The Food and Drug Administration is warning women against getting vaginal rejuvenation procedures, saying that it hasn’t reviewed or approved the procedures. The procedures generally use lasers to treat sexual dysfunction and other problems affecting women after childbirth or menopause. However, FDA Commissioner Scott Gottlieb said in a statement, “These products have serious risks and don’t have adequate evidence to support their use for these purposes.
The American College of Obstetricians and Gynecologists has been cautioning against surgical “rejuvenation” procedures for more than a decade. Even so, these treatments have been heavily promoted across newspapers, television, and digital news outlets. Celebrities have endorsed the procedures and given testimonials about how they have improved their lives. An internet search returns numerous ads from doctors offering the treatments.
The FDA claims that the procedures are harming women. The agency said in its statement, ““In reviewing adverse event reports and published literature, we have found numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain.” The agency was referencing a dozen reports from patients who experienced significant pain and discomfort following the procedures, as well as 29 published studies describing a burning sensation or bleeding that lasted more than three days after the procedure.
The FDA has now sent warning letters to seven companies about the “inappropriate marketing” of their devices for vaginal rejuvenation procedures. Those companies were Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen. Hologic, parent company of Cynosure, said in a statement, “We are evaluating the letter in full and will collaborate with the agency to ensure all product communications adhere to regulatory requirements.” The other companies have not yet issued statements regarding the matter.
The FDA has also issued a warning to doctors advising them against using laser or other energy therapies for these types of procedures. The FDA said, “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.”