FDA Warns about the Danger of Energy-Based Devices used to Perform Vaginal Rejuvenation
For the past couple of years, the topic of “vaginal rejuvenation” has appeared with increasing frequency in the media enticing a woman to “become your best self” and “make your life better”. Celebrities have touted their experiences with the non-surgical devices to achieve feminine rejuvenation, even showing their own procedures on reality television shows.
Vaginal Rejuvenation Claims
Marketing efforts for non-surgical vaginal rejuvenation tell women they can use energy-based devices for medical, sexual, and cosmetic reasons. These devices claim to help with the following issues:
- Vaginal laxity
- Vaginal Dryness
- Pain with sex
- Stress incontinence
- Vaginal external appearance
These are attractive claims especially to women who have medical and sexual issues following childbirth or menopause. In addition, many women are interested in the procedure purely for cosmetic reasons.
In fact, The International Association for Physicians in Aesthetic Medicine has ranked vaginal rejuvenation as the number one emerging trend in aesthetic medicine for 2018. These physicians join a wide range of doctors in other specialties offering these treatments including primary care doctors, obstetricians and gynecologists, plastic surgeons, general surgeons, and urologists.
U.S. Food and Drug Administration Warning
Now, the “safe and effective” feature advertised for these devices is coming into question. On July 30, 2018, the FDA issued a warning to both patients and the health care community about the use of energy-based devices to perform vaginal rejuvenation or vaginal cosmetic procedures. The FDA’s Safety Communication states that the safety and effectiveness has not been established, and the use of these devices may result in serious injuries such as vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain.
While these energy-based devices have received FDA clearance for general medical indications such as the treatment for genital warts and cancer, the FDA makes it clear that it “has not cleared or approved any energy-based device for vaginal ‘rejuvenation’ or vaginal cosmetic procedures, or for the treatment of vaginal symptoms related to menopause, urinary incontinence, or sexual function”.
Types of Energy-Based Devices for Vaginal Rejuvenation
The two main types of energy-based vaginal rejuvenation devices are radiofrequency devices and laser devices. The FDA singled out seven companies for inappropriately marketing dangerous vaginal rejuvenation devices for women: Inmode, Sciton, Alma Lasers, Thermigen, BTL Aesthetics, BTL Industries, and Cynosure. These and a number of other companies and their brand name products are listed below:
Radiofrequency (RF) Treatments: Emit electromagnetic waves to heat the tissue. Brand names include:
- ThermiVa (Thermigen)
- Viveve (Viveve Medical)
- ULTRA Femme 360 (BTL Aesthetics)
- ReVive (Viora)
- Venus Fiore (Venus Concept)
- Protégé Intima (BTL Aesthetics)
- Pelleve (Ellman International)
- Votiva (Inmode)
CO2 and Er:YAG (erbium: yttrium-aluminum-garnet) Lasers: Emit laser energy in the mid-infrared invisible light spectrum to heat the tissue. Brand names Include:
- FemiLift (Alma Lasers)
- MonaLisa Touch® (Cynosure)
- DiVa (Sciton)
- CO2RE Intima (Syneron)
- FemTouch™ (Lumens)
- IntimaLase (Fotana)
- Petit Lady (Lutronic)
Devices such as these can cause real harm. If you have had a serious complication following a treatment with an energy-based device used for vaginal rejuvenation or vaginal cosmetic procedures, you may be entitled to compensation for your injuries. An experienced attorney can help you understand your rights.
Call us at (800) 684-2136 or send us an email inquiry to discuss your legal options.
The consultation is free and confidential.
To find other products or pharmaceutical drugs that can often result in injuries, visit our in the news section.