Dermal fillers – Information for consumers and clinics

This page is for consumers of dermal fillers. It also has information for individuals administering dermal fillers.

We also explain what clinics, and others administering dermal fillers, should consider before administering or buying them.

What are dermal fillers?

Dermal fillers are gel-like substances that are injected under the skin to plump areas such as the lips and cheeks, in order to change appearance.

What are the risks of dermal fillers?

Injecting dermal fillers is an invasive procedure and it carries risk.

Some side effects can occur immediately after the injection, while some may develop later.

Common side effects include:

• Bruising
• Swelling
• Pain
• Lumps
• Rashes

Less common and more severe side-effects include:

• Blindness
• Stroke
• Infection
• Allergic reaction
• Scarring

Going to a qualified and experienced healthcare professional may reduce some of these risks.

If you had a side effect from dermal fillers, contact your doctor immediately. A delay in seeking treatment could result in serious harm and permanent injury.

Rare side effects of some COVID-19 vaccines can occur in people with facial fillers. For more information, please visit the HSE website.

How do I report a suspected side effect?

If you think you have experienced a side effect from dermal fillers, please let us know by completing our online report form. You can also contact us by email at devicesafety@hpra.ie.

Anyone can report suspected side-effects from a product to us.

By reporting suspected side effects, you can help us to identify and address safety concerns.

What should I consider before getting dermal fillers?

When considering dermal fillers, we recommend you:

• Do not get dermal fillers if you are under the age of 18.
• Make sure you are aware of the risks.
• Go to a qualified healthcare professional, such as a doctor, experienced in administering them. Doctors are best placed to discuss risks and to treat side effects.
• Ask about after-care and the ability to manage and treat side effects.
• Ask the person administering the dermal fillers if they are buying their products from a trustworthy source.
• Ask the person administering your dermal fillers about their qualifications and experience in administering them.
• Make sure you report suspected side-effects to your doctor.

What should I consider if I am administering dermal fillers?

Before administering dermal fillers, you should:

• Ensure you have the expertise to carry out this procedure, and to provide necessary aftercare.
• Tell clients or patients about possible risks and side effects.
• Tell clients they may need medical attention from a qualified healthcare professional.
• Ensure you are sourcing genuine dermal fillers from reputable suppliers.
• Review your products and work with suppliers to minimise the risk of unsafe products entering the supply chain.
• Keep up to date with relevant regulatory requirements.

What should I consider if I am buying dermal fillers?

If you are buying dermal fillers, we recommend you:

• Buy from a reputable source.
• Request a declaration of conformity document.
• Check if the product has a CE mark.
• Ensure there is an EU authorised representative and importer (e.g., an EU address) on the label for products imported from outside the EU.
• Ensure the label has manufacturer contact details.
• Ensure the product is sterile and has a sterile symbol.
• For CE marked dermal fillers, ensure there is a notified body 4-digit code under the CE mark.
• Ensure product information is in English.
• Ask for more information if in doubt of anything.
• Report any non-compliant devices to us using our online report form.

We are aware of fake dermal fillers on the EU market. This is concerning because:

• Their safety and quality cannot be assured.
• They may not have had the required testing to make sure they are safe.
• They could contain harmful chemicals or contaminants.

What is the HPRA’s role for dermal fillers?

Our role in regulating dermal fillers is to ensure that those available in Ireland are safe.

After a product has been placed on the Irish market, we carry out market surveillance and vigilance activities. 

We do not have a role in regulating the administration of dermal fillers or in clinical practice/qualifications. Similarly we do not have a role in the licensing of facilities or users that are administering dermal fillers.

We are continuing to work with the Department of Health on the regulation of dermal fillers. We submitted a policy paper to the Department of Health for review and consideration. This paper describes possible options to strengthen existing controls for dermal fillers on the Irish market.