FDA Issues Warning About 'Vaginal Rejuvenation' Devices

03 August, 2018, 11:09 | Author: Denise Dawson
  • Devices that promise vaginal

If you're dealing with painful sex or other sexual dysfunction issues-or if you're just into the idea of having a more enjoyable sex life-the recent trendiness of vaginal laser rejuvenation might have seemed like a magic wand.

"We're deeply concerned women are being harmed by these procedures", he added.

The FDA said "vaginal "rejuvenation" is an ill-defined term; however, it is sometimes used to describe non-surgical procedures meant to treat vaginal symptoms and/or conditions including, but not limited to: vaginal laxity; vaginal atrophy, dryness, or itching; pain during sexual intercourse; pain during urination; and decreased sexual sensation". Gottlieb added that "The deceptive marketing of a risky procedure with no proven benefit, including to women who've been treated for cancer, is egregious".

The FDA says these companies have not undergone the correct approval process required to show that the treatments they offer work as advertised or even that they're safe to use.

The agency said treating such symptoms by applying energy-based therapies to the vagina may lead to serious adverse events, including vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain.

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Gottlieb also said he was concerned that deceptive marketing of these devices might prevent some patients from getting appropriate therapies for severe medical conditions. But the safety and effectiveness of these devices hasn't been evaluated or confirmed by the FDA for 'vaginal rejuvenation'. Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton, and Thermigen have all been contacted already.

Although these devices have been approved to treat certain conditions, such as pre-cancerous lesions in the cervix, they have not been approved for vaginal rejuvenation, the FDA said.

The American College of Obstetricians and Gynecologists has been cautioning against surgical "rejuvenation" procedures for more than a decade. Since December of 2015, Deborah Kotz, a press officer with the FDA, said the agency has received a dozen reports of complications related to these procedures. "These products have serious risks and don't have adequate evidence to support their use for these purposes", Gottleib said.

However, these devices have not been approved for so-called vaginal rejuvenation. The company is one of several that was issued a letter from the agency prompting device manufacturers to respond within 30 days or face potential enforcement actions.

Hologic, Inc., owner of Cynosure, replied to this with an email saying they have "a strong track record of rooting our products in science and clinical evidence so, we take the contents of this letter seriously". We encourage those who've had an adverse event associated with the use of these devices to report their problem to MedWatch, the FDA Safety Information and Adverse Event Reporting program.

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