Vaginal rejuvenation by HIFU. Mechanism, clinical data and reliability analysis

1. Chronology and origin of the method

HIFU technology is not new, it has been used successfully in medicine for years, including in urology and oncology. Its application in aesthetic gynecology has been developing over the last decade.

Although it is not possible to specify an exact date of introduction, the boom in popularity and commercialization of vaginal HIFU, along with other energy devices (lasers and RF), is observed after 2014-2015 This is the period in which the market begins to actively offer non-surgical solutions for vaginal rejuvenation.

2. Индикации за прилагане на HIFU метода

Vaginal HIFU targets issues that arise as a result of aging, childbirth, and hormonal changes (e.g. menopause). This method promises to address the following underlying conditions:

1. Vaginal laxity: A common condition after normal childbirth that can reduce sexual satisfaction.
2. Mild stress urinary incontinence (SUI): Leakage of urine during physical exertion (coughing, sneezing, laughing) due to weakening of the pelvic floor muscles.
3. Symptoms of atrophy: Relieving vaginal dryness, irritation and pain during intercourse (Dyspareunia) associated with hormonal changes.

3. Main manufacturers and market trend

Since HIFU technology does not require a patent for the principle itself, many companies around the world offer devices with vaginal tips. The market is dominated by manufacturers who offer multifunctional and accessible platforms.

The promise of the method: The main promise that manufacturers and clinics make is non-surgical "rejuvenation" of the vaginal tissue, achieved by stimulating the collagen and elastin, leading to tightening and functional improvement with minimal downtime and recovery period.

Despite these promises, it is critically important to emphasize that these indications have not been unconditionally approved by regulatory authorities such as the FDA, which will be discussed in detail in the following sections.

4. Performing vaginal HIFU. Equipment and requirements for the doctor

The vaginal HIFU procedure is energy-based therapy, which requires a high degree of precision. Vaginal HIFU is performed with a specialized HIFU device, which differs from those for face and body lifting mainly in its vaginal tip (cartridge).

1. Specialized tip: The tip is designed to be inserted into the vaginal canal and emit the ultrasonic energy into roundabout around the vaginal wall.
2. Working principle: The tip is positioned precisely using different depths of focus – usually 3.0mm (for the mucous membrane) and 4.5 mm (for the muscle layer).
3. Execution: The procedure usually lasts between 20 and 40 minutesBecause it is non-invasive, no anesthesia is required, and the patient may feel a slight warming or tingling sensation. There is no recovery period required.

Requirements: Professional responsibility

As technology creates controlled thermal damage in the deep tissue layers, the qualification of the specialist is the main guarantor of safetyImproper application can directly lead to the serious risks indicated by the FDA (burns, scars, chronic pain).

Although HIFU is a non-invasive procedure, its application is medical certificatePatients should avoid centers that offer the procedure performed by non-medical personnel, as this directly violates professional standards and compromises safety.

5. Professional control and accessibility

Why is HIFU applied by beauticians, while other technologies require medical personnel??

Technologies such as CO2 lasers, Erbium YAG lasers, Radio Frequency (RF) and PRP injections are considered safe to use only by a medical professional (doctor or nurse).

Unlike them, HIFU (High Intensity Focused Ultrasound) can be applied by beauticians (beauty therapists), often with minimal training in a field in which they have no prior experience.

Here is an explanation for this contrast:

A. Availability and cost of HIFU

The main reason for the wider application of HIFU by non-medical personnel is rooted in financial and practical factors:

• Low initial cost and easy accessibilityThe popularity of HIFU is due to its significantly lower initial price of the device compared to other technologies and its easy accessibility for practitioners.

• Marketing and revenue growthThis accessibility makes it attractive to cosmetic clinics that want to take advantage of market trends and increase their revenues.

B. Why do other technologies require medical personnel?

Other technologies, particularly lasers and radiofrequency (RF) devices, require a high degree of medical expertise due to the potential risks and the need for accurate diagnosis and control of the energy:

• Lack of standardization and warnings from the FDA: In July 2018, the U.S. Food and Drug Administration (FDA) issued a public warning regarding the use of energy-based devices (EBDs) for vaginal rejuvenation or cosmetic procedures, emphasizing that has not approved their use for any specific gynecological indicationsThe FDA has expressed concern about uncontrolled application of lasers and other ECUs by medical professionals and non-medical professionals without clear medical indications.

• Risk of complications: The FDA noted that there have been reports serious complications, including vaginal burns, scarring, pain during intercourse, and chronic pain.

• Depth of penetration and mechanism of action: Radiofrequency devices deliver energy to the deeper connective tissue on the vaginal wall, while the laser devices deliver energy, creating consistent microtraumasHIFU also reaches deep tissue layers (such as SMAS), but other methods such as lasers work mostly at the surface level.

• Need for expertise: The lack of standardized criteria for patient selection and training makes the need for qualified medical personnel (who are familiar with anatomy and pathology) necessary. primary.

6. Клинична ефективност и надеждност

The effectiveness of HIFU has been evaluated in several surveys that use mostly subjective sensations, and long-term safety has not been proven:

• The results are recorded by self-reported questionnaire (self-assessment), which introduces subjective biasThe study no control group.

• These data support the mechanism of action (neocollagenesis), but do not replace the lack of RCTs (Randomized Controlled Trials).

• Small sample and lack of a control group are major limitations. Potential bias in the selection.

7. Opinions on the safety of HIFU

Official warnings and statements

The scientific community, represented by leading urogynecological societies, does not support the routine use of HIFU without more evidence.

• FDA Warning (2018): The U.S. Food and Drug Administration (FDA) has issued a public warning that it has not approved HIFU or other EBUs. for any specific gynecological indications such as symptoms of menopause, vaginal laxity or UI.
• AUGS (2022): The AUGS (American Urogynecological Society) clinical statement notes that lack of evidence is the reason why many statements about EBUs (energy-based devices) have not reached consensus.
• Long-term side effects: There are concerns that HIFU concentrates a significant amount of energy on the basal lamina of the epithelium, which may lead to disruption of the main network of the vaginal tissue. In the long term, this can lead to deterioration of the epithelium, potentially ending with prolapse of vaginal tissue.
• Medical evaluation requirement: Even when HIFU is applied, consultation with a sexual health specialistIn specialized clinics, vaginal HIFU treatment is performed by obstetrician-gynecologist, and it is emphasized that the procedure requires responsibility, technical training and professional ethics.

Sources used to create the article on vaginal rejuvenation using HIFU and energy-based devices: