The vaginal rejuvenation process has come under scrutiny by the FDA, leading to seven companies receiving letters from the regulatory agency.
On July 30, the U.S. Food and Drug Administration (FDA) reportedly issued letters to seven companies seeking more information about their marketing of a vaginal rejuvenation process using energy-based medical devices. Companies who received a letter 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 also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions,” FDA Commissioner Scott Gottlieb said in a statement. “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.”
The problem with this marketing, the FDA says, is that it could be in violation of the Food, Drug and Cosmetic Act.
The vaginal rejuvenation process is often marketed to women undergoing menopause or who have recently undergone chemotherapy for breast cancer. According to the FDA, these women may be at risk for unexpected injuries.
“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,” said the FDA in a statement.
Despite the scientific uncertainty associated with the vaginal rejuvenation process, the trend has been endorsed by numerous celebrities including many of the Real Housewives cast, the Kardashian family, and Jada Pinkett-Smith.
“The vaginal rejuvenation market has grown in the last five years,” said former American Society of Plastic Surgeons president Scot Glasberg in a statement to The Daily Beast. “It’s especially grown with minimally invasive techniques in the market.”
The vaginal rejuvenation process involves probes, lasers, and radio frequencies. A probe is reportedly inserted into the vagina to deliver “laser energy” to the vaginal wall. This energy reportedly encourages cell stimulation which revitalizes the vagina.
Glasberg explains that much of the appeal associated with the vaginal rejuvenation process comes from its minimally invasive nature, associated with less pain and shorter down time.
However, according to the FDA statement, the vaginal rejuvenation process may be associated with complications including burns, painful sex, scarring, and chronic pain. Women harmed by the process can experience side effects which may last the rest of their lifetimes.
Marketing for the vaginal rejuvenation process often appeals to women who have had difficult births associated with vaginal tearing and women who are experiencing the vaginal and sexual side effects of menopause. Other advertising targets women who believe their vagina needs to look a certain way to conform to societal expertations.
Qualified attorneys are reviewing the potentially deceptive claims associated with the vaginal rejuvenation process and evaluating the potential for legal action against the companies who provide the service. Individuals who suffered from complications related to the vaginal rejuvenation process may be eligible to participate in investigations into the matter.
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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