RF Microneedling Warning

Summer Hardy (00:01):
Welcome to Park Avenue Plastic Surgery Class, the podcast where we explore controversies in breaking issues in plastic surgery. I'm your co-host, Summer Hardy, a medical student in New York City. I'm excited to be here with Dr. Lawrence Bass, Park Avenue plastic surgeon, educator, and technology innovator. Today's episode is RF Microneedling Warning. A warning? That sounds scary. What are we talking about in this episode, Dr. Bass?

Dr. Lawrence Bass (00:26):
On October 15th, 2025, the FDA issued a warning letter to consumers, patients, and healthcare providers about serious complications with RF microneedling devices.

Summer Hardy (00:44):
What kinds of complications are we talking about?

Dr. Lawrence Bass (00:47):
The complications that FDA listed in the warning letter include burns, scarring, fat loss, disfigurement, and nerve damage. They also specifically mentioned the need for surgical repair or medical intervention to treat injuries.

Summer Hardy (01:10):
I've heard about different types of microneedling treatments. Can you clarify this for me?

Dr. Lawrence Bass (01:16):
Yes, that's a great question, Summer, because this letter is specifically about RF microneedling. However, it's also generically about RF microneedling. So this is a treatment where multiple tiny needles, typically between a quarter of a millimeter in thickness to 15 hundredths of a millimeter in thickness are inserted into the skin and a little zap of radiofrequency or RF energy is fired into the skin at a predefined depth or sometimes multiple depths. And that's different from microneedling, which just punctures the skin without any energy and other kinds of treatments that are injecting small amounts of different medicines or biologically active materials into the skin with microneedling. So this is the energy-based microneedling that FDA is talking about in this letter.

Summer Hardy (02:26):
So what is the FDA telling people to do then?

Dr. Lawrence Bass (02:30):
They're saying a few things that make good sense. Be aware of the risks. Because a lot of these risks go with almost any energy-based treatment, they're recommending that you use a licensed healthcare provider with training and experience on the use of RF microneedling devices. And again, that makes perfect sense. Someone who has experience with the devices and who's working in the specialty that they were trained in during all of their schooling and clinical training. They recommend that you know which device that provider is using. And I suggest that you verify that because there are a lot of counterfeit devices or a lot of times people are told that they're getting treated with a certain device, but it's really a no name device. The provider names the famous brand name because that's the one everyone's heard of, but they're actually using a device that doesn't really deliver the same energy parameters, even though it roughly works in the same way.

(03:40):
They also point out that RF microneedling is a medical procedure, not a cosmetic treatment like a facial. So you break the skin with these little needles and you have to be able to care for the open area after the treatment as your medical provider instructs you, has to be done in a clean, disinfected medical environment, not in a salon or someplace that isn't properly disinfected and managed like a medical office. Basically, they're also telling you don't use any of these devices at home. Unfortunately, there is a level of activity of use of injectable medical treatments and energy-based medical devices, and there are some energy-based medical devices that are specifically cleared by FDA for consumers to use at home. And those devices have been very carefully tailored with a variety of safety features to make them suitable for consumers to use. A medical device is a very powerful device.

(05:02):
These devices are configured with much more capability and power than what we ever use in a typical safe treatment. And for an experienced healthcare professional with extensive experience in energy-based treatments, they understand what energy parameters to select and how to apply these devices to use them safely. So again, that makes perfect sense. And this is why if you're an experienced driver, you can drive on the highway at high speed safely. If you're a beginning driver, maybe you stay off the highway. If you haven't gone to driving school yet, you're probably going to hurt yourself or others if you get behind the wheel, and you wouldn't go on the racetrack and drive at 170 miles an hour unless you were trained as a professional driver. So all of that makes sense and a lot of these devices are medical grade devices that are really for the medical professionals.

