Sculptra Consent Form


INTRODUCTION:

Sculptra therapy is the injection into the skin and underlying tissues of poly-L-lactic acid. Sculptra therapy isdesigned to help correct skin depressions, such as creases, wrinkles, folds, scars, hollow eye rings, degenerative skinaging, and 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 or 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.

Skinlogic Med Spa 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 can be shorter or longer. Most areas of treatment will require 2 to 6 sessions, usually at 6 to 8 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.

SCULPTRA RISKS

You are not a candidate for this treatment if you are currently pregnant, attempting pregnancy, or breastfeeding: .

By signing this consent, you are acknowledging the written risks as stated below, as well as unforeseen risks that may not be included on this list: After your treatment, some common injection-related reactions will likely occur: swelling, redness, pain, itching,discomfort, discoloration, and tenderness at the injection site. These reactions typically resolve within 1-15 days of the treatment. Induration, or a feeling of fullness, can be felt in the injection area. This is a normal response of the treated tissue to the process of inflammation and collagen stimulation. Please read more below about potential risks.

RESULTS: Sculptra Injectable has been shown to be a safe and effective form of collagen stimulation. Most patients are pleased and satisfied with results. As with all cosmetic procedures, there is no guarantee that all patients are 100% satisfied. There is no guarantee that wrinkles and folds will disappear completely, or that youwill not require additional treatments to achieve the results you seek. Sculptra results are temporary, and additional treatments may be needed periodically to continue desired effect.

ALLERGIC REACTIONS AND HYPERSENSITIVITIES: Allergic and systemic anaphylactic reactions may occur.Reactions can last as long as 3 to 4 months and in rare cases, for more than a year. Sculptra Injectable should not be used in patients with a history of multiple severe allergies, severe allergies previously resulting in anaphylaxis, or allergies to gram-positive bacterial proteins. Allergic reactions may require additional treatment and follow up appointments. Other rarely reported events include: skin hypertrophy and/or atrophy and general malaise or fatigue.

SKIN SENSITIVITY: Skin rash, itching, tenderness, and swelling may occur following injections. After treatment,you should minimize exposure of the treated area to excessive sun or UV radiation and extreme cold weatheruntil initial swelling or redness has subsided.Please do not undergo laser treatments, chemical peels, or other skin procedures in the treatment area for at least one month before or after Sculptra injections. Please do not treat the same areas with Hyaluronic Acid Filler for at least 3 months before or after Sculptra injections. Treatments with HA fillers can be used within 3 months to areas that were or are not being treated with Sculptra injections.

INFECTION: Although rare, bacterial, fungal, and viral infections can occur. Herpes Simplex Virus (cold sore) infections can present around the mouth and can also present in other areas of injections following treatment.This applies to individuals with a history of cold sores and those without a history of cold sore infections. Shouldany type of skin infection occur, additional treatment with antivirals, antifungals, or antibiotics may be necessary. 

I understand the risk of infection and will contact the office immediately with concerns following my Sculptra treatment: .

ERYTHEMA (SKIN REDNESS), BRUISING, NEEDLE MARKS: Redness of the skin occurs after injections. It can be present for a few days following the procedure. Bruises can occur when the needle punctures even small blood vessels in the skin. Bruising should subside in a few days. Small needle marks from the injections can occur and typically resolve in a few days. The use of anti-inflammatory drugs (i.e. ibuprofen), anti-clotting agents (i.e.
warfarin, Eliquis), or aspirin, as well as fish oil and alcoholic intake may cause bleeding or increased bruising in
the injection sites.

UNDER/OVER CORRECTION: The injection of Sculptra to correct wrinkles and create a desired youthfulness of the face is not a defined science and results may vary. The amount of correction may be inadequate or excessive. It may not be possible to completely control the process of Sculptra injection due to factors attributable to each patient’s facial structure. If under correction occurs, you may be advised to consider additional Sculptra treatment. If overcorrection occurs, Hyaluronidase can be used to metabolize the product.

ASYMMETRY: The human face is typically asymmetric side to side and varies in appearance based on underlying anatomy. It may not be possible to achieve or maintain exact symmetry with injection of Sculptra. Addressing symmetry may require additional treatments.

SKIN LUMPS: Small bumps under the skin may be felt in the treatment area. Usually, these bumps are only felt when pressing on the skin. They are typically not seen. These micro-nodules usually last 6-12 months and may spontaneously disappear. They typically do not require treatment. Visible bumps may occur in rare instances, and they may be associated with redness, tenderness, skin discoloration or textural changes. Painful masses in the skin and deeper tissues after Sculptra injections is a rare, but possible complication. Should these occur, additional medical treatments may or may not be necessary. Possible treatment options include but are not limited to: oral antibiotics, injections, freezing, or excision. To reduce the risks of nodules of the skin in the injection sites, it is imperative to massage the treated area as recommended by your injector for the duration and number of times given. By undergoing this treatment, youconsent to massage the treated area for 5 minutes, 5 times a day, for the following 5 days after your injections.

You will be honest about following these guidelines at any follow up appointments: .

