Vaginal 'rejuvenation' devices have serious side effects, might be unsafe, FDA says

"We are deeply concerned women are being harmed," FDA Commissioner Dr. Scott Gottlieb said.

Story highlights

  • FDA warns women against using energy-based vaginal "rejuvenation" devices
  • Devices may cause vaginal burns, scarring and pain during sexual intercourse

(CNN)Devices that promise vaginal "rejuvenation" to women with urinary incontinence or sexual or menopausal symptoms might not be safe and can have serious side effects, the US Food and Drug Administration warned Monday.

"We are aware that certain device manufacturers may be marketing their energy-based medical device for vaginal 'rejuvenation' and/or cosmetic vaginal procedures," the FDA said in a statement. "The safety and effectiveness of energy-based medical devices to perform these procedures has not been established."
    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.