Safety & Education

Dermal Filler Safety: What Every Australian Patient Must Know

Essential safety guide for dermal filler treatments in Australia. Learn about TGA-approved products, 16% adverse event rates, emergency protocols, and how to minimise risks.

Dr. Rebecca Thompson, MBBS, FRACGP, Dip. Aesthetic Med5 August 20259 min read1,699 words
dermal fillers
safety
complications
tga
risk management
patient education

Dermal Filler Safety: What Every Australian Patient Must Know

With dermal filler treatments increasing by 40% annually across Australia, understanding safety considerations has never been more critical. Recent studies indicate that up to 16% of dermal filler treatments result in some form of adverse event, ranging from minor bruising to serious vascular complications.

This comprehensive safety guide empowers Australian patients with evidence-based information about dermal filler risks, TGA-approved products, and emergency protocols, ensuring you can make informed decisions about your aesthetic treatments.

Understanding the 16% Adverse Event Rate

Recent peer-reviewed research published in the Australasian Journal of Dermatology reveals that adverse events occur in approximately 16% of all dermal filler treatments. Understanding this statistic is crucial for informed consent.

Breakdown of Adverse Events

Minor Events (14.5%)

  • Bruising and swelling
  • Temporary lumps
  • Mild asymmetry
  • Injection site reactions

Moderate Events (1.3%)

  • Persistent nodules
  • Infection
  • Allergic reactions
  • Migration of product

Severe Events (0.2%)

  • Vascular occlusion
  • Tissue necrosis
  • Vision impairment
  • Systemic reactions

⚠️ Dermal Filler Safety Statistics

Overall Risk Rates:

  • • Total adverse events: 16%
  • • Minor complications: 14.5%
  • • Serious complications: 0.2%
  • • Vascular occlusion: 1 in 6,410
  • • Blindness: 1 in 98,000

High-Risk Factors:

  • • Previous filler complications
  • • Autoimmune conditions
  • • Blood clotting disorders
  • • Unqualified practitioners
  • • Non-TGA approved products

*Data from Australian adverse event reporting 2020-2025

TGA-Approved Dermal Fillers in Australia

The Therapeutic Goods Administration (TGA) regulates all dermal fillers in Australia as Class III medical devices. Only TGA-approved products should be used for treatments.

Currently Approved Hyaluronic Acid Fillers

Allergan (AbbVie)

  • Juvederm Ultra Series
  • Juvederm Voluma
  • Juvederm Volift
  • Juvederm Volbella
  • Juvederm Volux

Galderma

  • Restylane Classic
  • Restylane Lyft
  • Restylane Refyne
  • Restylane Defyne
  • Restylane Kysse

Merz Aesthetics

  • Belotero Balance
  • Belotero Intense
  • Belotero Volume
  • Belotero Lips

Teoxane

  • Teosyal RHA Collection
  • Teosyal Ultra Deep
  • Teosyal Kiss

Non-Hyaluronic Acid Fillers

Collagen Stimulators

  • Sculptra (poly-L-lactic acid)
  • Radiesse (calcium hydroxylapatite)
  • Ellanse (polycaprolactone)

Permanent Fillers

  • Note: No permanent fillers are currently TGA-approved due to safety concerns

Identifying Non-Approved Products

Red flags for unapproved fillers:

  • No Australian packaging
  • Missing ARTG numbers
  • Unusually low prices
  • Practitioner reluctance to show packaging
  • Online or overseas purchases

Common Complications and Their Management

Immediate Complications (0-24 hours)

Bruising and Swelling

  • Incidence: 40-60% of treatments
  • Management: Ice, arnica, avoiding blood thinners
  • Resolution: 3-14 days

Pain and Tenderness

  • Incidence: 30-40%
  • Management: Paracetamol, cool compresses
  • Resolution: 2-5 days

Vascular Compromise Signs

  • Blanching (white discolouration)
  • Severe pain
  • Mottled skin
  • Action: IMMEDIATE medical attention required

Early Complications (1-14 days)

