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

Sculptra is a poly-L-lactic implant in the form of a sterile apyrogenic suspension. Poly-L-lactic acid is a biocompatible (does not harm the body), biodegradable (broken down or metabolized by the body), synthetic polymer from the alphahydroxy-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 allergies.

COSMED LASER CENTER  has informed me that depending in 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 in some cases the duration of the effect can be shorter or longer. Most areas if treatment require 2 to 4 sessions, usually at 3 to 6 week intervals for optimal correction. Because individual responses to Sculptra therapy may vary, the exact number of treatment 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.

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 (neocollagensis). At the time of you 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 tissue or fat loss, rather it is designed to improve the appearance of the affected area(s).

I have been educated on some of the features, benefits, and possible risks involved with using Sculptra, and have had my questions answered to my satisfaction. Some of these risks include:

After the injection(s) some common injection-related probability 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 the injection.

Because Sculptra therapy injections are administered in a solution containing water, there will be initial swelling, (edema) that will be noticeable for at least several hours and perhaps as long as several days. The 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 or visible, may be felt in the areas of treatment. Usually, these bumps are only 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 of 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 massage 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, malise, fatigue, and edema.

Sculptra therapy is contraindicated (not allowed) in pregnancy or during breast feeding. If you believe you may be pregnant or 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 people 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 US as an "off-label" 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 to inform us 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. I have been given the time and opportunity to review this informed consent.

I can reasonably expect the forgoing 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 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 treatments.

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

By signing this Informed Consent I agree to being treated with Sculptra as described above. I acknowledge and understand the procedures and risks and that it has been explained to my satisfaction. I agree to hold the authorized injector harmless from the described risks on the condition that the injections of Sculptra are administered in accordance with the appropriate guidelines.

 

PHOTOGRAPHIC RELEASE CONSENT:

I give permission to take photographs of my treatment areas for diagnostic purposes and to document for the medical record response to Sculptra therapy. I agree that these photographs are the property of the doctor's office, and I give my permission to use these photographs for teaching purposes, for use in scientific publications, books, journals, lectures, seminars and electronic media. It is understood that in any such publication I shall not be identified by name and that appropriate measures shall be made to protect my identity. I understand that I will not receive any compensation for use of my photos for scientific and teaching/educational purposes.

 

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