FemiLift Laser Vaginal Rejuvenation Lawsuit
FemiLift is a type of device used in “vaginal rejuvenation” procedures some women undergo in order to address complications they have in their most intimate of regions.
FemiLift is one of many brands to be put on notice by the U.S. Food and Drug Administration recently as the agency stated devices used for “vaginal rejuvenation” have little to no known benefits. There are instances where vaginal rejuvenation procedures have caused irreparable damage to the patient.
FemiLift is manufactured by Alma Lasers. According to its website, Alma Lasers is “a global innovator of laser, light-based, radiofrequency and ultrasound solutions.” The device works by creating tiny scars in the vaginal tissue which prompts a “tightening” of the area through the natural self-healing process of the body.
Vaginal rejuvenation using FemiLift is often performed by a gynecologist or plastic surgeon. It claims to alleviate 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.
FemiLift is a pain-free thermal heating and micro-ablation system that requires no anesthesia and is performed in-office.
In a recent statement, the U.S. Food and Drug Administration claimed vaginal rejuvenation procedures are approved for women with serious conditions, but for cosmetic purposes, the devices are being marketed deceptively.
The FDA has not approved or cleared an off-label use of the device to treat gynecological conditions beyond a serious need. 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 side effects from vaginal rejuvenation may include:
- Pain during sex
- Scarring
- Vaginal burns
- Recurring pain
- Chronic pain
In a letter addressed to Alma Lasers, the FDA asked for clarification as to why the device was used for “vaginal irregularities” and “vaginal mucosa revitalization” since the agency did not give clearance or approval for such claims.