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Table Of Contents
What’s the Problem?
Votiva legal claims involve legal action against InMode, the manufacturer of Votiva FormaV and FractoraV vaginal rejuvenation devices. The primary allegations center on the company’s failure to adequately warn doctors and patients about the risk of severe side effects including vaginal burns, scarring, and ongoing pain.
Latest Votiva Updates
- June 30, 2018 – The U.S. Food & Drug Administration issued warnings to InMode and 6 other device makers to stop marketing their medical lasers for vaginal rejuvenation techniques not sanctioned by the agency. The FDA stated 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 [1]. The agency also issued a general alert for patients and doctors warning against such procedures.
FDA Reports and Statistics
The FDA has documented severe adverse reactions associated with vaginal rejuvenation procedures using laser and other energy-based devices. These procedures, which have become extremely popular among women seeking treatment for vaginal atrophy, menopause symptoms, urinary incontinence, and sexual function issues, have resulted in numerous reports of complications. The agency’s concern stems from the lack of sufficient research demonstrating the safety and effectiveness of these treatments for cosmetic gynecological applications.
Votiva Injuries & Side Effects
Patients who have undergone Votiva treatments have reported a range of serious complications and adverse effects:
- Vaginal burns: Thermal injury to vaginal tissue from radiofrequency energy
- Scarring: Permanent tissue damage affecting vaginal structure and function
- Persistent pain: Ongoing discomfort that may interfere with daily activities
- Burning sensation: Continuous or recurring burning feeling in treated areas
- Other adverse events: Additional complications requiring medical intervention
Do You Qualify for a Votiva Lawsuit?
You may qualify for a Votiva lawsuit if:
- You received Votiva FormaV or FractoraV treatment
- You experienced serious side effects including vaginal burns, scarring, persistent pain, or burning sensations
- The injuries required medical treatment or ongoing care
- You can provide medical documentation linking your injuries to the Votiva procedure
Evidence Required for a Votiva Lawsuit
To build a strong case, you will need:
- Medical records documenting your Votiva treatment
- Documentation of injuries and complications following the procedure
- Timeline linking the device use to symptom onset
- Expert medical testimony connecting the device to adverse effects
Damages You Can Recover
Compensation in a Votiva lawsuit can include:
- Current and future medical expenses related to treating your vaginal injury
- Lost wages due to inability to work
- Pain and suffering damages
- In severe cases, punitive damages may be pursued to penalize the manufacturer for negligence
What are Votiva Treatments?
The Votiva treatments involve two separate procedures designed for different areas:
- 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.
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Statute of Limitations for Votiva Lawsuits
The statute of limitations for medical device lawsuits varies by state, typically ranging from 1 to 6 years from the date of discovery of the injury or from when the injury should have reasonably been discovered. In product liability cases involving medical devices like Votiva, the clock usually starts ticking when you knew or should have known that your injuries were caused by the device.
It’s crucial to act quickly as these time limits are strictly enforced by the courts. Missing the statute of limitations deadline can permanently bar you from seeking compensation, regardless of the merits of your case. Some states also have statutes of repose that place an absolute time limit on when lawsuits can be filed, regardless of when the injury was discovered.
FAQs
1. 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.
2. 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.
3. 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.
4. Can I file a lawsuit against InMode for Votiva complications?
Yes, patients may be able to take legal action against InMode for failure to adequately warn doctors and patients about the risk of vaginal burns, scarring and other serious side effects. Only a qualified attorney can determine your eligibility for a lawsuit.
5. What makes Votiva treatments problematic according to the FDA?
The FDA has stated that vaginal rejuvenation procedures using devices like Votiva are not only unapproved but have been linked to burns and other painful damage. These applications have not been sufficiently researched for safety and effectiveness.
Get a Free Votiva Lawsuit Evaluation With Our Lawyers
Time is limited to pursue legal action against medical device manufacturers. Filing a lawsuit can help hold the laser device’s manufacturer accountable for releasing an allegedly defective product into the marketplace and discourage other companies from engaging in similar conduct.
Our legal team offers:
- Free, confidential consultations
- No upfront costs or fees
- Payment only if we win your case
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.
Reference:
https://www.fda.gov/medical-devices/industry-medical-devices/letters-industry