ Juvederm®
WARNING!
The following is general information on injectable gels.
It is not medical advice nor authored by a medical professional.
Injectable Gel Dermal Fillers
(Information provided by www.FDA.gov)
Juvederm® Injectable Gel Filler
(Information provided by www.FDA.gov)
FDA Information on Juvederm ® Injectable Gel - August 2007
Product Name: Juvederm® Injectable Gel
Applicant: Inamed
Address: Inamed Corporation, 5540 Ekwill Street, Santa Barbara, California 93111
Approval Date: June 2, 2006
What is it?
Juvederm® is a colorless hyaluronic acid gel that is injected into
facial tissue to smooth wrinkles and folds, especially around the nose and mouth.
Hyaluronic acid is a naturally occurring sugar found in the human body. The role
of hyaluronic acid in the skin is to deliver nutrients, hydrate the skin by holding in
water, and to act as a cushioning agent.
What does Juvederm do?
Juvederm temporarily adds volume to facial tissue and
restores a smoother appearance to the face.
How is it used?
Juvederm is injected into areas of facial tissue where
moderate to severe facial wrinkles and folds occur. Juvederm ® temporarily
adds volume to the skin and may give the appearance of a smoother surface.
What will it accomplish?
Juvederm will help to smooth moderate to
severe facial wrinkles and folds. Most patients need one treatment to achieve
optimal wrinkle smoothing, and the results last about six months
What are the possible side effects of Juvederm ®?
Most side effects are mild or moderate in nature, and their duration is short lasting
(7 days or less).
The most common side effects include but are not limited to temporary injection site reactions such as:
-
redness
-
pain/tenderness
-
firmness
-
swelling
-
lumps/bumps
-
bruising
-
itching
-
discoloration
As with all skin injection procedures, there is a risk of infection.
Are there any reasons I should not receive Juvederm ®?
Your physician will ask about your medical history to determine if you are an
appropriate candidate for treatment.
Juvederm ® should not be used in
patients who have:
-
Severe allergies marked by a history of anaphylaxis or history or presence
of multiple severe allergies
- Patients with a history of allergies to gram-positive bacterial proteins.
What should my physician advise me about?
The following are important treatment considerations for you to discuss with your
physician and understand in order to help avoid unsatisfactory results and
complications:
-
Patients who are using substances that can prolong bleeding, such as
aspirin or ibuprofen, as with any injection, may experience increased
bruising or bleeding at injection site.
-
You should inform your physician
before treatment if you are using these types of substances.
-
If laser treatment, chemical peeling or any other procedure based on active
dermal response is considered after treatment with Juvederm ®, there
is a possible risk of an inflammatory reaction at the treatment site.
-
Juvederm ® should be used with caution in patients on
immunosuppressive therapy, or therapy used to decrease the body's
immune response, as there may be an increased risk of infection.
-
The safety of Juvederm ® for use during pregnancy, in breastfeeding
females or in patients under 18 years has not been established.
-
The safety of Juvederm ® in patients with a history of excessive
scarring (e.g. hypertrophic scarring and keloid formations) and
pigmentation disorders has not been studied.
What should my plastic surgeon warn me about?
The safety and effectiveness of Juvederm ® for the treatment of areas other
than facial wrinkles and folds (such as lips): please visit FDA.gov for more information.
Do the Juvederm ® injections hurt?
Injections may cause some discomfort during and after the injection. Juvederm ® is injected directly into the skin using a fine needle to reduce injection
discomfort.
Physicians may choose to numb (anesthetize) the treatment area to
further minimize discomfort.
What should I expect following the procedure?
Your physician will tell you what to expect following treatment with Juvederm ®.
Within the first 24 hours, you should avoid strenuous exercise, extensive
sun or heat exposure and alcoholic beverages.
Exposure to any of the above may
cause temporary redness, swelling, and/or itching at the injection sites.
If there is
swelling, you may need to place an ice pack over the swollen area.
You should
ask your physician when makeup may be applied after your treatment.
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.
What other treatments are available to me?
Other treatments for dermal soft tissue augmentation include bovine-based
collagen and other hyaluronic acid-based dermal fillers. Aside from these
treatments, additional options for the correction of lines and wrinkles do exist,
including facial creams, Botox® Cosmetic, chemical peels, and laser skin surface
treatments, and may be discussed with your physician.
When should I notify my physician?
Be sure to report any redness and/or visible swelling that lasts for more than a few
days or any other symptoms that cause you concern to your physician and/or
contact INAMED Product Support at (800) 624-4261.
For further questions and information please call 1-800-377-7790.
You should also check the www.FDA.gov - United States Food and Drug Administration web site for the latest information.
Put the word "Juvederm" into the search box.
You may also want to visit www.Juvederm.com for information.
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