Sculptra Consent Form Template (Biostimulators, 2026)

Template, not medical or legal advice. This page describes how a biostimulator consent document is commonly organized. It gives no injection technique, product preparation instructions, session counts or timelines, and it does not describe the law of any state. Sculptra and Radiesse are prescription medical devices; check every disclosure against the current FDA-approved labeling for the product you use, and have your medical director approve and a healthcare attorney review the final form before any patient signs it.

Biostimulators tend to arrive on a med spa menu after hyaluronic acid filler is already established, and the paperwork usually arrives the same way: someone takes the filler consent, adds the word "Sculptra" to the product line, and puts it into the intake packet. That form will look complete right up to the day a patient says they were told the result could be removed, or that they expected to see a change after the first appointment, or that nobody mentioned the lump that appeared many months later. Each of those complaints is about something a biostimulator consent should have recorded and a filler consent usually does not.

This page is limited to that one document. Running the program itself, from product selection and preparation standards to nodule management and series charting, belongs to our biostimulator compliance guide. Consent law in general, from capacity and minors to the legal standard for a valid consent, is covered in our med spa consent forms guide. What follows assumes both and concentrates on the words on the page a biostimulator patient signs.

Sculptra and Radiesse are trademarks of their respective owners. We use the brand names because that is how patients and staff refer to these products, not to describe or endorse any manufacturer's claims. Throughout, the generic material comes first: poly-L-lactic acid (PLLA) for Sculptra and calcium hydroxylapatite (CaHA) for Radiesse.

What Must a Sculptra or Biostimulator Consent Form Contain?

A biostimulator consent form must name the product and its generic material, the treatment areas, a gradual and variable result, the possible need for a series, alternatives, common reactions, serious risks including early and delayed nodules and granulomas, and the fact that hyaluronidase cannot dissolve it. Add series and payment terms, separate photo consent, aftercare, emergency contact and signatures re-confirmed at each session.

Read your current form against this list. Anything missing is a gap that a complaint will find first.

1. Product identification — brand and generic material (PLLA or CaHA), with the product actually used and its lot recorded in the chart.
2. Areas and plan — each area to be treated, and whether this visit is a single treatment or part of a planned series.
3. How the product works — a plain statement that it prompts the body to build collagen and that improvement develops gradually rather than appearing on the table.
4. Results and limits — that outcomes vary, cannot be guaranteed, and may not match what the patient has seen in other people's photographs.
5. Irreversibility — that the product cannot be dissolved with hyaluronidase or reversed on request.
6. Common reactions — the expected short-lived effects, kept apart from serious risks.
7. Serious risks — vascular complications, nodules and papules (early and delayed), granulomas and inflammatory reactions, infection, and allergic reaction, each on its own line.
8. Patient responsibilities — any post-treatment massage, follow-up visits or reporting duties your protocol includes.
9. Health history confirmation — that the screening answers given are complete and current.
10. Alternatives — hyaluronic acid filler, other treatments, and not treating.
11. Photography — clinical photographs for the record, with any marketing use authorized separately.
12. Series and financial terms — what the patient is paying for, what happens if they stop, and that no number of visits guarantees a result.
13. Warning signs and emergency contact — the symptoms that need an urgent call, and how to reach someone at any hour.
14. Signatures and session log — patient, consenting practitioner, treating injector, date, form version, and a re-confirmation entry for each later session.

Two items on that list rarely appear on an HA filler form at all: patient responsibilities and series terms. Two more appear on filler forms but carry far more weight here: irreversibility and delayed nodules. Those four are where the rest of this page spends most of its time.

How Does a Biostimulator Consent Differ From an HA Filler Consent?

The skeleton is shared, and our dermal filler consent form template sets it out for hyaluronic acid products. What changes is the decision the patient is making. An HA patient is buying a visible change today, with an enzyme available if the result is wrong. A biostimulator patient is buying a process: a change they will not fully see for some time, possibly spread over several appointments, with no enzyme to fall back on. Five differences follow from that, and each one needs its own wording.

Results are delayed and gradual

Our biostimulator guide describes PLLA as producing little immediate change and building over weeks to months, and CaHA as giving immediate volume from its gel carrier and then building as collagen forms. The form needs to say which pattern applies to the product used. For PLLA in particular, it should warn that early fullness from the injection itself may subside before any collagen-driven improvement appears, so the patient does not read that change as failure. Keep this descriptive. Do not print a number of weeks or months; a date on a consent form is read as a promise.

