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  • Sculptra Injectable Poly-L-Lactic Acid - Informed Consent

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  • Rationale

    Sculptra is a sterile suspension of Poly-L-Lactic acid, which is a biocompatible (does not harm the body), biodegradable, 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. 

    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 2-4 sessions at 4-6 week intervals, for optimal correction. 

    After each injection session, tissue volume in the treated area will gradually build up over the following weeks and months as the body produces new collagen. At the time of your next session of Sculptra treatment, your response to the previous treatment will be assessed and additional treatments can be performed if needed to optimize your 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.

    PROCEDURE

    Cleansers are used to prepare the site prior to injection. Numbing cream may be applied to the target area, and lidocaine is also mixed with the Sculptra solution.  After the area is cleansed, an entry port is made with a needle through the skin and Sculptra Aesthetic is  then injected using a blunt-tip tube called a microcannula.

    POST-PROCEDURE CARE AND PATIENT RESPONSIBLITY

    In order to prevent the formation of nodules, the areas of injection will be massaged immediately after the injection.  You understand and agree to further massage the areas on your own at home, as instructed, for a minimum of 5 minutes, 5 times per day, for 5 days following the procedure.  This is known as the "5-5-5 rule" in order promote smooth distribution of the Sculptra and reduce the chance of nodule formation.  You also agree to report any noticeable lumps or nodules to the clinic as soon as possible and follow up as recommended, usually about every 4-6 weeks as needed.

    I agree to inform my treatment provider PRP Medical Aesthetics immediately if I notice any changes which may indicate an adverse reaction, including skin changes, bruising, pain, vision changes, loss of sensitivity, excess swelling, or any other concern.  The phone number for PRP Medical Aesthetics is 604-330-2013.

    PREVIOUS COSMETIC PROCEDURES

    I certify that I have fully and accurately disclosed all previous cosmetic treatments which I have received, including all cosmetic surgery procedures and any negative outcomes.  I understand that this is important so that any risks associated with this current treatment may be managed properly.

    PREGNANCY AND ALLERGIES
    I am not aware that I am pregnant, I am not trying to get pregnant,

    I am not lactating (nursing).

    I do not have or have not had any major illnesses.

    I certify that I do not have multiple allergies or high sensitivity to medications, including but not limited to lidocaine.

    I have no known allergy to subcutaneous, absorbable suture material.

     

  • RISKS AND COMPLICATIONS

    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.

    8.  Asymmetry

    9.  Cold sore eruption

    10. Post-treatment bacterial, viral, and/or fungal infection

    11. Accidental intravascular injection: While it is an extremely rare complication of Sculptra Injectable, the product being unintentionally injected into an arterial structure can produce a blockage of blood flow. This may cause death of the skin and deeper soft tissue structures, resulting in discoloration, scarring, and loss of the
    overlying skin. Should this rare complication occur, additional treatments or surgery may be necessary.

    12. Blindness: As of November 2025, there have only be 2 known reports of blindness following a treatment with Sculptra Injectable: one in Europe, and one more recently in the United States. Over the hundreds of thousands of treatments that have been done with Sculptra Injectable, the chances of blindness are minimal to none, but not completely impossible.  

     

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    ALTERNATIVE PROCEDURES
    Alternative procedures to dermal fillers for lines and wrinkles include laser treatment, other injections such as with platelet-rich plasma, radiofrequency devices, botox, or surgery.  There is also always the option to do no treatment at all as aging is a natural part of life.

    PAYMENT
    I understand that this is an “elective” procedure and that payment is my responsibility and I agree to pay the full cost at the time of treatment.  I understand that the cost of this treatment is non-refundable.

    RESULTS
    I understand that results cannot be guaranteed and like any aesthetic procedure, the results are temporary and full results may not be visible immediately.  In addition, follow up treatments may be recommended for to improve results.  Most patients are pleased with the results of Sculptra treatment. Additional treatments may be required periodically, generally at 4-6 week intervals until the desired results are obtained.  I am aware that follow-up treatments may be needed to maintain the full effects. I am aware the duration of treatment is dependent on may factors but not limited to: age, sex, tissue conditions, my general health and life style conditions, and sun exposure. The correction, depending on these factors, may last up to 2 years and in some cases shorter and some longer. I have been instructed in and understand the post-treatment instructions.


    By signing below, you agree to the following statement:

    I understand this is an elective procedure and I hereby voluntarily consent to treatment with Sculptra for facial rejuvenation and replacing facial volume. The procedure has been fully explained to me.  I have read the above and understand it.  All my questions have been answered satisfactorily. I also understand that any treatment performed is between me and the doctor/healthcare provider who is treating me and I will direct all post-operative questions or concerns to the treating clinician. I have read the above and 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 doctor/healthcare professional who treated me immediately. I also state that I read and write in English.

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