The FDA has issued a women’s health warning that women who undergo vaginal rejuvenation treatment are at risk for serious injuries. The warning extends to patients as well as physicians who offer laser treatments or other methods for modifying vaginal tissues.

Women who have undergone such “rejuvenation” or are considering it should be aware that none of the procedures or devices employed have been approved by the U.S. Food and Drug Administration (FDA) for cosmetic or therapeutic purposes other than the treatment of disease.

Vaginal Rejuvenation Treatment

A publication from the University of Utah health and wellness program describes “vaginal rejuvenation” as a blanket term for numerous procedures, treatments and products. Most of these are used as attempts to correct issues that are the natural consequences of the aging process, such as changes caused by childbirth, vaginal dryness and even incontinence. This can include ointments, creams and even injections.

According to urogynecologist Dr. Jo Hill, vaginal rejuvenation is “…essentially anything that changes or alters the vaginal anatomy…[including] both internal and external structures.” It can also refer to surgical procedures.

Vaginal Rejuvenation Surgery

Treatments for vaginal rejuvenation may involve the use of lasers and radiofrequency devices. Normally, these techniques are used to remove or treat pre-cancerous lesions of the cervix or genital warts, purposes for which they have been approved by the FDA. However, with today’s commercially-driven obsession with youth and society’s often narrow definitions of what constitutes “beauty,” a number of clinics have opened in recent years in order to profit from aging women who are trying to hold on to their youth.

These clinics make frequent claims that vaginal rejuvenation treatment can “tighten” a vagina that has loosened as a consequence of giving birth or aging, or can increase sexual sensitivity and pleasure. However, the American College of Gynecologists says otherwise. A recent article on WebMD points out that, while vaginoplasty may be able to tighten the vagina, it cannot guarantee increased sensitivity, as sexual response is a highly complex phenomenon and depends on multiple factors, many of which are emotional and psychological.

The Dangers of Vaginoplasty

While the purported benefits of vaginal rejuvenation surgery are debatable at best, the risk of permanent and painful complications have been of great concern to reputable gynecologists. A report on female genital cosmetic procedures published in the International Journal of Women’s Health in 2017 pointed out that vaginal rejuvenation techniques have been poorly studied and that “more robust data” is required.

In July, 2018, the FDA published a warning against undergoing rejuvenation treatments for cosmetic purposes with the use of “energy-based devices.” Indeed, the federal agency has not approved any such devices for vaginal rejuvenation treatment. The FDA notes that long-term consequences can include burning, scarring and dyspareunia (painful intercourse).

Scott Gottlieb, the former FDA commissioner, noted in an official statement that the FDA had “become aware of a growing number of manufacturers marketing ‘vaginal rejuvenation’ devices to women and claiming these procedures will treat conditions and symptoms related to menopause, urinary incontinence or sexual function. ” He noted that “these [energy-based] 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,” Gottlieb said.

Be Forewarned

Any woman considering vaginoplasty for any reason other than the treatment of lesions or warts should research any claims made by a clinic before agreeing to undergo such a procedure.

A number of companies may be marketing energy-based devices for vaginal rejuvenation treatment, such as the following:

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

Filing a Vaginal Rejuvenation Lawsuit

If you have undergone a labial rejuvenation procedure and have since suffered from side effects like burning, scarring, or pain during sex, among others, you may be able to file a lawsuit and pursue compensation. Of course, filing a lawsuit cannot take away the pain and suffering caused by these problems, but it can at least help to alleviate any financial burden that may have been incurred, as well as hold those responsible accountable.

Filing a lawsuit can be a daunting prospect, especially while dealing with medical complications, so Top Class Actions has laid the groundwork for you by connecting you with an experienced attorney. Consulting an attorney can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.