Wednesday, 15 August, 2018

US Food and Drug Administration warns against vaginal rejuvenation devices

The “safety and effectiveness” of procedures promising to treat vaginal conditions related to menopause is unclear the U.S. Food and Drug Administration warned Monday ‘Vaginal rejuvenation’ laser treatments can cause burns and pain, FDA warns
Delores Daniels | 03 August, 2018, 02:26

The Food and Drug Administration on Monday announced that it had warned several companies to stop marketing laser devices for procedures billed as "vaginal rejuvenation", saying they were risky and deceptive treatments.

"These procedures are not medically indicated, and the safety and effectiveness of these procedures have not been documented", the group said in a 2007 statement.

"In addition to the deceptive health claims being made with respect to these uses, the "vaginal rejuvenation" procedures have serious risks", Gottlieb said.

The FDA said it was "deeply concerned" people were being injured with these procedures.

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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.

Treatment of these symptoms or conditions by applying energy-based therapies to the vagina may lead to burns, scarring, pain during sexual intercourse, and recurring/chronic pain.

The agency has sent letters to various manufacturers about the "inappropriate marketing" for vaginal rejuvenation devices, saying they should stop promoting those products outside of their approved uses - should they fail to comply, they could face mandatory recalls and product seizures.

Not only is vaginal rejuvenation likely ineffective when comes to its claims on sex drive, the FDA warns that the procedures come with other risky are downright unsafe.

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The agency originally permitted the lasers and related energy-based devices onto the market for treatment of serious conditions, like cancer, genital warts, or surgery including hysterectomies. Needless to say that the FDA has yet to review, let alone recommend, these procedures. We requested that the manufacturers address our concerns within 30 days.

So, for women who are experiencing incontinence or painful sex as a result of menopause, the best advice is to speak to your doctor about possible procedures which do work and to avoid vaginal rejuvenation procedures until more serious testing has been done. "If our concerns are not addressed, then the FDA will consider what next actions, including potential enforcement actions, are appropriate". FDA is committed to helping advance the development of safe, effective treatment options for these conditions. We will keep the public informed if significant new information becomes available.

Women who may not be candidates for certain FDA-approved treatments to relieve vaginal dryness, and who are seeking alternative nonhormonal options, may be particularly drawn to "vaginal rejuvenation" devices, ' according to the agency. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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