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 energy absorption 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
✔️ 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
- "Consensus Recommendations for Aesthetic Use of HIFU in Asians" - Journal of Cosmetic and Laser Therapy, 2018
Databases:
- PubMed
- ScienceDirect
Regulatory authorities:
- FDA (USA)
- EMA (EU)