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The FDA has publicly warned numerous companies to stop marketing laser devices for vaginal rejuvenation procedures after the agency received numerous adverse event reports relating to the procedures.
The FDA says that the safety and effectiveness of these procedures remain unclear.
The lasers, which were originally approved by the FDA for the purpose of treating more serious conditions such as cancer and surgical uses that were medically necessary, are now being marketed for unapproved vaginal health treatments.
Manufacturers, that took liberties with the broad definition of the purpose of the lasers, began promoting the lasers for cosmetic purposes, improvement of libido and women’s sexual health, vaginal atrophy, menopause, urinary incontinence and improved sexual function.
These treatments were never approved by the FDA. The manufacturers have not conducted proper research into the safety and use of these laser treatments for vaginal rejuvenation procedures.
Although there are no exact statistics on the number of patients who have undergone these procedures, laser treatment for vaginal health has become more popular, especially among younger women.
These treatments are offered at healthcare facilities by obstetricians and Gynecologists, as well as spas and cosmetic facilities.
Laser treatment vaginal rejuvenation procedures destroy or reshape vaginal tissue. While the manufacturers market these procedures as a safe and successful way to fix dryness and other ailments, the FDA says that these practices are unsafe.
The FDA addressed multiple laser manufacturers in a collection of publicly-available letters, warning the manufacturers not to market the lasers for off-label purposes such as vaginal health treatment.
BTL Industries – The FDA addressed BTL Industries for marketing the Exilis Ultra 360, a radio-frequency device, as being purposed for “women’s intimate health.” The product was never approved for vaginal health and was approved for dermatology treatment. BTL marketed the Exilis Ultra 360 as a product that can build collagen and increase elasticity in the vaginal area. The FDA requested that BTL cease to make these claims.
MonaLisa Touch, Femilift, Venus Fiore RF Aablation System – The FDA addressed these manufacturers, requesting them to cease similar claims about their products success in treating vaginal health issues.
The American College of Obstetricians and Gynecologists has made several statements detesting the use of these laser treatments for vaginal rejuvenation procedures, citing the products’ lack of FDA approval for treatment of these health issues.
The FDA has found cases of vaginal burns, vaginal scarring, scar tissue, and incessant pain post-procedure. The full scope of possible injuries is still unknown according to the FDA.
There are currently no studies that have been conducted to investigate the range of injuries or number of total injuries reported.
The FDA has received adverse event reports connecting laser treatment vaginal rejuvenation procedures with injuries, including burning sensations and chronic pain.
Dr. Scott Gottlieb, the F.D.A. commissioner, said that the agency is deeply concerned women are being harmed; Gottlieb went on to say that misrepresentative marketing of these laser products might prevent women from seeking appropriate treatment for their medical conditions.
If you developed an injury subsequent to undergoing laser treatment for vaginal rejuvenation, you may be eligible to participate in a vaginal rejuvenation lawsuit. Contact an experienced vaginal rejuvenation lawyer at TorHoerman Law for a free no-obligation vaginal rejuvenation lawsuit consultation.
TorHoerman Law is currently investigating vaginal rejuvenation cases for the following:
If you suffered an injury due to a laser procedure for vaginal rejuvenation and have not done so, you should seek medical attention right away.
Commissioner, Office of the. “Press Announcements - Statement from FDA Commissioner Scott Gottlieb, M.D., on Efforts to Safeguard Women's Health from Deceptive Health Claims and Significant Risks Related to Devices Marketed for Use in Medical Procedures for ‘Vaginal Rejuvenation.’” U S Food and Drug Administration Home Page, Center for Biologics Evaluation and Research, 30 July 2018, www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm615130.htm.
Last Modified: November 13th, 2019 @ 12:05 pm
If you have suffered an injury due to a laser treatment vaginal rejuvenation procedure, you may be eligible to participate in a vaginal rejuvenation lawsuit. Currently, TorHoerman Law is investigating the possibility of filing a lawsuit against the manufacturers of laser treatment vaginal rejuvenation devices.
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