Published: Fri, August 03, 2018
Medicine | By Debra Reynolds

Vaginal 'Rejuvenation' Procedures Are Unproven, Pose Serious Risks, FDA Warns

Vaginal 'Rejuvenation' Procedures Are Unproven, Pose Serious Risks, FDA Warns

These devices perform procedures that utilize lasers, and other energy-based elements to destroy or reshape vaginal tissue. In these cases, the FDA had not reviewed or approved the used devices for the goal of 'vaginal rejuvenation'.

The laser and ultrasound equipment used in these unapproved procedures has FDA approval for removing genital warts, other growths and in operations such as hysterectomies. These include empowering-sounding treatments that claim to tighten tissue, relieve pain, and boost sexual pleasure. However such claims seem spurious says the FDA.

"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". 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", said FDA commissioner Dr Scott Gottlieb in a statement. These alternative treatments have increased in popularity thanks to the media.

"The safety and effectiveness of energy-based devices for treatment of these conditions has not been established".

"It is a virtually painless procedure without surgery, anesthesia or downtime". But we're equally dedicated to monitoring the landscape to ensure products are delivering on their intended benefits and to ensure that if new health risks arise, we take appropriate action.

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"Bring your sexy body back with Ultra Femme 360", it says.

In addition, these treatments are also being marketed erroneously to women who have had cancer.

Celebrities, including actress Jada Pinkett Smith and Kim Kardashian, also often promote the procedures.

The Food and Drug Administration is cracking down on manufacturers promising "vaginal rejuvenation", saying it could have serious side effects.

This is why the agency has released the warning, adding that they have notified seven manufacturers about the "inappropriate marketing", asking for a response within 30 days.

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Hologic Inc., the parent company of Cynosure, told USA Today that it is aware of the FDA warning.

CNN reached out to these companies for comment.

The American College of Obstetricians and Gynecologists has been cautioning against surgical "rejuvenation" procedures for more than a decade.

"The treatment of these symptoms or conditions 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", FDA said.

Gottlieb is concerned that these procedures are aimed at women who had cancer treatment that caused early menopause, a fact he considers to be egregious and, adding that the manufacturers use "deceptive marketing of a unsafe procedure with no proven benefit".

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