The FDA warns doctors against “vaginal rejuvenation” treatments, saying procedures pose serious risks. On July 30, 2018, the FDA issued the following Safety Communication:
Be aware that the safety and effectiveness of energy-based devices to perform vaginal “rejuvenation” or cosmetic vaginal procedures has not been established.
They go on to say the FDA has not cleared or approved any energy-based medical device for vaginal “rejuvenation” or vaginal cosmetic procedures, or for the treatment of vaginal symptoms related to menopause, urinary incontinence, or sexual function. (FDA Warns Against Use of Energy-Based Devices to Perform Vaginal ‘Rejuvenation’ or Vaginal Cosmetic Procedures: FDA Safety Communication, 2018)
The FDA found manufacturers of laser devices were marketing procedures to treat symptoms for which the devices had not been tested or approved.
The FDA notified seven device manufacturers (Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton, and Thermigen) the marketing of these devices could be violating the Federal Food, Drug, and Cosmetic Act. These device manufacturers were sent “It Has Come to Our Attention” letters.
The devices used to perform vaginal rejuvenation are approved to treat some conditions, including destroying abnormal, pre-cancerous cervical or vaginal tissue as well as genital warts. These devices aren’t cleared to destroy or reshape vaginal tissue, which is done in vaginal rejuvenation. Vaginal rejuvenation is not considered to be a medically necessary procedure but rather a cosmetic procedure.
California gynecologist David Matlock was the first to market this type of surgery in the late 1990s. He was also the first to establish proprietary training and franchising for physicians in these techniques, developing a company known as the Laser Vaginal Rejuvenation Institute.
His business model and lack of long-term data were criticized in a Committee Opinion issued by the American College of Obstetricians and Gynecologists in 2007. They stated, these procedures are not medically indicated, and the safety and effectiveness of these procedures have not been documented. (ACOG Committee Opinion – Vaginal “Rejuvenation” and Cosmetic Vaginal Procedures, 2007)
Known side effects of vaginal rejuvenation surgery include the following:
• Dryness
• Burns
• Adhesions
• Bleeding
• Numbness or loss of sensation
• Pain with sexual intercourse
• Scarring
• Significant chronic pain
• Infection
ACOG Committee Opinion – Vaginal “Rejuvenation” and Cosmetic Vaginal Procedures. (2007). Obstetrics & Gynecology, 737-738.
FDA Warns Against Use of Energy-Based Devices to Perform Vaginal ‘Rejuvenation’ or Vaginal Cosmetic Procedures: FDA Safety Communication. (2018, July 2018). Retrieved from U.S Food & Drug: https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm615013.htm
