Products marketed for vaginal rejuvenation have not been approved as safe, and can lead to burns and chronic pain, theFood and Drug Administration said Monday.
The FDA sent out a warning letter toseven companiesthat produce vaginal rejuvenation devices, who they believe are “inappropriately marketing” their products as safe. The letter is also intended to caution doctors who use these devices.
The focus is on “energy-based devices” that use radiofrequency or lasers, and claim to heal or cure vaginal problems.
“To date, we have not cleared or approved for marketing any energy-based devices to treat these symptoms or conditions, or any symptoms related to menopause, urinary incontinence, or sexual function,” the letter states.
Rather, the FDA warns, these devices can cause more harm.
“These products have serious risks and don’t have adequate evidence to support their use for these purposes,” FDA Commissioner Dr. Scott Gottliebsaid in a statement. “We are deeply concerned women are being harmed.”
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Gottlieb added that the “deceptive” claims these manufactures make about their products pose “serious risks.”
Along with the FDA, theAmerican College of Obstetricians and Gynecologistsand theNorth American Menopause Societyhave not endorsed any vaginal rejuvenation products, and have said they are awaiting more comprehensive data before endorsing the procedure.
PEOPLE Health SquadmemberDr. Mary Jane Minkin, MD, a board-certified OB/GYN at Yale University School of Medicine, warns against the procedure, which stars likeJada Pinkett Smith have recommended.
“I won’t say there’s no data on it but the problem is there’s really no prospective randomized double-blind trials on any of this so a lot of it is anecdotal,”Minkin told PEOPLE. “I’m always concerned about something like a laser burning somebody or hurting somebody.”
source: people.com
