Patient Informed Consent
Please Read Carefully and Submit Your Acknowledgement
INFORMED CONSENT FOR COSMETIC PROCEDURES
Botox/Jeuveau, Dermal Fillers, Lidocaine
CERTIFIIED RN INJECTOR: Diane Chuprun
MEDICAL DIRECTOR: Rebecca Whelchel, NMD
NMD INSTRUCTIONS
Informed consent for Cosmetic Injections, and procedures which include Botox® and Jeuveau. Signing once gives consent for any of the listed procedures, but nothing will be done without your knowledge.
INTRODUCTION
Botulinum Toxin A is a neurotoxin produced by the bacterium Clostridium A. Also called neuromodulators, the most common botulinum toxin A products used for cosmetic purposes are Botox®, Jeuveau, Dysport® and Xeomin®. Neuromodulators can relax the muscles on areas of the face and neck that cause wrinkles associated with facial expressions, and treatment can cause your facial expression lines or wrinkles to reduce, soften over time, or eventually disappear. Treatments can also prevent or slow formation and deepening of these lines. FDA approved uses: frown lines, located between the eyes (glabella), crow’s feet (lateral areas of the eyes), and horizontal forehead wrinkles. Other uses are considered “off label” or not yet FDA approved for the same type of action on areas of the mid face and lower face. Though not FDA approved, there are areas commonly injected in the industry, with good results and similar risks. Areas considered “off-label” for which medical director allows nurse injection: around the nose/nasalis “bunny lines”,depressor ang. oris (DAO) for downturned mouth corners, browlift, chin dimpling, fine lines around mouth. Procedure: Small, controlled amounts of neuromodulator are injected into specific muscles with a tiny needle. Small amounts of stinging or discomfort are common. Effects of weakening of the muscles are clearly visible within 2 weeks.
Soft tissue dermal fillers are stabilized, sterile hyaluronic acid and/or calcium hydroxyapatite solutions used to smooth moderate to severe facial wrinkles and folds or shape facial contours. Soft tissue fillers have been FDA approved for the cosmetic treatment of moderate to severe facial wrinkles and soft tissue depressions. Use in some areas of the face are considered “off label” but are administered according to industry standard and training. Hyaluronic acid is naturally found in the skin. Hyaluronic acid is biocompatible and is a totally non-animal product – it is fermented from bacteria and stabilized; there is little risk of animal-based disease transmission or allergic reaction. These injections are customized for every patient, depending on his or her particular needs. These can be performed in areas involving the face, forehead, temples, cheeks, chin and lips. Soft tissue fillers cannot stop the process of aging. It can however, temporarily diminish the look of wrinkles and soft tissue depressions. These injections may be performed alone, in combination with other treatments such as neuromodulators (Botulinum toxin A, described above), or as an adjunct to a surgical procedure. Soft tissue fillers injections may require topical anesthetics to diminish discomfort. Fillers are injected into the face with a slim needle resulting in immediate results. Soft tissue fillers produce temporary discomfort (during injection), swelling, redness, and needle marks, which resolve after a few days’ time up to two weeks. Continuing treatments are necessary in order to maintain the effect of soft tissue fillers as the body absorbs them slowly. The length of effect for these injections is variable.
TOPICAL ANESTHETIC
The skin can be numbed or partially numbed, thereby REDUCING discomfort, by applying a cream with numbing components such as Benzocaine, Lidocaine and Tetracaine or similar agents. The cream is applied to a small area of skin and is removed after 15-20 minutes once the numbing has taken effect. Though quite safe, there is a chance of skin sensitivity and redness. There is a very rare chance of toxicity if too much of the cream is absorbed. The toxicity may result in irregular heartbeats. If a person has a heart condition or an arrhythmia, they should consult their cardiologist for consent to use topical anesthetic for a procedure.
ALTERNATIVE TREATMENTS
Alternative forms of management include treating the skin quality, laser treatments, chemical skin peels, or other skin procedures, alternative types of tissue fillers, or surgery. Another alternative is to do nothing.
RISKS OF RECEIVING BOTOX/JEAVEAU
Minor temporary drop of eyelid or eyebrow occur in approximately <5% of injections, more rare are changes in vision, lower eyelid retraction, occasional numbness of the forehead lasting up to 2-3 weeks, transient headache, heaviness, and flu-like symptoms. Extremely rare risks include paralysis or weakening of unintended locations which may reduce facial expressions, difficulty breathing, speaking or swallowing. Other, unforeseen risks may exist.
