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.”

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