On July 30, 2018, the FDA released a safety announcement warning several companies to stop marketing their devices for vaginal rejuvenation procedures. The FDA is claiming they are “dangerous and deceptive treatments". While the lasers and other energy-related procedures were intended for and approved to treat conditions like cancer and genital warts, manufacturers began to market the devices for symptoms related to vaginal rejuvenation procedures, such as vaginal atrophy, menopause, urinary incontinence, and sexual function.
What Is the Problem?
These manufacturers are illegally and deceptively marketing these lasers to be used for procedures that were never approved by the FDA. Any medical device or drug not approved by the FDA can be used off-label by a medical professional. However, the manufacturers of the device or drug cannot promote it off-label.
The FDA sent letters to several manufacturers regarding this off-label promotion. In some cases, the FDA even quoted the content on manufacturers’ websites that had false information. For example, BTL Industries, Inc. marketed the Exilis (Exilis Ultra 360), a radio frequency treatment, with “the Exilis Ultra 360 system is proven to increase elastin and collagen in the treatment area,” referring to vaginal rejuvenation procedures. The Exilis Ultra 360 was not approved for vaginal rejuvenation procedures, but rather for dermatology, including wrinkle treatment. BTL has removed the Exilis Ultra 360 page from their site following the FDA’s notice.
What Are the Injuries?
There have been 14 adverse events reported, including vaginal burns, scarring, and extreme pain following the procedure. Vaginal rejuvenation procedures can also cause bleeding, infection, adhesions, and numbness or loss of sensation.
What Are the Types of Vaginal Rejuvenation?
Vaginal rejuvenation surgery can have other names, including:
- Cosmetic gynecology
- Female genital plastic surgery
- Female genital rejuvenation surgery
- G-spot amplification
- Vulvovaginal plastic surgery
- Designer vagina surgery
Who Are the Defendants?
The FDA sent letters to Immode, Sciton, Alma Lasers, Thermigen, BTL Aesthetics, BTL Industries, and Cynosure because of their deceptive advertising. The American College of Obstetricians and Gynecologists issued a statement that advises obstetrician-gynecologists and patients to be cautious with these procedures, as they are not approved by the FDA for the treatments they are being marketed for.
GoldenbergLaw Can Help
If you or a loved one underwent a vaginal rejuvenation procedure and experienced a serious side effect, contact GoldenbergLaw immediately. Our defective medical device lawyers have over 30 years of experience and are national leaders.