The FDA is warning about illegal advertising and severe side effects of vaginal rejuvenation surgery, such as burns, scarring, and chronic pain.
Need a Texas Vaginal Rejuvenation Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. We are investigating potential lawsuits for people who were diagnosed with side effects of vaginal rejuvenation. If you were injured, you should contact our lawyers immediately for a free case consultation.
What is Vaginal Rejuvenation?
Vaginal rejuvenation surgery is advertised for the treatment of vaginal tightness or looseness, dryness, itching, pain during sexual intercourse, urinary incontinence, and other common symptoms.
What is the Problem?
Lasers, radio-frequency devices, cryotherapy, and other energy-based tools are not FDA-approved for any vaginal rejuvenation procedures, but they are being illegally advertised for unapproved uses in women.
Vaginal Rejuvenation Side Effects & Safety Risks
- Vaginal burns
- Pain with sexual intercourse
- Significant chronic pain
- Numbness or loss of sensation
FDA Letters for Vaginal Rejuvenation
In July 2018, the FDA sent letters to manufacturers because the agency was concerned about illegal advertising and serious side effects of vaginal rejuvenation, according to FDA Commissioner Dr. Scott Gottlieb:
“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.”
FDA Sends Letters to 7 Companies for Vaginal Rejuvenation
The following 7 companies received letters for advertising their lasers and other devices for unapproved vaginal treatments:
- Inmode MD, Inc. — (FormaV and FractoraV lasers)
- Sciton, Inc. — (JOULE Multi-Platform System for DiVa Laser Vaginal Therapy)
- Alma Lasers — (FemiLift)
- Thermigen, Inc — (THERMIva)
- BTL Industries, Inc — (Exilis Ultra 360 System)
- Cynosure, Inc — (MonaLisa Touch)
Other Names for Vaginal Rejuvenation Surgery
- Cosmetic gynecology
- G-spot amplification
- Female genital plastic surgery
- Female genital rejuvenation surgery
- Vulvovaginal plastic surgery
- Designer vagina surgery
Need a Vaginal Rejuvenation Lawyer in Texas?
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our lawyers for a free lawsuit review.