“Vaginal rejuvenation” procedures and devices unsafe says FDA

By Dr. Ananya Mandal, MDJul 31 2018

According to a warning from the United States Food and Drugs Administration (FDA), devices that are being sold for “vaginal rejuvenation” in women who are suffering from urinary incontinence or menopausal and sexual symptoms, can cause serious harm.

The devices are said to use laser or radiofrequency waves. They have been permitted by the US FDA earlier for treatment of abnormal and precancerous vaginal and cervical tissues and remove genital warts. These are in fact used by licensed gynaecologists. However these devices are also being increasingly used for treatment of vaginal laxity, itching and dryness said the FDA. The devices have not been approved for such use in sexual dysfunction. IT could lead to numbness in the region as well as pain during urination and sexual intercourse, the FDA warned.

The statement issued by the FDA says, “We are aware that certain device manufacturers may be marketing their energy-based medical device for vaginal 'rejuvenation' and/or cosmetic vaginal procedures. The safety and effectiveness of energy-based medical devices to perform these procedures has not been established.” The statement adds, “The treatment of these symptoms or conditions by applying energy-based therapies to the vagina may lead to serious adverse events, including vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain.”

As a further step, the FDA has sent notifications to Alma Lasers, BTL Aesthetics, BTL Industries, InMode, Cynosure, ThermiGen and Sciton. Their notifications express concerns over the “inappropriate marketing of their devices for 'vaginal rejuvenation' procedures.” Answers from the companies have been sought within the next 30 days. “Potential enforcement actions” might be taken warned the FDA, if suitable answers are not provided within the stipulated time.

According to a statement from FDA Commissioner Dr. Scott Gottlieb, “We are deeply concerned women are being harmed. 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.” They FDA has noted that these treatments are sold to women who have been treated for breast cancer early and experience menopausal symptoms. “The procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue. These products have serious risks and don’t have adequate evidence to support their use for these purposes,” Gottleib said.

Over a dozen adverse reports after the use of these treatments have brought this issue to the forefront. There is little scientific basis for the use of these methods state the FDA. Some of the companies such as Cynosure that is owned by Hologic Inc. state that they have based their treatments on science. However such claims seem spurious says the FDA. Cynosure has said in a statement that they are preparing an answer to the letter from the FDA.

These products are vigorously advertised online and in most visual and print media citing “better feminine life”, “better intimate health” and other false claims. The FDA has urged women to stop using these devices and report the issues to the FDA’s adverse event reporting programme called the MedWatch.