SCULPTRA INJECTABLE POLY-L-LACTIC ACID INFORMED CONSENT
Sculptra is a sterile suspension of Poly-L-Lactic acid, which is a biocompatible (does not harm the body), synthetic polymer from the
alpha-hydroxy acid family (fruit acids). Poly-L-Lactic acid has been used medically for many years in dissolvable stitches. Sculptra is
designed to help correct skin depression, such as creases, wrinkles, folds, scars, hollow eye rings, skin aging, and facial lip-atrophy
(loss of fat).
Sculptra has been used since 1999 in more than 150,000 patients in more than 30 countries, primarily for cosmetic use.
Your Anew Medspa team member has informed you that, depending on the area and condition treated, the volume of Sculptra used
in the injection, the effect of a treatment with Sculptra may last from 1 to 2 years, but that in some cases the duration of the effect
can be shorter or longer. Most areas of treatment will require multiple sessions at 4 week intervals, for optimal correction. Because
individual response to Sculptra may vary, the exact number of treatments sessions required cannot be predicted with complete
accuracy. Additionally, in order to maintain the desired degree of correction, intermittent “touch-up” treatments may be needed.
Risks and Discomfort
You have been informed on some of the features, benefits, and possible risks involved with Sculptra and have had your questions
answered to your satisfaction. Some of the possible risks include:
1. After the injection(s), some common injection-related reactions probably will occur. These may include swelling, redness,
pain, itching, discoloration and tenderness at the injection site. These typically resolve spontaneously, usually within 1 to
15 days after injection.
2. Because Sculptra is injected in a solution containing water, there will be an initial swelling (edema) that will be noticeable
for at least several hours and perhaps as long as several days. This effect is temporary and does not affect the long-term
tissue response.
3. Induration, or a feeling of fullness or thickness, can be felt in the injection areas. This is a normal response of the treated
tissue to the process of inflammation and new collagen formation. Simply massaging the treated areas gently 5 times per
day for 5 minutes after the injection can help minimize induration.
4. One possible delayed side effect is small bumps under the skin, termed micro-nodules, which may be non-visible or visible
and may be felt in the areas of treatment. Usually these bumps may only be felt when pressing on the skin. Micro-nodules
tend to occur within the first 6 to 12 months after the treatment. They usually do not require treatment and usually do not
have any symptoms.
5. Visible bumps may occur in rare instances and they be associated with redness, tenderness, skin discoloration or textural
alteration. These bumps, which may be termed granuloma, may or may not require treatment, including, but not limited
to, injection, freezing or excision.
6. Other rarely reported adverse events include: injection site abscess, allergic reaction, skin hypertrophy (exaggerated
reduction of collagen and tissue elasticity) and/or atrophy (reduction of collagen and tissue elasticity), malaise, fatigue and
swelling (edema).
7. The use of anti-inflammatory drugs, anti-clotting agents or aspirin might cause bleeding or increased bruising at the
injection site.
I understand this is an elective procedure and I hereby voluntarily consent to treatment for facial rejuvenation, establish
proper lip and smile lines, and replacing facial volume. The procedure has been fully explained to me. I have read the above
and understand it. My questions have been answered satisfactorily. I accept the risks and complications of the procedure and I
understand that no guarantees are implied as to the outcome of the procedure. I also certify that if I have any changes in my
medical history I will notify the Anew Medspa immediately. I also state that I read and write in English.
Patient Signature: ________________________________________________________ Date:____________________________
