From the FDA Drug Label
KYBELLA injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. The co-primary efficacy assessments were based on at least 2-grade and at least 1-grade improvements in submental convexity or fullness on the composite of clinician-reported and patient-reported ratings of submental fat 12 weeks after final treatment Reductions in submental fat volume were observed more frequently in the KYBELLA group compared to the placebo group as measured by the composite clinician and patient ratings A greater proportion of KYBELLA-treated subjects had at least a 10% reduction in submental fat volume as compared to placebo-treated subjects when evaluated by MRI (43% vs 5%, respectively)
Fat dissolution injections (lipolysis injections) with deoxycholic acid are effective for the improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults, as demonstrated by significant reductions in submental fat volume and improvements in clinician-reported and patient-reported ratings of submental fat 1.
From the Research
Lipolysis injections have limited effectiveness for fat reduction and are not recommended as a primary method for weight loss or body contouring. The most recent and highest quality study, published in 2019, investigated the safety and efficacy of combined cryolipolysis, shockwave therapy with cryolipolysis, shockwave therapy, and injection polyenylphosphatidylcholine-based lipolysis 2. This study found that the combination of cryolipolysis, radial shockwave, and injection lipolysis is a safe, well-tolerated treatment for reduction in subcutaneous fat. However, it is essential to note that lipolysis injections are not a replacement for a necessary change of lifestyle, nor are they a method of weight reduction or a treatment for obesity.
Some key points to consider:
- The only FDA-approved lipolysis injection is deoxycholic acid (Kybella), and it is only approved for reducing submental fat, commonly known as a "double chin" 3.
- For other body areas, lipolysis injections are considered off-label and lack substantial scientific evidence supporting their efficacy.
- Lipolysis injections can cause side effects such as swelling, bruising, and numbness.
- Traditional methods like diet, exercise, and, in some cases, surgical options like liposuction are generally more reliable and have more predictable outcomes for overall fat reduction and body contouring.
When considering lipolysis injections, it is crucial to consult with a board-certified dermatologist or plastic surgeon to discuss the potential benefits and risks for your specific situation. They can help determine the best course of treatment and ensure that you have realistic expectations about the outcomes. Additionally, it is essential to carefully evaluate the safety and efficacy of any treatment, especially when it comes to off-label uses or combination therapies.