New treatment for double chin: Kybella® approved by FDA

Posted by:

 

The American Society for Dermatologic Surgery reports that 70% of American adults consider submental fat, also known as a double chin, to be a key cosmetic concern. Until now, many have chosen to leave the problem untreated. A new cosmetic injectable medication may change all this when it becomes available this summer.

What is Kybella?

Kybella® is a non-invasive treatment that has been shown in two large clinical trials to be safe and effective when used for treatment of submental fat deposits. Before the recent FDA approval of Kybella®, the options for reduction of double chin were limited, primarily consisting of liposuction or surgical procedures and less invasive procedures like CoolSculpting that produce a more subtle result.

Kybella® has the potential to become the “new Botox” of aesthetic treatments. It’s a patented synthesized form of a naturally occurring compound known as deoxycholic acid, a molecule that aids in metabolism of dietary fat. The newly approved injectable works by lysis of fat cells through destruction of the fat cell membrane. This releases fat for absorption and metabolism by the body.

What is the Kybella Procedure Like?

One treatment with Kybella® consists of up to 50 injections carefully placed in a grid-like pattern in the region below the chin. The area is numbed with local anesthetic before the procedure, which normally takes less than 30 minutes. The most adverse side effects of treatment include swelling, bruising, pain, and numbness. The recovery period is relatively short compared to liposuction or surgical procedures, and patients can expect resolution of swelling and bruising within a few days.

How many Kybella Procedures will I need?

Kybella® is approved for up to six treatments spaced at least one month apart, depending upon the volume of the undesirable fat deposits. The drug is not approved for use in other areas of body fat, and the safety and efficacy of Kybella® in other areas is unknown. Although the drug can be used “off-label,” experts recommend restricting use to the area below the chin. When used properly, surrounding tissues are unaffected during the procedure and results can be seen within a few weeks of the initial treatment. Destruction of fat cells is permanent, so no maintenance treatments are required.

Precautions with Kybella

The new treatment is approved for adults over the age of 18 years for improvement in appearance of moderate to severe fullness associated with fat in the submental area. Some patients may have fullness under the chin resulting from an enlarged thyroid gland or from enlarged lymph nodes, so all patients considering this procedure should be screened by a physician. Patients with a significant amount of excess skin in the region may not be good candidates for treatment with Kybella®. Caution is also recommended when considering treatment with Kybella® for patients who have had prior surgeries or aesthetic treatments in the chin and jaw region.

What are the possible side effects of Kybella?

The FDA approval includes the warning that Kybella® injections should only be performed by a licensed healthcare professional. Doctors who participated in the clinical trials of the new drug warn consumers to choose doctors with appropriate training in the procedure. If the drug is improperly injected into the facial nerve, patients could experience significant facial asymmetry, particularly in the smile. Swallowing problems can also occur after injection, but usually resolve spontaneously in a median time of 3 days. Kybella® is not specific for destruction of fat cell membranes, and if improperly injected into the dermis of the skin, destruction of skin cells can cause ulceration.

Kybella® will be available commercially early this summer. Kythera Biopharmaceuticals, the manufacturer of Kybella®, plans to begin training doctors in June, prior to releasing the drug for sale. The company has not yet released a shelf price for the drug and company officials say details of treatment cost will not be released until the product is launched.

1
  Related Posts
  • No related posts found.

Comments

  1. louis acosta md  May 13, 2015

    looking forward to Kybella

    reply

Add a Comment