FDA Statement on Health Risks of Vaginal Rejuvenation
July 31, 2018 – FDA contacted the following 7 companies it believes are promoting the lasers for unapproved vaginal rejuvenation purposes: Inmode; Sciton; Alma Lasers; Thermigen; BTL Aesthetics, BTL Industries; and Cynosure. The agency also issued a general alert for patients and doctors, and warned the public against undergoing procedures involving the lasers.
“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.”
What is ‘Vaginal Rejuvenation’ Surgery?
The term ‘vaginal rejuvenation’ is a blanket term that covers a number of different procedures. Among the processes classified as vaginal rejuvenation are labiaplasty, clitoral hood reduction, labia majoraplasty, monsplasty and vaginoplasty. Vaginal rejuvenation may also be referred to as female genital plastic surgery, female genital rejuvenation surgery, female genital cosmetic surgery, vulvovaginal plastic surgery and designer vagina surgery, among other terms.
Vaginal Rejuvenation Complications
- Vaginal burns
- Persistent pain
- Burning sensation
- Numbness / loss of sensation
- Other adverse events
Female Genital Cosmetic Surgery Options
- Labiaplasty – Procedure that alters the labia minora and the labia majora, the folds of skin surrounding a woman’s vulva.
- Clitoral hood reduction – Process aimed at removing excess folds of the clitoral hood, or prepuce.
- Labia majoraplasty – Surgery intended to reduce the size, or to improve the contour of, labia majora.
- Monsplasty – Also known as a Pubic Lift, monsplasty is a surgical procedure that reduces and tightens the Mons Pubis, which can be performed for both cosmetic and functional reasons.
- Vaginoplasty – Vaginoplasty (also known as posterior colporrhaphy) is a process that tightens the vagina.
Can I File a Class Action?
At Schmidt & Clark, LLP, one of our primary goals is 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. Our lawyers understand that our clients are suffering emotionally and economically due to loss of wages and/or high medical bills and we plan to maximize each client’s recovery by investigating potential individual vaginal rejuvenation lawsuits on their behalf.
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 following a vaginal rejuvenation process, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.