Spa 35 is launching FDA approved fat injections, Kybella, on November 18th, 2015. Kybella is the first FDA approved non-surgical injection for improvement in the appearance of moderate to severe submental fullness (a.k.a. double-chin). Kybella is composed of deoxycholic acid a chemical naturally produced in the body to help it absorb fat.
The FDA approved treatment protocol outlines a series of treatments that can number as high as six. Each treatment can include as many as 50 injections into the submental fat.
Spa 35's owner, Warren Danforth commented on the FDA approval-
I'm excited to be a part of the launch of Kybella. Spa 35 clients have long asked for an FDA approved injectable solution for removing fat under the chin without surgery. We'll closely follow FDA and Allergan leadership to ensure our clients get the best results possible within approved protocols.
Spa 35 clients considering Kybella will receive a consultation that includes a review of their aesthetic goals and their medical history to ensure they are good candidates for the injections. Clients will be scheduled for a series of injections whose number will be based upon their goals and amount of submental fat to be removed.
There are a long number of on line resources for those who like to research new products and services. Below is a You Tube video of Kybella, many others can be found via an internet search.
Consultations regarding FDA approved Kybella can be schedule via telephone at 208-367-0700 or email at firstname.lastname@example.org
Kythera Biopharmaceuticals worked through the approval process with the FDA. Since the FDA approval of Kybella that organization has been acquired by Allergan, bolstering their world-class facial aesthetics portfolio that includes Botox, Juvederm and Latisse. More information on the acquition can be found at http://www.prnewswire.com/news-releases/allergan-successfully-completes-kythera-acquisition-adds-game-changing-kybella-treatment-for-double-chin-300152533.html
Below is the press released issued by the Food and Drug Administration on April 29, 2015. It can also be found on the internet at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm444978.htm
The U.S. Food and Drug Administration today approved Kybella (deoxycholic acid), a treatment for adults with moderate-to-severe fat below the chin, known as submental fat. Using Kybella for the treatment of fat outside of the submental area is not approved and is not recommended.
Kybella is identical to the deoxycholic acid that is produced in the body. Deoxycholic acid produced in the body helps the body absorb fats. Kybella is a cytolytic drug, which when injected into tissue physically destroys the cell membrane. When properly injected into submental fat, the drug destroys fat cells; however, it can also destroy other types of cells, such as skin cells, if it is inadvertently injected into the skin.
“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.”
Kybella is administered as an injection into the fat tissue in the submental area. Patients may receive up to 50 injections in a single treatment, with up to six single treatments administered no less than one month apart. Kybella is being provided in single patient use vials and should not be diluted or mixed with any other compounds.
The safety and effectiveness of Kybella for treatment of submental fat were established in two clinical trials which enrolled 1,022 adult participants with moderate or severe submental fat. Participants were randomly assigned to receive Kybella or a placebo for up to six treatments. The results showed that reductions in submental fat were observed more frequently in participants who received Kybella versus placebo.
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. The most common side effects of Kybella include swelling, bruising, pain, numbness, redness and areas of hardness in the treatment area.
Kybella should not be used outside of the submental area, and it should not be used if there is an infection at the injection site. Caution should also be used in patients who have had prior surgical or aesthetic treatment of the submental area.
Kybella is being distributed in a dispensing pack that has a unique hologram on the vial label. If there is no hologram, do not use the product.
Consumers and health care professionals are encouraged to report adverse reactions from the use of Kybella to the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-FDA-1088.
Kybella is manufactured by Kythera Biopharmaceuticals Inc. based in Westlake Village, California.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.