Fillers and Anvisa: how to verify the product

Every filler sold in Brazil has — or should have — a registration with Anvisa, the country's health regulator. Injectable products for aesthetic use are regulated medical devices, and they need an active registration to be marketed and used here.

This is not bureaucracy. The registration is what confirms the product has passed an assessment of quality, safety and traceability — and it is what makes it possible to know exactly what is being put into your face.

Why a product with no traceable origin is a real risk

An unregistered product may carry:

• A composition different from the one declared, including substances that have no business being there
• Microbiological contamination, from a failure in manufacturing or storage
• No traceability, which makes it impossible to identify the source if something goes wrong
• Improper conservation during transport and storage

And there is one consequence almost nobody considers: if the product is not what it claims to be, management of a complication is compromised. Hyaluronidase dissolves hyaluronic acid. If what was injected was something else, the antidote does not work — and nobody will know that until the emergency happens.

Fillers and Anvisa: how to verify

Before the procedure

Ask for the product's brand name. Not "hyaluronic acid" — the brand.

Look it up on Anvisa's public product search. The search is public and free. Look for the product name or the company that holds the registration, and confirm the status is active.

Ask whether the product is in stock at the clinic. A product ordered on demand, with no stock of its own, deserves attention as to the transport chain.

On the day

Ask to see the sealed packaging and to have it opened in front of you. That is your right.

Check:

• Product name, matching what you were told
• Batch number and expiry date visible
• Labelling in Portuguese, with the details of the registration holder
• Intact packaging, with no sign of tampering

A vial or syringe that is already open is reason to stop. Not because the practitioner is necessarily doing something wrong, but because you have no way to verify.

Afterwards

Ask for the batch to be recorded in your chart. Many clinics stick the peel-off label from the packaging onto the record, and that is the correct practice.

Keep that information. If years later you need a correction, an investigation or a second opinion, knowing exactly what was used changes everything.

Warning signs about a product's origin

• A price well below market. The cost of the material in a registered product has a floor. Below it, something was cut.
• Refusing to name the brand or to show the packaging.
• Product brought in from abroad by the practitioner personally. Irregular importation has no chain control and no traceability.
• A label only in a foreign language, with no national registration.
• Splitting a product between patients. Injectable syringes and vials are single-patient use.
• Treatment outside a clinical setting, where neither proper storage nor emergency support exists.

Fillers and Anvisa: the same goes for toxin

The same reasoning applies to botulinum toxin, with one aggravating factor: it requires refrigerated storage within a specific range.

A product that has been through a break in the cold chain may have reduced activity — which shows up as "the Botox didn't work", and the person never finds out why.

Asking how the product is stored is legitimate.

When we don't go ahead

• With a product whose active registration cannot be verified.
• With packaging already opened, or with no legible batch number and expiry date.
• With product left over from a previous patient's treatment.
• When someone brings their own product, bought on their own. The conservation chain cannot be attested to.
• Outside a clinical setting.

Frequently asked questions

How do I know if a filler is approved by Anvisa?

By searching the product name on Anvisa's product search site, which is public and free, and confirming the registration status is active.

Can I ask to see the packaging?

You can, and it is good practice. Watching a sealed product being opened in front of you is reasonable and common.

What is batch traceability?

It is being able to identify exactly which unit of the product was used on you. It serves investigation in the event of a complication, and recall, if there is one.

Is an imported product better?

Not by virtue of being imported. What matters is an active national registration, which is what guarantees control of the chain. A product brought in from abroad without it has no such control.

What if I've already had treatment and don't know which product was used?

Request a copy of your chart from the clinic — you are entitled to it. If that is not possible, say so clearly at any future assessment.