quarta-feira, 20 de janeiro de 2016

Kybella – FDA Approved Surgical Weight Loss

Kybella Review

Kybella is a new surgical weight loss procedure approved by the FDA in April 2015. It targets fat under the chin. Find out if Kybella is worth it today in our review.

What is Kybella?

Kybella is a surgical fat loss treatment that promises to treat moderate-to-severe fat below the chin, also known as submental fat. Or, it’s what some people refer to as a double chin.

In April 2015, the FDA approved Kybella specifically for removal of submental fat. It has not currently been approved for any other part of the body, and the FDA specifically said that using Kybella on other parts of the body is “not recommended”.

With 78 reviews over the past 24 months, Kybella has a sparkling 97% worth it rating from RealSelf.com, where real users post before and after pictures of their surgery and help other users determine if it’s worth it.

Kybella is priced at an average total cost of $1,500.

The procedure used to be known as ATX-101. The manufacturer then settled on the more marketable name of Kybella.

How Does Kybella Work?

Kybella involves injecting a naturally-occurring molecule into the upper neck.

That molecule eats away at fat while leaving other cells in the region healthy and intact.

The molecule is actually a synthetic form of a substance that’s naturally made by your body. That molecule is known as deoxycholic acid. Your body produces that substance to help absorb fats. It destroys fat cells at the location where it’s injected into the body.

So far, the treatment has not been approved for use on any other part of the body but the chin.

What to Expect During a Kybella Procedure

During a procedure, Kybella is injected under the skin directly into the area beneath your skin. This injection is performed by a healthcare provider.

Typically, patients undergo a series of up to 6 treatment sessions to maximize the effectiveness of the procedure. During each session, you may receive up to 50 injections.

To ease the pain of the procedure, some patients are treated with a topical numbing medicine or an ice pack.

Treatment sessions should be spaced no less than one month apart for maximum results. Typically, you’ll see results within 2 to 4 months.

Patient needs vary, and your doctor will help you decide how many Kybella injections and how many sessions you need depending on your desired results.

Each injection consists of 0.2mL of fluid, which means you can receive a total of 10mL of Kybella over the course of the procedure.

Each injection is spaced 1cm apart.

Is Kybella Safe?

The FDA has approved the use of Kybella when targeting fat in the upper neck area, like if you have a double chin.

Thus far, the FDA has not approved nor recommended the use of Kybella for targeting any other area of the body. There’s a chance this could change in the future, as more tests take place. But at the moment, nothing has been approved.

Kybella is also not recommended for certain other groups of people, like those all of the following:

— Those who are allergic to deoxycholic acid should not undergo Kybella

— If you have an infection in or around the area that will be treated, you should not undergo Kybella

As a relatively new procedure, Kybella has also not been studied for its effects on unborn babies or women who are breastfeeding. It has also not been approved for anyone younger than 18 years old.

The FDA also cautions that Kybella can cause serious side effects, including nerve injury in the jaw “that can cause an uneven smile or facial muscle weakness, and trouble swallowing.”

Patients may also experience side effects like:

— Swelling
— Bruising
— Pain
— Numbness
— Redness
— Areas of hardness

All of these effects will be observed in the treated area of the neck.

Scientific Evidence for Kybella

Up above, we mentioned that the FDA approved Kybella for fat reduction treatment in the neck.

This approval took place after the publication of two clinical trials. These trials enrolled 1,022 adults who had “moderate or severe submental fat”.

Participants were randomly assigned to receive Kybella or a placebo for up to six treatments.

By the end of the studies, researchers concluded that “results showed that reductions in submental fat were observed more frequently in participants who received Kybella versus placebo.”

Who Makes Kybella?

Kybella is made by a company named Allergan. That company is a $23 billion global pharmaceutical company that produces a wide range of products and treatments across dermatology, eye care, women’s health, and cardiovascular health niches.

The company is headquartered in Dublin, Ireland and maintains its US headquarters in Parsippany, New Jersey.

You can contact Allergan using their online form or by calling US customer relations at 1-800-433-8871.



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