Plastic Surgery Information:
Juvederm ®® (tm) by Inamed
FDA-approved dermal filler for facial wrinkles
  • What Is Juvederm®?
  • How does Juvederm® work?
  • What are the benefits, risks & costs of Juvederm®?
  • How long will a Juvederm® treatment/injection last?
  • How can I learn more about Juvederm®?
  • Find a ABPS board-certified plastic surgeon* for Juvederm ®: U.S. Directory of Plastic Surgeons

*Board-certified by the American Board of Plastic Surgery (ABPS) or the Royal College of Physicians and Surgeons of Canada
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Juvederm®
August 2007 Webmaster Note:

Because information on cosmetic surgery treatments and products changes quickly, the webmasters and administrators of this web site do NOT guarantee the accuracy of the following information on this product, nor that it is the latest information available.

The FDA has, in all likliness, posted other information on its site regarding Juvederm ® that MAY NOT appear on thig general information page.
Please visit http://www.FDA.gov and type in Juvederm in the search box to view the latest information on Juvederm ®.


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
Approval Letter


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 prodecures, 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.
Juv6derm ® 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) have not been established in controlled clinical studies.

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 1-800-766-0171.

4 Warnings and other information from FDA.gov about Juvederm ®

You should also check the 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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