DiVa Laser Vaginal Rejuvenation Lawsuit
The JOULE Multi-Platform System and DiVa Laser Vaginal Therapy are manufactured by Sciton, a company based out of Palo Alto, California. The JOULE device was cleared by the FDA as a laser/light powered
device for multiple general uses, but the DiVa laser was never approved for vaginal rejuvenation procedures.
Vaginal rejuvenation is a term many women describe as a “face-lift” for their vagina. The laser and light-powered devices have been approved for multiple uses but not for vaginal rejuvenation procedures.
The generally pain-free procedure is done in a doctor’s office and claims to alleviate symptoms such as vaginal dryness, pain, incontinence or laxity (often found after childbirth or menopause, cancer or surgeries).
Vaginal rejuvenation procedures also claim to correct urinary incontinence, painful sex (dyspareunia), recurrent infections (vaginitis) and excess pigmentation and discoloration of the vagina.
However, with the device not being approved by the FDA for vaginal rejuvenation procedures, women are putting their bodies at risk of severe consequences.
The possible side effects of vaginal rejuvenation procedures are:
- Pain during sex
- Vaginal burns
- Recurring, chronic pain
The U.S. Food and Drug Administration has not approved or cleared the off-label use of Sciton’s devices to treat gynecological conditions beyond a serious need such as cancer or genital warts.
Furthermore, the agency said, “The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious.”
The FDA issued an open letter to multiple companies that advertise their products can be used in “vaginal rejuvenation” procedures, asking them to clarify the clearance the devices are being used under.
Though the FDA has allowed devices to be used for serious reasons, the use of JOULE Multi-Platform System and DiVa Laser Vaginal Therapy for cosmetic gynecological procedures has yet to be approved.