INFORMED CONSENT FOR SCULPTRA® (POLY-L-LACTIC ACID) INJECTIONS
This informed consent confirms that I have been fully educated regarding
Sculptra® (poly-L-lactic acid, PLLA) injections, including their purpose,
mechanism of action, expected benefits, limitations, alternatives, risks,
and possible complications. I acknowledge that I have received sufficient
information to make a voluntary and informed decision to proceed with treatment.
Prior Injectable Disclosure
I have informed my practitioner of any previous dermal filler or biostimulator
injections, including the type of product, date of treatment, and area(s) treated.
Nature of Sculptra® & Mechanism of Action
I understand that Sculptra® is an FDA-approved injectable biostimulator that
works by stimulating fibroblastic activity and collagen production within the skin.
I understand that Sculptra® is composed of poly-L-lactic acid (PLLA), a
biocompatible and biodegradable synthetic material that is gradually absorbed
by the body while promoting collagen formation over time.
I understand that Sculptra® does not provide immediate volume, and results
develop gradually as my body produces new collagen.
Important Volume & Expectation Disclosure
I understand that Sculptra® improves skin thickness, firmness, and volume
through collagen stimulation, but does not replace lost fat volume or provide
immediate structural correction.
I understand that areas of significant fat loss, contour deficiency, or
structural volume loss may require hyaluronic acid (HA) fillers or other
volumizing treatments, either alone or in combination with Sculptra®, to
achieve desired aesthetic results.
Procedure Description
I understand that the procedure involves the use of a needle and/or cannula
to inject Sculptra® into specific layers of the skin or subcutaneous tissue.
I understand that as the PLLA microparticles are absorbed, collagen production
is stimulated gradually, resulting in progressive improvement in skin quality
and volume.
FDA-Approved & Off-Label Use
I understand that Sculptra® is FDA-approved for certain areas of the face.
I understand that use in other anatomical areas (including but not limited to
the neck, chest, arms, hands, abdomen, knees, or buttocks) constitutes off-label
use, which is legally permissible, commonly practiced, and within the accepted
standard of medical care.
Treatment Series & Timeline
I understand that Sculptra® requires a series of treatments to achieve optimal
results.
I understand that most treatment plans involve two to four sessions, typically
spaced 4–6 weeks apart, depending on individual goals, anatomy, and response.
I understand that results are gradual, and meaningful improvement may not be
apparent for several weeks to months, with noticeable changes often occurring
after the second treatment.
Longevity & Maintenance
I understand that once collagen stimulation is achieved, results may last two
years or longer, though individual response varies.
I understand that maintenance treatments may be required periodically to
sustain results over time.
No Guarantee of Results
I understand that although favorable outcomes are expected, medicine is not an
exact science, and no specific result or duration of effect can be guaranteed,
either expressed or implied.
I understand that I am paying for professional medical services, not for a
guaranteed aesthetic outcome.
Alternatives to Treatment
I understand that alternatives include, but are not limited to, hyaluronic
acid fillers, other biostimulatory injectables, energy-based devices, surgical
procedures, or no treatment, and I have discussed these options with my provider.
Medical History & Contraindications
I agree to fully disclose all medical conditions, allergies, and medications,
including supplements.
To the best of my knowledge, I have no known allergies or sensitivities to
poly-L-lactic acid or lidocaine.
I understand that injectable treatments may trigger cold sore or herpes simplex
outbreaks and have informed my provider if applicable.
I deny that I am currently pregnant, attempting to become pregnant, or
breastfeeding. I understand that the safety of Sculptra® during pregnancy and
breastfeeding has not been established. If uncertain, I will request pregnancy
testing prior to treatment.
Risks & Possible Complications
I understand that all injectable procedures involve risk. Potential risks include,
but are not limited to:
- Discomfort or tenderness
- Bleeding or bruising
- Swelling or redness
- Skin irritation
- Infection (rare)
- Scarring (rare)
- Allergic reactions
- Unknown or unforeseen side effects
Nodules & Massage Requirement
I understand that small subcutaneous bumps or nodules may occur and are usually
not visible and often resolve over time.
I understand that proper post-treatment massage is critical to reduce the risk
of nodule formation and agree to follow the recommended massage protocol
(commonly 3–5 times per day for 2–3 minutes for 2–3 weeks). Failure to massage
increases the risk of nodules.
Vascular Complications (Extremely Rare)
I understand that in extremely rare cases, unintentional injection into a blood
vessel may result in vascular occlusion, which can cause skin injury, permanent
scarring, vision abnormalities, permanent vision loss, stroke, or other serious
complications.
I agree to immediately notify AI Wellness Center of Excellence if I experience
severe pain, skin color changes (white, mottled, or dusky appearance), vision
changes, or neurologic symptoms such as difficulty speaking, facial drooping,
weakness, dizziness, confusion, or severe headache.
Post-Treatment Responsibility
I understand that individual responses vary and that delayed reactions may occur.
I agree that it is my responsibility to notify the clinic promptly of any concerns
and to allow AI Wellness Center of Excellence the opportunity to evaluate and
participate in my care.
Authorization & Provider Qualifications
I hereby authorize Dr. Gideon Kwok, D.O., and/or trained and qualified licensed
medical providers acting within their scope of practice to perform Sculptra®
injections on me.
I acknowledge that I have had the opportunity to ask about the qualifications and
experience of my provider and am satisfied.
I affirm that my consent is voluntary, informed, and freely given.
Final Acknowledgment
By signing below, I certify that:
- I have read and fully understand this consent form
- All disclosures have been explained to me
- I have had the opportunity to ask questions
- This consent supersedes any prior verbal or written disclosures
- I freely consent to Sculptra® injections