Infection

  • Incidence: 0.1-0.5%
  • Signs: Increasing pain, redness, warmth, pus
  • Management: Antibiotics, possible drainage
  • Prevention: Sterile technique, avoid makeup 24 hours

Allergic Reactions

  • Incidence: less than 0.1%
  • Signs: Widespread redness, itching, swelling
  • Management: Antihistamines, corticosteroids
  • Severe cases: Emergency department

Late Complications (>14 days)

Nodules and Granulomas

  • Incidence: 0.5-1%
  • Presentation: Firm lumps, may be inflamed
  • Management: Hyaluronidase, steroids, antibiotics
  • Resolution: Weeks to months

Product Migration

  • Incidence: 0.1-0.3%
  • Risk factors: Over-injection, wrong product choice
  • Management: Hyaluronidase dissolution
  • Prevention: Appropriate volumes and techniques

Emergency Protocols: What to Do

Vascular Occlusion Emergency

Immediate Signs

  1. Severe pain disproportionate to procedure
  2. Blanching (white/pale skin)
  3. Livedo reticularis (mottled pattern)
  4. Slow capillary refill

Emergency Actions

  1. Stop injection immediately
  2. Massage area vigorously
  3. Apply warm compress
  4. Inject hyaluronidase urgently
  5. Consider aspirin
  6. Transfer to emergency if needed

Vision Loss Protocol

Warning Signs

  • Sudden vision changes
  • Eye pain
  • Ptosis (drooping eyelid)

Immediate Response

  1. Call 000 immediately
  2. Lie patient flat
  3. Administer hyaluronidase if available
  4. Document time and symptoms
  5. Immediate hospital transfer

Anaphylaxis Response

Symptoms

  • Difficulty breathing
  • Swelling of throat/tongue
  • Rapid pulse
  • Dizziness/fainting

Actions

  1. Call 000
  2. Administer adrenaline if available
  3. Lie patient flat, elevate legs
  4. Monitor vital signs
  5. Be prepared for CPR

Risk Minimisation Strategies

Pre-Treatment Assessment

Medical History Review

  • Previous filler treatments and reactions
  • Autoimmune conditions
  • Bleeding disorders
  • Current medications
  • Allergies

Contraindications to Consider

  • Active skin infections
  • Pregnancy/breastfeeding
  • Immunosuppression
  • Recent dental work
  • Blood thinners (relative)

Choosing a Safe Practitioner

Essential Qualifications

  • AHPRA registration verified
  • Specific filler training completed
  • Emergency protocols in place
  • Hyaluronidase immediately available
  • Professional indemnity insurance

Clinic Safety Standards

  • Sterile treatment environment
  • Emergency equipment on-site
  • Clear consent process
  • Photographic documentation
  • 24/7 emergency contact

Treatment Day Precautions

Pre-Treatment

  • Avoid alcohol 24 hours prior
  • Discontinue blood thinners (with medical approval)
  • No active cold sores
  • Clean face, no makeup
  • Inform about all medications

Post-Treatment

  • No strenuous exercise 24 hours
  • Avoid extreme temperatures
  • No facial treatments 2 weeks
  • Sleep elevated first night
  • Follow specific aftercare instructions

Understanding Hyaluronidase: The Safety Net

Hyaluronidase is an enzyme that dissolves hyaluronic acid fillers, serving as a crucial safety tool.

Key Facts About Hyaluronidase

  • Rapidly dissolves HA fillers
  • Effects seen within hours
  • Multiple injections may be needed
  • Not effective for non-HA fillers
  • Can cause allergic reactions (rare)

When Hyaluronidase is Used

  • Vascular occlusion
  • Over-correction
  • Product migration
  • Lumps and nodules
  • Patient dissatisfaction

Frequently Asked Questions

What are the most serious risks with dermal fillers?

The most serious risks include vascular occlusion (blockage of blood vessels) which can lead to tissue death, and in extremely rare cases, blindness. These occur in approximately 1 in 6,410 and 1 in 98,000 treatments respectively. Choosing qualified practitioners who understand facial anatomy and have emergency protocols significantly reduces these risks.

How can I verify if my practitioner is using TGA-approved fillers?

