The FDA says some companies that advertise laser-based medical devices may be promoting them for unapproved vaginal cosmetic procedures.

Seven different manufacturers of energy-based vaginal treatment devices received letters from the U.S. Food and Drug Administration (FDA) expressing the agency’s concern that their promotion of these devices could be in violation of the federal Food, Drug and Cosmetic Act.

While it’s not unusual for medications or medical devices to be used for off-label reasons, the marketing of any medication or medical device for off-label purposes may violate the law.

An FDA press release quoted FDA Commissioner Scott Gottlieb saying, “The deceptive marketing of unproven treatments may not only cause injuries but also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions. These products have serious risks and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed.”

Vaginal cosmetic procedures include non-surgical laser treatments that are marketed to resolve vaginal dryness, itching, painful sex, painful urination, loss of elasticity or atrophy. Advertising and marketing of vaginal cosmetic procedures often is aimed at women who have survived breast cancer chemotherapy treatments or those who have undergone menopause.

The FDA has not cleared any medical device to be used in such vaginal cosmetic procedures. Women may be at risk for receiving burns to their vaginas, developing scar tissue, experiencing painful sex and living with chronic pain, according to reports submitted to the FDA.

Among the companies who received a letter regarding their alleged marketing of off-label vaginal cosmetic procedures are:

Some of the devices that may be used for vaginal cosmetic procedures include:

• Venus Fiore
• Ultra Femme 360
• Mona Lisa Touch
• FemLift
• diVA
• ThermiVA
• FormaV, FactoraV

The FDA is seeking more information from the manufacturers and promoters of these devices about their advertising of vaginal rejuvenation treatments.

Lasers Used in Vaginal Cosmetic Procedures

The lasers used in vaginal cosmetic procedures were cleared by the FDA for incision and ablation of soft tissues in certain dermatological, dental, ear/nose/throat treatments and dental and oral surgeries.

Cosmetic vaginal rejuvenation proponents say laser probes inserted into the vagina stimulate cell production, collagen production and moisture creation. Celebrities have touted vaginal rejuvenation as way to regain youthful genitalia after childbirth, but the FDA says these devices have not been properly reviewed and approved for these treatments.

Patient advocates are concerned that some medical device companies may have taken advantage of women who either through medical issues or through natural aging experienced dissatisfaction with their bodies.

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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