Photos courtesy of Allergan clinical case study and model
Kybella is the first FDA approved a non-surgical injectable for reducing moderate to severe fat on the upper neck, otherwise known as a “double chin. Kybella is deoxycholic acid, a fat-absorbing substance found in our bodies naturally. When injected, it destroys fat cells under the chin, which are reabsorbed by the body leaving the skin substantially tighter and the jaw more contoured. The procedure is non-invasive with minimal downtime or recovery required. Most treatments last between 15 and 20 minutes. Lidocain (a topical numbing anesthetic) can be used to minimize discomfort. Results depend on the amount of excess fat patient have under the chin. Most patients begin seeing results 3-4 weeks post injection. Many patients treated with KYBELLA™ experience visible contouring of their chin profile in 2 to 4 treatments (spaced at least one month apart). Some people require up to 6 treatments in order to achieve results. Once the aesthetic response is achieved no further treatments will be required unless submental fullness redevelops. The safety and effectiveness of Kybella were established in two large studies, which enrolled over 1,000 adult participants with moderate or severe submental fat. The participants who received Kybella (for up to six treatments) instead of a placebo (non-Kybella) more frequently saw reductions in fat and improved jawline/neckline contour.
Kybella can cause serious side effects (temporarily), 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. These side effects are also the most common side effects seen with Botox injections or dermal fillers like Juvederm and Restylane.
FAQ- Frequently Asked Questions
What is submental fullness?
- Submental fullness, sometimes referred to as “double chin,” is a common, yet undertreated facial aesthetic condition.1 It can detract from an otherwise balanced and harmonious facial appearance2 – leading to an older and heavier look.3
- Submental fullness can impact a broad range of adults, including both women and men, and can be caused by aging, genetics and weight gain.4
- According to a 2015 survey by the American Society for Dermatologic Surgery (ASDS), over 2/3 of consumers are bothered by submental fullness – nearly as many as those bothered by lines and wrinkles around the eyes.5
What is KYBELLA® (deoxycholic acid) injection?
- KYBELLA® (deoxycholic acid) injection is the first and only FDA-approved injectable drug that contours and improves the appearance of submental fullness due to submental fat.
- KYBELLA® is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.
- The safe and effective use of KYBELLA® for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended.
How does KYBELLA® work?
- KYBELLA® is a non-human and non-animal formulation of deoxycholic acid, a naturally-occurring molecule in the body that aids in the breakdown and absorption of dietary fat.7
- When injected into subcutaneous fat, KYBELLA® causes the destruction of fat cells. Once destroyed, those cells cannot store or accumulate fat. After the aesthetic response is achieved, retreatment with KYBELLA® is not expected.1
- To avoid potential tissue damage, KYBELLA® should not be injected into or in close proximity (1-1.5 cm) to the marginal mandibular nerve, salivary glands, lymph nodes and muscles.
What are the results of KYBELLA®?
- 68.2% of subjects treated with KYBELLA® experienced a ≥1-grade improvement with KYBELLA® compared to 20.5% of placebo-treated subjects, based upon validated physician and patient measurements.*
- 16% of patients experienced a ≥2-grade improvement with KYBELLA®, compared to 2% of patients who responded to placebo, based on validated physician and patient measurements
- KYBELLA® treatment resulted in high patient satisfaction – 79% of KYBELLA®-treated patients reported satisfaction with their appearance in association with their face and chin.
- Patients also reported improvement in the visual and emotional impact of submental fat when asked how happy, bothered, self-conscious, embarrassed, old and overweight they felt following treatment in relation to the amount of their submental fat.
- Marginal mandibular nerve (MMN) injury occurred in 4% and dysphagia occurred in 2% of subjects. To avoid potential tissue damage, KYBELLA® should not be injected into or in close proximity (1-1.5 cm) to the MMN, salivary glands, lymph nodes and muscles.
- The most common adverse reactions were edema/swelling, hematoma/bruising, pain, numbness, erythema and induration.
What are the side effects with KYBELLA®?
- The safety profile of KYBELLA® is well-characterized.
- KYBELLA® has been the focus of a global clinical development program involving over 20 clinical studies with more than 2,600 patients worldwide, of which over 1,600 have been treated with KYBELLA®.
- The most common adverse reactions were edema/swelling, hematoma/bruising, pain, numbness, erythema and induration.6
- KYBELLA® is manufactured through a highly-controlled, FDA-regulated process and approved facility to ensure patient safety.
- For more information, please see Important Safety Information