RISKS OF DERMAL FILLER INJECTIONS
Skin Lumpiness, Visible Tissue Filler Material
Lumpiness, ability to feel injected filler or see filler in areas of thin skin. Dermal filler can migrate from its original injection site, and produce visible fullness in adjacent tissue or other unintended effects.
RISKS ASSOCIATED WITH ANY INJECTION, NEEDLING PROCEDURE
Pregnancy and Nursing Mothers
The effects of cosmetic procedures on a fetus or breastmilk is not known, therefore, pregnant or nursing women will not be injected with Botox/Jeuveau or Dermal Fillers.
Drug Interactions
It is not known if cosmetic injections/procedures react with other drugs within the body
Long-Term Effects
Cosmetic injections/procedures injections should not be considered as a permanent treatment for the correction of wrinkles and soft tissue depressions. Over time, injected products are slowly absorbed by the body and wrinkles or soft tissue depressions will reappear. The natural process of aging will form wrinkles and depressions as well. Continuing cosmetic injections/procedures is necessary in order to maintain the effect achieved. Subsequent alterations in face and eyelid appearance may occur as the result of aging, weight loss or gain, sun exposure, or other circumstances not related to cosmetic injections/procedures.
ADDITIONAL ADVISORIES
Mental Health Disorders and Elective Procedures
It is important that all patients seeking cosmetic procedures have realistic expectations that focus on improvement rather than perfection. Please openly discuss with your primary care physician, prior to treatment, any history that you may have of significant emotional depression or mental health disorders. Although many individuals may benefit psychologically from the results of elective procedures, effects on mental health/stress levels cannot be accurately predicted.
Travel Plans
Any procedure holds the risk of complications that may delay healing and delay your return to normal life. Any effects of injections take 2 full weeks to heal and also at times require 2 full weeks for skin to return to normal (resolution of swelling, bruising, redness etc.) Keep this in mind and schedule procedures at least 2 weeks before vacations, or important events such as weddings, reunions, etc. where you want to look your best.
Label FDA Issues
There are many devices, medications, cosmetic procedures and injectable fillers that are approved for specific use by the FDA, but many uses are considered “Off-Label” and not supported by research for the effects they produce. These off- label uses are still commonly performed in the cosmetic industry. Understand these off-label uses are not experimental and the medical director and nurse injector believe it to be safe and effective.
Examples of commonly accepted “Off-Labels” include the use of aspirin for prevention of heart disease, retinoids for skin care, and injection of botulinum toxin for wrinkles around the mouth.
HEALTH INSURANCE
Most health insurance companies exclude coverage for cosmetic procedures and treatments, or any complications that might occur from the same. Patient is financially responsible for any medications or treatments resulting from a complication or adverse effect.ADDITIONAL TREATMENT NECESSARY
The above procedures have lasting but non-permanent effects, thus repeated treatments are needed at recommended intervals to maintain results as possible. Other complications and risks can occur but are even more uncommon. Should complications occur, surgery or other treatments may be necessary. The practice of medicine and surgery is not an exact science.
Although good results are expected, there is no guarantee or warranty expressed or implied on the results that may be obtained.
FINANCIAL RESPONSIBILITIES
The fees charged for this procedure do not include any potential future costs for additional procedures that you elect to have or require in order to revise, optimize, or complete your outcome. If touch-ups are needed, you are financially responsible for the procedure.
Additional costs may occur should complications develop from the procedures, and will also be your responsibility. In signing the consent for these procedures, you acknowledge that you have been informed about the risk and consequences, and accept responsibility for the clinical decisions that were made, along with the financial costs of this and all future treatments.
DISCLAIMER
Informed consent documents are used to communicate information about the proposed treatment along with disclosure of risks and alternative forms of treatment(s). The informed consent process attempts to define principles of risk disclosure that should generally meet the needs of most patients in most circumstances. However, informed consent documents should not be considered all-inclusive in defining other methods of care and risks encountered. Your injector may provide you with additional or different information, which is based on all of the facts pertaining to your particular case, and the current state of medical knowledge.
Informed consent documents are not intended to define or serve as the standard of medical care. 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. It is important that you read the above information carefully, and have all of your questions answered before signing the consent.