Botulinum Toxin Consent
Dr. Rebecca Small is a family medicine physician with the proper training and credentials to perform the procedures stated in this consent form. Other physicians that perform aesthetic procedures include, but are not limited to: plastic surgeons, dermatologists, oculoplastic physicians, and other adequately trained physicians. In addition, nurses (RNs, NPs) and physician assistants (PAs) may also perform these treatments.
This consent form is designed to give you the information you need to make an informed decision about whether or not to undergo botulinum toxin type A (e.g. Jeuveau, Dysport, Xeomin) treatment for facial wrinkles. If you have any questions please ask the physician or other healthcare provider at the office of Dr. Rebecca Small, RSMD, Medical Aesthetics.
The action of the botulinum toxin type A (protein) is to cause weakness of muscles that can last approximately three to four months. Injection of small amounts of botulinum toxin type A relaxes the treated muscles and can reduce facial wrinkles including: frown lines, and lines around the forehead, eyes (crow's feet), vertical lip lines, dimply chin, bunny lines on the nose, down-turned corners of the mouth and marionette lines, neck bands, excessive underarm sweating (axillary hyperhidrosis) that is unresponsive to other treatments. Botulinum toxin type A solution is injected with a small needle into the muscles. Typically, effects are seen in a few days and take 2 weeks to fully develop. Effects typically last for 2 ½ - 4 months for facial/neck treatment areas and 6 months for axillary hyperhidrosis, but can last for a shorter or longer amount of time. Botulinum toxin type A is FDA approved for treatment of frown lines and crows feet in adults ages 18 to 65, axillary hyperhidrosis, and is used off-label for all other cosmetic treatments. Botulinum toxin is primarily indicated for dynamic lines which are wrinkles formed with muscle contraction and facial expressions; results are usually dramatic for treatment of dynamic lines. Botulinum toxin treatments are also used for treatment of static lines which are wrinkles etched into the skin that are visible at rest. However, results are slower and less dramatic and in some cases no improvement is achieved with treatment of static lines.
Alternatives to botulinum toxin type A include, but are not limited to: dermal fillers, laser resurfacing, surgical face-lift or no treatment at all. Alternative therapies for axillary hyperhidrosis include topical antiperspirants and surgical procedures.
Patients with the following conditions may not receive botulinum toxin type A treatments: abnormal raised scarring or keloid formation; active inflammation or infection in the treatment area (e.g. pimples, rashes or hives); pregnancy or nursing; history of or current evaluation for neuromuscular condition including but not limited to: amyotrophic lateral sclerosis, myasthenia gravis or Lambert-Eaton syndrome, or muscular dystrophy.
The risks, side-effects and complications of treatment with botulinum toxin type A include, but are not limited to:
Pain, numbness, tenderness, redness and swelling at or around the treated site. These typically lessen or disappear within a few days. If prolonged redness or tenderness at the injection occurs notify RSMD, Medical Aesthetics.
Bruising may occur which usually resolves within 1-2 weeks after the injection. Patients taking medications that interfere with coagulation (e.g., Aspirin, Ibuprofen) have an increased risk of bruising and bleeding. Rarely, a significant bruise such as a hematoma, or a collection of blood outside of a blood vessel, may form. Hematomas may take up to a month or more to resolve. Treatments around the eyes commonly cause bruising.
Skin infection with redness, pain and rarely abscess formation.
Although rare, needles or cannulas can lead to permanent scars at or around the injection sites.
Treatment may result in a droopy upper (5%) or lower eyelid, which may be associated with blurry or double vision. This may also cause visual sun sensitivity and impair driving, working and other functions. A droopy cheek, lip and droopy eyebrow are also possible complications. A droopy upper eyelid can sometimes be improved with physician prescribed eyedrops and a droopy eyebrow can sometimes be improved with botulinum toxin type A injected under the eyebrow.
Rarely, an adjacent muscle may be weakened. Weakness of the muscles around the mouth and cheeks may occur leading to food trapping in the cheek area as well as difficulty with drinking, sipping, eating, speaking, or drooling. Muscle twitches can occur.
