The U.S. Food and Drug Administration (FDA) issued a safety alert this week about injuries that have been reported with certain uses of radiofrequency (RF) micro-needling (MN) devices.
The FDA describes micro-needling as small electrodes that deliver RF energy into and under the skin, intended to treat facial flaws, such as wrinkles.
"RF micro-needling is a medical procedure, not a cosmetic treatment, and these devices should not be used at home," the FDA said.
Each MN produces a small area of intense heat at its tip, which leads to changes in the skin's tissue.
When MN is combined with RF energy in mild to moderate skin laxity, it can create a tighter, more rejuvenated skin surface, according to Dr. Amir Mahan Ghaznavi, founder of AMG Plastic Surgery in Herndon, Virginia.
"While RF micro-needling will not prevent the aging process of the skin, it will stimulate a robust collagen response under the skin," Ghaznavi told NTD. "Micro-needling is a popular choice because it provides clients with darker skin an alternative to an ablative laser for skin rejuvenation."
Ablative laser for skin rejuvenation works by removing the outer layers of damaged skin to reveal a smoother, more taut dermal surface as it heals.
What surprises Ghaznavi about the FDA safety alert is the emphasis that RF micro-needling is not a cosmetic treatment and should not be performed at home.
"To my knowledge, there are no portable or home devices on the market," Ghaznavi said.
The FDA urged patients, caregivers, and health care providers to report complications related to the use of the devices for dermatologic or aesthetic skin procedures in order to help the FDA identify and better understand the risks associated with the device.
RF MN devices are Class II medical devices cleared through the FDA's 510(k) process.
Ghaznavi attributes bad outcomes from RF MN facials to a combination of poor training, unqualified practitioners, and pressure to see results.
"Burns are the result of excessive RF energy applied to the skin, causing a thermal injury," he added. "Fat loss results from overly aggressive needle depth penetration combined with the heat from RF "melting" the deep fat. Nerve damage is the result of poor knowledge of the local anatomy, combined with too deep penetration of the heated microneedles."