The U.S. Food & Drug Administration (FDA) announced on June 30, 2018, that it had warned several companies they were recklessly marketing medical lasers for unapproved uses, including a variety of vaginal rejuvenation processes, which have not been adequately studied for those purposes, and actually been linked to serious side effects including vaginal burns, scarring and persistent pain.
Free Confidential Lawsuit Evaluation: If you or a loved one suffered complications after a vaginal rejuvenation procedure, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
What’s the Problem?
In recent years, medical device manufacturers have been heavily promoting laser devices that were originally approved by the FDA to treat serious conditions like cancer, for women’s cosmetic procedures, including vaginal rejuvenation processes. Also known as cosmetic gynecology, these procedures are generally used to treat symptoms related to vaginal atrophy, menopause, urinary incontinence and sexual function. Vaginal treatments using laser and other devices for women’s health have also recently become extremely popular among younger women.
FDA Warning on Vaginal Rejuvenation
The above vaginal cosmetic procedures, which typically involve the use of lasers or ultrasound, are not only unapproved, but have also been linked to burns and other painful damage, FDA said the letter. The agency has warned InMode and 6 other device makers to stop marketing their lasers for these processes, and also issued a general alert for patients and doctors. The agency has also warned the public against asking for such procedures.
What are Votiva Treatments?
The Votiva treatments involve two separate procedures, one for the internal part of the vagina, the other for the external:
- FormaV (internal) - Delivers thermal tissue remodeling of the genitals and provides uniform RF heating of the internal vaginal tissue and external vulvar laxity and/or labial hypertrophy.
- FractoraV (external) - Delivers deep fractional tissue coagulation through the use of technology that combines fractional coagulation and heating. This is designed for remodeling external areas such as the labia majora.
Vaginal Rejuvenation Side Effects
- Vaginal burns
- Persistent pain
- Burning sensation
- Other adverse events
Can I File a Votiva Lawsuit?
Only a qualified attorney can determine whether you are eligible to file a lawsuit against InMode, the maker of the Votiva FormaV and FractoraV treatment, which is why we are currently offering free case evaluations. Simply fill out the confidential evaluation form below to contact our law firm now.
Most cases involving medical devices allege that a product was sold with design, manufacturing, and/or marketing defects, which typically refers to a company’s failure to warn of a potential side effect or complication. In the case of Votiva, our attorneys suspect that patients may be able to take legal action in light of claims that inMode failed to adequately warn doctors and patients about the risk of vaginal burns, scarring and other serious side effects.
How Can Filing a Lawsuit Help Me?
By filing a lawsuit against the maker of Votiva, you may be entitled to collect compensation for all current and future medical expenses related to the treatment of your vaginal injury, as well as for damages for pain and suffering. Additionally, filing a lawsuit can help hold the laser device’s manufacturer accountable for releasing an allegedly defective product into the marketplace, and to discourage other companies from engaging in similar conduct.
Do I have a Votiva Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Votiva lawsuits. We are handling individual litigation nationwide and currently accepting new vaginal rejuvenation injury cases in all 50 states.
Free Case Evaluation: Again, if you were injured from Votiva treatment, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.