DAMAGE TO DEEPER STRUCTURES: Underlying skin structures including blood vessels and nerves can be damaged during the course of injection. Injury to deeper structure may be temporary or permanent.

ACCIDENTAL INTRAVASCULAR INJECTION: While it is an extremely rare complication of these 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.

UNSATISFACTORY RESULTS: Sculptra injections alone may not produce the outcome that meets your expectations for improvement in wrinkles or soft tissue depressions. There is the possibility of a poor or inadequate response from Sculptra. Additional injections may be necessary. Surgical procedures or other treatments may best fit your cosmetic goals.

An appropriate consult will take place in which the provider will define the product needed to reach each patient’s individual goals. If you, the patient, choose to treat with less than recommended, you take responsibility for unsatisfactory results. Additional treatments with Sculptra or other products may be needed
for desired results and will be an additional cost to the patient.

DRUG INTERACTIONS: It is not known if Sculptra injections interact with other medications, whether over the
counter or prescribed.

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.            

 It is important that you read this information carefully and completely.  Please initial this each section indicating that you have read the page and sign the consent for this procedure as proposed by your injectionist and agreed upon by you. .

FINANCIAL RESPONSIBILITIES

The cost of filler injection may involve several charges. The  fees  charged  for  this procedure  do not include any potential future costs for additional procedures  that you elect to have or require in order to revise, optimize, or complete your outcome.  Additional costs may occur should complications develop from the injections and will also be your responsibility.   In signing the consent for this procedure, you acknowledge that you have been informed about its risk and consequences and accept responsibility  for the clinical decisions that were made along with the financial costs of all future treatments.

  I understand and unconditionally and irrevocably accept this.

DISCLAIMER

The informed-consent process attempts to define principles of risk disclosure that should generally meet the needs of most patients in most circumstances.

However,  informed-consent  documents  should not be considered  all-inclusive  in defining other methods of care and risks encountered.    Your injectionist may provide  you with additional  or different  information  which is based on all of the facts pertaining to your particular case and the current state of medical knowledge.

Informed-consent  documents are not intended to define or serve as the standard of medical care.   Standards of medical care are determined on the basis of all of the facts involved in an individual case and are subject to change as scientific knowledge and technology advance and as practice patterns evolve.

CONSENT FOR PROCEDURE or TREATMENT

  1. I hereby authorize Skinlogic Med Spa’s injectionists to perform the following procedure or treatment:
  • Sculptra Injections
  1. I recognize that during the course of the procedure and medical treatment, unforeseen conditions may necessitate  different  procedures than those I therefore authorize the injectionist  to perform such other procedures that are in the exercise of his or her professional judgment necessary and desirable. The authority granted under this paragraph shall include all conditions that require treatment and are not known to my injectionist at the time the procedure is begun.
  1. I understand what my injectionist can and cannot do, and understand  there are no warranties  or guarantees, implied or specific about my outcome. I have had the opportunity to explain my goals and understand which desired outcomes are realistic and which are not. All of my questions have been answered, and I understand the inherent  (specific)  risks to the procedures  I seek, as well as those additional  risks and complications, benefits, and alternatives. Understanding all of this, I elect to proceed.
  1. I consent to be photographed which will used for medical records. I understand before any future touch up or correction that I must have photos taken before anything can be performed and if I refuse no service will be performed.
  1. I realize that not having the procedure is an option.
  1. IT HAS BEEN EXPLAINED TO ME:
        1. THE ABOVE TREATMENT OR PROCEDURE TO BE UNDERTAKEN
        2. THERE MAY BE ALTERNATIVE PROCEDURES OR METHODS OF TREATMENT
        3. THERE ARE RISKS TO THE PROCEDURE OR TREATMENT PROPOSED

 

I CONSENT TO THE TREATMENT OR PROCEDURE AND THE ABOVE LISTED ITEMS (1-6). I AM SATISFIED WITH THE EXPLANATION.

  I understand that multiple treatments will be needed to achieve desired results and if I decide not to have further treatments that desired results will not be achieved.

   I understand that if I decided to not have a treatment today that I will be charged $100 for the sculptra consultation.

Issues in signing document?  Scroll up to see required areas marked in red that you need to fill out then re-sign.

IT HAS BEEN EXPLAINED TO ME IN A WAY THAT I UNDERSTAND:  

  1. A. THE ABOVE TREATMENT OR PROCEDURE TO BE UNDERTAKEN.  
  2. B. THERE MAY BE ALTERNATIVE PROCEDURES OR METHODS OF TREATMENT.  
  3. C. THERE ARE RISKS TO THE PROCEDURE OR TREATMENT PROPOSED.

I certify that I have read all pages of this document and give my consent for my injectable procedure.  

  Date:

 

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Signature Certificate
Document name: Sculptra Consent Form
lock iconUnique Document ID: 8efba62d9de235faccb620f692c177e68ce7e2fa
Timestamp Audit
August 29, 2025 9:49 am PSTSculptra Consent Form Uploaded by scott smith - scottsm8@gmail.com IP 98.203.141.236