Unfortunately, manufacturers are making these deceptive health claims to women, particularly those who are experiencing early menopause or who just completed breast cancer treatment.
During menopause, the levels of estrogen in a woman's body decrease and this may lead to symptoms such as the ones mentioned above and pain during sexual intercourse.
Today, we're warning women and their healthcare providers that the FDA has serious concerns about the use of these devices to treat gynecological conditions beyond those for which the devices have been approved or cleared.
The FDA said it was "deeply concerned" people were being injured with these procedures. "These products have serious risks and don't have adequate evidence to support their use for these purposes", Gottleib said. "In reviewing adverse event reports and published literature, we have found numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain", writes Dr. Gottlieb.
The agency has notified the firms, including Alma Lasers, BTL Aesthetics, BTL Industries, InMode, Sciton and Thermigen, that they have 30 days to respond to its questions about their marketing practices for the unapproved use.
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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.
FDA also said that it has approved such devices which commonly use beams and radio frequencies for specific gynecologic uses including the destruction of precancerous cervical or vaginal tissue and also the removal of genital warts.
"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", said Gottlieb, in a statement. If its concerns are not addressed, the agency could take enforcement action. There is little scientific basis for the use of these methods state the FDA.
In a statement, Jane Mazur, Hologic's vice president of global divisional communications, said that "Hologic has a strong track record of rooting our products in science and clinical evidence" and that it is "evaluating the letter in full and will collaborate with the agency to ensure all product communications adhere to regulatory requirements".
One such company that received a letter from FDA is Cynosure, which manufactures a device called MonaLisa Touch.
These products are vigorously advertised online and in most visual and print media citing "better feminine life", "better intimate health" and other false claims. We encourage those who've had an adverse event associated with the use of these devices to report their problem to MedWatch, the FDA Safety Information and Adverse Event Reporting program.