FDA Warning About Laser Devices for 'Vaginal Rejuvenation'
Posted on August 14, 2018
Source:
Medscape
The US Food and Drug Administration (FDA) is cracking down on manufacturers marketing the use of laser or other energy-based devices for "vaginal rejuvenation" which manufacturers claim will treat conditions and symptoms related to menopause, urinary incontinence, or sexual function.
"The procedures use lasers and other energy-based devices [such as radiofrequency] to destroy or reshape vaginal tissue. 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," FDA Commissioner Scott Gottlieb, MD, said in a statement.
The FDA has cleared laser and energy-based devices for destroying abnormal or precancerous cervical or vaginal tissue, as well as condylomas (genital warts) and other serious conditions.
But the safety and effectiveness of these devices have not been evaluated or confirmed by the FDA for "vaginal rejuvenation," Gottlieb stressed.
It notes that "vaginal rejuvenation" is an "ill-defined" term; however, it is sometimes used to describe nonsurgical procedures intended to treat vaginal symptoms and/or conditions including, but not limited to, vaginal laxity, vaginal atrophy, dryness or itching, pain during sexual intercourse, and decreased sexual sensation.