KYBELLA/PDA CONSENT FORM
Kybella (deoxycholic acid ) LipoDissolve (phosphatidylchiline 50mg/deoxycholic acid 42mg-PDA) injection is indicated for improvement in the appearance of moderate to severe fullness associated with submental fat, also called “double chin,” in adults. Kybella/PDA is injected into the fat under the chin as well as other areas of superficial fat for fat removal. Multiple treatments are usually required and will be given at least 1 month apart.
Listed below are risks reported during clinical studies that are specific to the injection of Kybella/PDA.
Common potential side effects include swelling, bruising, pain, numbness, redness and areas of hardness in the treatment area Kybella/PDA injections can also cause tingling, nodule, itching, skin tightness and headache. These side effects typically resolve themselves without treatment and do not usually result in patients stopping treatment.
Less common potential side effects include: nerve injury – Kybella/PDA injections could cause nerve injury in the area of the jaw resulting in an uneven smile or facial muscle weakness. In the clinical trials these all resolved without treatment and do not usually result in patients stopping treatment in an average of 6 weeks. Kybella/PDA injections can temporarily cause trouble with swallowing (this is thought to be due to neck swelling), superficial skin erosions and small patches of hair loss in the beard area. There is a possibility of an unsatisfactory result. The procedure may also result in more noticeable platysma bands, unacceptable visible deformities or asymmetry in the treatment area.
Before receiving Kybella/PDA patients should tell their healthcare provider about all of their medical conditions, including if they: have an infection in the treatment area; have had or plan to have surgery on the face, neck or chin; have had cosmetic treatments on the face, neck or chin; have had or have medical conditions in or near the neck area; have had or have trouble swallowing; have bleeding problems or are taking blood thinners; are pregnant or plan to become pregnant. It is not known if Kybella/PDA will harm an unborn baby; are breastfeeding or plan to breastfeed. It is not known if Kybella/PDA passes into your breast milk.
I understand this is an elective procedure and I hereby voluntarily consent to treatment for facial rejuvenation, establish proper lip and smile lines, and eliminating fat. The procedure has been fully explained to me. I have read the above and understand it. My questions have been answered satisfactorily. I accept the risks and complications of the procedure and I understand that no guarantees are implied as to the outcome of the procedure. I also certify that if I have any changes in my medical history I will notify DermaLux Medical Aesthetics, LLC immediately. I also state that I read and write in English.