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Sculptra

Is Sculptra right for you?

WHO MIGHT BENEFIT FROM TREATMENT WITH SCULPTRA?

SCULPTRA is intended for use in people with healthy immune systems. SCULPTRA is injected in or under the facial skin through a small needle for correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles.

A treatment regimen of SCULPTRA consists of up to 4 injection sessions scheduled 3-4 weeks apart. SCULPTRA may provide cosmetic correction of facial wrinkles with a Wrinkle Assessment Score of 2, 3, or 4 as shown in the following photos:

Your healthcare provider can help you determine if you might benefit from SCULPTRA and the optimal cosmetic correction expected for you.

WHO SHOULD NOT GET SCULPTRA? (CONTRAINDICATIONS)

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.

Precautions

WHAT SHOULD I BE AWARE OF BEFORE RECEIVING SCULPTRA INJECTIONS?

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 health care practitioner immediately.

A reported side effect following treatment with SCULPTRA are lumps and bumps (nodules) that appear in the treated area. These could be visible or are not visible but can be felt under the skin.

The risk of these lumps and bumps occurring could possibly be increased if you inject large volumes of the product at the same place, and if you treat the deep wrinkles in the corner of your mouth (smile lines). These lumps or bumps usually go away on their own or after treatment with drugs, but surgery could in some cases be required.

The following are important treatment considerations for you to discuss with your doctor and understand to help avoid unsatisfactory results and complications.

  • SCULPTRA has not been studied under the age of 18.
  • Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. The safety of SCULPTRA has not been studied in women who are pregnant or breastfeeding.
  • Tell your doctor if you are taking any medications used to decrease the body’s natural defence system (immunosuppressants). SCULPTRA injections may then result in an increased risk of infection.
  • Tell your doctor if you have a bleeding disorder or are taking any medication that can thin your blood or prolong bleeding, such as aspirin and warfarin. As with any injection procedure this may increase your risk of bruising or bleeding at the injection site.
  • Avoid or minimize hard (strenuous) exercise and exposure to extensive sun, UV lamps, indoor tanning beds/booths, or extreme temperatures within the first 24 hours after treatment with SCULPTRA. Any of these may cause temporary redness, swelling, pain and/or itching at the injection site.
  • Tell your doctor if you have recently had skin therapies such as laser treatment, mechanical or chemical peels or hair removal. This may lead to increased risk of side effects such as redness, swelling, heat or pain of the skin.

If you have any additional questions about any topic in this section, please discuss further with your doctor.

How does it work?

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 in a grid pattern to correct a wrinkle at the nasolabial fold or other facial wrinkles where this injection technique is appropriate.

Are skin tests needed?

ARE SKIN TESTS NEEDED BEFORE TREATMENT WITH SCULPTRA?

No skin testing is required prior to use in immunocompetent people with skin that heals normally.

When do I see results?

ARE THE RESULTS FROM SCULPTRA IMMEDIATE?

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, a contour defect 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 wrinkle to reappear – you may look as you did before your treatment. Visible wrinkle correction results appear slowly. Your healthcare provider should see you again in three or more weeks to decide if you need additional injections.

How many treatments do I need?

HOW OFTEN ARE SCULPTRA TREATMENTS GIVEN AND HOW MANY TREATMENTS ARE REQUIRED?

Your healthcare provider should see you at approximately three-four 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.

How long do results last?

HOW LONG DO SCULPTRA TREATMENT EFFECTS LAST?

In a U.S. clinical study treatment result for some subjects lasted for up to 25 months after the last treatment session.

Is it painful?

DO INJECTIONS OF SCULPTRA HURT?

As with any injection, to decrease pain during injection, a topical or a local anesthetic may be used when injecting SCULPTRA.

What to expect

WHAT CAN I EXPECT TO HAPPEN AT A TREATMENT SESSION?

Your healthcare provider will answer all your questions and ask about your medical history to determine if SCULPTRA injection is the medicines you are taking, even over the counter medicines or treatments. You and your healthcare provider will determine if a topical or local anaesthetic 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 in grid pattern.
  • After injection, the treated area should be massaged to distribute the product evenly.
  • An ice pack should be applied to the treatment area to help reduce swelling unless otherwise directed by your healthcare provider.

Post-treatment instructions

WHAT CAN I EXPECT AFTER TREATMENT?

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.

Your healthcare provider will give you specific post-treatment care instructions.

Some specific instructions you should follow after the treatment are:

  • Massage the treated area for 5 minutes 5 times per day for 5 days after your treatment.
  • Within the first 24 hours after your treatment, apply ice or an ice pack wrapped in cloth (avoid putting ice directly on your skin) to the treatment area to help reduce swelling
  • Avoid or minimize hard (strenuous) exercise and exposure to extensive sun, UV lamps, indoor tanning beds/booths, or extreme temperatures within the first 24 hours after treatment with SCULPTRA.
  • Report any worsening or longer-lasting signs of symptoms to your healthcare provider.

HOW QUICKLY CAN I GET BACK TO MY DAILY ACTIVITIES?

Most patients can get back to their activities immediately following treatment.

WHEN WILL I BE ABLE TO APPLY MAKE-UP AFTER TREATMENT?

Make-up may be applied a few hours after treatment if there are no complications such as open wounds or bleeding.

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