The U.S. Food and Drug Administration (FDA) recently issued a warning to patients and healthcare providers regarding the safety and effectiveness of vaginal “rejuvenation” and cosmetic vaginal procedures. The FDA contends that not only are these procedures unproven, they may cause serious adverse events, such as vaginal burns, scarring, and chronic pain.
Energy based devices, including radio frequency or laser, have been cleared by the FDA for procedures such as removing abnormal or precancerous tissue and general gynecologic indications. “Many manufacturers are marketing procedures for symptoms that the devices haven’t been tested or approved for, such as vaginal dryness, menopause symptoms, urinary incontinence and sexual function, and that’s a problem” says, Stephanie S. Faubion, M.D., director of a women’s health clinic in Minnesota.
Since December 2015, there has been a number of adverse reports to the FDA regarding energy based devices for vaginal rejuvenation and cosmetic vaginal procedures. In addition to this, the FDA has also received voluntary medical reports from individual patients who have experienced significant pain and discomfort from procedures related to these devices. As a result, the agency has issued attention letters to seven manufacturers notifying them they may be marketing the devices in a manner that violates federal law.
If you have had vaginal rejuvenation or cosmetic vaginal procedures please contact Finkelstein, Blankinship, Frei-Pearson, & Garber to discuss your legal options. You may have been a victim of consumer fraud.