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FDA Targets Unapproved Vaginal Rejuvenation Devices

Posted 30 July 2018 | By Michael Mezher 

FDA Targets Unapproved Vaginal Rejuvenation Devices

The US Food and Drug Administration (FDA) on Monday warned patients and healthcare providers against using energy-based devices involving radiofrequency or lasers for vaginal "rejuvenation" or cosmetic vaginal procedures.

The warning comes after FDA sent letters last week to seven device makers raising concerns that they may be inappropriately marketing energy-based devices for vaginal rejuvenation procedures. The companies, which include Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen, have been given 30 days to respond to FDA before the agency says it will consider taking enforcement action.

While most of the devices cited in the letters are cleared for other indications, FDA said it has not cleared or approved any energy-based devices for vaginal rejuvenation or cosmetic vaginal procedures.

FDA added that vaginal rejuvenation is an "ill-defined" term that often describes non-surgical procedures meant to treat vaginal laxity, pain during intercourse or urination and decreased sexual sensation.

FDA Commissioner Scott Gottlieb said the claims made about the devices are "deceptive" and noted that the agency has reviewed numerous adverse event reports and medical literature indicating patients have suffered injury due to the improper use of the devices.

"The treatment of these symptoms or conditions by applying energy-based therapies to the vagina may lead to serious adverse events including vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain," FDA said.

FDA Safety Communication, Gottlieb Statement

Categories: Regulatory News

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