Sculptra Aesthetic is the first facial injectable that can give you noticeable results that emerge subtly. It replaces lost collagen to give you a more natural-looking appearance without giving you away. A full treatment of Sculptra Aesthetic — on average, 3 injection sessions over a few months, can last for more than 2 years.**Individual results and treatment sessions may vary. Clinical trial ended at 25 months.

In 2009, the FDA granted approval of Sculptra Aesthetic in the U.S. for the correction of shallow to deep nasolabial fold (smile lines) contour deficiencies and other facial wrinkles, which are treated with the appropriate injection technique in healthy people.

Sculptra Aesthetic works to target the underlying causes of the signs of aging such as collagen loss. Sculptra Aesthetic is a facial injectable that works gradually in a series of treatments — an average of 3 injection sessions over a period of a few months — to produce a refined, more youthful-looking appearance. During the course of your Sculptra Aesthetic treatments, collagen is replaced. Over time, you'll notice changes to your face that can last for more than 2 years.*

Sculptra Aesthetic is made of a synthetic material called poly-L-lactic acid, which works to replace lost collagen. Poly-L-lactic acid is safe — absorbed naturally by the body — and has been used for years in dissolvable stitches.

Sculptra Aesthetic replaces lost collagen in the mid to lower face and chin area. It treats these 3 areas:

• Deep folds between the nose and the mouth (nasolabial folds) also called "smile lines"
• The lines framing your mouth (marionette lines)
• Chin wrinkles

Sculptra Aesthetic is the first facial injectable with results that can last for more than 2 years* after your last treatment. *Individual results and treatment sessions may vary. Clinical trial ended at 25 months.

No. Because Sculptra Aesthetic targets the underlying causes of the signs of facial aging, it can give you noticeable results that emerge subtly and can last more than 2 years.* Some visible improvements can be seen within the first few weeks of treatment, but the Sculptra Aesthetic regimen is designed to deliver its unique effects, with an average of 3 treatment sessions, over the course of a few months. And because results happen gradually, you'll see subtle yet noticeable results in the appearance of facial wrinkles and folds.**

If you want subtle yet noticeable results, Sculptra Aesthetic may be right for you. Sculptra Aesthetic is injected beneath the skin and works to gradually replace lost collagen, targeting the underlying cause of the signs of facial aging, for results that can last more than 2 years.

Sculptra® Aesthetic (injectable poly-L-lactic acid) is made from a synthetic material called poly-L-lactic acid, which is gradually and naturally absorbed by the body as it works to replace lost collagen. Poly-L-lactic acid has been used safely for decades in dissolvable stitches and as a facial injectable since 1999 in over 30 countries.

Side effects may include injection site discomfort, pain, redness, bruising, swelling, and/or tenderness. Small bumps and larger lumps under the skin in the treated area may also appear. These typically go away on their own. You should talk to your doctor if you experience any side effects or have questions after treatment.

In a clinical trial for Sculptra Aesthetic, participants most commonly reported the following side effects:

• Redness
• Swelling
• Tenderness
• Injection site pain

Some participants also reported bruising, bleeding, and/or itching at the injection site.

With each treatment session, your doctor will provide you with aftercare instructions that may help minimize side effects. Aftercare may include massaging and icing the treated area. Do not apply ice directly to the skin.

No anti-inflammatory drugs (Ibuprofen, Motrin, Advil, Aleve, Vioxx, etc.), aspirin, high doses of Vitamin E, or Ginko Biloba one week prior to treatment. This will reduce the possible side effects of bruising and/or swelling in the treated area(s).

Consumption of alcoholic beverages prior to treatment can increase the chances of bruising and/or swelling.

You cannot be pregnant or breastfeeding to receive treatment.

If you have a history of oral herpes, you must pre-treat with an anti-viral three days before your scheduled visit.

Swelling, redness, and tenderness will occur after your treatment and usually resolves within 72 hours.

Cold compresses (a cloth dipped in cold water, wrung out, and applied to the injected area) may be used immediately after treatment to reduce swelling.

Avoid touching the treated area within 6 hours of treatment so you do not accidentally injure your skin. After that, the area can be gently washed with soap and water.

Until there is no redness or swelling, avoid exposure of the treated area to intense heat (sun lamp or sun bathing) or extreme cold weather.

If you have suffered previously from facial cold sores, there is a risk that the needle punctures could contribute to another occurrence. Ask your treatment provider about medications that may minimize a recurrence.

Avoid taking aspirin and other non-steroidal anti-inflammatory medications, St. John's wort, and high doses of Vitamin E supplements for one week after treatment. These agents may increase the risk of bruising and bleeding at the injection site.

Avoid aesthetic lasers, microdermabrasion, or IPL over areas with JUVÉDERM® Injectable Gel for a minimum of one week after treatment.

*Proper aftercare is necessary in order to help get the best possible results. Your doctor will give you specific instructions at each injection session. The following general guidelines will help you get the most from your treatment:

Within the first 24 hours of treatment, help reduce swelling by applying a cloth-wrapped ice pack to the area for a few minutes at a time. Avoid applying ice directly to the skin.
Post-treatment, massage the treated area for 5 minutes 5 times a day for 5 days, as recommended by your physician. This will help evenly distribute Sculptra Aesthetic.
Until any initial swelling and redness goes away, avoid excessive sunlight and UV lamp exposure.
When will I be able to apply makeup after treatment?

If there are no complications, makeup can be applied several hours after treatment. Consult your doctor after treatment.

When should I see my doctor for my next treatment?

On average, 3 treatment sessions are needed over the course of a few months, but treatment does vary, so talk to your doctor about the treatment option that's right for you.

Follow up treatments should be scheduled usually every six months.

Consistent repeated treatments will produce best resolution of wrinkles.

Indication: Sculptra®Aesthetic is intended for use in people with healthy immune systems as one time treatment
regimen of up to 4 injection sessions that are scheduled about 3 weeks apart for correction of shallow to deep
nasolabial fold contour deficiencies and other facial wrinkles in which deep dermal grid pattern (cross-hatch) injection technique is appropriate. Sculptra Aesthetic may provide cosmetic correction of facial wrinkles with a Wrinkle Assessment Score of 2,3 or 4 as shown in the photos (Figure 1) of the Patients Guide to Treatment. Important Safety Information: You should not use Sculptra Aesthetic if you are allergic to any ingredient of the product or have a history of keloid formation or hypertrophic scarring. It should not be injected while you have an active skin infection or inflammation in the treatment area and should not be injected into the red area of the lip. Use in the skin near the eyes is not recommended.

Side effects may include injection site discomfort, redness, bruising, bleeding, itching and swelling. Other side effects may include small lumps under the skin that are sometimes noticeable when pressing on the treated area. Larger lumps, some with delayed onset with or without inflammation or skin discoloration, have also been reported. In a key clinical study the numbers of small and larger lumps were low and most resolved without treatment.