On Monday, the Food and Drug Administration (FDA) issued a warning against the use of several vaginal rejuvenation procedures. Utilizing laser and ultrasound treatment, these procedures are not approved by the FDA and have been reported to cause painful burns in patients.
Specifically, the FDA is warning against the use of energy-based devices, such as laser or radiofrequency, for these rejuvenation procedures. These devices are FDA approved for use in removing pre-cancerous or abnormal cervical and vaginal tissues, and genital warts, but is not approved for cosmetic use. In their statement, the FDA also claims that use of energy-based devices for “non-surgical vaginal procedures to treat symptoms related to menopause, urinary incontinence, or sexual function may be associated with serious adverse events.” Vaginal rejuvenation is a vague term that commonly refers to nonsurgical procedures intended to treat vaginal tightness, loss of muscle tone, various pains, and lack of sexual sensation.
The FDA stated that these procedures have not been cleared or approved to increase sexual pleasure, tighten muscles, or offer pain relief. In fact, the procedure has often been reported to cause the pain it is designed to relieve during sexual activity. Other adverse events that can result from these procedures include vaginal burns, chronic or recurring pain, and scarring.
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Companies who manufacture these devices have been heavily marketing these products, often making claims that lack credibility. One company, Alma Lasers, advertises their device as one that can provide “a better feminine life.” BTL markets their Femme 360 product as “a noninvasive, no downtime procedure with minimal risk,” using enticing claims to help women bring their “sexy body back”.
To combat inappropriate marketing of these devices, the FDA has contacted seven companies who are currently marketing their devices outside of their approved and intended uses.These companies include Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen. In their messages to these companies, the FDA voiced their concerns and claims they “will be monitoring their claims about uses of their products”.