Forbidden areas for HIFU therapy: How to avoid complications?

1. What is HIFU and why are there limitations?

HIFU (High-Intensity Focused Ultrasound) is a non-invasive technology that uses focused ultrasound waves to stimulate collagen synthesis and achieve a lifting effect. HIFU generates strong thermal energy, which requires strict adherence to restrictions when treating certain areas.

According to FDA (2019), incorrect application of HIFU can lead to temporary or even permanent side effects.

2. Prohibited areas where HIFU is contraindicated

2.1. Area around the eyes

• Anatomy: Thin skin (<2 mm), close to the eyeball
• Risks:
  • Injury to the orbicularis oculi muscle
  • Temporal asymmetry (in 3% of cases, Aesthetic Surgery Journal, 2020)
  • Dry eyes, drooping eyelids, visual disturbances
• Source: PubMed, 2020

2.2. Thyroid gland

• Risks:
  • Disorders in hormonal function
  • Damage to glandular tissue
• Source: Journal of Cosmetic Dermatology, 2021 (ScienceDirect)

2.3. Lateral part of the neck

• Anatomy: Facial nerves, large blood vessels (e.g. external jugular vein)
• Risks:
  • Neuritis
  • Thrombosis
• Source: Plastic and Reconstructive Surgery, 2018 (NCBI)

2.4. Midline of the face (nose, hump)

• Risks:
  • Uneven result
  • Pain due to bone energy absorption
• Source: Ultherapy White Paper, 2022

2.5. Bony prominences (cheekbones, jaw)

• Risks:
  • Periosteal injury
  • Intense pain
• Source: Ultrasound in Aesthetic Medicine, Schonauer, 2021

2.6. Pigmented lesions (birthmarks, melanomas)

• Risks:
  • Stimulation of pigment or tumor cells
• Source: FDA Recommendations, 2019

3. Conditionally permitted areas (subject to strict conditions)

3.1. Upper eyelid

• Conditions:
  • Depth ≤ 4 mm
  • Reduced energy ≤ 0.5 kJ
• Source: Dermatologic Surgery, 2023

3.2. Neck (excluding midline)

• Conditions:
  • Reduced energy ≤ 0.5 kJ
• Source: Dermatologic Surgery, 2023

4. Key safety factors

4.1. Qualification of the therapist

• Special HIFU training
• Certificate from a recognized institution
• Source: FDA Guidelines

4.2. Equipment quality

• Recommended devices: Ultherapy, Ultraformer III, Doublo
• Source: Aesthetic Surgery Journal, 2022

4.3. Preliminary assessment of the patient

• Skin analysis
• Marking risk areas before the procedure

5. Alternatives for risk areas

For the eye area:

• Radiofrequency therapy (RF)
• Microcurrent therapy
• Advantage: controlled depth of impact

For pigmented lesions:

• Laser therapy
• Cryotherapy

6. Frequently Asked Questions

Is it possible for HIFU to cause permanent nerve damage?
Yes – especially with improper treatment of the neck and the area above the collarbone.
Source: Plastic and Reconstructive Surgery, 2018

Why is the midline of the face risky?
Due to the absorption of energy by the bones, which can lead to pain and uneven results.
Source: Ultherapy, 2022

7. Conclusion and recommendations

• HIFU is an effective method for non-surgical lifting, but:
• Requires strict adherence to contraindications
• Should only be performed by qualified professionals
• It requires high-quality equipment and an individual approach

• Advice to customers:
• Always require qualification documents
• Check the equipment and certificates
• Don't hesitate to ask questions.

8. Additional resources and scientific literature

Sources:

• "Safety and Efficacy of High‑Intensity Focused Ultrasound in Aesthetic Medicine", Dermatologic Surgery, 2015 – review of clinical data on the safety and effect of HIFU in different dermal and subcutaneous areas
• "Consensus Recommendations for Aesthetic Use of HIFU in Asians", Journal of Cosmetic and Laser Therapy, 2018 – safety recommendations and treatment areas in the Asian population.

Databases:

• PubMed
• ScienceDirect

Regulatory authorities:

• FDA (USA)
• EMA (EU)