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10) Using energy-based devices is promoted by the manufacturers as safe to handle, however, long-term effects remain, in my opinion, to be monitored and confirmed ideally by the most unbiased specialists who act as the standing guards to women’s health. [7]
On July 30, 2018, the U.S. Food and Drug Administration (FDA) issued a <a title="warning about energy-based devices used to treat vaginal conditions and symptoms related to menopause, urinary incontinence, or sexual function." href="https://www.breastcancer.org/research-news/fda-issues-warning-on-vagina-laser-tx" target="_blank" rel="noopener">warning about energy-based devices used to treat vaginal conditions and symptoms related to menopause, urinary incontinence, or sexual function.</a> Currently, no vaginal laser device or procedure is cleared or approved by the FDA for any of these vaginal issues.
The FDA is concerned that the safety and effectiveness of these devices haven’t been proven in scientific studies and that using the devices could lead to serious side effects, including vaginal scarring and burns.
“We’ve recently become aware of a growing number of manufacturers marketing ‘vaginal rejuvenation’ devices to women and claiming these procedures will treat conditions and symptoms related to menopause, urinary incontinence or sexual function,” said FDA Commissioner Scott Gottlieb, M.D., in a statement. “The procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue. These products have serious risks, therefore, case selection and procedures should be performed by highly experienced gynaecologists.
<a class="_3Bkfb _1lsz7" title="https://www.breastcancer.org/research-news/fda-issues-warning-on-vagina-laser-tx" href="https://www.breastcancer.org/research-news/fda-issues-warning-on-vagina-laser-tx" target="_blank" rel="noopener" data-hook="linkViewer">https://www.breastcancer.org/research-news/fda-issues-warning-on-vagina-laser-tx</a>
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References:
1. General Medical Council: “Good Medical Practice”-Revised Guidance. April 29th 2014.
2. Anthony Tarantino, <a class="_3Bkfb _1lsz7" title="Governance, Risk, and Compliance Handbook" href="https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3D3aUyqPxYw10C&data=02%7C01%7C%7C46b639da7a7444d10ac908d6be707f30%7C84df9e7fe9f640afb435aaaaaaaaaaaa%7C1%7C0%7C636905787711541598&sdata=woRpssFqxlz3jIcMSxXz75Dbmaozpz7zNObKqi%2BDn1Q%3D&reserved=0" target="_blank" rel="noopener" data-hook="linkViewer">Governance, Risk, and Compliance Handbook</a>, <a class="_3Bkfb _1lsz7" title="ISBN" href="https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fen.wikipedia.org%2Fwiki%2FInternational_Standard_Book_Number&data=02%7C01%7C%7C46b639da7a7444d10ac908d6be707f30%7C84df9e7fe9f640afb435aaaaaaaaaaaa%7C1%7C0%7C636905787711551610&sdata=BO4dwy4OQtmeU297AZVrOd9F6Usl8B%2BqN%2FKjL1OMKQs%3D&reserved=0" target="_blank" rel="noopener" data-hook="linkViewer">ISBN</a> <a class="_3Bkfb _1lsz7" title="978-0-470-09589-8" href="https://apc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fen.wikipedia.org%2Fwiki%2FSpecial%3ABookSources%2F978-0-470-09589-8&data=02%7C01%7C%7C46b639da7a7444d10ac908d6be707f30%7C84df9e7fe9f640afb435aaaaaaaaaaaa%7C1%7C0%7C636905787711561615&sdata=BqUepzbQzE1%2FuMqnUWx3ZPABBn9FxXw499FmyUrYVQg%3D&reserved=0" target="_blank" rel="noopener" data-hook="linkViewer">978-0-470-09589-8</a>(2008-02-25).
3. Royal College of Obstetricians and Gynaecologists. “Standards for Gynaecology; Report of a Working Party”. London: RCOG 2008.
4. General Medical Council. “Intimate Examinations: Guidance for Doctors”. London: GMC; 2006.
5. Royal College of Obstetricians and Gynaecologists. “Improving Patient Safety: Risk Management for Maternity and Gynaecology”. Clinical Governance Advice No.2, September 2009.
6. Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to safeguard women’s health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for “vaginal rejuvenation” [news release]. Silver Spring, MD; July 30, 2018: FDA website. <a class="_3Bkfb _1lsz7" title="http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm615130.htm" href="http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm615130.htm" target="_blank" rel="noopener" data-hook="linkViewer">http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm615130.htm</a>. Accessed July 30, 2018.

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