JUVÉDERM®

About JUVÉDERM™ Ultra Plus

Soft tissue fillers are flexible materials that can be injected into a specific layer of the skin and subcutaneous tissue to enhance the appearance of fine to moderate wrinkles, plump lips, fill hollow cheeks, repair a variety of facial imperfections, and improve scars. The results are a smoother, more youthful appearance with minima l downtime.

Plastic Surgeons use a variety of soft tissue fillers like calcium hydroxyappetite ( Radiesse®), hyaluronic acid (Restylane®, Juviderm®), and autologous fat (one's own fat)

Since soft tissue fillers do not require major surgery and are cost effective, both men and women are using these youth enhancing products.

JUVÉDERM® restores the skin's volume in a way so subtle that everyone will notice, but no one will know.

Individual results may vary.

What does it do?

JUVÉDERM™ Ultra Plus injectable gel temporarily adds volume to facial tissue and restores a smoother appearance to the face.

How is it used?

JUVÉDERM™ Ultra Plus injectable gel is injected into areas of facial tissue where moderate to severe facial wrinkles and folds occur. JUVÉDERM™ Ultra Plus injectable gel temporarily adds volume to the skin and may give the appearance of a smoother surface.

What will it accomplish?

JUVÉDERM™ Ultra Plus injectable gel 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 1 year.

What are possible side effects?

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, and discoloration. As with all skin-injection procedures, there is a risk of infection.

Are there any reasons why I should not receive JUVÉDERM™ Ultra Plus injectable gel?

Your physician will ask about your medical history to determine if you are an appropriate candidate for treatment. JUVÉDERM™ Ultra Plus injectable gel 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 the 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 JUVÉDERM™ Ultra Plus injectable gel, there is a possible risk of an inflammatory reaction at the treatment site
JUVÉDERM™ Ultra Plus injectable gel 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 JUVÉDERM™ Ultra Plus injectable gel for use during pregnancy, in breastfeeding females, or in patients under 18 years has not been established
The safety of JUVÉDERM™ Ultra Plus injectable gel in patients with a history of excessive scarring (eg, hypertrophic scarring and keloid formations) and pigmentation disorders has not been studied

What should my physician warn me about?

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

What did the clinical study show?

In a US clinical study, 144 subjects were followed for 24 weeks after injection with JUVÉDERM™ Ultra Plus injectable gel in one nasolabial fold (NLF) and ZYPLAST® dermal filler (bovine-based collagen) in the other. The percentage of subjects who reported common injection-site responses is presented in the table below.

Injection-site responses were similar in duration and frequency for the JUVÉDERM™ Ultra Plus injectable gel and ZYPLAST® dermal filler treated sides, were usually mild or moderate in severity, did not require intervention, and lasted 7 days or less.

JUVÉDERM™ Ultra Plus injectable gel was found to provide a more persistent wrinkle correction than ZYPLAST® dermal filler over the 24-week course of the study. The percentage of subjects who maintained improvement with JUVÉDERM™ Ultra Plus injectable gel at 24 weeks was 90% compared to 40% with ZYPLAST® dermal filler. At the conclusion of the study, 123 (84%) of the 146 subjects expressed a preference for JUVÉDERM™ Ultra Plus injectable gel, while only 15 (10%) expressed a preference for ZYPLAST® dermal filler, and 8 (5%) had no preference.
Subjects who completed the 24-week study were invited to return for a complimentary repeat treatment. Subjects returned at their (or their physician's) convenience, rather than at a prescribed time point. Of the 146 subjects, 111 (76%) returned for repeat treatment, on average at 9 months after their last injection. Fortyseven (47) subjects returned more than 36 weeks (9 months) after their last injection: the percentage of those subjects who had maintained improvement with JUVÉDERM™ Ultra Plus injectable gel was 81%. Of the twenty-three (23) subjects who returned more than 48 weeks (1 year) after their last injection, 78% had maintained improvement.

At multiple time points in the clinical study, subjects' nasolabial folds were rated on a scale from 0 to 4: Using this 5-point wrinkle assessment scale, the mean improvement since baseline was 2.0 at 2 weeks, 1.5 at 24 weeks, and 1.1 beyond 48 weeks after treatment.

A subset of these subjects enrolled in a second study that followed subjects for 24 to 48 weeks after repeat treatment. Twenty-four (24) subjects were enrolled in the study. Twenty-three (23) were evaluated at 24 weeks (6 months) after repeat treatment with 91% maintaining improvement. Ten (10) subjects returned for evaluation 48 weeks (1 year) after repeat treatment:
the percentage of those subjects who had maintained improvement with JUVÉDERM™ Ultra Plus injectable gel was 90%.

The mean improvement since baseline at different time points after repeat treatment was 1.7 at 24 weeks, and 1.5 at 48 weeks after repeat treatment.

Do the injections hurt?

Injections may cause some discomfort during and after the injection. JUVÉDERM™ Ultra Plus injectable gel 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 JUVÉDERM™ Ultra Plus injectable gel. 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. Less material (about half the amount) is usually needed for repeat injections.