Review and clinical experience exploring evidence, clinical efficacy, and safety regarding nonsurgical treatment of feminine rejuvenation

Gold, Michael H.; Andriessen, Anneke; Bader, Alexandros; Alinsod, Red; French, Elizabeth Shane; Guerette, Nathan; Kolodchenko, Yegor; Krychman, Michael; Murrmann, Susan G.; Samuels, Julene B.

doi:10.1111/jocd.12524

Cited by 44 publications

(45 citation statements)

References 28 publications

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“…Non‐ablative laser therapy has also gained interest in various medical conditions, such as GSM, urinary incontinence, and other medical conditions . In human soft tissue, the 2940 nm erbium yttrium‐aluminum‐garnet medium (Er:YAG) laser in the non‐ablative thermal mode has been shown to stimulate deep collagen remodeling and improve tightness and elasticity of the treated area .…”

Section: Discussionmentioning

confidence: 99%

“…Increasing in prevalence, vaginal rejuvenation has been characterized as a laser and energy‐based technique (ablative and non‐ablative lasers, and radiofrequency devices) to optimize sexual function and alleviate genitourinary syndrome of menopause (GSM)‐related symptoms in women. It has also been offered to those experiencing pelvic floor dysfunction, urinary incontinence, and dissatisfaction with vulvovaginal anatomy . Current literature lacks data supporting the efficacy of these procedures and characterizing safety profiles.…”

Section: Introductionmentioning

confidence: 99%

“…Current literature lacks data supporting the efficacy of these procedures and characterizing safety profiles. Potential risks of these treatments include tissue damage, adhesions, scarring, altered sensation, dyspareunia, and infection . For these reasons, the FDA has encouraged reporting adverse events associated with vaginal rejuvenation procedures through its databases and registries .…”

Section: Introductionmentioning

confidence: 99%

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Lasers and energy‐based devices marketed for vaginal rejuvenation: A cross‐sectional analysis of the MAUDE database

2019

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Introduction:The FDA issued a statement on July 30, 2018, expressing concern over the marketing of lasers and energy-based devices to promote "vaginal rejuvenation." The FDA stated that there is insufficient data to recommend this modality for optimization of sexual function and alleviation of genitourinary syndrome of menopause (GSM)-related symptoms in postmenopausal or postpartum women. This analysis aims to characterize the mandatory and voluntary reports concerning laser and energy-based procedures marketed for vaginal rejuvenation. Methods: Cross-sectional analysis of the FDA database, Manufacturer and User Facility Device Experience (MAUDE), for events related to laser and energy-based devices for vaginal rejuvenation. Results: Between October 2015 and January 2019, 45 distinct events describing 46 patients were recorded and reviewed. The most commonly reported adverse event related to the procedure was pain (vulvar, bladder, urethral, or unspecified) (n ¼ 19). The majority of patients sought medical care for their injuries, which included evaluation by urgent care, urology, gynecology, neurology, gastroenterology, pelvic floor therapy, primary care providers, and the device operator. Thirtythree patients indicated chronicity of their injury, which included long-term pain, numbness, burning, bladder disturbances, infections, scarring, dyspareunia, worsening symptoms, aggravation of lichen sclerosis, and disfigurement. Conclusions: A variety of adverse events associated with the use of laser and energy-based devices for "vaginal rejuvenation" was reported to the MAUDE database. Although the circumstances surrounding these events were unclear, these reports signify the importance of clinical trials that investigate the efficacy and safety profile of laser and energy-based devices for optimization of sexual function and treatment of GSM-related symptoms. Lasers Surg. Med.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Lasers and energy‐based devices marketed for vaginal rejuvenation: A cross‐sectional analysis of the MAUDE database

2019

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“…Recent RF studies showed an increase in the small nerve fiber density in the papillary dermis ( Gold et al, 2018 ; Table 3 ). Posttreatment biopsy tests have demonstrated neocollagenesis and neoelastogenesis in the submucosa after RF ( Leibaschoff et al, 2016 ; Figure ).…”

Section: Noninvasive Modalitiesmentioning

confidence: 99%

Vaginal rejuvenation: From scalpel to wands

Desai

Kroumpouzos

Sadick

2019

International Journal of Women's Dermatology

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Vaginal rejuvenation procedures are increasing in popularity in terms of types of treatment offered, number of patients undergoing them, clinical studies, and in the controversy surrounding them. Both non-invasive and invasive solutions are being developed by pharmaceutical and technological companies. Radiofrequency devices and lasers are spearheading the energy-based device space, and fillers and platelet-rich plasma are used to address several concerns surrounding vaginal health. In this review, an overview of the growing field of vaginal rejuvenation is presented, as well as the authors’ personal view and analysis of this clinical space.

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“…The aim of treatment is to heat vaginal/vulvar epithelium to approximately 40-45°C for a defined treatment time, with each zone being treated for 3-5 minutes, for a total time of 25-30 minutes per treatment session [23]. These sessions may be repeated at 4-6 week intervals [24]. Ultrasound gel is needed during the treatment process.…”

Section: Treatment Of Genitourinary Syndrome Of Menopausementioning

confidence: 99%

Genitourinary syndrome of menopause treatment using lasers and temperature-controlled radiofrequency

Wańczyk-Baszak

Woźniak

Milejski³

et al. 2018

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Perimenopausal changes caused by oestrogen deficiency are accompanied by a decrease in the content of collagen and elastin in the tissues, leading to thinning of the epithelium and the resultant disappearance of the superficial layer, which leads to smooth muscle dysfunction as well as connective tissue degradation. This aetiopathogenetic chain results in a set of symptoms experienced by approximately 50% of women in the peri-and postmenopausal period. Symptoms of dryness, burning, dyspareunia and urgency contribute to a significant reduction in the quality of sexual function and general comfort of life due to recurrent infections of the vagina, vulva and urinary tract. Different therapeutic methods may benefit genitourinary syndrome of menopause (GSM), while innovative methods such as lasers or radiofrequency deserve further study in this area.

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Review and clinical experience exploring evidence, clinical efficacy, and safety regarding nonsurgical treatment of feminine rejuvenation

Cited by 44 publications

References 28 publications

Lasers and energy‐based devices marketed for vaginal rejuvenation: A cross‐sectional analysis of the MAUDE database

Lasers and energy‐based devices marketed for vaginal rejuvenation: A cross‐sectional analysis of the MAUDE database

Vaginal rejuvenation: From scalpel to wands

Genitourinary syndrome of menopause treatment using lasers and temperature-controlled radiofrequency

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