Treatment may be a series, not a single visit

Many PLLA plans involve more than one session, and CaHA patients sometimes return for additional areas or touch-ups. The form should say that more than one visit may be recommended, that the number depends on the individual and is decided by the treating practitioner, and that the consent is re-confirmed before each one. It should not state a number. If a patient is told "usually three" and needs four, the form becomes evidence for the complaint rather than against it.

Not reversible with hyaluronidase

This is the statement the whole form hinges on. With HA filler, the reversibility line usually reassures. With a biostimulator, it has to do the opposite: tell the patient, prominently and in plain words, that there is no enzyme that dissolves PLLA or CaHA, that an unwanted result or a misplaced product cannot be erased on request, and that complications are managed over time rather than undone. Give it its own box or bold heading and ask the patient to initial it. Our hyaluronidase guide explains why that drug's role is limited to hyaluronic acid products.

Nodule and granuloma disclosure carries more weight

Nodules are the complication most associated with biostimulators, and our compliance guide distinguishes early papules and nodules from delayed nodules that can surface long after treatment, some of them inflammatory. On an HA form, a lump is often something the practice can dissolve. Here it may mean a prolonged period of observation and treatment. The form should name early nodules, delayed nodules and granulomas separately, say that a delayed reaction can appear well after the series ends, and tell the patient to report any new lump at any point rather than assume it will settle.

Reconstitution and massage acknowledgments, if your protocol includes them

PLLA is supplied as a powder and reconstituted before use; CaHA is supplied ready to use. The patient does not need preparation details, and the form should not contain them. What some practices do want on record is a short acknowledgment that the product was prepared under the practice's written standard, if your protocol includes one, and that the patient received and agreed to follow post-treatment massage instructions, if your protocol includes a home massage routine. These lines matter because a nodule in a patient who was never instructed reads very differently from a nodule in a patient who signed for the instructions and did not follow them.

Annotated Biostimulator Consent Template, Section by Section

The outline below is a working layout. Each part has a note on what it is for and the error it most often contains. It is structure, not finished wording: your medical director supplies the clinical language and counsel confirms it against your state's requirements.

Part A: Patient, visit and form identifiers

Patient name, date of birth, date of this visit, chart or visit reference, and the version number of the form. Note: the version number is what lets you prove, years later, which wording a patient actually saw. Without it, a revised template can quietly stand in for the one that was signed.

Part B: Treatment description

Product brand and generic material, a field to record a substitute product if one is used, each area to be treated, and a checkbox for whether this visit is a stand-alone treatment or one visit in a planned series. Identify any use outside the product's labeled indications. Note: a form listing both PLLA and CaHA with neither selected tells a reviewer the patient consented to a menu, not a treatment.

Part C: How biostimulators work and what to expect

Two or three plain sentences: the product stimulates the body's own collagen; improvement develops gradually; results differ between people; further visits may be recommended; no particular outcome is guaranteed. Note: this is where the "nothing happened" complaint is won or lost. The patient should be able to point to this paragraph and recognize what they were told in the room.

Part D: Irreversibility statement

A boxed statement, initialled by the patient, that the product cannot be dissolved with hyaluronidase or removed on request, and that if a complication or an unwanted result occurs it will be managed over time. Note: never soften this box with "rarely needed" or "most patients love their results." Reassurance next to an irreversibility warning reads as an attempt to dilute it.

Part E: Common reactions

Swelling, bruising, redness, tenderness and temporary unevenness at the treatment sites, with a note that these usually settle on their own. For PLLA, the early fullness that subsides. Note: keep this list physically separate from Part F. A patient who sees bruising and vision loss in the same sentence tends to skim both.

Part F: Serious risks

One line per risk, each with a space for initials: vascular complications including the possibility of tissue damage and, rarely, vision loss, worded as your medical director decides against the labeling; early nodules or papules; delayed nodules; granulomas or other inflammatory reactions, including late ones; infection, including late infection; allergic or hypersensitivity reaction; asymmetry, contour irregularity or visible or palpable product. Note: the vascular wording should tell the patient the practice keeps a written emergency plan and can arrange transfer to a hospital, and that dissolving the product is not part of that response for a biostimulator.

Part G: Patient responsibilities

Checkboxes for the items your protocol includes: post-treatment massage as instructed on the separate sheet; attending follow-up visits; reporting any new lump, swelling, pain or skin change at any time, including after the series ends; disclosing changes in health or medications before each visit. Note: list only what your protocol actually requires. A form that obliges the patient to do something staff never explain creates a duty nobody can show was met.

