Women who underwent vaginal cosmetic procedures using Sciton’s diVa system and later suffered unexpected injuries may have grounds for a diVa lawsuit.

Sciton is one of several manufacturers of energy-based medical devices whose marketing campaigns have recently gotten the attention of the FDA. The FDA also recently warned the public that undergoing a vaginal rejuvenation process may put women at risk for developing serious side effects and vaginal injuries.

A vaginal rejuvenation process is a treatment designed to address changes that sometimes come about after childbirth or menopause. Women who undergo a vaginal rejuvenation process are often contending with physical changes including vaginal dryness or damage to the vaginal wall. These problems can also cause urinary incontinence, interfere with their sex life, and impact the woman’s overall quality of life.

Vaginal rejuvenation process options typically involve lasers or radiofrequency, which are used to stimulate vaginal tissue. These procedures may be marketed to help restore a vagina’s firmness, elasticity, and lubrication.

These energy based vaginal rejuvenation process options have been allegedly linked to serious problems for women, which spurred major concern from the FDA and medical community. The side effects reported from cosmetic vaginal rejuvenation process treatments include, but not limited to:

• • Vaginal Burns
  • Vaginal Scarring
  • Painful Intercourse
  • Recurring Pain
  • Vaginal Laxity
  • Vaginal Atrophy
  • Decreased Sensation during Sex

Women who suffered side effects like these and would not have chosen to undergo vaginal rejuvenation if they had been given a better warning of the related risks may qualify to join an ongoing diVa lawsuit investigation.

Overview of Vaginal Rejuvenation Process Warning

The FDA released a statement on July 30, 2018, stating that energy based products used for vaginal rejuvenation process treatments have not been evaluated or approved for such purposes.

The FDA noted that the approved uses for these products are limited to specific medical purposes such as “pre cancerous cervical or vaginal tissue and condylomas (genital warts).”

Even though these products are not FDA-approved for vaginal rejuvenation process use, some manufacturers have been allegedly marketing them for these purposes. The FDA had contacted companies like Sciton with letters, expressing concern about their marketing campaigns related to vaginal rejuvenation.

The FDA encourages patients who underwent vaginal rejuvenation process to report any side effects to MedWatch, the FDA’s Safety Information and Adverse Event Reporting program.

“We’ve recently 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,” said the FDA Commissioner Dr. Scott Gottlieb.

Dr. Gottlieb further stated that the agency was “deeply concerned women are being harmed” and that these vaginal rejuvenation products “have serious risks” and insufficient medical evidence that these devices should be used for these purposes.

Since vaginal rejuvenation is not an approved use for these devices, the FDA is concerned it may lead further medical complications for the patients. The FDA further states that it will continue to monitor the concern surrounding vaginal rejuvenation process treatments, and how the companies present products to the general public.

Overall, patients are being encouraged not to use vaginal rejuvenation products and to talk to their doctors about other treatment options.

Women who suffered injuries after undergoing a vaginal rejuvenation process may benefit from participating in a free lawsuit investigation. A diVa lawsuit could help affected patients get compensation for their injuries.

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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