(06:12):
The last thing that they pointed out was also really important, and it's something that is often a problem because little things can happen with any kind of medical treatment. And they're saying if there is a problem, something's not healing right, something got exposed to energy that the skin doesn't like, isn't agreeing with the skin, that a licensed healthcare provider should see you in person, evaluate the problem and manage your care. And that's really important. And a lot of times treatments that are not done in a doctor's office, when a problem develops, there's a strong temptation to ignore the problem, to naysay or pooh-pooh the problem, pretend it doesn't exist, and then something that might be easy to address gets set in concrete and becomes a big problem that can be permanent. So if there is a problem, you need to be seen by a dermatologist, by a plastic surgeon, somebody who understands how to take care of problems in healing.

Summer Hardy (07:26):
Okay. That all makes sense to me. Is there a but there?

Dr. Lawrence Bass (07:31):
So I said a lot of very supportive things about this FDA warning letter because I agree with them in my opinion, but it's not so much that there's a but, but rather that there's a little more to the story. So like any news story, there's five W's, right? Who, what, when, where, and why. We learned that when we were in elementary school in English class and the FDA warning doesn't really tell you the five Ws.

Summer Hardy (08:07):
Okay. So let's take them one at a time. Tell me about the who.

Dr. Lawrence Bass (08:11):
So the who is who is performing the treatment. And even by title, there's a lot of variation in how much experience people have. There are dermatologists who just do medical skin conditions and they've got a new energy device, or there are plastic surgeons who just think about surgery, they got a new energy device. There are a lot of people who just took a few hour training course versus somebody who has spent years or decades. I mean, I've been delivering energy-based treatments for 30 plus years. I've been doing research and energy-based treatments for nearly 40 years. It's different if I apply a treatment or I pick the energy parameters versus somebody who took a short course and trained. And there are people with all titles who have a great deal of experience, but there are predictably people with a medical degree and working in their specialty have a lot of experience with these things and many of the people delivering these treatments don't have.

(09:29):
Separate from that, it's very complex because state laws differ significantly on who can perform energy treatments and which energy treatments they're able to perform legally in that state. And that varies state to state, and I can't really review 50 states worth in the podcast, and that's separate from clearance by FDA. There are spa units, units that FDA has cleared with restricted amounts of energy, often with other safety features and interlocks that prevent them being used in ways that are unsafe. And those are designated for use in a spa or by a medical aesthetician, somebody who's passed an aesthetician training course and a licensing exam or a certification. And then there are medical units which can be used under medical supervision, often performed by an aesthetician or a laser technician or a nurse or somebody else, but under the supervision of a physician. And so that who is very important, for example, in my practice, everyone is seen by me before they're treated.

(10:54):
Everyone is examined by me as the physician, the MD in the office, and I select the parameters.

Summer Hardy (11:03):
Okay. So next we come to the what.

Dr. Lawrence Bass (11:07):
So actually there are a bunch of whats. What machine, what the indication is, what the condition or feature that you're trying to treat, and what parameters you select. So the machines, there are probably a dozen current machines on the market and probably three times that in previous versions of those machines. So there are many, many different RF devices on the market. Some are lower powered, some are higher powered, some have insulated needles where only the tip of the needle for a third or a half of a millimeter is exposed and releasing energy, and some have uninsulated needles. So all of this creates huge differences device to device. And this is a limitation of the FDA warning letter. It warns you that RF microneedling can create problems, but there are some devices that are being very safely used in a highly medically supervised setting, and there are other devices that may have features less protections, less feedback to the energy.

(12:28):
So the warning letter doesn't distinguish that. And so in that sense, it's not as helpful as it could be for both consumers and for the providers. The indications that are being treated differ a lot. Typical things that RF microneedling is used for include large pores, rough skin texture, early wrinkling, acne scarring. There's also a lot of use of RF devices at different parameter settings for mild skin laxity, and this may be where some of the mischief comes in. So the parameters that a provider's going to use are going to be different depending on what you're trying to treat. And some may pose more risk of some of those problems that FDA was warning about than others. And the parameters selected make a big difference. Again, you're going to pick your parameters based on what you're trying to treat and what the particular characteristics of that particular RF microneedling device are.

(13:43):
And some parameters are going to be more aggressive than others, and that may affect the amount of risk that you're facing getting one of those treatments.

Summer Hardy (13:53):
There's a lot of complexity then. What can you tell me about the where?

