News & Announcements
SUFU Statement Regarding FDA Communication on “Vaginal Rejuvenation”:
posted: August 7, 2018
On July 30, 2018, the FDA posted a communication regarding the use of energy-based devices, including laser and radiofrequency, for vaginal cosmesis and “rejuvenation.”¹
The FDA communication states that energy-based treatment for conditions including but not limited to vaginal atrophy, dryness, dyspareunia, and urinary incontinence has not been well studied and is not yet cleared specifically for these indications. The FDA urges clinicians and providers to discuss the risks and benefits of this modality when considering therapy. The FDA has also communicated with companies via “It has come to our attention (IHCTOA)” letters², which request information, but do not impose any specific restrictions.
Laser therapy for treatment of vaginal conditions should continue to undergo rigorous assessment with high quality study analysis. Certain indications such as lichen sclerosis (vulvar dystrophy) and vaginal atrophy may respond well to treatment, however vaginal cosmesis with laser based devices is, as of yet, unproven and lacks supportive evidence and at this time should not be recommended.
While SUFU encourages the consideration of new technologies, the Society is also resolute regarding the importance of robust data and randomized trials to provide evidence upon which to base our practices.
¹ “FDA Warns Against Use of Energy-Based Devices to Perform Vaginal ‘Rejuvenation’ or Vaginal Cosmetic Procedures: FDA Safety Communication,” FDA, July 30, 2019
²“Letters to Industry,” FDA