The Food and Drug Administration on Monday announced that it had warned several companies to stop marketing laser devices for procedures billed as "vaginal rejuvenation", saying they were unsafe and deceptive treatments.
Be aware that the safety and effectiveness of energy-based devices to perform vaginal "rejuvenation" or cosmetic vaginal procedures have not been established. These products have serious risks and don't have adequate evidence to support their use for these purposes. "We are deeply concerned women are being harmed", said FDA commissioner Dr Scott Gottlieb in a statement.
The devices in question typically use laser or radiofrequency waves and have been cleared by the FDA for use by licensed gynecologists to treat abnormal and pre-cancerous vaginal and cervical tissue, as well as genital warts.
The FDA said the full extent of the risks is unknown, but that the agency has found cases of vaginal burns, scarring, and lasting pain after the treatments.
The agency recently notified seven device manufacturers expressing concern about "inappropriate marketing" and requested that they respond within 30 days.
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"The FDA has serious concerns about the use of these devices to treat gynecological conditions beyond those for which the devices have been approved or".
"These products may be particularly appealing to women who may not be candidates for certain FDA-approved treatments to relieve vaginal dryness, and thus are seeking alternative, non-hormonal options", he explained. On its website, the company said, "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".
United States regulator the FDA says it will take action if deceptive marketing of the "dangerous procedure with no proven benefit" continues.
The agency noted in one letter that a manufacturer, BTL Industries, was marketing a radio-frequency device, Exilis Ultra 360, as a new approach to "women's intimate health" even though the product had been approved by the FDA only for uses in dermatology like wrinkle treatment, including the eyelids.
So, for women who are experiencing incontinence or painful sex as a result of menopause, the best advice is to speak to your doctor about possible procedures which do work and to avoid vaginal rejuvenation procedures until more serious testing has been done. The FDA commissioner added that these "unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions". FDA is committed to helping advance the development of safe, effective treatment options for these conditions.
He also encouraged women who've suffered problems after such procedures to report them to the FDA's MedWatch program.