Women who received femal rejuvenation treatments with devices like the FemiLift may have grounds for a FemiLift lawsuit to compensate for unexpected complications.

Female rejuvenation, or vaginal rejuvenation, is an “ill-defined” term, according to the FDA. However, the term generally pertains to treatments and even vaginal plastic surgery that addresses changes in the female reproductive system that sometimes follow childbirth or menopause.

According to the FDA, female rejuvenation is linked to adverse side effects including painful damage and burns. The FDA has since warned the public about female rejuvenation procedures, in addition to contacting seven companies that have been marketing devices for these procedures. A general alert has also been sent out to physicians and patients alike.

Devices like the FemiLift by Alma Laser Surgical have been approved by the FDA to treat medical conditions like genital warts or pre-cancerous cervical tissue. However, the FDA says these devices are now being marketed for procedures that haven’t gotten a full review and approval.

According to the FDA’s Commissioner Dr. Scott Gottlieb, “We’ve recently become aware of a growing number of manufacturers marketing ‘vaginal rejuvenation’ devices to women claiming these procedures will treat conditions and symptoms related to menopause, urinary incontinence or sexual function.”

He added that, “These procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue. These products have serious risks and don’t have adequate evidence to support their use for these purposes.”

There have been promotions for these procedures in media coverage and online advertisements. Promotions for these procedures frame women who undergo the procedures as taking back control of their health. But consumer advocates are concerned these companies may be exploiting some women’s insecurities about their bodies.

A FemiLift advertisement describes the procedure as a “virtually painless procedure without surgery, anesthesia or downtime. The lasting benefits of FemiLift can be an improved quality of life and deeply enhanced self-esteem,” according to Today.

However, despite these advertisements and promotions, the FDA iterates that these devices have not gone through the right approval process to confirm that they can be safely and effectively used for these treatments.

According to the FDA, “To date, we have not cleared or approved for marketing any energy-based devices to treat these symptoms or conditions, or any symptoms related to menopause, urinary incontinence or sexual function,” they stated.

According to recommendations stated by the American College of Obstetricians and Gynecologists, they have consistently cautioned against female rejuvenation procedures.

In 2007, the organization stated that “[t]hese procedures are not medically indicated, and the safety and effectiveness of these procedures have not been documented.” They have added that “[i]t is deceptive to give the impression that vaginal rejuvenation, designer vaginoplasty, revirgination, G-spot amplification, or any such procedures are accepted and routine surgical practices.”

According to the FDA, “In reviewing adverse event reports and published literature, we have found numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain,” They’ve also said that, “The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious.”

Women who suffered complications as a result of these treatments may qualify to joint a FemiLift lawsuit investigation.

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.

Companies who are allegedly marketing vaginal laser rejuvenation with these devices include:

• Venus Concept – Venus Fiore
• BTL Industries – Ultra Femme 360
• Cynosure – Mona Lisa Touch
• Alma Lasers – FEMILIFT
• Sciton – diVA
• Thermigen – ThermiVA
• Inmode MD – FormaV, FactoraV

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