On July 30, 2018, the United States Food & Drug Administration (FDA) issued a formal warning to manufacturers of laser gynecological devices and patients who have undergone, or plan to undergo, treatment with such devices. The FDA initially cleared these “energy based” devices for the treatment of serious health conditions, including cancer and hysterectomies. However, after reviewing reports of problems and the results of several studies, the agency has issued a stern warning against the use of these devices for “off label” purposes—including vaginal rejuvenation. Although these devices have been approved for the treatment of serious health conditions, the FDA has not approved their use for the treatment of other conditions for which they are being used. Seven device manufacturers have been targeted with warning letters, and the FDA has requested their feedback before deciding what actions, including potential enforcement actions, are appropriate.
April 18, 2019
March 19, 2019