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techkenyot.com September 21, 2018


FDA Warns on Unapproved Vaginal 'Rejuvenation' Procedures

03 August 2018, 11:12 | Silvia Roy

FDA Warns on Unapproved Vaginal 'Rejuvenation' Procedures

FDA Warns on Unapproved Vaginal 'Rejuvenation' Procedures

The U.S. Food and Drug Administration is warning women and healthcare providers about serious concerns surrounding devices marketed for "vaginal rejuvenation" procedures, after some reported suffering burns, scarring and pain. "We are deeply concerned women are being harmed", says the FDA warning.

The term is used to describe non-surgical procedures meant to treat vaginal laxity, atrophy, dryness, or itching; reduced sexual sensation; and pain with sex or urination.

"Deceptive marketing of a risky procedure with no proven benefit, including to women who've been treated for cancer, is egregious", Gottlieb fumed in one tweet. For patients, the FDA suggests discussing any vaginal issues with your doctors.

We haven't reviewed or approved these devices for use in such procedures. He said the agency found numerous cases of injuries including vaginal burns, scarring and recurring pain in a review of adverse event reports.

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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.

Understand that the FDA has not cleared or approved any energy-based medical device for vaginal "rejuvenation" or vaginal cosmetic procedures, or for the treatment of vaginal symptoms related to menopause, urinary incontinence, or sexual function. "The procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue".

The agency has notified the firms, including Alma Lasers, BTL Aesthetics, BTL Industries, InMode, Sciton and Thermigen, that they have 30 days to respond to its questions about their marketing practices for the unapproved use.

The FDA clarifies that they have approved laser and energy-based devices for use to treat serious conditions such as genital warts.

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The new laser and ultrasound devices are being marketed as safer, but the FDA said they could be harmful. In addition, there are many reports of women being injured by these procedures.

The idea is that the vaginal rejuvenation process will help boost sexual desire and sexual function, but there's just one problem: These claims are probably all BS, says Dr. Gupta.

The FDA is warning consumers against serious risks of some "vaginal rejuvenation" devices, and a lack of evidence to support their uses for this objective.

In an official statement issued by the agency, Scott Gottlieb, FDA commissioner, says they are recently aware of an increasing number of companies claiming that their products provide vaginal rejuvenation to women.

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"We are evaluating the letter in full and will collaborate with the agency to ensure all product communications adhere to regulatory requirements", Mazur said. Women considering treatment for vaginal symptoms should speak to their doctor about the potential and known benefits and risks of all available treatment options.



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