Alma Lasers Inc. is accused of marketing the FemiLift for unapproved vaginal rejuvenation treatments, while failing to warn women about the risk of burns, scarring, pain, and other severe side effects.
What is the Alma FemiLift?
FemiLift is a vaginal rejuvenation treatment that uses an Alma Pixel CO2 Laser to revitalize vaginal mucosal tissue. The procedure is performed by inserting a probe into the vagina, where it delivers thermal energy (heat treatments) to stimulate collagen production and tightening vaginal tissues. Each treatment takes approximately 10 minutes, with 3 treatments every 4 weeks for optimal results.
What is the problem?
In July 2018, Alma Lasers, Inc. received a letter from the FDA for possibly promoting the FemiLift Pixel CO2 Laser System for unapproved vaginal rejuvenation treatments with serious safety risks.
Vaginal Rejuvenation Side Effects
- Vaginal burns
- Persistent pain
- Pain during sexual intercourse
- Burning sensation
- And more
Failure to Report 3rd Degree Burns from Alma Lasers
In June 2013, Alma Lasers received another warning letter from the FDA for failing to report a serious injury — specifically a woman who suffered a 3rd-degree burn:
“Use of your firm’s device resulted a third degree burn to the patient (i.e. full thickness burn). A third degree burn is an injury that results in permanent impairment of a body function or permanent damage to a body structure.”