Women who underwent a vaginal rejuvenation procedure using a device manufactured by Venus Concept may be in a position to file a Venus Fiore lawsuit.

The FDA has expressed concern that companies like Venus Concept may be marketing vaginal rejuvenation devices in a manner that potentially violates the Federal Food Drug and Cosmetic Act (FD&C Act), because there is not sufficient research on the safety of such treatments.

Originally, laser treatments and energy-based devices like the Venus Fiore system were approved by the Food and Drug Administration to treat conditions like cancer and genital warts. The devices were also approved for use in surgeries like hysterectomies.

Recently, manufacturers have been advertising these treatments for purposes for which they were not approved.

According to marketing, vaginal rejuvenation treatments, done with lasers and energy-based devices can treat a range of conditions including sexual function, vaginal dryness, urinary incontinence, as well as symptoms connected to menopause or vaginal atrophy. But critics say these promotional campaigns exploit women’s insecurity about their appearance, compelling them to take unreasonable risks with unproven medical procedures.

It is legal for doctors to use medical devices for purposes for which they were not originally approved, but the FDA questions their efficacy in vaginal rejuvenation treatments. Promotional materials that mislead women about the true nature of these devices and the risks involved could create grounds for a Venus Fiore lawsuit.

The FDA disagrees with some manufacturers who say that these treatments can be used to reshape or destroy vaginal tissue to treat dryness and other conditions.

FDA Commissioner Dr. Scott Gottlieb says that “these products have serious risks and don’t have adequate evidence to support their use for these purposes,” according to The New York Times.

Allegedly, cases of vaginal burns, scarring, and persistent pain following treatments have been reported. The FDA has received 14 reports of adverse reactions to the treatment.

Expert worry that the marketing is ahead of the science in the case of these treatments. The FDA has been under pressure to approve new medical devices, as demand rises for vaginal rejuvenation treatments, spurred on in part by advertisements on social media and endorsements from celebrities. Experts worry that already, the FDA approves too many devices too quickly without sufficiently monitoring their use.

Pushing back against this trend, the FDA warned patients and doctors about the risks of using energy-base devices for a vaginal rejuvenation procedure, saying that “the safety and effectiveness of energy-based devices for treatment of these conditions has not been established.

The FDA then went on to contact companies to express the agency’s concern that they may be marketing vaginal rejuvenation devices in a manner that potentially violates the Federal Food Drug and Cosmetic Act (FD&C Act). Dr. Gottlieb says that experts at the agency are “deeply concerned women are being harmed,” The New York Times reports.

Dr. Gottlieb worries that because vaginal rejuvenation is often seen as a less-invasive or cheaper treatment for conditions that might otherwise require surgery, the availability of a vaginal rejuvenation procedure might deter patients from seeking more appropriate and more reliable therapies.

Women who suffered unexpected complications following a vaginal rejuvenation procedure may qualify to participate in a Venus Fiore lawsuit investigation that could lead to compensation for their injuries.

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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CORRECTION 10/24/18: A previous version of this article incorrectly stated that Venus Concept had been warned by the FDA about its marketing practices. The article now correctly states that the FDA expressed concern that its marketing practices may potentially violate the Federal Food Drug and Cosmetic Act (FD&C Act).