Apr. 30, 2015 -- A shot that dissolves fat will offer people with a double chin a way to get rid of it without surgery.
The FDA approved the new drug, called Kybella, on Wednesday. It will be available in cosmetic surgeons' and dermatologists' offices in June.
Here's what you need to know.
What is the treatment and how does it work?
Kybella is identical to something your body makes called deoxycholic acid, which helps to absorb fats, the FDA says.
It works by destroying fat cells. It can also destroy other kinds of cells, including skin cells, if it's not used correctly, the FDA says.
The shot is an alternative to liposuction or surgery to treat double-chin fat.
Why is it needed?
"Upwards of 80% of people [with double chins] are concerned about the condition," says
Derek H. Jones, MD, an associate clinical professor of dermatology at UCLA's David Geffen School of Medicine. Jones was the lead investigator in a study sponsored by the drug's maker, Kythera Biopharmaceuticals.
How many rounds of treatment do you need, and what results should you expect?
It varies. Alan Matarasso, MD, a plastic surgeon in Manhattan, thinks patients will need a series of 12-20 injections per visit. You may need two to three total visits, spaced a month apart. Each treatment takes about 15 minutes.
Some people may get up to 50 injections in a single treatment, with up to six single treatments no less than a month apart, the FDA says. Many people saw results in two to four treatments, according to Kythera.
Although it's not approved for saggy skin, can it help tighten it?
Experts don't agree. "It doesn't tighten your skin. It is there to melt fat," Matarasso says. But Jones says some people did notice a tightening effect.
Before approving the drug, the FDA looked at the results of two U.S. trials that included more than 1,000 people. Those who got the drug more often saw less fat under the chin. More than 80% of those getting the drug said they noticed some improvement in their chin fat, the company says.
The results may last several years, Jones says.
What are the potential side effects?
Most common are bruising, swelling, pain, numbness, and small, firm areas around the injection sites, according to the company. "There can be a bit of numbness at the site, which resolves over time," Jones says.
A possible serious side effect is an injury to the marginal mandibular nerve, which helps control facial expressions, causing an off-balance smile, Jones says. This likely happens when shots are given too close to this nerve.
In trials including more than 5,000 people, this side effect happened in 4% of patients, according to a report from the FDA advisory panel. It eventually went away in all of them.
Could the drug help destroy fat cells in other areas of the body?
"Right now it is only approved for below the neck, the chin," Matarasso says.
Don't count on it to dissolve love handles or muffin tops, Jones says. Kybella works best on small areas, he says.
"Although it may be useful for very small collections of fat cells, such as lipomas (fatty collections under the skin) or eye bags, there may be considerable safety risks in these areas," and more study is needed, Jones says.
What will it cost? And will insurance cover it?
Kythera won't release pricing info until the product becomes available in June, a company spokesperson says. Some experts predict it will cost about the same as dermal fillers, such as Juvederm and Restylane. These cost about $560 per treatment, according to the American Society of Plastic Surgeons. Again, Kybella requires more than one treatment.
Because it's a cosmetic procedure, insurers aren't likely to cover it, Jones says.
2 hours ago
Health insurers are not going to like this.
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