Originally approved for the treatment of serious conditions like cancer and genital warts, the lasers have been increasingly used in recent years for symptoms associated with vaginal atrophy, menopause, urinary incontinence and sexual function. When used in these “off-label” capacities, FDA says the lasers have not been well studied and may actually be very dangerous to unsuspecting women.
Free Confidential Lawsuit Evaluation: If you or a loved one suffered complications after undergoing a vaginal rejuvenation process, 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.
FDA Statement on Vaginal Rejuvenation Risks
FDA said in the letter that the full extent of potential health risks of the various vaginal rejuvenation procedures is currently unknown, but that it has received reports from women of vaginal burns, scarring, and lasting pain following the treatments. The agency is aware of at least 14 reports of adverse events related to the treatments, including burning sensations and significant pain.
“These products have serious risks and don’t have adequate evidence to support their use for these purposes,” said Dr. Scott Gottlieb, Commissioner of the FDA. “We are deeply concerned women are being harmed.”
Vaginal Rejuvenation Complications
- Vaginal burns
- Persistent pain
- Burning sensation
- Numbness / loss of sensation
- Other adverse events
Which Companies are Affected?
The following companies are named specifically in the FDA letter: Inmode; Sciton; Alma Lasers; Thermigen; BTL Aesthetics, BTL Industries; and Cynosure.
How Much Does it Cost?
Depending on the specific procedure the patient elects to undergo, the cost of vaginal rejuvenation can range from $4,000 to $10,000. Most health insurance companies consider vaginal rejuvenation a cosmetic surgery, and therefore do not offer coverage. However, in cases where the procedure is done to correct a legitimate covered medical condition, the patient may be eligible for cost reductions.
Can I File a Vagnial Rejuvenation Lawsuit?
Only a qualified attorney can determine whether you are eligible to file a lawsuit against manufacturer of a vaginal rejuvenation treatment laser, 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 device was sold with design, manufacturing, and/or marketing defects, which typically refers to a company’s failure to warn of a certain potential complication. In the case of vaginal rejuvenation lawsuits, our attorneys suspect that patients may be able to take legal action in light of claims that manufacturers 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 a vaginal rejuvenation laser, you may be entitled to collect compensation for all current and future medical expenses related to the treatment of your injury, as well as for damages for pain and suffering. Additionally, filing a lawsuit can help hold the 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 Vaginal Rejuvenation 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 vaginal rejuvenation lawsuits. We are handling individual litigation nationwide and currently accepting new injury cases in all 50 states.
Free Case Evaluation: Again, if you were injured by a vaginal rejuvenation procedure, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.