In The Media

VIVE: FDA Warning Letter Should Weed-Out Imposters and Benefit VIVE

Aug 2, 2018

On July 30th FDA issued a Safety Communications letter warning against the use of “Energy-Based Devices to Perform Vaginal ‘Rejuvenation’ of Vaginal Cosmetic Procedures”. The purpose of the letter is to “alert patients and health care providers that the use of energy-based devices to perform vaginal “rejuvenation,” cosmetic vaginal procedures, or non-surgical vaginal procedures to treat symptoms related to menopause, urinary incontinence, or sexual function may be associated with serious adverse events. The safety and effectiveness of energy-based devices for treatment of these conditions has not been established.” Read the full article on Yahoo Finance.

 

Aug 1, 2017