‘Vaginal Rejuvenation’ Devices Have Serious Side Effects, Unproven Claims: FDA

The FDA warned against

‘Vaginal rejuvenation’ laser treatments can cause burns and pain, FDA warns

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 unsafe and deceptive treatments.

The FDA warned against "vaginal rejuventation" treatments. These are in fact used by licensed gynaecologists.

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. Needless to say that the FDA has yet to review, let alone recommend, these procedures.

During menopause, the levels of estrogen in a woman's body decrease and this may lead to symptoms such as the ones mentioned above and pain during sexual intercourse.

In a statement Monday, FDA Commissioner Scott Gottlieb said that a growing number of manufacturers are marketing their devices for unapproved uses such a vaginal "rejuvenation", in which tissue typically is destroyed or reshaped. What's more, vaginal rejuvenation procedures have been tied to serious side effects, including vaginal burns, scarring, pain during sexual intercourse and recurring or chronic pain.

The seven companies called out by the FDA are: BTL Industries, Inc; Cynosure, Inc.; Alma Lasers; Sciton, Inc.; Thermigen, Inc.; BTL Aesthetics; and Inmode MD Ltd.

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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. We requested that the manufacturers address our concerns within 30 days. If the companies fail to respond, the FDA said, it will consider next steps, which might include "potential enforcement actions". "We are deeply concerned women are being harmed", stated the safety alert released on the agency's website.

"The deceptive marketing of unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions", Gottlieb continues. "The deceptive marketing of a unsafe procedure with no proven benefit, including to women who've been treated for cancer, is egregious".

The agency said that it has approved such devices, which commonly use laser beams or radiofrequencies, for specific gynecologic uses, including the destruction of precancerous cervical or vaginal tissue and the removal of genital warts.

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

As part of this critical work, we remain dedicated to closely monitoring reports of adverse events associated with "vaginal rejuvenation" procedures. There is little scientific basis for the use of these methods state the FDA. Cynosure has said in a statement that they are preparing an answer to the letter from the FDA.

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