The devices warned about by the FDA typically use laser or radiofrequency waves, and have previously been approved by the FDA for more serious medical conditions such as the removal of pre-cancerous vaginal and cervical tissue, as well as genital warts.
Free Confidential Lawsuit Evaluation: If you or a loved one has been injured by the vaginal rejuvenation process, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
FDA Warning on Vaginal Rejuvenation
FDA’s letter is not technically considered a formal warning; However, the companies have been asked to provide details on the product and on what basis they are assuming approval. The use of vaginal rejuvenation techniques to treat vaginal dryness, itching and laxity have not been approved and are considered “off-label,” the agency said. The devices also have not been approved to treat sexual dysfunction (i.e. decreased sexual sensation, pain during intercourse, or urination).
“We are aware that certain device manufacturers may be marketing their energy-based medical device for vaginal ‘rejuvenation’ and/or cosmetic vaginal procedures,” FDA said. “The safety and effectiveness of energy-based medical devices to perform these procedures has not been established.”
Vaginal Rejuvenation Complications
- Vaginal burns
- Persistent pain
- Burning sensation
- Other adverse events
Which Companies are Affected?
FDA named the following companies in the letter issued Monday: Inmode; Sciton; Alma Lasers; Thermigen; BTL Aesthetics, BTL Industries; and Cynosure. The companies did not immediately respond to the action, according to The New York Times.
Is Your Firm Filing a Class Action?
At this time, our lawyers have decided against the filing of a class action lawsuit over injuries alleged from vaginal rejuvenation laser treatments, and are instead filing individual claims on behalf of injured parties. At Schmidt & Clark, LLP, we always attempt to maximize compensation for our clients. It has been our experience that in these types of cases, class action lawsuits can be a detriment to many class members, as they are often forced into a blanket “low ball settlement” and higher attorney fees.
Can I File a Vaginal Rejuvenation Lawsuit?
Only a qualified attorney can determine whether you are eligible to file a lawsuit against one of the device manufacturers above, 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 allegedly defective 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 certain potential complication. In the case of vaginal rejuvenation laser treatments, our attorneys suspect that patients may be able to take legal action in light of claims the manufacturers failed to adequately warn the public and healthcare communities about the risk of vaginal burns, scarring, and other serious injuries.
Do I Have a Vaginal Rejuvenation Lawsuit?
The Class Action 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 had complications after vaginal rejuvenation surgery, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.