A growing number of medical professionals, along with patients who have received a vaginal rejuvenation procedure, report that the results fail to live up to the claims made about the methods, that often include the application of lasers to women’s genital areas.

According to Med Edge, the U.S. Food and Drug Administration has issued a warning over these vaginal rejuvenation procedures, which use lasers or energy-based devices to reshape or remove vaginal tissue.

Proponents claim these procedures treat a broad variety of conditions. When new procedures pick up popularity due to uses other than what they were originally designed for, safety advocates and government regulators might grow concerned about the dangers faced by patients getting these treatments.

Marketing materials associated with the vaginal rejuvenation procedure have claimed to treat symptoms associated with sexual function, urinary incontinence, and menopause. In response, the FDA has urged companies marketing this technology for these purposes to recognize that they may be risking the safety of their patients. The federal agency also noted that marketing this treatment in this manner may violate the Federal Food Drug and Cosmetic Act.

The Food and Drug Administration has now warned the medical community and the public that they have received numerous reports of problematic and painful side effects from rejuvenation procedures including chronic or recurring pain, post-procedure pain during sexual intercourse, and scars or burning tied to the vaginal rejuvenation procedure.

Former FDA Commissioner Scott Gottlieb noted in an official statement issued over vaginal rejuvenation claims that “these 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.

The FDA has also alerted creators of these treatments in the past that publicizing benefits not supported by scientific evidence may be confusing or deceptive for patients using this information to decide whether or not to get the procedure.

CNBC reports that the Food and Drug Administration has currently not approved any vaginal rejuvenation procedure to treat urinary incontinence, vaginal atrophy or reduced sexual function. Many of the women who have undergone this vaginal rejuvenation procedure claim they did so without realizing that there was limited scientific evidence about the efficacy or safety of these procedures.

According to the Food and Drug Administration, vaginal rejuvenation procedures have been marketed for relieving painful sex, particularly in post-menopausal women. The FDA commissioner has gone on the record saying that he was deeply concerned that women may be hurt by the number of different procedures carried out under the umbrella of vaginal rejuvenation.

Physicians have already been warned against using energy and laser therapies to treat sexual dysfunction because the devices are not approved for this purpose.

The Food and Drug Administration has already sent communications to seven different manufacturers regarding their marketing of the vaginal rejuvenation procedures developed by those companies.

The vaginal rejuvenation procedure might go by several different names, including revirgination, designer vaginoplasty, or v-spot amplification.

Concerns have also been raised regarding whether or not vulnerable women are a target market for this procedure, including those who recently went through cancer treatment. Women who underwent breast cancer treatments, for example, might experience early menopause symptoms and believe the marketing statements about all the procedure’s alleged benefits.

Many of the women who have used marketing materials to make their decision about undergoing these treatments say they have seen this marketed as an alternative therapy for treatments and hormonal replacement pills.

However, the Food and Drug Administration says that it is concerned about the adverse event reports associated with these procedures and the dangers of inappropriately marketing vaginal rejuvenation procedures as cure-alls for a variety of different symptoms and side effects.

A number of companies may be marketing energy-based devices as a safe and effective form of vaginal rejuvenation treatment, including:

• 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 vaginal rejuvenation procedure and have since suffered from side effects—including burning, scarring, or pain during sex—you may be able to file a lawsuit and pursue compensation.

Of course, filing a lawsuit cannot undo the pain and suffering caused by these complications, but it can at least help to alleviate the financial burden incurred by medical expenses, lost wages, and more.

Filing a lawsuit can be a daunting prospect, 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.