SCULPTRA is intended for use in people with healthy immune systems. SCULPTRA is injected in or under the facial skin through a small needle. SCULPTRA may be used for:

• correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles.
• correction of fine lines and wrinkles in the cheek region.

A treatment regimen of SCULPTRA typically consists of 3-6 total vials scheduled 5 weeks apart.

You should not get SCULPTRA if you:

• Have severe allergies with a history of severe reactions (anaphylaxis) or multiple severe allergies. Use of SCULPTRA may result in an allergic reaction.
• Are allergic to any ingredient of SCULPTRA: “poly-L-lactic acid” (PLLA), carboxymethylcellulose (USP) or non-pyrogenic mannitol (USP).
  Previously had or have risks factors for hypertrophic scarring or keloid formation.

Warning: One of the risks with using this product is unintentional injection into a blood vessel.

The chances of this happening are very small, but if it does happen, the complications can be serious, and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. If you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms, or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment, you should notify your healthcare professional immediately

The use of SCULPTRA if you have skin sores, pimples, rashes, hives, cysts, or infections should be postponed until healing is complete. Use of SCULPTRA where these are present could delay healing or make your skin problems worse.

Collagen production in the body decreases as you get older and/or are exposed to the sun.

Wrinkles are one of the first visible signs of this. SCULPTRA is injected into the deep layer of the skin where collagen naturally exists and is made. SCULPTRA works by initially filling a wrinkle with small PLLA beads. As the beads biodegrade the body may produce new collagen where SCULPTRA is injected. SCULPTRA is injected with multiple small injections using a fine needle to correct nasolabial fold contour deficiencies, other facial wrinkles or fine lines and wrinkles in the cheek region.

No. Unlike other wrinkle fillers, SCULPTRA provides a gradual improvement of the depressed area over several weeks as the treatment effects occur. During the initial treatment session with SCULPTRA, the contour deficiency, line or wrinkle should be under-corrected, not fully-corrected or over-corrected. It may seem that your treatment worked immediately because of swelling caused by injection and the water used to dilute SCULPTRA. This usually resolves in several hours to a few days and may cause the original defect to reappear: you may look as you did before your treatment. Visible contour, line or wrinkle correction results appear slowly. Your healthcare professional should see you again in three or more weeks to decide if you need additional injections.

Your healthcare professional should see you at approximately four-five weeks after each treatment session to assess whether you need additional treatment. You may need one to four treatment sessions (typically three to achieve the optimal correction possible. The safety and effectiveness of SCULPTRA has only been studied in a single treatment regimen of up to four sessions at three four-week intervals.

In a U.S. clinical study, treatment results for some subjects lasted for up to 25 months after the last treatment session. However, the improvement depended on the severity of the contour deficiency that a subject had before treatment. Discuss with your health care provider the optimal cosmetic correction you may expect.

As with any injection, to decrease pain during injection, a topical or a local anesthetic may be used when injecting SCULPTRA. In a U.S. clinical study, subjects recorded pain in diaries: 71% of all treated patients reported some pain after first injection, 14% of subjects had moderate pain. Most pain resolved in less than 24 hours.

Your healtheare professional will answer all of your questions and ask about your medical history to determine if SCULPTRA injection is appropriate for you. Tell your healthcare professional about all the medicines you are taking, even over the counter medicines or treatments. You and your healthcare professional will determine if a topical or local anesthetic is needed.

To prepare for an injection session, all make-up should be removed. An injection grid will be decided for each facial wrinkle that is candidate for this treatment and the area to be injected will be cleaned with an antiseptic.

SCULPTRA will be injected in multiple small amounts into or under the skin using a fine needle. After injection, the treated area should be massaged to distribute the product evenly. An ice pack wrapped in cloth should be applied to the treatment area to help reduce swelling unless otherwise directed by your healthcare professional. Avoid any direct contact of the ice with the skin.

As with any injectable wrinkle filler, you can expect injection-related side effects, such as bleeding, tenderness or pain/discomfort, redness, bruising, or swelling. These side effects generally resolve within a few hours to a few days but could last for 14 days or longer.

Most patients are able to get back to their activities immediately following treatment. However we recommend no vigorous activity for 24 hours and no lying down for 4 hours.

Makeup may be applied 24 hours after treatment.