On July 30, 2018, the FDA issued a warning advising against the use of “Energy-Based Devices” (lasers and radio-frequency devices) to perform vaginal rejuvenation procedures.¹  The FDA reported that it had become aware of various device manufacturers who were marketing their devices for cosmetic vaginal procedures for which they had not obtained FDA approval.²  Robins Kaplan’s Mass Tort Group is currently investigating cases involving severe and permanent injuries arising out of the use of these devices for vaginal cosmetic procedures. 

FDA Commissioner Scott Gottlieb said “[t]hese products have serious risks and don’t have adequate evidence to support their use for these purposes.”³ The FDA has found cases of “vaginal burns, scarring, and lasting pain following the treatments,” and as of July 30, had received 14 reports of adverse events.⁴

Patients who have experienced severe injuries from these types of procedures can call Robins Kaplan LLP and speak to a registered nurse.