Informed Consent Form Template for Collagen Biostimulator

November 11, 2026 · 6 min read

Editorial illustration about an informed consent template for a biostimulator

The informed consent form for a collagen biostimulator documents a conversation that must truly happen: the patient understood what the procedure is, how it usually works, what risks exist (including rare ones) and what the alternatives are. Because biostimulators act gradually and, in general, have no quick antidote equivalent to the hyaluronidase used with hyaluronic acid fillers, the patient needs to know this before deciding.

The template below is generic by class. It does not include technique, dose, dilution, depth or brand name. Those details belong in the patient record and to the decision of the qualified professional.

When should you use this template?

Before the first application of any injectable biostimulator, such as those based on poly-L-lactic acid, calcium hydroxylapatite or polycaprolactone, after the medical history and the conversation about indication. Consent is a step in the process, not a paper to sign at the treatment room door: hand it over in advance, when possible, so the patient can read it calmly.

For an overview of the classes, see biostimulators: overview. Reading the entry on informed consent helps recall what makes the document valid.

How do you adapt it?

Record the exact class to be used (do not leave the word "biostimulator" on its own) and the area treated.
Include whatever is specific to your routine: expected number of sessions, interval, costs of additional sessions and return policy.
Keep the language simple. If the patient needs a dictionary to understand the risk, the form has failed in its purpose.
Give one copy to the patient and keep the other in the patient record.
Never fill in the declaration fields for the patient: they read and sign.

What can never be missing?

Item	Reason
Class of procedure and area	Defines what was consented to
How the effect usually appears (gradual, over weeks)	Avoids the expectation of an immediate result
Common and rare risks, including nodules and vascular events	Clear information is the basis of consent
That results vary and are not guaranteed	No promises, in line with professional ethics
Possibility of more than one session, and costs	Avoids financial surprises
Alternatives, including not treating	The patient decides with options
Right to withdraw before the procedure	Free consent
Place, date and signatures	Validity of the record

Informed consent form template for collagen biostimulator

Template

FREE AND INFORMED CONSENT FORM: INJECTABLE COLLAGEN BIOSTIMULATOR

Patient: ________

Date of birth: ________

CPF: ________

Responsible professional: ________

Council and registration number: ________

Clinic: ________

1. What the procedure is

Collagen biostimulators are injectable substances that, instead of just taking up space, stimulate the body to produce collagen over time in the treated area. The procedure proposed for me is the application of a biostimulator of the class: ________ in the areas: ________.

2. What it is for

It was explained to me that the goal is to improve, gradually and within the limits of my body, aspects such as skin firmness and quality and the support of areas of the face or body, according to the professional's assessment. I understand that the goal is a possible improvement and not a certain change.

3. How it is done

The product is applied by injection, with a needle or cannula, at the professional's discretion, after cleaning the skin. Topical or local anesthetic may be used, depending on the assessment. The technique, amount and injection points are defined by the professional, according to my individual assessment. In some cases the professional may give specific care instructions after the application, which I must follow exactly as explained.

4. When the effect appears

I understand that the effect is not immediate: it usually builds up over weeks to months, varies from person to person and may require more than one session. The swelling seen right after the application does not represent the final result. Expected number of sessions: ________. Cost of additional sessions: ________.

5. Common risks and effects

The following may occur, generally temporarily: pain or discomfort, redness, swelling, bruising, tenderness to the touch, itching, small palpable irregularities and asymmetry. These effects usually fade over the days, but how long they last varies.

6. Less common and rare risks

The following may occur, rarely and sometimes late: palpable or visible nodules or lumps, which may appear weeks, months or longer afterward; persistent inflammatory reaction or formation of granulomas; infection; herpes reactivation; allergic reaction; contour irregularities; a result smaller than expected or uneven between the sides; pain or change in sensation; scarring. In very rare cases, the product may enter or compress a blood vessel, causing a lack of circulation in the tissue, with risk of necrosis (tissue loss) and, in the face, of serious vision changes. These complications require immediate care.

I understand that some of these effects may need additional treatment (medication, procedures or prolonged follow-up) and that, in general, biostimulators cannot be quickly undone the way some other fillers can. I have also been informed that these treatments may have a cost.

7. Who should not have it, or should postpone it

I have truthfully told the professional about my illnesses, allergies, medications, pregnancy or breastfeeding, active infection, autoimmune diseases, clotting problems, previous procedures and materials in the face and any other relevant condition. I know that omitting information increases the risks.

8. Alternatives

Alternatives were presented to me, including other aesthetic procedures, skin treatments, changes in habits and the option of not having any procedure. I freely choose this option.

9. Care before and after

I received written instructions on care before and after the application, and I know how to contact the professional if I have questions or any warning sign (severe pain, paleness or discoloration of the skin, blisters, fever, lumps that grow, vision changes). Contact: ________.

10. No guarantee of results

I understand that the result depends on individual factors, such as my body, my skin, my age and my habits, that the professional cannot guarantee a specific result and that illustrative images, when used, do not promise what will happen.

11. My data

I authorize the use of my personal and health data for my care and for recording in the patient file, with confidentiality and protection, in accordance with Brazil's General Data Protection Law (LGPD). The use of my photographs for other purposes depends on a separate form.

12. Declaration

I have read this form, or it was read to me. I had the opportunity to ask questions, which were answered satisfactorily. I understood the information and I freely decide to have the procedure. I know I can change my mind at any time before the application.

Place and date: ________

Signature of the patient or legal guardian: ________

Name of the legal guardian and relationship, if applicable: ________

Signature of the professional: ________

Witness (optional): ________

After the form is signed

The form does not end the conversation. Hand over the post-biostimulator instructions in writing, schedule the return visit to assess progress and record in the patient file what was agreed. If the patient still has doubts about the initial swelling, the text biostimulator swells the face helps explain it. The rules on storing and protecting photos and documents are in consent and LGPD for photos.

Frequently asked questions

Do I need a specific consent form for a biostimulator?

Ideally you have a dedicated form for each class of procedure, because the risks and alternatives change. The risks of a biostimulator, such as delayed nodules and gradual results, do not appear in a generic filler consent form. Confirm the required format with your professional council and a lawyer.

Does the consent form protect the professional from a lawsuit?

It documents that the patient was informed and agreed, which is important, but it does not replace a good explanation or remove responsibility for a failure of care. What really protects you is the whole package: medical history, careful indication, consent that was understood, record in the patient file and good follow-up.

Does the form need to name the product?

This template is generic by class and leaves a field for you to record the product, batch and expiry used, information that usually goes in the patient record. How and where to record it is up to you, according to your professional council's rules.

Terms mentioned

Collagen biostimulator Polylactic acid Calcium Hydroxylapatite Polycaprolactone (PCL)Nodule after filler Foreign Body Granuloma After Filler Informed consent in orofacial harmonization Hyaluronidase