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The FDA recently warned women that trendy new female genital rejuvenation procedures are unproven by scientific evidence and may pose serious health risks.
On July 30, the U.S. Food and Drug Administration (FDA) issued a warning regarding female genital rejuvenation, trendy procedures which are touted to treat vaginal dryness, pain during intercourse, vaginal laxity, and numerous other vaginal symptoms and conditions.
Female genital rejuvenation procedures often use lasers to destroy or reshape vaginal tissue. These devices have been approved by the FDA to treat a variety of conditions, including pre-cancerous cervix lesions and genital warts.
However, the devices used in female genital rejuvenation have not been approved for those applications, according to the FDA. They may cause severe side effects such as vaginal burns, scarring, pain during sexual intercourse and recurring or chronic pain.
“These products have serious risks and don’t have adequate evidence to support their use for these purposes,” said FDA Commissioner Dr. Scott Gottlieb. “We are deeply concerned women are being harmed.”
Concern by the FDA has prompted the agency to send letters to seven companies, notifying that their marketing techniques for female genital rejuvenation pose serious concerns. Companies who received these letters include Venus Concept, BTL Industries, Cynosure, Alma Lasers, Sciton, Thermigen, and Inmode MD.
“The deceptive marketing of unproven treatments may not only cause injuries but may also keep some patients form accessing appropriate, recognized therapies to treat severe medical conditions,” Gottlieb states.
Unfortunately, these allegedly deceptive marketing strategies seem to work. Scot Glasberg, the former president of the American Society of Plastic Surgeons, has said that healthy women across the country are opting for female genital rejuvenation as an easy fix to a variety of problems. With celebrities such as the stars of Real Housewives, Jada Pinkett-Smith, and the Kardashians speaking highly of the treatments, many women are seeing female genital rejuvenation in a positive light.
The recommendations of popular celebrities have compounded the draw of low prices and no need for surgical recovery. However, authorities warn that the low price tag may be offset by side effects caused by the use of untested equipment and the inevitable costs of future medical treatment.
As the FDA warns, the laser devices have not been sufficiently tested for use in female genital rejuvenation. Additionally, companies may be engaging in marketing practices that promote the devices for uses that have not been fully evaluated by the FDA.
“In some cases, these devices are being marketed for this use to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause,” Gottlieb said in a statement.
If you or a loved one experienced adverse side effects of female genital rejuvenation, you may be eligible to participate in a lawsuit investigation. A female genital rejuvenation lawsuit investigation could help recover compensation for pain and suffering, wrongful death, loss of consortium, and more.
If you or a loved one has undergone vaginal rejuvenation and experienced adverse side effects, including burning, pain, or scarring, you may qualify to join a vaginal rejuvenation class action lawsuit investigation that aims to hold these companies responsible. Fill out the FREE form on this page for more information.
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