FDA Issues Warning against Vaginal Rejuvenation Procedures, Citing Potential for Severe Injury

The Food & Drug Administration (FDA) has issued a warning to women who are considering vaginal rejuvenation cosmetic procedures that would use energy-based devices. Per the FDA, “To date, we have not cleared or approved for marketing any energy-based devices” for the procedure. FDA Commissioner Scott Gottlieb made an additional statement about the devices used in the procedure:

“the safety and effectiveness of these devices hasn’t been evaluated or confirmed by the FDA for ‘vaginal rejuvenation.’ In addition to the deceptive health claims being made with respect to these uses, the ‘vaginal rejuvenation’ procedures have serious risks. In some cases, these devices are being marketed for this use to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause. The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious.”

What is vaginal rejuvenation?

Vaginal rejuvenation is a group of cosmetic procedures aimed at reconstructing a woman’s genitals. These procedures may be performed after a woman has sustained a trauma, has gone through childbirth, or – as Mount Sinai explains it – to “restore [the] genital area to its original, youthful appearance for balance, symmetry, and function.” In some cases, the procedures may be necessary to correct a birth defect of some kind.

There are approved ways of performing these procedures, but energy-based devices are not on the list of FDA-approved devices. Furthermore, companies are claiming that vaginal rejuvenation can help cure symptoms such as:

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

The FDA has not approved energy-based devices to address any of these symptoms, nor does the FDA claim that vaginal rejuvenation procedures can actually fix any of these symptoms.

What is an “energy-based” device?

There are two categories of energy-based devices: Radiofrequency (RF) Treatments, which use electromagnetic waves, and CO2 and Er:YAG Lasers, which use infrared light. The FDA has approved these devices for the removal of growths, for use in hysterectomies, and for cancer treatments.

The dangers of laser and RF vaginal rejuvenation treatments

The FDA has received multiple complaints from women who have undergone vaginal rejuvenation procedures with these “off label” devices, and suffered adverse effects. Those effects include:

• Burning sensations
• Burn injuries to the vaginal area
• Chronic, recurring or long-term pain
• Painful sexual intercourse
• Scarring

Which companies have been using deceptive practice to market vaginal rejuvenation?

So far, the FDA has issued warning letters to seven manufacturers about their devices and their deceptive marketing practices. Those seven companies are:

• Alma Lasers, manufacturer of the Alma Lasers Pixel CO2 Laser System, marketed as the FemiLift
• Venus Concept, Ltd., manufacturer of the Venus Fiore System, marketed as the same
• BTL Industries, manufacturer of the Exilis (Exilis Ultra 360) system, marketed as the ULTRA Femme 360
• Cynosure, manufacturer of the DEKA SmartXide2 Laser System, marketed as the MonaLisa Touch
• InMode, manufacturer of the FormaV and FractoraV lasers, marketed as the same
• Sciton, manufacturer of the JOULE Multi-Platform System, marketed for DiVa Laser Vaginal Therapy
• Thermigen, manufacturer of THERMIva, marketed as the same

I sustained injuries from vaginal rejuvenation surgery; now what?

If you underwent vaginal rejuvenation surgery and sustained serious injuries, or because you were told that an energy-based device could be used off-label to fix an issue you had, you should report your experience to the FDA.

Next, you should call the defective medical device lawyers of McGowan, Hood, Felder & Phillips, LLC. We have spent many years fighting on behalf of product liability clients in different parts of the country. We have the skills, resources and experience to handle complex litigation against medical device manufacturers.

Serious injuries require aggressive representation. To learn more about our services, or to schedule a free consultation, please call 803-327-7800 or fill out our contact form.