Their notifications express concerns over the "inappropriate marketing of their devices for "vaginal rejuvenation" procedures".
Experts say the "therapies", offered by some private clinics in the United Kingdom and the U.S., pose a serious risk of burns, scarring and recurring pain.
Laser and energy-based devices have been approved for use in destroying pre-cancerous cells in cervical or vaginal tissue, as well as genital warts, but they have not undergone testing for rejuvenation therapies.
"As a leader in women's health, Hologic has a strong track record of rooting our products in science and clinical evidence, so we take the contents of this letter seriously", Jane Mazur, a representative for Hologic, Inc., said in a statement.
"Vaginal rejuvenation procedures claim to tighten the skin and the vaginal tissue beneath the skin by using various forms of energy devices", says Adeeti Gupta, M.D., a board-certified gynecologist and founder of Walk In GYN Care in NY. Thus, the full extent of the risks is unknown. "But these reports indicate these procedures can cause serious harm", the FDA said.
Several manufacturers - Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton, and Thermigen - were put on notice, and their device claims will be monitoring. The agency is requesting the companies to address their concerns within one month. "The deceptive marketing of a risky procedure with no proven benefit, including to women who've been treated for cancer, is egregious", he said.
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.
Not only is vaginal rejuvenation likely ineffective when comes to its claims on sex drive, the FDA warns that the procedures come with other risky are downright unsafe.
So, for women who are experiencing incontinence or painful sex as a result of menopause, the best advice is to speak to your doctor about possible procedures which do work and to avoid vaginal rejuvenation procedures until more serious testing has been done. FDA is committed to helping advance the development of safe, effective treatment options for these conditions.
In a move to improve their oversight of such devices, the FDA has also started building device safety registries.
The devices are said to use laser or radiofrequency waves.
According to CNBC, the American College of Obstetricians and Gynecologists recommends "doctors inform patients about the lack of data supporting the efficacy and potential complications of vaginal rejuvenation and other similar procedures". The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.