Ask to see the product packaging before treatment - all TGA-approved fillers have an ARTG number starting with 'AUST R' followed by 6 digits. You can verify this number on the TGA website. Reputable practitioners will happily show you the sealed product packaging and lot numbers.

What should I do if I experience complications after hours?

Every clinic should provide 24/7 emergency contact details. For serious complications like severe pain, vision changes, or skin discolouration, go immediately to your nearest emergency department. Take photos of the affected area and bring details of the product used and practitioner information.

Are dermal fillers safe if I have an autoimmune condition?

Patients with autoimmune conditions have higher risks of complications including inflammatory reactions and granuloma formation. While not absolutely contraindicated, you need thorough consultation with both your specialist and cosmetic practitioner. Some practitioners may decline treatment based on individual risk assessment.

How long should I wait between different filler treatments?

Generally, wait at least 2 weeks between treatments in different areas, and 4 weeks for the same area. This allows time to assess results and ensure no delayed reactions occur. For different types of fillers, longer intervals may be recommended. Always inform your practitioner about recent treatments.

Long-Term Safety Considerations

Filler Accumulation

  • MRI studies show fillers can persist years beyond expected
  • Repeated treatments may lead to product buildup
  • Consider treatment breaks
  • Regular assessment of facial volume

Immunological Concerns

  • Repeated exposure may increase sensitivity
  • COVID-19 vaccine reactions reported
  • Delayed inflammatory reactions possible
  • Maintain treatment records

Aging Considerations

  • Facial anatomy changes over time
  • Previous safe areas may become higher risk
  • Regular practitioner review essential
  • Consider alternative treatments with age

Making Informed Decisions

Questions to Ask Before Treatment

  1. What specific product will be used?
  2. Can I see the product packaging and ARTG number?
  3. What is your experience with this treatment area?
  4. Do you have hyaluronidase on-site?
  5. What is your emergency protocol?
  6. Can I contact you 24/7 post-treatment?
  7. What are the specific risks for my anatomy?
  8. How many syringes do you anticipate needing?

Red Flags to Avoid

  • ❌ Practitioners who minimise risks
  • ❌ No consultation before treatment
  • ❌ Pressure to treat immediately
  • ❌ Extremely low prices
  • ❌ Home or hotel treatments
  • ❌ No discussion of complications
  • ❌ Reluctance to show credentials

Medical Disclaimer

This information is for educational purposes only and does not replace professional medical advice. Dermal fillers are prescription medical devices requiring assessment by qualified healthcare practitioners. Individual risks vary based on medical history, anatomy, and treatment areas. Always consult with AHPRA-registered practitioners and seek immediate medical attention for any concerning symptoms. Statistics cited are from published medical literature and may not reflect individual risk.

Find Safety-Conscious Practitioners on Evolou

Prioritise safety with Evolou's vetted network of dermal filler practitioners:

  • ✓ All practitioners AHPRA-verified
  • ✓ TGA-approved products only
  • ✓ Emergency protocols confirmed
  • ✓ Complication management expertise
  • ✓ Transparent safety discussions
  • ✓ 24/7 aftercare support

Find Safe Practitioners →

Your safety is paramount. Whether seeking treatment in Sydney, Melbourne, Brisbane, Perth, or regional Australia, Evolou connects you with practitioners who prioritise safety, use only TGA-approved products, and maintain the highest clinical standards.

References

  1. Australasian College of Dermal Therapists. (2025). "Dermal Filler Adverse Events: A Comprehensive Analysis." ACDT Safety Report.

  2. Therapeutic Goods Administration. (2025). "Medical Device Safety Update: Dermal Fillers." TGA Safety Communication.

  3. Fitzgerald, R., et al. (2023). "Adverse Events in Facial Aesthetics: A Global Registry Study." Aesthetic Surgery Journal, 43(6), 678-690.

  4. Australian Society of Plastic Surgeons. (2025). "Clinical Guidelines for Dermal Filler Safety." ASPS Position Statement.

  5. Wang, L.L., et al. (2023). "Vascular Complications from Facial Fillers: Prevention and Management." Australasian Journal of Dermatology, 64(2), 145-156.

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