On June 30, 2018, the U.S. Food & Drug Administration (FDA) issued warnings to numerous companies for irresponsibly promoting the use of medical lasers [1] for uses not sanctioned by the agency, such as various vaginal rejuvenation techniques. These applications have not been sufficiently researched for safety and effectiveness and have been associated with severe adverse reactions, including vaginal burns, scarring, and ongoing 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.
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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
- Scarring
- 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.
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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.
FAQs
What are the potential side effects of using Votiva?
Potential side effects of using Votiva include burns, scarring, pain during or after treatment, infection, and other complications. These adverse effects can lead to significant physical and emotional distress.
What compensation can be sought in a Votiva lawsuit?
Compensation in a Votiva lawsuit can include medical expenses, pain and suffering, lost wages, and other related costs. In severe cases, punitive damages may also be pursued to penalize the manufacturer for negligence.
How can I prove that Votiva caused my injuries?
Proving that Votiva caused injuries involves gathering medical records, documenting the timeline of device use and symptom onset, and obtaining expert testimony linking the device to the adverse effects.
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.