Part H: Health history confirmation

A statement that the patient has answered the screening questions fully and will tell the practice about any change. The screening itself usually sits on the intake form; this part ties it to the consent. Note: the confirmation is only as good as the intake behind it, which is the subject of the screening section below.

Part I: Alternatives

A short list of the options discussed, with the patient's initials. Note: covered in its own section below, because for a biostimulator the alternatives conversation is also a candidacy conversation.

Part J: Photography

Consent to clinical photographs at each visit for the medical record, with a pointer to a separate, optional authorization for any marketing use. Note: see the photo consent section below.

Part K: Series and financial terms

A reference to the written package or treatment-plan agreement, or the key terms in summary. Note: see the series terms section below; this is the part most often left off entirely.

Part L: Aftercare, warning signs and emergency contact

Confirmation that written aftercare and, if applicable, massage instructions were given and explained; the warning signs that need an immediate call; an after-hours number; and an instruction to call emergency services for any change in eyesight, trouble breathing or other alarming symptoms. Note: warning signs are part of what the patient is being warned about, so print them on the signed page as well as the handout.

Part M: Attestation, signatures and session log

The patient's first-person attestation, signatures and dates, practitioner details, witness if your policy requires one, and a session re-confirmation table for later visits in the series. Note: see the signatures section below.

Product-Specific Acknowledgment Blocks

Our biostimulator guide is clear that a PLLA consent and a CaHA consent are not the same document. The cleanest way to achieve that without maintaining two entirely separate forms is a shared body with one product block per family, and only the block for the product being used is completed and initialled. A practice that prefers fully separate forms can lift each block into its own document. Either way, the block sits immediately after Part B so the product-specific facts are read before the general risks.

Two cautions on these blocks. First, keep them free of manufacturer language. Product labeling is the source for what must be disclosed, but the form should be written in your practice's own words and approved by your own medical director, and it should never repeat marketing claims about longevity or naturalness. Second, if you offer a further biostimulator or a permanent filler, give it its own block rather than squeezing it into one of these. Each product family has its own risk profile, and a block written for one does not cover another.

Contraindication and Candidacy Screening on the Form

Screening decides whether the consent conversation should happen at all. A patient who is a poor candidate for an irreversible, gradual product is better served by being steered elsewhere before any form is signed, and the chart should show that decision was made deliberately.

What the screening should capture

The clinical criteria are your medical director's to set from the product labeling, but the intake and consent together should record the answers to questions such as:

• Any active infection, inflammation or skin condition at or near the proposed treatment area.
• Autoimmune conditions, a history of granulomas or other granulomatous disease, or a past reaction to an injectable.
• Allergies, including to any component of the product and, if your protocol adds a local anesthetic, to anesthetics.
• Current medications and supplements, including any that affect bleeding or bruising or the immune system.
• Previous fillers, biostimulators or permanent fillers in the same area, with the product type if the patient knows it.
• Pregnancy or breastfeeding, recorded so the treating practitioner can apply the practice's policy.
• Recent illness or other recent or planned procedures, if your medical director treats these as relevant.

The intake form gathers most of this; our intake form template guide covers how to structure and refresh it. The consent form's job is to have the patient confirm that what they disclosed is complete, and to oblige them to update it before each later session.

Expectation and candidacy questions

Our compliance guide lists unrealistic expectations, body dysmorphic tendencies, and a specific wish for an instant, reversible result among the signs of a poor biostimulator candidate. Those are not boxes a patient ticks; they come out of the conversation. A short practitioner field on the form, recording that expectations were discussed and that the patient understands the result is gradual and cannot be reversed, gives a reviewer something to hold. Where the practitioner steers a patient toward HA filler instead, the chart should say so.

Alternatives the Form Should Record

Informed consent means the patient chose this treatment knowing there were others. For a biostimulator, the alternatives discussion also tests whether the patient is in the right place. The form should record, with the patient's initials, that the practitioner discussed:

• Hyaluronic acid filler, which gives a more immediate result and can generally be dissolved, for a patient who values speed or reversibility.
• The other biostimulator family, where the practice offers both, and why the chosen one suits the patient's goal.
• Non-injectable options your practice or others offer, such as energy-based treatments or skin-quality treatments, without arguing their merits on the form.
• Surgical consultation, where the patient's goal may be better met that way.
• No treatment, stated as a real option.

