Risk Management

Juvederm Consent Form

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PLACE LETTERHEAD HERE AND REMOVE NOTE.   Version 04/01/2008
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NOTE:  THIS FORM IS INTENDED AS A SAMPLE ONLY OF THE INFORMATION YOU AS THE SURGEON SHOULD PERSONALLY DISCUSS WITH THE PATIENT.  PLEASE REVIEW IT AND MODIFY TO FIT YOUR ACTUAL PRACTICE.  GIVE THE PATIENT A COPY.

Consent for use of JUVEDERMTM and JUVÉDERM™ Ultra

Indications
JUVEDERMTM and JUVÉDERM™ Ultra injectable gel are injected into areas of facial tissue where moderate to severe facial wrinkles and folds occur.  It temporarily adds volume to the skin and subcutaneous tissues, may give the appearance of a smoother skin surface and may help smooth moderate to severe facial wrinkles and folds.

Correction is temporary; therefore, touch-up injections as well as repeat injections are usually needed to maintain optimal correction.  Less material (about half the amount) is usually needed for repeat injections.  Most patients need one or possibly two treatments to achieve optimal wrinkle smoothing.  The results may last as long as 9 months to 1 year.

Alternatives
Other treatments for dermal soft-tissue augmentation include but are not limited to, products such as Radiesse, Restylane, Hylaform, Cosmoderm and Perlane.  Aside from these treatments, additional options for the correction of lines and wrinkles do exist, including facial creams, BOTOX® Cosmetic (Botulinum Toxin Type A), chemical peels, and laser skin surface treatments, and surgery. Other options not mentioned here may exist. All options should be discussed with your physician.

Side Effects and Complications
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, infection and discoloration.

In the first 24 hours after injection, 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.

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.

Contraindications
JUVEDERMTM and JUVÉDERM™ Ultra injectable gel should not be used if you have:
•    Severe allergies marked by a history of anaphylaxis or history or presence of multiple severe allergies
•    A history of allergies to Gram-positive bacterial proteins

The following are important treatment considerations for you to discuss with us and understand in order to help avoid unsatisfactory results and complications:
•    Please inform us prior to treatment: If you are using substances that can prolong bleeding, such as aspirin or ibuprofen, as with any injection, may experience increased bruising or bleeding at the injection site.
•    Please inform us prior to treatment: If you are on immunosuppressive or therapy used to decrease the body’s immune response, as there may be an increased risk of infection
•    Please inform us prior to treatment: If you are pregnant or breastfeeding,
•    Please inform us prior to treatment:  If you have history of excessive scarring (e.g., hypertrophic scarring and keloid formations) and pigmentation disorders.

If laser treatment, chemical peeling, or any other procedure based on active dermal response is considered after treatment with JUVEDERMTM and JUVÉDERM™ Ultra injectable gel, there is a possible risk of an inflammatory reaction at the treatment site

The safety and effectiveness of JUVEDERMTM  and JUVÉDERM™ Ultra injectable gel for the treatment of areas other than facial wrinkles and folds (such as lips) have not been established in controlled clinical studies.  Use in patients under 18 years has not been established

PATIENT’S ACCEPTANCE OF RISKS
I have read the above information and have discussed it with my physician. I understand that it is
impossible for the doctor to inform me of every possible complication that may occur.  No guarantees about results have been made. By signing below, I agree that my doctor has answered all of my questions and that I understand and accept the risks, benefits, and alternatives of JUVEDERMTM and JUVÉDERM™ Ultra

_______________________________    _________________________
Patient Signature                    Date