FDA warns companies about 'deceptive' vaginal rejuvenation claim

Enlarge  Food and Drug Administration Commissioner Scott Gottleib is not

Enlarge Food and Drug Administration Commissioner Scott Gottleib is not

"These products have serious risks and don't have adequate evidence to support their use for these purposes", said Dr. Scott Gottlieb, the FDA commissioner. But it has found "numerous cases" of harm in adverse-event reports and published literature, he said.

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

As a further step, the FDA has sent notifications to Alma Lasers, BTL Aesthetics, BTL Industries, InMode, Cynosure, ThermiGen and Sciton. If its concerns are not addressed, the agency could take enforcement action.

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.

The U.S. Food & Drug Administration warned against "vaginal rejuvenation" treatments due to potential health and safety risks, including burns and scarring. The devices have also not been FDA approved for use in treating sexual dysfunction, such as decreased sexual sensation or pain during intercourse or urination.

Gottlieb said the agency had recently become aware of a growing number of manufacturers marketing "vaginal rejuvenation" devices to women and claiming these procedures will treat conditions and symptoms related to menopause, urinary incontinence or sexual function. "The deceptive marketing of a risky procedure with no proven benefit, including to women who've been treated for cancer, is egregious", he said.

Hologic, Inc., who owns the company Cynosure that markets the Mona Lisa Touch laser, addressed a reviewer who says she developed debilitating bladder pain after using the device.

"The deceptive marketing of a unsafe procedure with no proven benefit, including to women who've been treated for cancer, is egregious", Gottlieb said.

"These products may be particularly appealing to women who may not be candidates for certain FDA-approved treatments to relieve vaginal dryness, and thus are seeking alternative, non-hormonal options", he explained. We've also established the Women's Health Technologies Strategically Coordinated Registry Network (CRN) to provide more complete evidence in clinical areas that are unique to women, such as uterine fibroids and pelvic floor disorders.

If you suffered any adverse effects associated with these procedures, the FDA wants you to file a report through MedWatch.

The FDA says that companies offering these services haven't gone through the correct approval process to demonstrate the treatments work as advertised, or even that they're safe.

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