In a July 30, 2018 Safety Communication , the FDA warned women considering elective vaginal “rejuvenation” procedures (and the health care providers who perform these procedures) to proceed with caution, citing the absence of FDA clearance or approval for these procedures.
Originally designed and marketed for the treatment of abnormal or pre-cancerous tissue and growths, energy-based devices that involve radiofrequency or laser technology have garnered FDA approval for general gynecological purposes. Growing in popularity, however, are cosmetic or “rejuvenating” non-surgical procedures that use these same energy-based devices to treat vaginal symptoms or conditions such as:
• Vagina laxity
• Vaginal atrophy, dryness, or itching
• Pain during sexual intercourse
• Pain during urination
• Decreased sexual sensation
According to the FDA, the safety and efficacy of using energy-based devices for the above indications have not been determined. In fact, the FDA has not cleared or approved the use of these devices, which include lasers manufactured an sold by Alma Lasers, BTL Aesthetics, BTL Industries, InMode, Cynosure, ThermiGen, and Sciton, for these conditions.
The Food And Drug Administration Urges Caution
The FDA cautions potential patients that the use of energy-based devices for the treatment of these conditions, or any symptoms relating to menopause, urinary incontinence, or sexual function can lead to serious adverse events such as burning, scarring, pain during intercourse, and chronic pain. Examples of such adverse events are available for public review on the FDA’s Adverse Event Report Databases.
According to a statement issued by FDA Commissioner Scott Gottlieb, M.D., the FDA’s review of adverse event reports associated with these devices produced alarming results: “we have found numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain… the full extent of the risks is unknown. But these reports indicate these procedures can cause serious harm.”
If you have undergone a cosmetic vaginal “rejuvenation” procedure such as the “Mona Lisa Touch” laser procedure or the “Thermiva” device and are experiencing symptoms such as those listed above, reach out to a KBA attorney today about your rights and options.