{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T17:14:04Z","timestamp":1783358044456,"version":"3.54.6"},"reference-count":17,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2021,7,26]],"date-time":"2021-07-26T00:00:00Z","timestamp":1627257600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"name":"NICHD Women\u2019s Reproductive Health Research Career Development Program","award":["5K12HD063087"],"award-info":[{"award-number":["5K12HD063087"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,5,18]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>A description of energy-based genitourinary non-surgical devices (energy-based devices) safety data is outlined given their rapid adoption.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>The authors sought to describe adverse events for energy-based devices in the Manufacturer and User Facility Device Experience database and to compare with similar devices and other subspecialty applications. We hypothesized that products with genitourinary applications had similar adverse events to dermatologic or general surgery applications.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>The authors used Reed Tech Navigator to compile adverse events reports for all registered energy-based devices. Individual adverse events reports associated with (1) non-ablative, (2) fractionated, (3) unfractionated, (4) radiofrequency, and (5) hybrid laser technologies were categorized. Adverse event characteristics were compared among genitourinary applications (n\u2005=\u200539) and other subspecialty applications within the same devices (n\u2005=\u200579).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Eighteen manufacturers were identified, which collectively manufacture 43 products with genitourinary applications. Thirty-nine genitourinary adverse events were reported and isolated to 6 manufacturers with 11 products, of which 82% (n\u2005=\u200532) were injuries, 15% (n\u2005=\u20056) were device malfunction, and 3% (n\u2005=\u20051) were related to improper maintenance. Local treatment reactions were the most commonly reported injury (62%, n\u2005=\u200521). Adverse events varied by device type, with CO2 lasers having more burns and radiofrequency devices having higher rates of sensation loss. Comparing similar technology types, genitourinary energy-based devices had the fewest adverse events reports per device in the Manufacturer and User Facility Device Experience database.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Adverse events were reported for one-quarter of the products currently available, and most were local treatment reactions. The reporting of adverse events is equal to that of other subspecialties, suggesting similar risk profiles. Improved reporting is needed to fully evaluate the safety of individual energy-based devices.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Level of Evidence: 4<\/jats:title>\n                  <jats:p\/>\n               <\/jats:sec>","DOI":"10.1093\/asj\/sjab299","type":"journal-article","created":{"date-parts":[[2021,7,26]],"date-time":"2021-07-26T14:20:09Z","timestamp":1627309209000},"page":"689-694","source":"Crossref","is-referenced-by-count":11,"title":["What Is Being Reported About Vaginal \u201cLasers\u201d?: An Examination of Adverse Events Reported to the Food and Drug Administration on Energy-Based Devices"],"prefix":"10.1093","volume":"42","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2228-9223","authenticated-orcid":false,"given":"Linda","family":"Burkett","sequence":"first","affiliation":[{"name":"Magee-Womens Hospital University of Pittsburgh Medical Center, Magee Womens Research Institute , Pittsburgh, PA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pamela","family":"Moalli","sequence":"additional","affiliation":[{"name":"Magee-Womens Hospital University of Pittsburgh Medical Center, Magee Womens Research Institute , Pittsburgh, PA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary","family":"Ackenbom","sequence":"additional","affiliation":[{"name":"Magee-Womens Hospital University of Pittsburgh Medical Center, Magee Womens Research Institute , Pittsburgh, PA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2021,7,26]]},"reference":[{"key":"2022112120142485000_CIT0001","author":"US Food and Drug Administration (FDA)","year":"2013"},{"issue":"1","key":"2022112120142485000_CIT0002","doi-asserted-by":"crossref","first-page":"429","DOI":"10.1007\/s10103-014-1677-2","article-title":"Microscopic and ultrastructural modifications of postmenopausal atrophic vaginal mucosa after fractional carbon dioxide laser treatment","volume":"30","author":"Zerbinati","year":"2015","journal-title":"Lasers Med Sci"},{"key":"2022112120142485000_CIT0003","doi-asserted-by":"crossref","DOI":"10.3843\/GLOWM.10023","article-title":"Lasers in gynecology","author":"DeLeon","year":"2008","journal-title":"Glob Libr Women\u2019s