It's not life-threatening, but as many as 7 in 10 Americans say they're bedevilled by double chin, a condition for which the US Food and Drug Administration has now approved a new treatment: an injectable substance called deoxycholic acid, to be marketed as Kybella.
Kybella is the first treatment the agency has approved for "moderate-to-severe fat below the chin," which is known in medical parlance as sub-mental fat. The maker of Kybella – Kythera Biopharmaceuticals – called sub-mental fat "a common yet under treated aesthetic condition" that can "result in a person feeling older and heavier."
The newly approved product is expected to become available in late summer through dermatologists, plastic surgeons and facial plastic surgeons who have been trained in the proper administration of the injectable.
Kybella is a synthetic version of deoxycholic acid, a cholesterol by-product that is naturally produced in the body that helps with the absorption of fat. When injected into tissue, it destroys the cell membrane. When injected into subcutaneous fat such as that which accumulates under the chin, Kybella causes fat cells to dissolve.
But the FDA cautioned that Kybella was not approved for use outside of the area under the chin, where "pre-platismal fat" accumulates in pockets that are just under the skin. Its use on deeper and more concentrated pockets of fat that accumulate elsewhere, such as in the belly and buttocks, has not been found safe.
Under local anesthetic, patients would receive up to 50 injections – placed about 1cm apart – in a single treatment. As many as six single treatments, administered no less than one month apart, may be necessary to achieve the desired results. Unlike injectable cosmetic fillers, the effect appears to be enduring. Once the treatment has been completed, re-treatment is not expected to be necessary, the company said.
Sub-mental fat can be the result of genetics, aging and weight gain. But the clinical trial that prompted the FDA's decision excluded people with obesity.
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