KYBELLA INFORMED CONSENT
This is an informed-consent document that has been prepared to help inform you concerning using deoxycholic acid injection injections with Kybella. The use of aesthetic injections with Kybella has its risks and alternative treatments.
Kybella is a cytolytic drug indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental (neck) fat in adults. The safe and effective use of Kybella for the treatment of subcutaneous fat outside the submental region (neck) has not been established and is not recommended. Kybella is injected into the fat under the chin (no more than 50 injections or 10mL under the skin). Kybella injections will be given at least one month apart. Your healthcare provider will decide how many treatments and injections are needed. Any other cosmetic use is considered “off label.”
There are alternative forms to Kybella that are non-surgical and surgical. The non-surgical alternatives consist of topical neck products, weight loss, and neck homeopathic treatments. The surgical alternatives of Kybella are a neck lift, neck liposuction, and several others. Risks and potential complications are associated with alternative forms of treatment.
There are risks of using Kybella. Every cosmetic procedure involves a certain amount of risk, and it is important that you understand the risks involved. An individual’s choice to undergo a cosmetic procedure is based on the comparison of the risk to potential benefit. Although the majority of patients do not experience complications, you should discuss each risk with your provider or affiliated medical personnel.
ADDITIONAL TREATMENTS MAY BE NECESSARY
In some situations, it may not be possible to achieve optimal results with a single aesthetic injectable treatment. Multiple sessions may be necessary. Should complications occur, additional injectables or other treatments may be necessary
Informed consent documents are used to communicate information about the proposed injectable treatment along with disclosure of risks and alternative forms of treatments. The informed consent process attempts to define principles of risk disclosure that should generally meet the needs of most patients in most circumstances. This informed consent should not be considered all inclusive in defining other methods of care and risks encountered. Your provider or affiliated medical personnel may provide you with additional or different information, which is based on all the facts in your particular case and the state of medical knowledge. Standards of medical care are determined on the basis of all of the facts involved in an individual case and are subject to change as scientific knowledge and technology advance and as practice patterns evolve. Even though risks and complications occur infrequently, the risks cited are the ones that are particularly associated with Kybella. Other complications and risks can occur but are even more uncommon. The practice of medicine and aesthetic injectables is not an exact science. Although good results are expected, there cannot be any guarantee or warranty expressed or implied on the results that may be obtained.
I CONSENT TO THE TREATMENT OR PROCEDURE AND THE ABOVE LISTED ITEMS (1-7). I AM SATISFIED WITH THE EXPLANATION.
I acknowledge that I have been informed about the Off-Label FDA status & uses Kybella (Deoxycholic Acid) and I understand it is not experimental and accept its use. I take full liability and responsibility for any and all risks, undesired outcomes, or adverse events associated with the procedure and will not hold the providers or Hair Restoration & Aesthetics of Buffalo, LLC. liable for any unfavorable outcome or adverse event. I release Hair Restoration & Aesthetics of Buffalo, LLC., owners, and medical staff from liability associated with the procedure. This consent form is freely and voluntarily executed and shall be binding upon my spouse, relatives, legal representatives, heirs, administrators, successors and assigns.