July 31, 2018 – Stating that the FDA’s “most fundamental obligation” is “providing patients with access to safe and effective medical products to meet their health care needs,” FDA Commissioner Scott Gottlieb, M.D., issued a statement July 30 warning women that the FDA has “serious concerns” about laser and energy-based devices cleared or approved for the treatment of serious conditions being marketed for “vaginal rejuvenation.”

“We recently notified seven device manufacturers of our concerns about inappropriate marketing of their devices for ‘vaginal rejuvenation’ procedures. They are: Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen,” according to Gottlieb’s statement. “The deceptive marketing of unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions.”

The statement also stresses that although safety and efficacy are the FDA’s top priorities, “we’re equally dedicated to monitoring the landscape to ensure products deliver on their intended benefits and to ensure that if new health risks arise, we take appropriate action.”

“While the number of Warning Letters on drug advertising is down in the Gottlieb era, this case demonstrates a serious attempt to stop the marketing of devices that create harm when used off-label, said Coalition for Healthcare Communication Executive Director John Kamp. “Note the Commissioner’s obvious distain for claims that lead to harm and expect more of the same.”