Informed consent form template for microfocused ultrasound

November 11, 2026 · 4 min read

Quick facts

Document: Informed consent form
Technology: Microfocused ultrasound
Key point: Contraindications, pain during the session and gradual effect
Review: A lawyer and your professional board's rules before use

Microfocused ultrasound is a technology, not an injectable, and the consent form needs to reflect that. No gel is placed under the skin, but energy is focused into layers of tissue, some patients feel pain during the session, there are specific contraindications, and the effect is usually gradual.

The template is generic and includes no equipment settings: they depend on the device and on the qualified professional. For context, see ultrasound in HOF and the comparison in biostimulator or microfocused ultrasound.

When should you use this template?

At the assessment, after the medical history, with questions specific to the technology. The patient should know what they will feel during the session and that the response is not immediate.

What must never be missing?

Item	Reason
Screening and contraindications	Protects the patient and the professional
Pain or discomfort in the session	Avoids surprises
Redness, swelling, tingling	Expected effects
Burns, blisters, color changes	Risks from heat
Changes in sensation or movement	Rare risk, usually temporary
Gradual and variable effect	Avoids the expectation of an immediate effect
Alternatives	Free consent

Consent form template for microfocused ultrasound

Template

INFORMED CONSENT FORM: MICROFOCUSED ULTRASOUND

Patient: ________

Date of birth: ________

CPF (Brazilian taxpayer ID): ________

Responsible professional: ________

Professional board and registration number: ________

Clinic: ________

1. What the treatment is

Microfocused ultrasound is a technology that delivers focused energy into layers of the skin and the tissue beneath it, with the aim of stimulating the body itself to firm the tissue, according to the professional's assessment. Areas to be treated: ________.

2. How it is done

The device is applied over the skin, with gel. Settings and areas are defined at my individual assessment. It may be done in one or more sessions.

3. During and right after

I may feel warmth, tingling, sharp pricks or pain during the session, which can be strong in some areas. There may be mild redness and swelling for hours or days, tenderness to the touch and bruising.

4. Possible risks

Burns, blisters, changes in skin color, prolonged tingling or numbness, persistent pain, irregularities, asymmetry, insufficient effect and, in rare cases, temporary or prolonged change in the movement of some part of the face.

5. Contraindications and health information

I have truthfully reported whether I have a pacemaker or other electronic devices, metal implants, pregnancy or breastfeeding, infection or a wound in the area, skin diseases, autoimmune diseases and medications in use, as well as previous fillers or threads. I know that leaving out information increases the risks.

6. Result and duration

The effect is usually gradual, appears over weeks or months and varies from person to person. It may not be enough, and the treatment may need to be repeated, at a cost.

7. Alternatives

Other options were presented to me, including other treatments and the option not to treat. I freely choose this one.

8. Aftercare and follow-up

I received written instructions and know how to reach the professional: ________. Planned follow-up: ________.

9. No guarantee of results

I understand that the result cannot be guaranteed. Illustrative images and simulations are only for discussing possibilities.

10. My data

I authorize the processing of my personal and health data for my care and medical record, in accordance with the LGPD (Brazil's General Data Protection Law). Using my images for other purposes requires separate authorization.

11. Declaration

I have read this form, or it was read to me, and my questions were answered. I decide to have the treatment of my own free will and I may withdraw before it begins.

Place and date: ________

Patient or legal guardian signature: ________

Professional signature: ________

How do you explain the gradual effect?

Patients often expect a change the following week. Tell them that the tissue responds over time, that the response varies, and that the scheduled reassessment is part of the treatment. See a ready-made conversation in the script for explaining a gradual result.

Keep the signed copy according to the guidance on medical record documentation.

Frequently asked questions

Is the microfocused ultrasound form the same as the injectables form?

No. Nothing is injected, but there are risks of its own, such as pain during the session, burns and changes in sensation. The form should cover them and the contraindications.

Do I need to record implants and pacemakers?

Yes. Metal implants, pacemakers, pregnancy and active skin infection are usually points of concern. Record the answers in the medical history and follow the equipment manual.

Is the effect immediate?

It is usually gradual, with the tissue responding over weeks or months, and it varies from person to person. The form should say so, without promising results.

Terms mentioned

Informed consent in orofacial harmonization Swelling after harmonization Hematoma After Filler Facial asymmetry