The increased popularity of vaginal rejuvenation treatments, as described in my blog “VAGINAL REJUVENATION: ARE WE GOING TO SEE HOME-USE DEVICES IN THE MARKET?”, has stimulated quite a few companies to market energy based (laser or RF) vaginal rejuvenation devices. The term “Vaginal rejuvenation” is a controversial one, often used to describe non-invasive treatment of symptoms such as vaginal laxity, vaginal atrophy, dryness, itching, pain during sexual intercourse, pain during urination and decreased sexual sensation.
While the treatment has gained a lot of popularity, recently, FDA Commissioner Scott Gottlieb, M.D., issued a warning letter stating: “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. The procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue. These products have serious risks and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed.”
The FDA’s statements specifically raise concerns regarding adverse side effect of the products – “In reviewing adverse event reports and published literature, we have found numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain.”
The FDA encourages women who have undergone treatment for vaginal “rejuvenation” and experienced a complication to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Women considering vaginal rejuvenation procedure are strongly advised to carefully read summary results of published clinical studies in order to ensure that they are making an educated decision. Here are two such studies.
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1. “Vaginal rejuvenation using energy-based devices” authored by Cheryl Karcher, MD and Neil Sadick, MD
2. “Review and clinical experience exploring evidence, clinical efficacy, and safety regarding nonsurgical treatment of feminine rejuvenation” authored by Michael Gold MD et al.