Informed Consent Documentation Note (Aesthetic Procedures)

Date/Time of Consent: [Date and time of consent] (Confirm this occurred before any premedication, sedation, or the procedure.)

Obtaining Clinician: [Name, credentials]

Location: [Clinic/office/facility name]

Procedure(s) Consented:

• [Procedure name (commercial and generic if applicable); treatment area(s) and anatomic site(s); product category/specific product; planned anesthesia/analgesia]
• (Add additional bullet points for each additional procedure as applicable.)

Decision-Maker: [Patient / Surrogate: name, relationship, and decision-making authority]

Interpreter: [Language; interpreter type (in-person / video / phone); interpreter ID] (Only include if an interpreter was used; omit entirely if not needed.)

Capacity Confirmed: [Brief statement confirming patient was alert, oriented, not intoxicated or sedated, and able to understand and deliberate]

Indication and Patient Goals

[Aesthetic concern/indication prompting the procedure and the patient's specific goals and priorities] (Use 2–4 sentences. Include direct patient quotes when goals are highly specific, expectations may be unrealistic, or the patient expresses particular risk tolerance. Address expectation alignment by stating realistic outcomes and known limitations.)

Proposed Procedure and Expected Outcomes

[Plain-language description of what will be done and why, including modality and brief technique overview] (If someone other than the obtaining clinician will perform key parts, specify who.)

[Expected benefits: onset, peak effect, duration, and maintenance/retreatment expectations] Individual results may vary; no specific outcome is guaranteed.

Risks

• Common/expected: [Pain; swelling; bruising; redness; tenderness]
• Less common: [Infection; prolonged edema; nodules; asymmetry; pigment changes]
• Rare but serious:
  • (For dermal fillers) [Vascular occlusion; skin necrosis; vision loss/blindness; stroke]
  • (For neuromodulators) [Ptosis; asymmetry; symptoms of systemic spread including trouble swallowing or breathing]
  • (For energy devices/lasers/peels) [Burns; blistering; scarring; dyspigmentation; ocular injury]
  • (For threads or minor surgery) [Bleeding; nerve injury; poor scarring; need for revision]
• Patient-specific risk modifiers: [Relevant factors such as anticoagulants, keloid history, HSV history, prior complications, autoimmune conditions] (Include only if applicable.)

Escalation instructions: [Symptoms requiring urgent contact or emergency evaluation, tailored to the procedure—e.g., vision changes, severe pain, skin blanching or discoloration, difficulty swallowing or breathing]

(Include only risk categories relevant to the procedure(s). If a material serious risk was not discussed, do not finalize consent—document deferral and reason in the Decision section.)

Alternatives

• No treatment/observation: [Brief tradeoff statement]
• [Alternative modality/procedure]: [Brief tradeoff—downtime, durability, risk profile]
• (Add or remove alternatives as appropriate.)

Aftercare and Follow-up

• [Anticipated downtime and appearance changes]
• [Activity restrictions and timeline]
• [Key aftercare instructions; reference written handout if provided]
• [When to call urgently and after-hours contact process]
• [Planned follow-up timing]

Off-Label Use

(Include this section only if the planned use differs from FDA-labeled indication, route, dose, or anatomic site; omit entirely if not applicable.)

Off-label element(s): [What specifically is off-label]

Clinical rationale: [Reason for recommending off-label approach]

Uncertainty statement: [What is known vs. not known for this use]

Patient acknowledgment: [Patient confirms understanding and agrees to off-label use]

Questions and Understanding

Patient questions: [Questions asked and concise responses] (If no questions, state "Patient had no additional questions.")

Understanding confirmation: [Patient's demonstration of understanding via teach-back—what is being done, expected results and timeline, major risks and when to seek help, and alternatives including no treatment] (Include a direct patient quote if they verbalized understanding of specific risks. Do not infer understanding from silence or nodding.)

Decision

[Proceeding today / Deferring: next steps / Declining: alternatives offered / Consent not obtained—procedure not performed: reason] (If consent not obtained due to capacity concerns, language barrier without interpreter, or material risks not reviewed, state the reason clearly.)

Documentation and Attestation

• Signed procedure consent form: [signed; scanned/uploaded; copy provided to patient]
• Educational materials provided: [List handouts or materials]
• Clinical photographs taken for medical record: [Yes / No / Not applicable]
• Separate marketing/social media photo authorization: [Obtained / Declined / Not requested] (Include only if applicable.)

Clinician Attestation: The relevant elements of informed consent were discussed, questions were answered, the patient demonstrated understanding via teach-back, and the patient consented voluntarily.

Obtaining Clinician Signature: ____________________________ [Name, credentials, date/time]