Modesto Plastic Surgeon, Lars P. Enevoldsen, M.D., is proud to be offeringKYBELLA® . KYBELLA® is the first and only FDA-approved injectable drug that contours and improves the appearance of submittal fullness.
The number of injections and the number of treatments should be tailored to the individual patient’s submental fat distribution and treatment goals.
WHAT IS SUBMENTAL FULLNESS?
- Submental fullness, sometimes referred to as “double chin,” is a common, yet undertreated facial aesthetic condition. It can detract from an otherwise balanced and harmonious facial appearance – leading to an older and heavier look.
- Submental fullness can impact a broad range of adults, including both women and men, and can be caused by aging, genetics and weight gain.
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.
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.
- 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.
WHAT ARE THE RESULTS OF KYBELLA®?
- When injected into the fat under your chin, 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.
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.
Important Safety Information
Cases of marginal mandibular nerve injury, manifested as an asymmetric smile or facial muscle weakness, were reported during clinical trials. To avoid the potential for nerve injury, KYBELLA® should not be injected into or in close proximity to the marginal mandibular branch of the facial nerve. All marginal mandibular nerve injuries reported from the trials resolved spontaneously (range 1-298 days, median 44 days).
Difficulty swallowing (dysphagia) occurred in the clinical trials in the setting of administration site reactions, e.g., pain, swelling, and induration of the submental area. Cases of dysphagia spontaneously resolved (range 1-81 days, median 3 days). Subjects with current or prior history of dysphagia were excluded from clinical trials. Avoid use of KYBELLA® in these patients as current or prior history of dysphagia may exacerbate the condition.
In clinical trials, 72% of subjects treated with KYBELLA® experienced injection site hematoma/bruising. KYBELLA® should be used with caution in patients with bleeding abnormalities or who are currently being treated with antiplatelet or anticoagulant therapy as excessive bleeding or bruising in the treatment area may occur.
To avoid the potential of tissue damage, KYBELLA® should not be injected into or in close proximity (1-1.5 cm) to salivary glands, lymph nodes and muscles.
The most commonly reported adverse reactions in the pivotal clinical trials were: injection site edema/swelling, hematoma/bruising, pain, numbness, erythema, and induration.
We invite you to call us at 209.524.6204 today!
Lo invitamos a que nos llame al 209.524.6204 ¡Hoy mismo!