Treatments around the eyes may result in eyelid swelling and rarely, impaired eyelid closure or blinking reflex, which can result in dry eyes and corneal injury.
Treatment to alleviate headaches may exacerbate headaches in the short term or long term. The act of receiving an injection itself can trigger a headache. This is common in patients that have a headache at the time of treatment, who have frequent headaches, or who's headaches are easily triggered.
Asymmetry and undesired temporary disfiguring facial changes may occur, such as: excessive lip curvature and protrusion, undesired changes in eyebrow shape, worsening eye bags, wrinkles in areas adjacent to the treated areas.
In rare cases, antibodies to botulinum toxin may be present or develop after treatments, rendering treatments ineffective.
Treatments to the neck area may also result in difficulty swallowing, vocalizing and neck instability, particularly weakness with flexing forwards. In severe cases, weakening of the neck and throat (pharyngeal) muscles can affect eating and drinking necessitating a temporary feeding tube, and airway obstruction may occur requiring airway support.
Treatments to the masseter muscle(s) may result in problems with chewing, bite occlusion, headaches, nerve damage, change in bite force, speech disturbance, muscle pain, facial asymmetry, increased cheek bone prominence and worsening of jowls.
Allergic reaction with itchiness, redness, and in extremely rare cases generalized allergic response such as whole body swelling, respiratory problems, shock and the remote possibility of death due to a severe allergic reaction.
Severe complications may necessitate hospitalization and can typically be reversed using medications such as acetylcholine stimulating medications (pyridostigmine) that have significant side-effects while taken including but not limited to: muscle weakness or cramps, stomach pain, nausea, vomiting, diarrhea, sweating, increased salivation, blurred vision.
Complications and side effects may adversely affect social and work activities.
Post marketing safety data suggests that botulinum toxin type A effects may, in some cases, be observed beyond the site of local injection. The symptoms are consistent with the mechanism of action of botulinum toxin and may include but are not limited to: generalized muscle weakness, diplopia, blurred vision, ptosis (eyelid droop), difficulty swallowing, difficulty speaking, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death related to effects from spread of toxin. The risk of symptoms is probably greatest in children treated for spasticity but symptoms occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. No serious adverse events have been reported due to distant spread of toxin effects associated with dermatologic use of cosmetic botulinum toxin type A at the labeled dose of 20 units (for glabellar lines) or 100 units (for axillary hyperhidrosis).
Certain conditions require caution with injectable treatments and may preclude a patient from receiving treatment: long-term use of prednisone or other steroid therapy; recurrent viral infections such as herpes simplex (cold sores) may be activated by botulinum toxin type A treatments particularly around the mouth and a medication can be prescribed prior to your treatment to help prevent a herpes outbreak. The physician or nurse must be notified of these conditions prior to treatment.
RSMD, Medical Aesthetics provides a 2 week follow-up visit with a complimentary touch-up if needed (i.e., if excessive muscle contraction is present in the treatment area, not if static lines are present). However, if patients require repeated touch-ups and/or their treatment dose escalates over time, RSMD, Medical Aesthetics reserves the right to increase the cost of the initial treatment.
My signature below certifies that I am an adult of at least 18 years of age. I have fully read this consent form and understand the information provided to me regarding the proposed procedure. I have been adequately informed about the procedure including: the potential benefits, limitations, alternative treatments, and I have had all questions and concerns answered to my satisfaction. I understand and accept the risks, side-effects and possible complications inherent in undergoing botulinum toxin type A treatments. I have fully disclosed all of my medical history. I understand that it is my responsibility to inform and update RSMD, Medical Aesthetics's physician or nurse of any change in my health status and medical history (e.g., medications, allergies, adverse response to treatments or products) at each visit and that failure to do so may increase the likelihood or severity of complications.
I consent to be photographed and/or videoed. These shall be part of the medical record and may be used for educational purposes, training and marketing.
