Sponsored by BTL Aesthetics
EMFEMME 360® from BTL Aesthetics (Boston, Mass.) may represent the top of the heap for women’s wellness, providing a completely non-invasive radiofrequency-based option that both tightens and improves tissue quality in an eight minute treatment session. Coupled with BTL’s EMSELLA® for pelvic floor muscle improvement, via the Pelvic Power protocol, there is currently no 
more profound one-two punch for women’s health and wellness in the device-based treatment space.
According to the FDA 510k clearance, EMFEMME 360 is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms and increase in local circulation. As per Health Canada, the EMFEMME 360 applicator is intended for the treatment of vaginal laxity after childbirth to improve sexual function and symptoms associated with Genitourinary Syndrome of Menopause (GSM). EMSELLA is FDA cleared to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female urinary incontinence.
“What EMFEMME 360 does is uniformly deliver RF energy to the entire inner circumference of the treated area in a comfortable and therapeutically advantageous way,” said Kimberly Evans, MD, an OB-GYN in Houston, Texas.
The three handpieces are a key benefit, she added. Two are full-length internal probes of differing circumference. “These provide 360° treatment of the vaginal wall, with different sizes accommodating natural anatomical variation,” Dr. Evans explained.
According to Dr. Evans, in some cases a woman undergoing a course of EMFEMME 360 therapy will transition from the larger to the slimmer probe, representing obvious improvement. “The third handpiece is for externally focused treatments and improves tissue quality, which is part of the suite of conditions that affect women as they age. So, it can treat from the inside, out, including the perineum.”
“We have always known, but women are finally able to admit, that not only does GSM affect women almost universally, it inhibits sexual function and torpedoes quality of life,” said Carolyn DeLucia, MD, an OB-GYN and director of ViVa Rejuvenation Center (Hillsborough, N.J.). “Local hormone therapy is the standard of care but can only be used to the point where it remains local, because systemic treatment has ramifications that need attention. Low level therapy limits the impact and barely replenishes hormones that provide improved tolerance of sex, for example. With EMFEMME 360, especially if you add EMSELLA for Pelvic Power, you have actual restoration of enjoyment, which is a much higher and more appealing standard by far.”
GSM describes a suite of symptoms that typically develop in women as they age, more so in women who have experienced vaginal child- birth. Vaginal laxity and dryness, incontinence, pain, even tissue tearing during intercourse, and more, are included, said Joseph Berenholz, MD, an OB-GYN and director of the Michigan Center for Women’s Health (Farmington Hills, Mich.) who has specialized in aesthetic gynecology and women’s health for 35 years. “Attacking these issues is day-to-day work for us and others,” he said, “so we are always looking for the safest, more effective, least invasive option when addressing conditions of the vagina.”
In fact, safety is a hallmark of both EMFEMME 360 and EMSELLA, Dr. Evans said. “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. EMFEMME 360 RF is naturally non-invasive, and the feedback-based mechanisms that govern treatment make it easy to delegate to staff.”
The key difference between EMFEMME 360 and its predecessor, ULTRA FEMME 360, lies in these mechanisms. “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 40° C to 45° C. It also monitors treatment time,” Dr. Evans added.
Ultimately, the ‘intelligent’ safety features also optimize results Dr. Berenholz added. “With other technologies we are almost treat- ing blindly, using other probes and so forth to monitor temperature and hoping we don’t over- or under-treat,” he said. “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 throughout the 360° area of effect, 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.”
Improved moisture and sensation, reduction in discomfort and internal tissue laxity, and improvement in external tissue quality and laxity all add up to dramatic improvement in quality of life. “Some women can’t drive to my office without having to stop and use the bathroom. They come to me in tears when they can drive distances without incontinence,” Dr. Berenholz shared. “Return and/or improvement of orgasmic function with improvement in duration and strength drives patient satisfaction upward significantly.”
As Dr. DeLucia explained, EMSELLA adds much to the picture because pelvic floor dysfunction leads to clinical manifestations such as pelvic prolapse and various forms of incontinence that are devastating to quality of life. 
“We often see complete cessation of sexual intimacy because of leakage from incontinence or pain during intercourse. What EMSELLA does for incontinence is extraordinary. Treat additional structures with EMFEMME and you have the complete package.”
Pelvic Power is especially powerful for orgasmic dysfunction. “When you consider the role of sensation, lubrication and pelvic floor musculature in achievement of orgasm, you check all the right boxes,” said Dr. Berenholz. “The combination is as complete and comprehensive of a device-based women’s wellness treatment as we’ve seen to date.”
BTL’s Emsculpt Classic or Neo also provide adjunctive advantages, Dr. DeLucia added. “Adding Emsculpt Classic or Neo addresses one more issue affecting pelvic floor function – diastasis rectus, which 33% of women are affected by for life – non-invasively and naturally. Extensive physical therapy doesn’t do much, and surgical intervention is often not desired. Those affected muscles are contiguous with pelvic floor musculature so the impact will be increased.”
Dr. DeLucia described what she called a typical case. “A woman in her late 50s comes to mind; she experienced vaginal dryness and reduced sensation, plus incontinence, which basically ended her sex life. EMSELLA improved incontinence and sexual function, but when we added EMFEMME 360 she had more dramatic overall improvement. Now she enjoys an active intimate life with her partner and is amazed. This is about changed lives.”
