Women who suffered complications following laser vaginal rejuvenation may be in a position to bring an Ultra Femme 360 lawsuit.

The FDA has recently warned that laser vaginal rejuvenation using systems like the Ultra Femme 360 system made by BTL Aesthetics may have serious side effects, and that potential dangers of this procedure are not fully understood.

Women who undergo laser vaginal rejuvenation are often suffering from incontinence, sexual dysfunction, and menopausal symptoms, with the hope it will be an effective treatment measure.

However, the FDA recently stated that laser vaginal rejuvenation and other devices that are meant for vaginal rejuvenation could cause serious complications.

Laser vaginal rejuvenation typically uses a laser or radio frequency waves that were originally approved by the FDA to treat abnormal or pre-cancerous tissue in the vagina and cervix, as well as genital warts.

However, the FDA says these products have not been fully evaluated for the cosmetic uses that some companies and physicians are allegedly advertising them for. These advertised cosmetic purposes reportedly include treating vaginal dryness, itching, and laxity, as well as problems related to sexual dysfunction. Patient advocates are concerned these advertisements take advantage of women’s insecurity about their bodies to entice them into trying untested and potentially hazardous medical procedures.

In addition, some women have also sought laser vaginal rejuvenation to treat pain that occurs during sexual intercourse or urination. However, treatment with laser vaginal rejuvenation may also put these women at risk for serious side effects, which could be grounds for an Ultra Femme 360 lawsuit.

“The treatment of these symptoms or conditions by applying energy-based therapies to the vagina may lead to serious adverse events, including vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain,” the FDA stated.

Overview of Vaginal Rejuvenation Treatment Concern

The FDA has recently contacted BTL Aesthetics about its advertising of the Ultra Femme 360 system, as well as six other manufacturers of similar devices, advising them that their advertising of these treatments may be in violation of the Food, Drug and Cosmetic Act.

Approximately a dozen injury reports have been submitted to the FDA regarding vaginal rejuvenation complications. Patients say that their compilations were caused by the companies’ different vaginal rejuvenation products.

According to one woman who says she underwent a laser vaginal rejuvenation procedure with the Mona Lisa Touch laser marketed by Cynosure, she developed severe and debilitating bladder and urethral pain after the procedure. She reported that she also had to undergo several doctor visits, but these long laser complications have not yet been resolved.

Another woman had reportedly used the Thermiva device from ThermiGen to treat her urinary incontinence, and had experienced serious pain soon after. According to her injury report, the woman’s gynecologist stated that she had severe bruising. She says she then learned that the device was not approved to treat urinary incontinence by the FDA.

FDA Commissioner Dr. Scott Gottlieb stated that the FDA was deeply concerned over the potential side effects these vaginal rejuvenation products could cause, as well as the marketing tactics used by the companies.

“The deceptive marketing of unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions,” Dr. Gottilieb stated.

The FDA is currently recommending that those who undergo laser vaginal rejuvenation and other vaginal treatment methods report any issues to the FDA’s adverse event reporting program called MedWatch. The FDA also recommends that women who suffered complications from vaginal rejuvenation should contact their doctor to discuss their problems.

Filing an Ultra Femme 360 lawsuit could help patients seek compensation for unexpected complications. If you suffered injury following a laser vaginal rejuvenation treatment, you may benefit from participating in this lawsuit investigation.

If you or a loved one has undergone vaginal rejuvenation and experienced adverse side effects, including burning, pain, or scarring, you may qualify to join a vaginal rejuvenation class action lawsuit investigation that aims to hold these companies responsible.

Companies who are allegedly marketing vaginal laser rejuvenation with these devices include:

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

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