A patient who later says "I would have had filler if I'd known this couldn't be reversed" is making an alternatives argument. A form showing that HA filler was offered and declined, with the reason, answers it.

Photo Consent for a Treatment Measured Over Time

Photographs matter more for biostimulators than for almost any other injectable, because the result is gradual and the patient's own memory of their baseline fades. Our compliance guide recommends standardized photographs at every visit. Without them, the practice has nothing to show a patient who believes nothing changed, and nothing to show a reviewer when a complaint about the result arrives.

Clinical photographs

The treatment consent should cover clinical photographs at each visit in the series and at follow-up, kept in the medical record and used for care. Say so in a sentence and have the patient agree. It helps to tell the patient that these photographs are how progress will be judged, which also reinforces the gradual-result message.

Marketing use is a separate decision

Before-and-after images of a biostimulator series are attractive marketing material, which is exactly why they need a separate, optional and revocable authorization rather than a line in the treatment consent. A patient should be able to agree to treatment and decline marketing use without any pressure. Our guides to before-and-after photo rules and testimonial and marketing consent cover the advertising and privacy side.

Series, Package and Financial Terms

Biostimulators are often sold as a plan rather than a single visit, and money is where many disputes actually start. A patient who stops midway, moves away, develops a contraindication or simply loses patience will want to know what happens to what they paid. If the answer is not in writing and signed, it becomes an argument.

What the terms should cover

• What is included. The product, visits and follow-up the price covers, described in the treatment plan rather than as a promised outcome.
• No result guarantee. That payment is for treatment, not for a particular appearance, and that the number of visits recommended may change.
• Stopping early. What happens to unused visits or product if the patient stops, or if the practitioner decides further treatment is not appropriate.
• Touch-ups and additional areas. Whether they are included, charged separately, or consented separately.
• Refunds and expiry. The practice's policy, or a reference to it, with the patient's signature that they received it.

Package terms, prepayment and refunds raise contract and consumer-protection questions that vary by state, so counsel should approve the wording. Many practices keep the full terms in a separate treatment-plan agreement and have the consent form refer to it, which keeps the clinical document readable. What matters is that the patient signed both before the first visit.

Keep the money away from the risks

Do not place payment terms inside the risk section, and do not ask for payment before the consent conversation. A patient who has already paid for a package may feel committed to proceeding even after hearing something that worries them, and a reviewer may read the sequence as pressure.

Signatures, Attestation and the Session Log

The signature page of a biostimulator consent has more to do than the one on a single-visit form, because it has to cover visits that have not happened yet.

The first-visit signature block

The patient's first-person attestation that they read the form, asked their questions, had them answered and agree to proceed; patient signature and date; the printed name, credentials and signature of the clinician who conducted the consent conversation; the same for the treating injector if a different person; a witness if your policy calls for one; and the form version. Whether a witness is required is a question for your state's rules and your counsel.

The session re-confirmation log

Our biostimulator guide says consent should be signed before the first session and re-confirmed at each session in a series. A simple table at the end of the form makes that routine. Each row records the visit date, the product and areas for that visit, a yes/no answer to "has anything changed in your health, medications or the previous treatment area since your last visit," patient initials, and practitioner initials. A "yes" triggers review and, where material, a fresh full consent. Many practices simply have the full form signed again at every visit, which is equally sound; what matters is that a policy exists and is followed.

Who Should Obtain Biostimulator Consent?

The consent conversation belongs to a practitioner who can answer clinical questions about the product: the injector who will treat, or the clinician whose examination led to the treatment order. It should not be handed to a front-desk coordinator or a sales consultant, however well briefed. Biostimulator questions tend to be specific, such as what happens if a lump appears or why the result cannot be reversed, and a patient who received confident but wrong answers has a strong argument that consent was never informed.

Who may lawfully order, inject and supervise a biostimulator is set by each state and depends on license type, supervision and delegation rules, so there is no national answer, and this template does not attempt one. Our guide to who can inject in the United States explains how those rules generally work, while our regulations by state hub summarizes each state's framework. Whatever your state allows, the form's signature lines should match who actually examined, consented and treated the patient, and your delegation documents should match the form. Our guide to good-faith exam requirements covers where the examination fits.

Warning Signs and Emergency Wording

Biostimulator warning signs fall into two groups, and the form should present both. The first is the immediate group shared with any facial injectable: severe or worsening pain, skin turning pale, dusky or mottled, a treated area that feels cold, blistering, any change in vision, severe headache, facial swelling or difficulty breathing. These need an immediate call or emergency care. The second is the delayed group that is particular to biostimulators: a new lump, firmness, redness, warmth or tenderness at a treated site, whenever it appears, including after the series has finished.

