Since Morpheus8 got the co-sign from the likes of Kim Kardashian (the Skims founder once praised this specific treatment for her six-pack), radio-frequency microneedling quickly became the treatment on everybody’s wish list. That was until last month, when the US Food & Drug Administration began to question the treatment’s safety.
On October 15, 2025, the FDA issued a warning on the potential negative side effects that can arise when using RF microneedling devices. Those who have gone to a doctor for an RF microneedling session may be familiar with those downsides, but now the FDA is encouraging the public to be even more aware of these risks as they continue to grow in popularity.
“The FDA is aware of reports of serious complications (adverse events) including burns, scarring, fat loss, disfigurement, and nerve damage, and the need for surgical repair or medical intervention to treat injuries,” reads the statement. “While the FDA’s evaluation is ongoing, we are asking patients, caregivers, and health care providers to report any complications related to the use of these devices for dermatologic or aesthetic skin procedures to the FDA. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.”
But why make this warning now? RF microneedling is not new, and devices such as Morpheus8, Potenza RF Microneedling, and many more have been out in the market for some time. Experts are unsure what made the FDA put out a statement on these treatments, but it may point to a bigger issue of misleading information and inadequate training when using the device.
What to Worry About
For those unfamiliar, RF microneedling is a treatment that delivers radio-frequency energy to the dermis layer of the skin through tiny punctures in hopes of smoothing wrinkles and treating scars. Daniel Belkin, MD, board-certified dermatologist at New York Dermatology Group, explains that when the skin is heated by the radio-frequency energy, it causes collagen to contract, and over time, your body responds to those tiny injuries by synthesizing new collagen.
One of the biggest benefits, Dr. Belkin says, is that this treatment penetrates into the dermis (the middle layer of skin) without disrupting the top layer (which many of the more aggressive treatments do). Typically, complications happen when the device is used incorrectly by someone who is not well-trained.
#Safe #Radiofrequency #Microneedling
