In 2018, the FDA warned against having vaginal rejuvenation treatments for improving conditions like urinary incontinence, symptoms of menopause and sexual function, stating that there were “numerous” reports of adverse side effects such as vaginal burns and scarring. Some devices were cleared for other uses, including the the treatment of genital warts and precancerous tissue, but any of them that made claims outside these parameters were forced to reevaluate their messaging. Hence, the “VR” space, as I like to call it, seemed to go quiet for several years, despite many doctors—from OBGYNs to dermatologists—advocating the need for them in support of women’s sexual health and wellness.
Now, BTL (creators of cult-favorite muscle toner Emsculpt) is reigniting the VR conversation with the introduction of its new ENFEMME 360 device, a radio-frequency treatment that heats vaginal tissue to both tighten and improve its quality. According to the device’s FDA 510k clearance, it has the “purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms and increase in local circulation.” These effects lend themselves well to the treatment of vaginal laxity after childbirth to improve sexual function and symptoms associated with Genitourinary Syndrome of Menopause (GSM), though BTL isn’t FDA-indicated for these concerns.
How it Works
In one eight-minute session, “EMFEMME 360 uniformly delivers radio-frequency energy to the entire inner circumference of the treated area via an internal probe that provides 360-degree treatment of the vaginal wall,” says Houston OBGYN Kimberly Evans, MD, noting that there are two different sizes of probes (shown below) depending on the patient’s anatomy, and to ensure comfort. A third, smaller probe can be used for “externally focused treatments,” aka improving the tissue quality of the vulva. “Additionally, the probes are single-use for each patient, so there’s no worry about cross-contamination or anything like that,” Dr. Evans adds.
In a 2022 article in The Aesthetic Guide, treatments are described as improving vaginal moisture and sensation, reducing discomfort and internal tissue laxity, and improving external tissue quality and laxity. “Some women can’t drive to my office without having to stop and use the bathroom,” says Farmington Hills, MI OBGYN Joseph Berenholz, MD. “They come to me in tears when they can drive distances without incontinence. Return and/or improvement of orgasmic function with improvement in duration and strength drives patient satisfaction upward significantly.”
Safety Measures
Where this innovation differs from some of its competitive predecessors, including BTL’s own former ULTRA FEMME 360, is that “EMFEMME 360 tracks tissue temperature and impedance, adjusting energy delivery to more uniform and rapidly administered energy that quickly raises and maintains tissue temperature to within that scientifically determined range of 104 to 113 degrees,” Dr. Evans says, adding that it also monitors the length of the treatment. It’s currently the only device on the market with this type of built-in intelligence, making it very desirable to patients who were once wary of these types of treatments for a fear of getting burned. “In the past, I could not tell how hot the vagina was getting, but this allows me to track the temperature and also make sure the patient is comfortable. It’s safer, and there’s also no downtime. I have patients who go home and have sex that same night. Couples are coming back in and high-fiving me, saying they can feel the difference.”
Dr. Berenholz agrees. “With other technologies we are almost treating blindly, using other probes and so forth to monitor temperature and hoping we don’t over- or under-treat,” he says, noting that other energies, such as lasers, work, but are more invasive and have a greater chance of causing burns or scarring in that sensitive and intimate area. “We could do this safely, but efficacy inevitably suffered. With EMFEMME 360 and its Dynamic Impedance Technology (DIT) we are assured that the tissue heating is rapid and maintained continuously and consistently, and automatically adjusted as needed to stabilize and maximize energy delivery. This optimizes the effect on collagen and elastin production. And we are done in eight minutes, which is remarkably faster than anything else on the market.”
So when can we expect the FDA to give its full approval of this new device? “To get FDA approval is a very slow process—it can take up to 10 years—but the technology is beautiful and the results are there,” says Dr. Evans. “I’ve been doing this job for 20 years, and I think ENFEMME 360 should be the gold standard, but that’s just my opinion. It’s really groundbreaking and it has the ability to change people’s lives, and couple’s lives, too. And we need more love in this world right now.”
