Celebrities are talking about it with People Magazine. Reality stars are having it done on their shows and live streaming it on social media. Laser Vaginal Rejuvenation is becoming a popular cosmetic procedure.
Meyers & Flowers are warning patients that this trendy treatment is also potentially dangerous.
What is LaserVaginal Rejuvenation
Lasers or devices using radiofrequency waves have been approved by the U.S. Food & Drug Administration (FDA) and used by gynecologists for many years. Often, lasers are used to treat abnormal and pre-cancerous vaginal and cervical tissue, remove genital warts and for surgical procedures such as hysterectomies.
Recently, the FDA has found these same devices are being marketed by laser manufacturers for off-label, nonapproved vaginal rejuvenation procedures. The companies are touting their laser treatments for vaginal dryness and laxity, sexual dysfunction issues like decreased sexual sensation and pain during intercourse or urinary incontinence. The lasers are being used to remove or reshape the vaginal tissue, while in some cases they have only been approved to treat specific dermatologic issues.
Concerns by the American Collegeof Obstetricians and Gynecologists
The American College of Obstetricians and Gynecologists (ACOG) Committee issued a statement in 2007 cautioning its members about the growing vaginal rejuvenation trends. The ACOG reaffirmed its stance about vaginal rejuvenation procedures in 2017.
The highly respected medical association indicated that it was deceptive to give the impression that vaginal rejuvenation (also known as designer vaginoplasty, revirgination, G-spot amplification) or similar procedures are accepted and routine surgical practices. “Absence of data supporting the safety and efficacy of these procedures makes their recommendation untenable.
Patients who are anxious or insecure about their genital appearance or sexual function may be further traumatized by undergoing an unproven surgical procedure with obvious risks. Women should be informed about the lack of data supporting the efficacy of these procedures and their potential complications, including infection, altered sensation, dyspareunia, adhesions, and scarring.”
The FDA issues Statement
In an August 2 statement, the FDA outlined their concerns about marketing claims being made about vaginal rejuvenation by the device manufacturers. According to the agency, “These products have serious risks and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed. We’ve recently become aware of a growing number of manufacturers marketing “vaginal rejuvenation” devices to women and claiming these procedures will treat conditions and symptoms related to menopause, urinary incontinence or sexual function.”
Over the last few years, some laser manufacturers have promoted their products for the off-label treatment of symptoms of vaginal atrophy, urinary incontinence, menopause, and sexual function. The laser vaginal rejuvenation procedures may also be marketed as designer vaginoplasty, revirgination, and G-spot amplification treatments.
The FDA has continued to receive reports of serious burns, scarring and lasting pain due to laser vaginal rejuvenation procedures. This led to the agency issuing letters to seven device manufacturers outlining its concerns about inappropriate marketing of their devices for “vaginal rejuvenation” procedures.
The companies are:
- Alma Lasers
- BTL Industries
- Cynosure
- InMode
- Sciton
- Thermigen
- Venus Concept
Who is being injured?
For the many women who experience incontinence and sexual dysfunction as well as changes due to pregnancy and menopause, these laser vaginal rejuvenation treatments seem like an easy answer. Instead, some are now facing serious health issues due to these off-label treatments that include:
- Vaginal burns and infection
- Bleeding and scarring
- Dryness and Pain with sexual intercourse
- Reoccurring or chronic pain
- Numbness or loss of sensation
- Bladder and Urethral pain
How Meyers & Flowers can help
Meyers & Flowers has a decades-long history of seeking justice for those injured by defective medical devices and are ready to provide you with information about your legal recourse and moving forward with a case against the laser manufacturers.
If you or a loved one has suffered serious injury, or worse, we can help. We are relentless in attaining justice for the injured. We are nationally recognized for our many high-value awards and settlements, and for our dedication to our clients. Call us today for more information about filing a claim for damages in a laser vaginal rejuvenation injury case.