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Sculptra®...
a sculpting agent that restores volume to correct the
signs of facial fat loss.
Sculptra® is an enduring treatment approved by the FDA
for restoration and/or correction of the signs of facial
fat loss, or lipoatrophy, in people with human
immunodeficiency virus. It is the first FDA-approved
product of its kind for this condition.
Facial fat loss, or lipoatrophy, is the loss of fat
beneath the skin, which can result in sunken cheeks,
indentations, and hollow eyes.
Sculptra® is a safe,
synthetic, and biocompatible material that is injected
below the surface of the skin in the area of fat loss.
It provides a gradual and significant increase in skin
thickness, improving the appearance of folds and sunken
areas. No skin testing is required.
Sculptra® has been safely used outside the United States
since 1999 in over 150,000 patients under the trade
names New-Fill™ and Sculptra®.
What It Does
Sculptra® is an injectable product that restores and
corrects the signs of facial fat loss by replacing lost
volume. Sculptra® provides an increase in skin
thickness, helping to create a more natural facial
appearance in those with facial lipoatrophy.
Lasting Results
The effects of Sculptra® are enduring. In a clinical
study, effects lasted for up to 2 years after the first
treatment session in most patients. The results from
Sculptra® are not immediate; Sculptra® provides a
gradual increase in skin thickness. Your healthcare
provider will see you again in a few weeks to decide if
additional injections are needed. Touch-up treatments
may be needed to maintain the desired effects.
People with mild lipoatrophy will require fewer
treatments than those with severe lipoatrophy.
What is Sculptra®?
Sculptra® is a synthetic injectable material known as
"poly-L-lactic acid." Poly-L-lactic acid is
biocompatible (a material that does not harm the body)
and biodegradable (able to be broken down by the body).
Poly-L-lactic acid has been widely used for many years
in dissolvable stitches, soft tissue implants, and other
types of implants.
How does Sculptra® work?
Sculptra® is injected below the surface of the skin in
the area of fat loss. Sculptra® provides a gradual
increase in skin thickness. Visible results appear
within the first few treatment sessions.
Sculptra® will not correct the underlying cause of the
facial fat loss, but will help improve the appearance by
increasing skin thickness in the treated area.
FREQUENTLY ASKED QUESTIONS
Do I need a skin test before being treated with
Sculptra®?
No skin testing is required prior to use.
Are the results from Sculptra® immediate?
No. At your first treatment visit, it may appear that
Sculptra® worked immediately because of swelling from
the injections and the water used to dilute Sculptra®.
In a few days, when the swelling goes down and the water
is absorbed by your body, you may look as you did before
your treatment. Sculptra® takes time to gradually
correct the depression in your skin. Your healthcare
provider will see you again in a few weeks to decide if
you need more Sculptra® injections.
How many treatments are required?
Your healthcare provider will decide the appropriate
number of treatment sessions and the amount of
Sculptra®
you will need at each session. Patients with severe
facial fat loss may require 3 to 6 treatment sessions.
How long do treatment results last?
Treatment results will differ for each person. In a
clinical study, the treatment results lasted for up to 2
years after the first treatment session, in most
patients. Touch-up treatments may be needed to maintain
the desired effect.
Do injections of Sculptra® hurt?
As with any injection, injections with
Sculptra® may
hurt. Sculptra® is injected in small amounts using a
very fine needle. Your healthcare provider may apply a
topical or local anesthetic.
What can I expect to happen at a treatment session?
Your healthcare provider will answer all of your
questions and prepare you for the treatment.
• Make-up should be removed.
• The area where the injections will be given will be
cleaned with an antiseptic.
• You and your healthcare provider will determine if a
topical or local anesthetic is needed.
• Sculptra® will be injected in small amounts into the
skin using a very fine needle. Multiple injections will
be needed.
• An ice pack should be applied to the treatment area to
help reduce swelling.
• After the treatment session, the area should be
thoroughly massaged to distribute the product evenly.
What can I expect after treatment?
Immediately following a treatment session with
Sculptra®, redness, swelling, pain, bruising or all of
these signs can happen in the treatment area. These
signs usually go away in a few hours to a few days. Some
have been known to last up to 17 days. Your healthcare
provider will give you specific post-treatment care
instructions. You should massage the treated area (a few
times each day) for several days after the treatment
session. Within the first 24 hours after treatment, an
ice pack should be applied for a few minutes at a time
to the treatment area to help reduce swelling. Wrap the
ice in a cloth and avoid putting ice directly on your
skin. Avoid excessive sun and UV lamp exposure until any
initial swelling and redness has resolved.
How quickly can I get back to my daily activities?
Most patients feel comfortable going back to their
normal activities following treatment.
When will I be able to apply make-up after treatment?
Make-up may be applied a few hours after treatment if no
complications are present (for example, open wounds or
bleeding).
What are the possible side effects of treatment with
Sculptra®?
The most common side effects with the use of
Sculptra®
include injection-related side effects at the site of
the injection such as bleeding, tenderness or pain,
redness, bruising, or swelling. These side effects
generally last, on average, 3 to 17 days.
One possible delayed side effect with
Sculptra® can be
small bumps under the skin in the treated area. These
small bumps may not be visible, and you may notice them
only when you press on the treated skin. These bumps
tend to happen within the first 6 to 12 months after the
first treatment. Occasionally, these bumps go away on
their own. Visible bumps, sometimes with redness or
color change to the treated area, have also been
reported. As with all procedures that involve an
injection through the skin, there is a risk of
infection.
Who should not use Sculptra®?
You should not use
Sculptra® if you are allergic to any
ingredient of Sculptra®. Talk to your healthcare
provider about your medical history when deciding on
treatment options.
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