Dr. Lawrence Bass (13:58):
So we talked about this a little bit. These treatments are being done in med spas, which theoretically have medical supervision, basically doctor, supervision, or another advanced provider, depending on what the state rules say is required. There are doctor's offices where, again, an MD is either involved in the treatment, supervising the treatments, and the entire facility is set up and run for the MD's use. And then there are conventional spas and salons that are trying to do these treatments and even at home, as FDA warned about. And unfortunately, the FDA report does not stratify or discuss where these problems are occurring or where they're mostly occurring. So is it safe in doctor's offices and not safe at home or is it more or less happening everywhere? We don't know.

Summer Hardy (15:03):
Okay. And now the big question, why do these problems occur? Is it the safety of the devices?

Dr. Lawrence Bass (15:10):
So as I mentioned, there's so much variation in the devices that are out there on the market, but basically mostly the answer is no. It's not that the devices are unsafe, it's that they require proper medical supervision, proper aftercare, and proper parameter selection in order to avoid trouble. So we use a lot of things that improperly used are dangerous and properly used can be very useful and very safe as well, which is very important for aesthetic treatments. So as I mentioned, also if there is a problem, medical evaluation is important. So some of the reasons we may be getting trouble is inadequate training, use of medical equipment by non-medical personnel without supervision. Something that I worry about is pushing too hard to make the machines do something that they're really not designed to do. So RF microneedling is never going to substitute for a surgical facelift.

(16:27):
If there's mild laxity, a modest reduction in laxity can often be obtained using RF microneedling. But if there's significant laxity, that's really not a substitute for a facelift and amping up the energy to try to maximize the result just creates complications. And this may be one of the major ways that these problems are occurring that FDA is warning about because everyone would like to avoid surgery. They're just hoping that energy treatment is going to somehow magically tighten up all that loose skin. And by pushing the device too hard and too hot, you end up with a healing problem. And Vic Ross, who's the head of energy-based treatments in the dermatology group at Scripps in San Diego, Scripps Clinic, talked about this on an earlier device selection podcast episode where he said when there's mild laxity, one of the main things he uses RF microneedling for is mild neck skin laxity.

(17:38):
But when there's significant laxity, he sends that patient to his plastic surgery colleagues. There also is the risk as the companies design the devices that they try to, again, pack more energy in, put more energy at more layers. That's probably a good thing. But if you push that too hard and the energy overlaps, you can end up with an unintended effect. And likewise, some of the machines have feedback control. They measure how much energy is going into the tissues, what the resistivity or impedance of the tissues is so that they can dose the energy correctly. And again, in an effort to get a maximum result, some designs don't use the same kind of careful feedback control or they're minimizing that feedback control and that creates more risk. So that's a technical complexity that goes with the devices.

Summer Hardy (18:49):
Okay, Dr. Bass. So what does all of this mean? What should I do if I'm thinking of doing an RF microneedling treatment?

Dr. Lawrence Bass (18:57):
Of course, that's what everybody wants to know. In other words, should you be afraid because FDA issued this warning letter? And basically in experienced hands, these devices are on the safer end of the spectrum for aesthetic medical treatments, but they're still medical treatments and so all appropriate safety considerations should be observed. In those circumstances, the risk from a properly performed treatment with proper parameters by somebody experienced is very, very low. It's not zero, risks are never zero, and that's part of why medical providers, doctors, in particular, are trained and ready to care for and fix any healing problem and avoid trouble by picking the right device and the right parameters. So that's part of what medical personnel are trained to do and part of the benefit of working with them. Although again, these treatments are very commonly performed by others, but ideally under the supervision of medical personnel and for a medically clear device that's an essential as the FDA warning letter points out.

Summer Hardy (20:19):
Thank you, Dr. Bass, for updating us on this newsworthy item and sharing so much important safety information. I'm sure our listeners will find it useful. Thank you for listening to the Park Avenue Plastic Surgery Class Podcast. Follow us on Apple Podcasts, write a review, and share the show with your friends. Be sure to join us next time to avoid missing all the great content that is coming your way. If you want to contact us with comments or questions, we'd love to hear from you. Send us an email at podcast@drbass.net or DM us on Instagram @drbassnyc.