The FDA recently issued a warning regarding vaginal cosmetic procedures on July 30, 2018, stating they could be dangerous to women. More specifically, the FDA says these vaginal rejuvenation procedures have not been evaluated as treatments for menopause, urinary incontinence, or other related procedures, or patients could risk developing serious complications.

The FDA warning pertained to certain devices that used radiofrequency or lasers for vaginal rejuvenation treatments. These devices can be used in approved gynecological procedures such as destroying abnormal cervical or vaginal tissue and genital warts.

However, these devices have not been approved for vaginal cosmetic procedures that typically pertain to vaginal tighteners or sexual health including:

• Vaginal laxity
• Vaginal atrophy, dryness, or itching
• Painful sexual intercourse
• Painful urination
• Decreased sexual sensation

Vaginal rejuvenation
typically refers to non-surgical procedures that are used to change or alter vaginal tissues for cosmetic or therapeutic purposes. These procedures are used by numerous women to improve vaginal appearance, and even use these devices to treat vaginal conditions mentioned previously or for more gynecologic purposes like urinary tract infection or menopause.

However, the long lasting effects of vaginal cosmetic procedures have not been evaluated, and the FDA is warning that women could be at risk for suffering serious injuries from these unapproved treatment procedures including, but not limited to:

• Infection
• Chronic pain
• Scarring
• Vaginal burns
• Pain during sexual intercourse

Overview of FDA Vaginal Rejuvenation Concerns

The FDA’s warning also points out that the effectiveness of vaginal rejuvenation devices has yet to be determined, nor have they been cleared by the FDA to be marketed for this purpose.

Letters have been sent from the FDA regarding their marketing of these vaginal rejuvenation devices. The FDA warned some of them that their promotional materials may be in violation of the Federal Food Drug and Cosmetic Act (FD&C Act). These companies include, but may not be limited to:

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

The FDA intends to investigate any potential violations against this act and will continue monitoring the situation while keeping an eye out for injury reports.

The FDA is currently recommending that patients be aware of the safety and effectiveness of energy based vaginal rejuvenation treatments, including the fact that they are not fully known.

If one or more these companies are found to be in violation, the FDA stated it will take appropriate action. In addition, the FDA stresses the importance that these devices were not cleared for such treatment purposes.

Vaginal rejuvenation has become increasingly popular over the years, with a number of celebrities including Jada Pinkett Smith having endorsed such treatments. With this increased popularity, the number of vaginal rejuvenation related injury reports has also grown in number.

Patients should also discuss risks and benefits of all available treatment options with their doctors, and report any injuries they may experience from vaginal rejuvenation procedures through Medwatch, the FDA Safety Information and Adverse Event Reporting program.