In 2018, the FDA warned in opposition to having vaginal rejuvenation treatments for enhancing circumstances like urinary incontinence, signs of menopause and sexual operate, stating that there have been “quite a few” studies of antagonistic uncomfortable side effects equivalent to vaginal burns and scarring. Some units had been cleared for different makes use of, together with the the therapy of genital warts and precancerous tissue, however any of them that made claims exterior these parameters had been pressured to reevaluate their messaging. Therefore, the “VR” area, as I prefer to name it, appeared to go quiet for a number of years, regardless of many docs—from OBGYNs to dermatologists—advocating the necessity for them in assist of ladies’s sexual health and wellness.
Now, BTL (creators of cult-favorite muscle toner Emsculpt) is reigniting the VR dialog with the introduction of its new ENFEMME 360 machine, a radio-frequency therapy that heats vaginal tissue to each tighten and enhance its high quality. Based on the machine’s FDA 510k clearance, it has the “goal of elevating tissue temperature for chosen medical circumstances equivalent to non permanent aid of ache, muscle spasms and enhance in native circulation.” These results lend themselves nicely to the therapy of vaginal laxity after childbirth to enhance sexual operate and signs related to Genitourinary Syndrome of Menopause (GSM), although BTL isn’t FDA-indicated for these issues.
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