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FDA’s Warns Against Use of Energy-Based Devices: The VELA® Safety Communication

Volume 12 - Issue 2

Marco Gambacciani1* and Mauro Cervigni2

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    • 1Department of Obstetrics and Gynecology, Pisa University Hospital, Pisa. Italy
    • 2Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome, Italy
    • *Corresponding author: Marco Gambacciani, Department of Obstetrics and Gynaecology, Pisa University Hospital, Via Roma 67, 56100 Pisa, Italy

Received: December 04, 2018;   Published: December 17, 2018

DOI: 10.26717/BJSTR.2018.12.002224

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Abstract

Objective: The aim of this short review is to react to the oversimplification to the US Food and Drug Administration (FDA) Safety Communication [1] to alert patients and healthcare providers that the use of Energy-Based Devices (EBD), as fractional ablative carbon dioxide (CO2) laser, are not approved to treat Stress Urinary Incontinence (SUI) and Genitourinary Syndrome of Menopause (GSM) and may be associated with serious adverse events. This strong statement could interfere worldwide in the lay public and medical community consideration of all laser procedures.

Methods: Revision of the available literature the use of the non-ablative Vaginal Erbium Laser (VEL®) SMOOTH® technology.

Results: The VEL-SMOOTH® produces effective, non-invasive procedure for the safe treatment of GSM and SUI.

Conclusion: VEL-Smooth® can offer a new, long term therapeutic option, to improve the quality of life, allowing women to choose, considering the limits and the balance between benefits and risks associated with each therapeutic approach.

Abbreviations : FDA: Food and Drug Administration; EBD: Energy-Based Devices; CO2: carbon dioxide; SUI: Stress Urinary Incontinence; GSM: Genitourinary Syndrome of Menopause; VEL®: Vaginal Erbium Laser; VELA: Vaginal Erbium Laser Academy

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