Monalisa Touch is one of the brands the U.S. Food and Drug recently called out in an effort to combat the misuse of energy-based devices as a means for “vaginal rejuvenation.”
Monalisa Touch is a device manufactured by Cynosure. The global company develops and manufactures medical treatment and light-based aesthetic systems.
The Monalisa Touch vaginal probe is inserted into the vagina which delivers a laser energy to produce the desired results. It works by creating small tears in the vaginal tissue, which is supposed to stimulate collagen development and strengthen tissue.
According to the Monalisa website, the procedure takes less than five minutes. It is used to treat vaginal atrophy, a natural side effect in menopausal and postmenopausal women experience.
Some of the side effects of using devices like Monalisa touch may be as follows:
- Pain during sex
- Vaginal burns
- Recurring pain
- Chronic pain
“Vaginal rejuvenation” is a term used to describe treatment for women who are dissatisfied with the productivity of their reproductive system. It encompasses anywhere from vaginal atrophy, cancer, genital warts, or dryness associated with menopausal or postmenopausal women.
Though these devices are approved by the FDA to treat specific, serious conditions, it is not intended for cosmetic use. It is illegal for doctors to use them for off-label conditions.
In a letter to Cynosure, the FDA pointed out the agency is unable to identify the clearance for the following claims of the Monalisa Touch website:
- “MonaLisa Touch is the only technology for vaginal and vulvar health with over 18+ published clinical studies.”
- “MonaLisa Touch is a simple, safe, and clinically proven laser treatment for the painful symptoms of menopause, including intimacy.”
- “During a treatment, a vaginal probe is inserted into the patient’s vagina, and delivers gentle, virtually painless laser energy to the vaginal wall, stimulating a healing response.”
- “It penetrates the wall of the vagina, and stimulates cells that are important in creating fluid, improving collagen synthesis.”
- “Fibroblasts activate biosynthesis of new collagen and produce main components of ground substance.”
Cynosure was not the only company the FDA issued a warning letter to. Inmode, Sciton, Alma Lasers, Thermigen, BTL Aesthetics, BTL Industries and Venus Concept were among the others.
In the announcement, FDA commissioner Dr. Scott Gottlieb said the agency would strengthen its studies of devices after they have been approved for sale.