In addition to warning consumers, the FDA revealed that it has taken action, sending warning letters to seven companies marketing “energy-based” devices that are being used outside of their cleared or approved intended uses. Some of the devices, which are commonly radiofrequency- or laser-based, have legitimate uses such as removing warts or pre-cancerous vaginal or cervical tissue.
But, the agency notes, there’s no proof that these devices are effective for any of the “rejuvenating” procedures companies claim and some celebrities promote. These include empowering-sounding treatments that claim to tighten tissue, relieve pain, and boost sexual pleasure. More specifically, the companies collectively claim that the devices are able to treat vaginal “laxity,” pain during urination or intercourse, decreased sexual sensation, and vaginal dryness, itching, or atrophy. Some of these issues are symptoms related to menopause, urinary incontinence, or sexual function issues.
In a twitter thread Monday, FDA Commissioner Scott Gottlieb noted that some of the companies specifically targeted patients who had undergone breast cancer treatments and were experiencing symptoms from early menopause.
“Deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious,” Gottlieb fumed in one tweet.
Gottlieb went on to note that the agency has reviewed patient reports and medical literature and found “numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain” from the treatments.
“We’re deeply concerned women are being harmed by these procedures,” he added.
The FDA plans to monitor and follow up with the companies, as well as look into ways to revamp its oversight of such medical devices. For patients, the FDA suggests discussing any vaginal issues with your doctor.
The seven companies called out by the FDA are: BTL Industries, Inc; Cynosure, Inc.; Alma Lasers; Sciton, Inc.; Thermigen, Inc.; BTL Aesthetics; and Inmode MD Ltd.
