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RAKYATKU.COM – The Food and Drug Administration (FDA) warned Monday against the use of energy-based devices for badl rejuvenation or cosmetic procedures. The agency said the treatment could cause badl burns, scars and chronic pain.
The agency said to have approved the device, which generally uses laser light or radiofrequency, for specific gynecological uses, including the destruction of precancerous cervical or badl tissues and the removal of bad warts , quoted in the Wednesday Washington Post (1/8/2018).
But the agent did not clear the device of symptoms related to menopause, urinary incontinence or badual function. The FDA noted in a safety warning released Monday that "rejuvenation" of the bad is often used to describe non-surgical procedures designed to treat symptoms such as badl elasticity, atrophy or dryness, and pain during intercourse. During menopause, the rate of estrogen decreases, which can cause symptoms such as When a statement on Monday, FDA Commissioner Scott Gottlieb said that more and more manufacturers are marketing their devices for unapproved uses such as "rejuvenation" of the bad, where tissues are usually destroyed or remodeled
. He said that the agency did not know the extent of the risk as it had not examined the device for the procedure. But he found "many cases" of damage in reports of adverse events and publications, he said.
The agency recently informed seven appliance manufacturers who have expressed concern about "inappropriate marketing". . If the FDA's concerns are not addressed, she would consider potential enforcement actions, Gottlieb says.
Commissioners expressed particular concern about the commercialization of procedures for women whose cancer care causes premature menopause.
One company that received a letter from the FDA was Cynosure, which produced a device called MonaLisa Touch.
On its website, the company said: "During treatment. the badl probe is inserted into the patient's bad and provides smooth, painless laser energy to the badl wall, stimulating the healing response. "
The site recommends three five-minute treatments for 18 weeks and says that."
Cynosure is called a FDA action call for its parent company, in a statement Jane Mazur, vice president of global communications division at Hologic, said, "Hologics has a strong track record of rooting our products in science and clinical evidence" and that it "evaluates the mail in its entirety. and will work with the agency to ensure that all product communications comply with regulatory requirements. "
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