Radiofrequency with Microneedling: DANGER⚠️?

https://www.fda.gov/medical-devices/safety-communications/potential-risks-certain-uses-radiofrequency-rf-microneedling-fda-safety-communication

⚠️ The U.S. Food and Drug Administration (FDA) has recently issued a safety communication regarding certain radiofrequency microneedling devices, following multiple reports of serious adverse effects — including burns, subcutaneous fat loss, nerve damage, and permanent scarring.

It is important to emphasize that radiofrequency combined with microneedling is a true medical procedure, and must not be confused with a simple cosmetic treatment.Like all energy-based treatments (laser, ultrasound, radiofrequency), it must be performed by an experienced physician, trained in facial anatomy and in the safe management of energy parameters according to each patient’s skin type and treatment area.

🔍 Summary of the risks and complications reported to the FDA:

1. Major Thermal and Skin Risks

Because the procedure combines microneedles with the thermal energy of radiofrequency, the risk of heat-induced injury is significantly increased if parameters are not properly controlled.

• Thermal Burns:Burns ranging from superficial to deep (dermo-epidermal), occasionally requiring complex wound care or even surgical debridement.

• Scarring:Development of permanent scars, including hypertrophic or keloid scars, when the thermal injury is too intense.

• Fat Atrophy (Lipoatrophy):Unwanted loss of subcutaneous fat (lipolysis), which can create a hollowed or distorted appearance, especially on the cheeks or temples.

2. Neurological and Structural Risks

When radiofrequency microneedling is applied at excessive depths or energy levels, it may affect deeper anatomical structures.

• Nerve Injury:Reported cases include nerve damage leading to numbness (anesthesia) or abnormal sensations (dysesthesia), potentially due to overly deep penetration or excessive energy delivery in facial areas near nerve branches.

• Facial Disfigurement:Resulting from a combination of scarring, atrophy, or pigmentary changes.

3. Other General Risks (Common to All Microneedling Procedures)

All standard microneedling risks apply as well — and may be amplified in cases of poor technique or inadequate hygiene:

• Infection:Higher risk if needle cartridges are reused or aseptic protocols are not followed.

• Post-Inflammatory Hyperpigmentation (PIH):More common in darker skin types (Fitzpatrick IV–VI) due to a strong inflammatory response.

• Herpes Reactivation:Cold sore flare-ups may occur post-treatment in predisposed patients.

FDA Recommendations for Clinicians

The FDA emphasizes the critical role of the treating physician in minimizing these risks:

• Comprehensive Evaluation:Carefully assess treatment parameters (needle depth, energy level, pulse duration) for each patient and each facial zone.

• Anatomical Knowledge:A solid understanding of facial anatomy is essential to avoid risk zones (major nerves, arteries, or fat compartments).

• Patient Education:Patients must be clearly informed about potential risks and proper post-procedure care (especially strict sun protection).

• Reporting:Any adverse event or unexpected complication should be promptly reported to the FDA through the MedWatch system to support post-market surveillance and device safety improvements.

Conclusion

While RF Microneedling remains a powerful tool for skin rejuvenation and collagen stimulation, its effectiveness is paired with the potential for serious complications when misused.This is why the FDA’s warning is fully justified and underscores the importance of rigorous training and medical supervision for all practitioners.

Medsearch analysis :

·       Efficacy and Safety of Radiofrequency and Focused Ultrasound in Facial Rejuvenation: A Single-Center, Single-Blind, Non-Randomized Prospective Trial

·       Comparison of the effects of fractional microneedle radiofrequency and microneedling on modulating the senescent fibroblast milieu in aged skin

·       Comparison of Non-insulated Microneedle Fractional Radiofrequency and Ablative Fractional Carbon Dioxide Laser for the Treatment of Facial Atrophic Acne Scarring: A Pilot Randomized Split-face Clinical Study

#microneedling #radiofrequence #fda #medecineesthetique #drbenadiba #genève #aestheticmedicine #skintightening  #sécurité #canovaIA