FDA Approves Kybella Treatment for Double Chins
In recent news, the FDA announced that the wait is finally over for a newly approved treatment that can help many people lose their double chin without surgery.
In an update of a previous report of a new non-surgical way to help cosmetic patients get rid of their double chin, the FDA announced this past week that the initially-named drug “ATX-101” now called “Kybella,” is ready for licensed health care professionals and their patients for getting rid of unwanted neck fat medically known as submental fat.
Submental fat gets its name from the submental region―the area under the chin―where it is found. The significance of removing submental fat is that the area under the chin is an important facial feature that at its best reveals your true age and at its worst makes you appear older than you are. The reason for this is that multiple factors such as aging and genetics leads to eventual fat and sagging skin accumulating under the chin region resulting in what is referred to as a “double chin.”
The FDA states that Kybella is identical to the natural deoxycholic acid that is produced in the body that helps the body absorb fats. When Kybella is injected into submental fat, Kybella physically destroys the fat cells after which the body metabolizes away the cellular remnants. However, where the injections take place has to be carefully controlled as Kybella can dissolve away skin cells as well. Moreover, Kybella should only be used on treating submental fat and not fat in other areas of the body.
“Treatment with Kybella should only be provided by a licensed health care professional, and patients should fully understand the risks associated with use of the drug before considering treatment,” said Amy G. Egan, M.D., M.P.H., deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “It is important to remember that Kybella is only approved for the treatment of fat occurring below the chin, and it is not known if Kybella is safe or effective for treatment outside of this area.”
Treatment consists of up to 50 injections per session, with up to 6 sessions spaced no sooner than one month apart each.
Kybella can cause serious side effects, including:
• Nerve injury in the jaw that can cause an uneven smile or facial muscle weakness.
• Difficulty with swallowing.
The most common side effects of Kybella include swelling, bruising, pain, numbness, redness and areas of hardness in the treatment area.
People Who Should Not Take Zybella
• Patients with excessive amounts of skin under their chin and neck are poor candidates for this drug as it works on removing fat, but not sagging skin.
• Patients with infections near the injection site.
• Possibly patients with prior surgical or aesthetic treatment of the submental area that needs to be reevaluated by a specialist.
To help insure that patients are not receiving bogus Kybella injections, Kybella is being distributed in a dispensing pack that has a unique hologram on the vial label. FDA officials warn that if there is no hologram on the vial, do not use the product.
For more about how to get rid of a double chin, here is an informative article about other non-surgical solutions for a double chin.
FDA Press Release― “FDA approves treatment for fat below the chin”