AUGS: Vaginal Energy-Based Devices

The writing group used a modified Delphi process to assess statements that were evaluated for consensus after a structured literature search.

A total of 40 statements were assessed and divided into 5 categories: (1) patient criteria; (2) health care provider criteria; (3) efficacy; (4) safety; and (5) treatment considerations.

In a July 2018 Safety Communication, the U.S. Food and Drug Administration (FDA) issued a public warning about the use of EBDs to perform vaginal rejuvenation or vaginal cosmetic procedures.¹

The statement highlighted the imprecision of the term “vaginal rejuvenation” and emphasized that, although the FDA is aware that devices such as lasers are used for a variety of surgical applications, the agency has not approved their use for any specific gynecologic indication.

Health care providers who subspecialize in female pelvic medicine and reconstructive surgery are positioned to evaluate and manage genitourinary syndrome of menopause (GSM) and vulvovaginal atrophy (VVA), and some of these clinicians deliver patient services using the EBDs that are discussed in the FDA Safety Communication. The vulvovaginal EBD devices that will be addressed in this document include laser and radiofrequency (RF) devices.

Concurrent with the FDA’s Safety Communication, a December 2018 International Urogynecological Association Writing Group Opinion summarized the small, but growing, body of evidence as well as concerns about vulvovaginal EBD.²

This document explored evidence for the use of laser-based devices for GSM, vaginal laxity, and stress urinary incontinence (SUI).

An International Continence Society/International Society for the Study of Vulvovaginal Disease Best Practice Consensus Statement published in February of 2019 concluded that, based on the currently available literature, laser is not recommended for routine treatment of VVA or SUI except as part of a well-designed clinical trial or with special arrangements for clinical governance, consent, and audit.³

The primary author, Dr. Alshiek, stated that AUGS found it timely to provide guidance by convening a panel of experts to compile a clinical consensus statement (CCS). In the absence of strong Level I evidence, this CCS was created based on rigorous criteria to compile the most important agreed upon expert opinion statements supported by the available literature as it pertains to use of vulvovaginal EBDs.

Target devices were defined as all vulvovaginal EBDs applied to treat the conditions listed above, including:

• Non-ablative Er:YAG lasers: A solid-state infrared light laser whose active laser medium is erbium-doped yttrium aluminum garnet (Er:Y3Al5O12), which typically emits light with a wavelength of 2.94 μm.⁴
• Fractional microablative CO2 laser: A CO2 laser that produces a beam of continuous infrared light with the principal wavelength bands centering on 9.4 and 10.6 micrometers (μm).

HYBRID -- Combination of non-ablative and ablative approaches

• Hybrid fractional lasers: A laser device that applies tunable non-ablative (1.47 μm) and ablative (2.94 μm) wavelengths to the same microscopic treatment zone.⁴ This allows for simultaneous ablation and coagulative effects.

OTHER – current base EBD devices

• Radiofrequency (RF):A device that uses RF energy to heat tissue and stimulate subdermal collagen production in order to reduce the appearance of fine lines and loose skin. The technique induces tissue remodeling and production of new collagen and elastin. RF treatment also causes apoptosis of fat cells, which leads to fat layer reduction in the treated area.⁴

Recommendations

Absence of consensus on many statements about EBD therapy practices currently in clinical use without preliminary scientific evidence exposes a significant knowledge gap about the efficacy and safety profile of the vulvovaginal EBD therapies, their indications, contraindications, maintenance regimens, comparison with available current treatments, and long-term benefits.

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This was created in partnership with the American Urogynecologic Society (AUGS). AUGS was established in 1979 and represents more than 1,900 members, including practicing physicians, nurse practitioners, physical therapists, nurses and health care professionals, and researchers from many disciplines.

Full text of AUGS’ Clinical Consensus Statement on Vaginal energy-based devices can be found at: AUGS.ORG/ASSETS/1/6/VAGINAL_ENERGY_BASED_DEVICES.3.PDF

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References

1.US Food and Drug Administration. FDA Warns Against Use of Energy-Based Devices to Perform Vaginal 'Rejuvenation' or Vaginal Cosmetic Procedures: FDA Safety Communication. August, 1 2018 https://www.fda.gov/medical-devices/safety-communications/fda-warns-against-use-energy-based-devices-perform-vaginal-rejuvenation-or-vaginal-cosmetic#:~:text=To%20alert%20patients%20and%20health,associated%20with%20serious%20adverse%20events. Accessed July 13, 2020.

2.Shobeiri SA, Kerkhof MH, Minassian VA, Bazi T, IUGA Research and Development Committee. IUGA committee opinion: laser-based vaginal devices for treatment of stress urinary incontinence, genitourinary syndrome of menopause, and vaginal laxity. Int Urogynecol J. 2019 Mar;30(3): 371-376. doi: 10.1007/s00192-018-3830-0.

3.Preti M, Vieira-Baptista P, Digesu GA, Bretschneider CE, Damaser M, Demirkesen O, et al. The clinical role of LASER for vulvar and vaginal treatments in gynecology and female urology: An ICS/ISSVD best practice consensus document. Neurourol Urodyn. 2019 Mar;38(3): 1009-1023. doi: 10.1002/nau.23931.

4.Tadir Y, Gaspar A, Lev-Sagie A, Alexiades M, Alinsod R, Bader A, et al. Light and energy based therapeutics for genitourinary syndrome of menopause: Consensus and controversies. Lasers Surg Med. 201 Feb7;49(2):. 137-159. doi: 10.1002/lsm.22637.