Med"},{"key":"2022112120142485000_CIT0004","doi-asserted-by":"crossref","first-page":"S101","DOI":"10.1055\/s-0039-1700481","article-title":"Overview of lasers","volume":"41","author":"Patil","year":"2008","journal-title":"Indian J Plast Surg"},{"issue":"3","key":"2022112120142485000_CIT0005","first-page":"141","article-title":"Laser physics and lasertissue interaction","volume":"16","author":"Welch","year":"1989","journal-title":"Tex Heart Inst J"},{"issue":"8","key":"2022112120142485000_CIT0006","doi-asserted-by":"crossref","first-page":"845","DOI":"10.1097\/GME.0000000000000401","article-title":"Histological study on the effects of microablative fractional CO2 laser on atrophic vaginal tissue: an ex vivo study","volume":"22","author":"Salvatore","year":"2015","journal-title":"Menopause"},{"key":"2022112120142485000_CIT0007","author":"Administration US FDA","year":"2018"},{"issue":"5","key":"2022112120142485000_CIT0008","doi-asserted-by":"crossref","first-page":"683","DOI":"10.1007\/s00192-018-3844-7","article-title":"The use of laser in urogynaecology","volume":"30","author":"Bhide","year":"2019","journal-title":"Int Urogynecol J"},{"issue":"8","key":"2022112120142485000_CIT0009","doi-asserted-by":"crossref","first-page":"671","DOI":"10.1002\/lsm.23084","article-title":"Lasers and energy-based devices marketed for vaginal rejuvenation: a cross-sectional analysis of the MAUDE database","volume":"51","author":"Ahluwalia","year":"2019","journal-title":"Lasers Surg Med"},{"issue":"10","key":"2022112120142485000_CIT0010","doi-asserted-by":"crossref","first-page":"1177","DOI":"10.1097\/GME.0000000000001577","article-title":"Vaginal laser treatment of genitourinary syndrome of menopause: does the evidence support the FDA safety communication?","volume":"27","author":"Guo","year":"2020","journal-title":"Menopause"},{"issue":"2","key":"2022112120142485000_CIT0011","doi-asserted-by":"crossref","first-page":"188","DOI":"10.1001\/jamadermatol.2013.1384","article-title":"Common causes of injury and legal action in laser surgery","volume":"149","author":"Jalian","year":"2013","journal-title":"JAMA Dermatol"},{"issue":"5","key":"2022112120142485000_CIT0012","doi-asserted-by":"crossref","first-page":"730","DOI":"10.1097\/DSS.0000000000001466d","article-title":"Ablative lasers: 24 years of medical malpractice cases in the United States","volume":"44","author":"Pierce","year":"2018","journal-title":"Dermatol Surg"},{"issue":"8","key":"2022112120142485000_CIT0013","doi-asserted-by":"crossref","first-page":"467","DOI":"10.1080\/14764172.2016.1226505","article-title":"Why some of the dermatologists choose to avoid carrying out minimally invasive cosmetic procedures?","volume":"18","author":"Yildiz","year":"2016","journal-title":"J Cosmet Laser Ther"},{"issue":"4","key":"2022112120142485000_CIT0014","doi-asserted-by":"crossref","first-page":"501","DOI":"10.1016\/j.det.2009.08.002","article-title":"Cosmetic dermatology: legal issues","volume":"27","author":"Goldberg","year":"2009","journal-title":"Dermatol Clin"},{"issue":"3","key":"2022112120142485000_CIT0015","doi-asserted-by":"crossref","first-page":"737","DOI":"10.1097\/01.AOG.0000263927.82639.9b","article-title":"ACOG committee opinion no. 378: vaginal \u201crejuvenation\u201d and cosmetic vaginal procedures","volume":"110","author":"Committee on Gynecologic Practice","year":"2007","journal-title":"Obstet Gynecol"},{"issue":"1","key":"2022112120142485000_CIT0016","first-page":"e36e42","article-title":"American College of Obstetricians and Gynecologists\u2019 Committee on Gynecologic Practice. ACOG clinical document (published January 2020 through present): elective female genital cosmetic surgery ACOG committee opinion No. 795","volume":"135","year":"2020","journal-title":"Obstet Gynecol"},{"key":"2022112120142485000_CIT0017","author":"American Urogynecologic Society","year":"2018"}],"container-title":["Aesthetic Surgery Journal"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/academic.oup.com\/asj\/advance-article-pdf\/doi\/10.1093\/asj\/sjab299\/40313701\/sjab299.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/asj\/article-pdf\/42\/6\/689\/47170239\/sjab299.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/asj\/article-pdf\/42\/6\/689\/47170239\/sjab299.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,11,21]],"date-time":"2022-11-21T20:15:51Z","timestamp":1669061751000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/asj\/article\/42\/6\/689\/6328506"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,7,26]]},"references-count":17,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2021,7,26]]},"published-print":{"date-parts":[[2022,5,18]]}},"URL":"https:\/\/doi.org\/10.1093\/asj\/sjab299","relation":{},"ISSN":["1090-820X","1527-330X"],"issn-type":[{"value":"1090-820X","type":"print"},{"value":"1527-330X","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2022,6,1]]},"published":{"date-parts":[[2021,7,26]]}}}