FDA warns about 'vaginal rejuvenation' procedures
The FDA released a warning Monday, July 30, about the safety and effectiveness of vaginal “rejuvenation” or vaginal cosmetic procedures. Companies have been offering services using lasers or similar energy-based devices to treat symptoms and conditions related to menopause, urinary incontinence and sexual function.
The FDA stated it has not reviewed or approved for marketing any of these devices to treat such symptoms. Such treatments have resulted in serious complications including vaginal burns, scarring and chronic or recurring pain.
“We are aware that certain device manufacturers may be inappropriately marketing their energy-based devices for the uses noted above that are outside of their cleared or approved intended uses,” according to the FDA statement. “We have contacted these manufacturers to share our concerns and will be monitoring their claims about uses of their products. In addition, we will continue to monitor reports of adverse events associated with this issue and will keep the public informed if significant new information becomes available.”
The FDA recommends anyone who has experienced such complications to report it here.
FDA Commissioner Scott Gottlieb, MD, took to Twitter to announce the news.
Nicholas joined TriMed in 2016 as the managing editor of the Chicago office. After receiving his master’s from Roosevelt University, he worked in various writing/editing roles for magazines ranging in topic from billiards to metallurgy. Currently on Chicago’s north side, Nicholas keeps busy by running, reading and talking to his two cats.