FormaV and FractoraV Vaginal Rejuvenation Lawsuit
Manufactured by Inmode MD Ltd., FormaV and FractoraV lasers were targeted by the U.S. Food and Drug Administration recently for claims they can be used to treat “sexual dysfunction, vaginal rejuvenation and urinary stress incontinence.”
The FDA has approved and cleared devices such as FormaV and FractoraV to treat serious medical conditions such as abnormal or pre-cancerous cervical or vaginal tissue, or genital warts. However, the FDA has not approved the use of these devices for “vaginal rejuvenation.”
FDA commissioner Dr. Scott Gottlieb said in a statement recently, “The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious.”
“Vaginal rejuvenation” is a term that many women describe as a “face-lift” for their vagina. The term claims to alleviate discomfort from vaginal dryness, pain, incontinence or laxity (often found after childbirth or menopause, cancer or surgeries). It also claims to correct urinary incontinence, painful sex (dyspareunia), recurrent infections (vaginitis) and excess pigmentation and discoloration of the vagina.
According to the Inmode website, FormaV is used in “the treatment of sexual dysfunction or as an adjunct to Kegel exercises (tightening of the muscles of the pelvic floor to increase muscle tone) and cleared to temporary improve blood circulation, muscle pain relief and muscle relaxation.”
FractoraV is used “in dermatologic and general surgical procedures for electrocoagulation,” according to the Inmode website.
Both devices have been marketed in cosmetic treatment for vaginal rejuvenation. However, without regulation or clearance from the FDA, such marketing claims can put women at risk of health consequences.
The FDA said in a statement recently, “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. The procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue. 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.”
Some of the side effects from energy-based devices like FormaV and FractoraV may include:
- Vaginal burns
- Scarring
- Pain during sexual intercourse
- Recurring or chronic pain
The FDA issued a letter to a handful of companies that manufacture devices being used for “vaginal rejuvenation.”
Inmode was asked for the clearance and approval number for their products being used for vaginal rejuvenation, as well as the basis in which the company determines it is not required to obtain FDA clearance or approval.