A crisp jawline is a sign of youth and beauty, and until this week, the best way to get rid of submental fat—as double-chin fat is known—was liposuction under the chin or a face-lift or neck lift. But yesterday the FDA approved Kybella, a treatment to slim down the underside of the jaw in those with moderate to severe fat under the chin. It involves no scalpels or lipo tubes, just injections. But be warned: It will take a lot more than a few shots to get rid of fat there. And as with so many minimally invasive treatments, repeat treatments are required to get the maximal result.
According to the FDA’s news release, “patients may receive up to 50 [editor’s note: yes, 50!] injections in a single treatment, with up to six single treatments administered no less than one month apart.” Lidocaine administered beforehand will make the treatment almost painless.
It took two double-blind trials in the U.S. and Europe, with 1,022 adult subjects, to show that Kybella (known in the studies as ATX-101) works. Subjects injected with Kybella were more likely to lose fat than those who received a placebo. Kybella is a synthetic form of deoxycholic acid, which occurs naturally in the body and absorbs fat. When Kybella is injected, it destroys not just the fat but the cell envelope containing the fat, which means that if it’s injected improperly—say, into the skin—”it can cause skin ulceration,” says Derek Jones, an associate clinical professor of dermatology at UCLA and the lead investigator in the studies. For this reason, Kythera, the manufacturer, will start a training program for physicians.
Fat-melting shots have a checkered history. Several years ago, lipodissolve clinics around the country offered injections of deoxycholic acid derived from cows, along with phosphatidylcholine formulated with no standardization by compounding pharmacies. Though these mixtures destroyed fat cells, they also caused some serious reactions and were not approved by the FDA. It has since been discovered that the deoxycholic acid is what causes the fat destruction. A hologram on Kybella’s packaging is designed to deter counterfeiters.
Despite the purity and standardization of the proprietary synthetic deoxycholic acid in Kybella, there are side effects, most commonly swelling, bruising, pain, numbness, redness, and some hardness in treated areas. That’s why Jones says he will recommend that the first treatment be done on a Friday so the patient has two or three days to recover. Subsequent treatments should require less recovery time. In trials there were also rare cases of nerve injury, muscle weakness causing uneven smile, and trouble swallowing, which was caused by injections into a nerve on the edge of the jaw. “They were quite uncommon and related to technique in early cases. When they did occur, they were short-lived,” says Jones. Expertise is also required to avoid salivary glands under the chin. Overall, though, patient satisfaction was high, says Jones, “almost 70 percent.” In patients who were stage one—having the least amount of excess fat—results were good, he says. The shots even tightened skin in patients who had more loose skin than fat, but there’s no approval for that yet.
One final note: As anyone who has dealt with fat reduction knows, there’s a high likelihood patients will ask to be injected with Kybella in other areas as well. But the FDA warns that it is “not approved and not recommended for any other part of the body.”
For more on the latest cosmetic procedures, check out:
• A Fat-Melting Cream Is in the Works
• The Surprising New Trends in Plastic Surgery
• This New Product Promises a Better Way to Get Full Lips