Some of the devices, which are commonly radiofrequency- or laser-based, have legit uses such as removing warts or pre-cancerous vaginal or cervical tissue.
Procedures marketed to improve a woman's "intimate health" using lasers or ultrasound are not only unapproved, but are also causing burns and other painful damage, the Food and Drug Administration said Monday.
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. If the companies fail to respond, the FDA said, it will consider next steps, which might include "potential enforcement actions". They FDA has noted that these treatments are sold to women who have been treated for breast cancer early and experience menopausal symptoms.
Gottlieb said the agency had recently become aware of a growing number of manufacturers marketing "vaginal rejuvenation" devices to women and claiming these procedures will treat conditions and symptoms related to menopause, urinary incontinence or sexual function. Dr. Cheryl B. Iglesia, director of the section of female pelvic medicine and reconstructive surgery at MedStar Washington Hospital Center, said the laser technology held promise but more study was needed to understand the safety as well as which patients the devices might help. "These products have serious risks and don't have adequate evidence to support their use for these purposes", Gottleib said.
But their use to treat vaginal dryness, itching and laxity, the FDA said, has not been approved. He said the agency doesn't know the extent of the risks because it hasn't reviewed the devices for such procedures.
The deceptive marketing of unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions. "We are deeply concerned women are being harmed", stated the safety alert released on the agency's website.
The FDA says vaginal rejuvenation devices have not gone through the correct approval process required to show they're effective, or let alone safe to use. There is little scientific basis for the use of these methods state the FDA.
Hologic, Inc., which owns Cynosure, wrote in an email that they have "a strong track record of rooting our products in science and clinical evidence so, we take the contents of this letter seriously".
The FDA says it's received complaints about burns and other damage.
The companies involved say they are reviewing the warning letters from the FDA, which advises them to stop promoting the treatments.
These products are vigorously advertised online and in most visual and print media citing "better feminine life", "better intimate health" and other false claims.
If you have undergone treatment for vaginal "rejuvenation" and experienced a complication, file a report through the FDA's MedWatch.