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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®.

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.
FREQUENTLY ASKED QUESTIONS
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.
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.
Report any worsening or longer-lasting symptoms or
signs to your healthcare provider.
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.
Report any side effects to your healthcare provider.
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.
FURTHER USEFUL INFORMATION
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