Sciton Inc. is accused of failing to warn about side effects like burns, scars, and pain when the JOULE DiVa Laser Vaginal Therapy is used for unapproved vaginal rejuvenation treatments.
Sciton JOULE DiVa Laser Vaginal Rejuvenation
Sciton Inc. advertises the JOULE Multi-Platform System for several types of cosmetic procedures, including the DiVa® Laser Vaginal Therapy, also known as “vaginal rejuvenation.” Sciton claims that this procedure can tighten vaginal tissue and treat sexual dysfunction.
What is the Problem?
In July 2018, Sciton Inc. received a letter because the FDA never approved the JOULE DiVa® Laser for any type of vaginal rejuvenation treatment.
Numerous women who had vaginal rejuvenation have suffered severe side effects. The FDA is concerned because the JOULE DiVa® Laser was not safety tested before it was marketed for vaginal treatments.
“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.”
Side Effects of Vaginal Rejuvenation
- Vaginal burns
- Pain with sexual intercourse
- Significant chronic pain
- Sexual dysfunction
- And more