FDA Warns Women That Vaginal Rejuvenation Can Trigger Pain And Burns

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These devices perform procedures that utilize lasers, and other energy-based elements to destroy or reshape vaginal tissue.

Vaginal rejuvenation is often used to describe a non-surgical procedure meant to relieve symptoms such as vaginal laxity, vaginal atrophy, dryness or itching, pain during sexual intercourse, pain during urination and decreased sexual sensation.

"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.

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.

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The use of these vaginal rejuvenation devices has been found to cause side effects including vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain.

In addition to the deceptive health claims being made about the products, the devices are in some cases being marketed to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause, Gottlieb said.

Hologic's (HOLX +1.7%) Cynosure unit is one of seven manufacturers warned by the FDA over their marketing of energy-based devices, including lasers, for "vaginal rejuvenation", an unapproved indication.

But, the agency notes, there's no proof that these devices are effective for any of the "rejuvenating" procedures companies claim and some celebrities promote. 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.

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"Today, we're warning women and their healthcare providers that the FDA has serious concerns about the use of these devices to treat gynecological conditions beyond those for which the devices have been approved or cleared", Gottlieb says. The companies are: Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen.

Scott Gottlieb, commissioner of the Food and Drug Administration, said several device makers are marketing their products for uses that have not been approved by the agency. Gottlieb explains that if the manufacturers don't rectify these concerns, "the FDA will consider what next actions, including potential enforcement actions, are appropriate".

The FDA urges anyone who suffered a complication linked to a vaginal "rejuvenation" treatment to report it through MedWatch.

"It is deceptive to give the impression that vaginal rejuvenation, designer vaginoplasty, revirgination, G-spot amplification, or any such procedures are accepted and routine surgical practices".

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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 continued.

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