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Monday, July 30, 2018 (HealthDay News) – Despite their growing popularity, there is no evidence that so-called "vaginal rejuvenation procedures" are either safe or effective, warns the US Food and Drug Administration. United States.
procedures, which use lasers and other energy-based devices to remove or reshape vaginal tissue, claim to treat conditions and symptoms related to menopause, urinary incontinence or sexual function. But in a statement released on Monday, the FDA said cases of vaginal burns or scars related to vaginal rejuvenation, as well as post-operative pain during intercourse or chronic or recurrent pain.
It is true that the agency has "authorized or approved laser and energy devices severe conditions such as the destruction of abnormal or precancerous cervical or vaginal tissues," or genital warts, noted the commissioner of the FDA, Dr. Scott Gottlieb in the statement.
"But the safety and effect the use of these devices has not been evaluated nor confirmed by the FDA for" vaginal rejuvenation, "he added.
"In addition to misleading health claims about these uses," vaginal rejuvenation "procedures have" In some cases, women who have had early menopause after breast cancer treatment opt for these procedures, but "The misleading marketing of a dangerous procedure without proven benefit, including for women who in fact, the FDA recently informed seven device manufacturers of inappropriate marketing of their devices for procedures of 'vaginal rejuvenation The companies are: Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen
They have been given 30 days to address the FDA's concerns. not at this time, the FDA stated that it would consider its next actions, which could include enforcement measures.
"Misleading marketing of tr unproven evidence can not only cause injury but also prevent some patients from accessing "These products may be particularly appealing to women who might not be candidates for certain FDA-approved treatments to relieve vaginal dryness, and therefore seek non-hormonal alternatives, "Gottlieb explains. He explained.
"Women who are considering treatment for vaginal symptoms should talk to their doctor about the potential and known benefits and risks of all available treatment options," he advised. Gottlieb said:
He also encouraged women who suffered problems after such procedures. o report them to the FDA MedWatch program
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