Scientists say vagina rejuvenating therapies 'pose serious risk'Naija247news

If you're dealing with painful sex or other sexual dysfunction issues-or if you're just into the idea of having a more enjoyable sex life-the recent trendiness of vaginal laser rejuvenation might have seemed like a magic wand. He also said that officials have found "numerous cases" of serious harm.

The FDA noted in a safety alert issued Monday that vaginal "rejuvenation" often is used to describe nonsurgical procedures meant to treat symptoms such as vaginal laxity, atrophy or dryness, and pain during intercourse or urination.

Unfortunately, manufacturers are making these deceptive health claims to women, particularly those who are experiencing early menopause or who just completed breast cancer treatment.

Women are being warned against risky cosmetic "rejuvenating" procedures to reshape and tighten the vagina.

We haven't reviewed or approved these devices for use in such procedures. The FDA commissioner added that these "unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions".

The lasers and ultrasound equipment used in these unapproved treatments have FDA approval for some procedures, such as removing genital warts and hysterectomies, but not for the "vaginal rejuvenation" purposes claimed by a number of manufacturers (and promoted by celebrities such as Kim Kardashian and Jada Pinkett Smith).

The FDA has notified Alma Lasers, BTL Aesthetics, BTL Industries, InMode, Cynosure, ThermiGen and Sciton over "concerns about inappropriate marketing of their devices for "vaginal rejuvenation" procedures", and expects them to address the issues raised by the agency within 30 days.

"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". Parent company Hologic, Inc. said it is aware of the FDA warning.

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. 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.

These products are typically not covered by insurance, especially more serious treatment procedures, which are often referred to as "designer vaginoplasty", "revirgination", or "G-spot amplification".

The agency posted copies of letters it sent to manufacturers of the MonaLisa Touch, Femilift, Venus Fiore RF Ablation System and other devices, telling them to stop promoting them for the rejuvenation procedure. 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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