The emergency wording should explain that a written emergency plan exists and that the patient could be sent to a hospital if needed, give an after-hours contact that actually answers, and avoid describing the clinical response. It should not mention dissolving as part of that response. The clinical side of recognizing and escalating vascular events belongs in your protocols; our vascular occlusion guide and filler complications guide cover that ground. The aftercare handout itself is covered in our aftercare instructions template guide.

Common Biostimulator Consent Mistakes

Each of these shows up in complaints because each leaves a specific question without a documented answer.

The HA form, renamed

A filler consent with "Sculptra" typed into the product line still says what a filler consent says, often including a sentence that the result can be dissolved. That one sentence turns an irreversibility dispute into a misrepresentation claim.

A combined form with no product selected

Listing PLLA and CaHA side by side without marking which one was used leaves the patient free to say they did not know what was injected, and leaves the practice unable to show which product-specific warnings applied.

A timeline or session count printed on the form

Any number on the consent, whether visits, weeks or months of duration, becomes the benchmark the patient measures the practice against. Describe the pattern; leave the specifics to the practitioner's notes for that patient.

Delayed reactions mentioned only in passing

A form that lists "lumps" among the common reactions, or that never says a nodule can appear long after treatment, gives no support when a patient returns many months later. Name delayed nodules and granulomas as serious risks in their own right.

Massage required, never acknowledged

If your protocol includes a home massage routine and the patient never signed for the instructions, the practice cannot show it did its part when a nodule develops.

Consent signed once for the whole series

A single signature at the first visit, with no record of re-confirmation, cannot show that the patient's health was checked or that they still agreed at the later visits.

Product prepared before consent was signed

Where a protocol involves preparing product before the appointment, the patient may feel the decision has already been made for them. The consent should be complete before the patient is told anything has been prepared, and the patient should be free to decline even then.

Record Retention for Biostimulator Consent

The signed consent, the session log and any acknowledgment sheets belong to the medical record, so they are kept for as long as the rest of the chart must be. That period is set by state law and other obligations that differ from place to place, which is why no period appears here. Our medical records retention guide explains how to set yours.

Two habits make biostimulator records easier to defend. Keep every document for a series together, so the consent, each session entry, the product and lot used, the photographs and any follow-up can be read as one story. And keep the superseded versions of your template with the date each went into use, because a reaction that surfaces long after treatment will be judged against the form the patient signed, not the one you use today.

Keeping the Form and Your Biostimulator SOPs Aligned

The consent form is the patient's view of risks your SOPs manage for the practice, so the two must say the same thing. Run a short check whenever either changes. Does every risk your nodule pathway anticipates appear on the form? Does the form promise follow-up that your scheduling actually provides? If the form refers to a massage sheet or a preparation standard, does that document exist, signed and current? Does anything on the form imply a reversal option your emergency protocol does not have?

Labeling changes are a particular trigger. Our compliance guide notes that PLLA preparation guidance has changed more than once, and any such change should prompt a review of the form as well as the SOP. Record the review in your version log even when the wording stays the same. Our injectables safety and compliance guide places this form inside the broader injectables program, and the FDA dermal fillers resource is the federal starting point for the labeling documents your medical director checks against.

Key Takeaways

• A biostimulator consent shares the filler skeleton but records a different decision: a gradual, possibly multi-visit treatment with no enzyme to undo it.
• Name the product and its generic material, PLLA or CaHA, and complete only the acknowledgment block for the product used.
• Make the irreversibility statement prominent, boxed and initialled, and never pair it with reassurance.
• Disclose early nodules, delayed nodules and granulomas separately, and tell the patient to report a new lump at any time.
• Include massage and preparation acknowledgments only if your protocol includes them.
• Describe results and series in general terms; print no session counts or timelines.
• Put series and payment terms in writing, signed before the first visit and kept apart from the risk section.
• Take clinical photographs at every visit under the treatment consent, and handle marketing use separately.
• Re-confirm consent at each session with a logged health check.
• Your medical director approves the wording against current labeling, and counsel reviews it against your state's rules.

General information about how a biostimulator consent document is structured; not medical or legal advice, and not a statement of any state's law. Sculptra and Radiesse are trademarks of their respective owners, named for identification only. Your medical director approves the form against current labeling and a healthcare attorney licensed in your state reviews it before use.