By Tracy Colman  |  October 5, 2018

Category: Legal News

FDA Warns Against Using Devices for Vaginal Rejuvenation SurgeryVaginal rejuvenation surgery is a term coined for newer treatments that offer to treat symptoms that women sometimes experience as menopause sets in. When estrogen decreases in the body as women approach and negotiate menopause, the vaginal walls can become thinner, dryer, and swollen. These changes cause some women to experience pain during sex.

Additionally, vaginal rejuvenation surgery is allegedly supposed to help women with the reduction of sexual pleasure that often follows pregnancy and childbirth. This reduction is attributed to a loss of muscle tone following childbirth.

According to a CNBC article, the U.S. Food and Drug Administration (FDA) has issued a warning to doctors and patients regarding employing certain devices approved for other purposes in vaginal rejuvenation surgery to alleviate sexual dysfunction. The drug and device oversight agency is very concerned about the development of vaginal rejuvenation surgery utilizing tools that have not been approved for that purpose.

According to Scott Gottlieb, head of the agency, the use of lasers, radio-frequency-wielding and other energy devices may be misleading women by offering them unproven treatments for low libido, incontinence, and vaginal dryness secondary to childbirth and menopause.

By being offered vaginal rejuvenation surgery, according to the CNBC article, women may be being driven away from legitimate and proven therapies. In the process, they may be getting injured or hurt. The FDA has purportedly been on the receiving end of two reports of post-procedure hemorrhaging and pain, as well as twelve additional reports of gross discomfort and pain during vaginal rejuvenation surgery.

As part of the agency’s review of this trend, it was discovered that 29 published studies on the subject reported symptoms of burning and bleeding lasting well into the third day after the procedure. The devices being used for vaginal rejuvenation surgery are approved by the FDA to remove genital warts or pre-cancerous tissue on the vaginal wall or cervix.

With this new cosmetic treatments, the energy-based tools are actually used to reshape vaginal tissue. More and more women are asking for this treatment based on advertising by doctors using associated devices for off-label purposes.

The FDA sent out letters to seven companies whose marketing tactics might violate the Food, Drug and Cosmetic Act. According to the CNBC article, these seven companies include Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen.

The American College of Obstetricians and Gynecologists has also weighed in on the matter of vaginal rejuvenation surgery. The organization has issued a recommendation to all of its affiliated doctors to speak with female patients requesting this type of procedure. It is their hope that the doctors will dissuade women from this track by educating them on the lack of supporting evidence behind the procedures.

If you or a loved one has undergone vaginal rejuvenation and experienced adverse side effects, including burning, pain, or scarring, you may qualify to join a vaginal rejuvenation class action lawsuit investigation that aims to hold these companies responsible. Fill out the FREE form on this page for more information.

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