On July 30, 2018, FDA Commissioner Scott Gottlieb, M.D., announced that the FDA had become aware of a growing number of manufacturers marketing “vaginal rejuvenation” devices to women and claiming “vaginal rejuvenation” procedures would treat conditions and symptoms related to menopause, urinary incontinence, or sexual function. In some cases, these devices are being marketed for this use to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause. The procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue. These products have serious risks and do not have adequate evidence to support their use for these purposes.
The FDA has cleared or approved laser and energy-based devices for the treatment of serious conditions like the destruction of abnormal or pre-cancerous cervical or vaginal tissue, as well as condylomas (genital warts). But the safety and effectiveness of these devices has not been evaluated or confirmed by the FDA for “vaginal rejuvenation.” In addition to the deceptive health claims being made with respect to these uses, the “vaginal rejuvenation” procedures have serious risks.
The FDA has serious concerns about the use of these devices to treat gynecological conditions beyond those for which the devices have been approved or cleared. In reviewing adverse event reports and published literature, the FDA found numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain.
The FDA notified seven device manufacturers of the concerns about inappropriate marketing of their devices for “vaginal rejuvenation” procedures. The manufacturers that were warned were Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton, and Thermigen. The FDA requested that the manufacturers address the concerns within 30 days.
The deceptive marketing of unproven treatments may not only cause injuries but also may keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions.
See the FDA Announcement
See also Medical Law Perspectives Report: Using Medical Devices Off-Label: False Claims, Overpromotion, Malpractice, and Other Dangerous Territory