Sculptra® Therapy Consent

Sculptra® Therapy is the injection into the skin and underlying tissues of poly-L-lactic acid. Sculptra® therapy is designed to help correct skin depressions, such as creases, wrinkles, folds, scars, hallow eye rings, degenerative skin aging ad facial lipoatrophy (loss of fat).

Sculptra® is a poly-L-lactic acid implant in the form of a sterile apyrogenic suspension. Poly-L-lactic acid is a biocompatible (does not harm the body), biodegradable (broken down/metabolized by 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, and does not require pre-treatment skin testing for allergies.

My physician has informed me that depending on the area and condition treated, the volume of Sculptra® used and the injection technique, the effect of a treatment with Sculptra® may last from 1 to 2 years, but that in some cases the duration of the effect may be shorter or longer. Most areas of treatment will require 2 to 4 sessions, usually at 3 to 6 week intervals, for optimal correction. Because the individual responses to Sculptra® therapy may vary, the exact number of treatment sessions required cannot be predicted with complete accuracy. Additionally, to maintain the desired degree of correction, intermittent “touch-up” treatments may be needed.

After each injection session, tissue volume in the treated area will gradually build up over the following weeks and months, as your body produces new collagen (neocollagenesis). At the time of your return visit for your next session of Sculptra® therapy, your response to the previous treatment will be assessed, and additional treatments can be performed if needed and agreed upon to optimize your correction. Sculptra® therapy does not treat or cure the underlying cause or disease of the tissue or fat loss; rather it is designed to improve the appearance of the affected area(s).

Some of the possible risks of Sculptra® therapy include:

• 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.
• Because Sculptra® therapy injections are administered in a solution containing water, there will be an initial
  swelling (edema) that will be noticeable for at least several hours, or perhaps several days. This effect is
  temporary, and does not affect the long-term tissue response.
• Small bumps under the skin, termed micro-nodules, which may be non-visible to visible, may be felt in the
  areas of treatment. Usually, these bumps may only be felt when pressing on the skin. Micro-nodules
  typically last from 6 to 12 months, and may spontaneously disappear. They usually do not require treatment,
  and usually do not have any symptoms.
• Induration, or a feeling of fullness or thickness, can be felt in the injection area. This is a normal response of
  the treated tissue to the process of inflammation and neocollagenesis. Simply massaging the treated areas
  gently 3 to 5 times per day for 3 to 5 minutes, for 3 to 5 days after the injection, can help minimize
  induration.
• Visible bumps may occur in rare instances, and they may be associated with redness, tenderness, skin
  discoloration or textural alteration. These bumps, which may be termed granulomas, may or may not require
  treatment, including, but not limited to, injections, freezing or excision.
• Other rarely reported adverse events include: injection site abscess, allergic reaction, skin hypertrophy
  and/or atrophy, malaise, fatigue, and edema.
• Sculptra® therapy is contraindicated (not allowed) in pregnancy or during breast feeding. If you believe you
  may be pregnant or you are breastfeeding, please inform the provider prior to injection
• Sculptra® therapy has been approved by the United States Food and Drug Administration (FDA), for the
  restoration and/or correction of facial fat loss (lipoatrophy) in period with HIV. Sculptra® therapy has not
  been specifically approved by the FDA for aesthetic (cosmetic use). Sculptra® therapy (New-Fill®) has been performed since 1999 in more than 150,000 patients in more than 30 countries, principally for cosmetic use.                

Treatment with Sculptra® for cosmetic and reconstructive use is allowed in the United States, as an “offlabel” indication.

• The use of anti-inflammatory drugs, anti-clotting agents or aspirin might cause bleeding or increased
  bruising at the injection site. If you’ve previously had facial herpes simplex at the injection site, the injection
  might provoke an outbreak. If any of these conditions apply to you, please inform your provider.
• Any injection, for any reason, carries a small risk of infection. If the needle accidentally punctures a blood
  vessel, this may result in temporary discoloration of the treated area, scabbing, shedding and shallow
  scarring.
• Allergic reactions are rare. An allergic reaction can manifest itself by prolonged redness, itching, swelling or
  hardening of the skin around the injection site. The reactions can last for as long as 3 to 4 months and in
  rare cases, more than a year. Please make sure you inform your provider of all known allergies and
  sensitivities.

The use of and indication for Sculptra® has been explained to me, and I have had the opportunity to have my questions answered to my satisfaction. My provider has provided me with this informed consent and I have been given the time and opportunity to review it with any other individuals of my choice.

I have received the “Post Treatment Checklist” setting forth follow-up procedures, including follow up appointments, which I must follow after receiving injections. The consents of this checklist have been reviewed and I agree to follow the procedures and medical information given.

I have been told that I can reasonably expect the foregoing benefits from Sculptra®, but that no results can be guaranteed or assured, and no such guarantees or assurances have been given to me. Additionally, I understand that the practice of medicine is not an exact science, and positive outcomes cannot be guaranteed, nor can promises or guarantees be made regarding potential negative outcomes. I have had appropriate alternative treatments to Sculptra® therapy explained to me including other fillers, surgical procedures and topical treatments.

I have been informed that Sculptra® needs to be reconstituted (prepared) prior to my appointment, and if I cancel with less than 24 hour notice, I will be charged the full price of the vial. I agree to this financial policy.