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JUVEDERM® ~ Injectable Gel Filler
FDA Information

Smooth wrinkles and fill folds in the face for facial rejuvenation.
This website is not associated with Allergan®, makers of Juvederm®


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Juvederm® - Injectable Filler - Facial Rejuvenation

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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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