{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T06:00:43Z","timestamp":1788328843011,"version":"build-2803163510"},"reference-count":45,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2019,3,29]],"date-time":"2019-03-29T00:00:00Z","timestamp":1553817600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Lasers Surg Med"],"published-print":{"date-parts":[[2019,10]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>The FDA issued a statement on July 30, 2018, expressing concern over the marketing of lasers and energy\u2010based devices to promote \u201cvaginal rejuvenation.\u201d 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)\u2010related symptoms in postmenopausal or postpartum women. This analysis aims to characterize the mandatory and voluntary reports concerning laser and energy\u2010based procedures marketed for vaginal rejuvenation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Cross\u2010sectional analysis of the FDA database, Manufacturer and User Facility Device Experience (MAUDE), for events related to laser and energy\u2010based devices for vaginal rejuvenation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      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                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200919). 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. Thirty\u2010three patients indicated chronicity of their injury, which included long\u2010term pain, numbness, burning, bladder disturbances, infections, scarring, dyspareunia, worsening symptoms, aggravation of lichen sclerosis, and disfigurement.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>A variety of adverse events associated with the use of laser and energy\u2010based devices for \u201cvaginal rejuvenation\u201c 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\u2010based devices for optimization of sexual function and treatment of GSM\u2010related symptoms. Lasers Surg. Med. \u00a9 2019 Wiley Periodicals, Inc.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/lsm.23084","type":"journal-article","created":{"date-parts":[[2019,3,29]],"date-time":"2019-03-29T11:02:40Z","timestamp":1553857360000},"page":"671-677","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":48,"title":["Lasers and energy\u2010based devices marketed for vaginal rejuvenation: A cross\u2010sectional analysis of the MAUDE database"],"prefix":"10.1002","volume":"51","author":[{"given":"Jusleen","family":"Ahluwalia","sequence":"first","affiliation":[{"name":"Department of Dermatology University of California San Diego School of Medicine  9500 Gillman Drive La Jolla 92093 California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mathew M.","family":"Avram","sequence":"additional","affiliation":[{"name":"Dermatology Cosmetic and Laser Center Massachusetts General Hospital Harvard Medical School  Boston Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arisa E.","family":"Ortiz","sequence":"additional","affiliation":[{"name":"Department of Dermatology University of California San Diego School of Medicine  9500 Gillman Drive La Jolla 92093 California"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,3,29]]},"reference":[{"key":"e_1_2_5_2_1","unstructured":"U.S. Food and Drug Administration. Statement from the FDA Commissioner Scott Gottlieb MD on efforts to safeguard women's health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for \u201cvaginal rejuvenation\u201d. July2018.https:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm615130.htm. Accessed August 10 2018."},{"key":"e_1_2_5_3_1","unstructured":"Center for Devices and Radiological. 510(k) Clearances. Device Approvals and Clearances.https:\/\/www.fda.gov\/MedicalDevices\/ProductsandMedicalProcedures\/DeviceApprovalsandClearances\/510kClearances\/ucm089319.htm. Accessed December 31 2018."},{"key":"e_1_2_5_4_1","doi-asserted-by":"publisher","DOI":"10.1097\/DSS.0000000000000697"},{"key":"e_1_2_5_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/jocd.12524"},{"key":"e_1_2_5_6_1","unstructured":"U.S. Food and Drug Administration. 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