I hereby waive, release, discharge any and all claims and agree to indemnify, defend and hold harmless Dr. Small, the medical staff, specific technician, and RSMD, Medical Aesthetics , its members, employees, and affiliates for any injury, loss, expenses, or damages of any nature which may arise or be alleged as a result of my treatments, including that caused solely or in part by the fault of the above-named parties.
I consent and authorize Dr. Rebecca Small, a physician assistant or registered nurse of RSMD, Medical Aesthetics to perform botulinum toxin type A treatments for unwanted lines, wrinkles and facial contouring. This consent shall apply to all subsequent botulinum toxin type A treatments. I understand that the practice of medicine is not an exact science and that no guarantees can be or have been made concerning expected results in my case. If I have questions or problems after treatments I will contact RSMD, Medical Aesthetics directly at (831) 475-1077.
I certify that I have fully read and agree to adhere to the pre-procedure and post-procedure instructions with each appointment. I understand that failure to carefully follow these instructions may affect my treatment outcome and increase the likelihood and severity of complications. Any applicable paragraphs were stricken before I signed. I also state that I speak, read, and write English.
Botulinum Toxin Pre & Post Instructions
What is botulinum toxin therapy and why is it done? Small amounts of cosmetic botulinum toxin injected into specific facial muscles can temporarily relax them to smooth forehead and eyebrow wrinkles as well as crow’s feet. It can be very effective for active wrinkles such as when frowning or squinting, and when repeated periodically can delay or prevent the formation of wrinkles at rest. Botulinum toxin is also indicated for excessive underarm sweating (hyperhidrosis).
What are the risks of botulinum toxin therapy? Botulinum toxin has been used cosmetically since 1986 and has been found to be very effective and safe. The risks of treatment include, but are not limited to pain: bruising, swelling, numbness, lack of response, and eyelid swelling. Less common side effects include: drooping of the upper eyelid or eyebrow. If you have a disease of the nerves and/or muscles or are pregnant or lactating, you should not receive treatment.
What are the alternatives to botulinum toxin therapy? No other therapy is currently in use that can achieve the effects of botulinum toxin. Other available treatment for wrinkles include: topical creams, chemical peels, laser peels, face-lift and surgical destruction of the muscles that form wrinkles.
How long does it take to work; how long does it last? The effects typically take two weeks to fully develop and can last up to 3-4 months for facial muscles and up to 6 months for underarm sweating.
Prior to Treatment
Avoid aspirin (e.g., Excedrin), vitamin E, St. John’s Wort and other dietary supplements including: ginkgo, evening primrose oil, garlic, feverfew, ginseng, bilberry, cayenne, dong quai, fish oil, ginger, and licorice root for 2 weeks.
Avoid alcohol consumption for 2 days.
Avoid ibuprofen (Advil, Motrin), naproxen (Aleve) and any other anti-inflammatory medications for 2 days.
For hyperhidrosis, avoid antiperspirant and shave underarms 24 hours before treatment.
If possible, increase consumption of green leafy vegetables (such as kale and spinach) for 2 days.
After Treatment
Medications that may help support healing and reduce bruising and swelling are: Arnica Montana (cream, oral supplements), bromelain, and vitamin C.
Do not massage the treated areas on the day of treatment.
Avoid lying down for 4 hours immediately after treatment.
Avoid applying heat to the treated area and activities that can cause flushing for 4 hours after treatment or as instructed by provider including: consuming alcohol, exercising, extensive sun or heat exposure, using hot tub or sauna.
RSMD offers a complimentary touch-up for botulinum toxin up to 2 weeks after treatment. Please contact our office to make a follow-up appointment. Touch-ups scheduled beyond the 2 week period will have associated fees.
RSMD Medical Spa also offers a complimentary IPL bruise spot treatment if dark bruising occurs. Multiple bruise treatments are offered if necessary. Please contact our office to make an appointment for bruise treatment.
Please contact RSMD at (831) 475-1077 if you have any questions. If problems arise after hours please contact your nearest urgent care facility.