FDA Warning on Vaginal Cosmetic Procedures

MEMO

To:                  Arkansas Mutual Policyholders: OB/GYN, Family Practitioners, Plastic Surgeons
From:              Rebecca Tutton, RN, JD, Risk and Patient Safety, Arkansas Mutual Insurance Company, Rebecca.tutton@arkansasmutual.com

Dear Policyholders:

I have provided a link to an FDA warning that came out June 30, 2018 regarding the use of energy-based devices to perform vaginal “rejuvenation” or vaginal cosmetic procedures, at the end of this memo.

An FDA August 2, 2018 update letter included some manufacturers that had been overlooked in the June 30 letter. I have included the link to this letter as well.

The warning states

“we alert patients and health care providers that the use of energy-based devices (commonly radiofrequency or laser) to perform vaginal rejuvenation, cosmetic vaginal procedures or non-surgical vaginal procedures to treat symptoms related to menopause, urinary incontinence, or sexual function may be associated with serious adverse events. The safety and effectiveness of energy-based devices for treatment of these conditions has not been established.”

The marketing has not been cleared or approved for these devices to treat these symptoms or conditions, or any symptoms related to menopause, urinary incontinence, or sexual function. The serious events include vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain.

The manufacturers about inappropriate marketing of these devices include Alma (Lasers, BTL Industries, Cynosure, inMode, Sciton, Themigen and Venus Concept. The manufactures have 30 days to respond to the FDA concerns. The two most popular devices include the Femilift which is made by Alma and the Mona Lisa which is made by Cynosure, both included in the warning. Currently, from my understanding, the manufacturers have suspended the sale of their machines while they work with the FDA.

The following are FDA and Arkansas Mutual recommendations for health care providers.

  • Be aware that the safety and effectiveness of energy-based devices to perform vaginal “rejuvenation” or cosmetic vaginal procedures has not been established.
  • Understand that 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.
  • Discuss the benefits and risks of all available treatment options for vaginal symptoms with your patients.
  • Include in the consent form that the device is not FDA approved for the vaginal rejuvenation or vaginal cosmetic procedure being performed.
  • Include the above adverse events under the risks listed in the consent form.
  • If any patients experience adverse effects from procedures that involved the use of energy-based devices to perform vaginal “rejuvenation,” cosmetic procedures, or treat genitourinary symptoms of menopause, sexual dysfunction, or urinary incontinence, please file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program (/Safety/MedWath/HowToReport/ucm085568.htm).

Please feel free to contact me if you have any questions.

Attachments:

https://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm615013.htm

https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm615130.htm

References:

https://www.acog.org/Clinical-Guidance-and-Publications/Committee-Opinions/Committee-on-Gynecologic-Practice/Vaginal-Rejuvenation-and-Cosmetic-Vaginal-Procedures

https://www.acog.org/Clinical-Guidance-and-Publications/Position-Statements/Fractional-Laser-Treatment-of-Vulvovaginal-Atrophy-and-US-Food-and-Drug-Administration-Clearance