POST CARE INSTRUCTIONS: Neurotoxin

WHAT TO EXPECT

● Results are usually seen in 2-6 days.

● 10% of people may not respond for unknown reasons

● You should contract “exercise” muscle(s) that was treated for 1 hour after injection

● You should: remain upright for 4hrs, NO exercise for 4hrs, NO hats or headbands after treatment (treatment day only), and please NO massage

● You can expect results to last from 2-6 months

● You may apply ice, arnica or any other anti-inflammatory topical agents to treat or prevent pain/bruising/swelling

POSSIBLE SIDE EFFECTS AND LESS COMMON COMPLICATIONS

● Side effects associated with the injection include: localized pain, infection, inflammation, tenderness, swelling redness, and/or bleeding/bruising

● Less common reactions may include: nausea, fatigue, flu-like symptoms, headache, excessive weakness of the muscle, temporary eyelid drooping, temporary brow drooping

CALL THE OFFICE 617-964-1440 IF YOU EXPERIENCE: shortness of breath, difficulty swallowing, difficulty talking, severe lower eyelid droop, obstructed vision, excessive weakness around the injection site, rash or a sign of an allergic reaction

IN CASE OF AN EMERGENCY CALL 911

***Do not have neurotoxin injections if you are allergic to any of the ingredients in the botulinum toxin or had a reaction to any other botulinum toxin product; have severe allergies and with a history of anaphylaxis; are pregnant or nursing; are under the age of 18; have an active infection at the site of injection or are on immunosuppressive therapy

BOTOX® COSMETIC CONSENT FORM 

INSTRUCTIONS 

This is an informed-consent document that has been prepared to help inform you about  BOTOX® Cosmetic (Botulina Toxin Type A, Allergan) injections, its risks, as well as alternative  treatment(s). It is important that you read this information carefully and completely. Please initial  each page, indicating that you have read the page and sign the consent as proposed by your  provider and agreed upon by you.  

GENERAL INFORMATION 

Clostridia botulina bacteria produce a class of chemical compounds known as “toxins”. The  Botulina Type A Toxin (Botox® Cosmetic) is processed and purified to produce a sterile product  suitable for specific therapeutic uses. Once the diluted toxin is injected, it produces a temporary  paralysis (chemodenervation) of muscle by preventing transmission of nerve impulses to  muscle. The duration of muscle paralysis generally lasts for approximately three to four months.  BOTOX® Cosmetic is an FDA approved treatment to temporarily improve the appearance of  both moderate to severe frown lines between the brows and crow’s feet lines in adults.  BOTOX® Cosmetic injections are customized for every patient, depending on his or her  particular needs. These can be performed in areas involving the eyelid region, forehead, and  neck. Botox® Cosmetic cannot stop the process of aging. It can however, temporarily diminish  the look of wrinkles caused by muscle groups. Botox® Cosmetic injections may be performed  as a singular procedure or as an adjunct to a surgical procedure.  

ALTERNATIVE TREATMENTS  

Alternative forms of management include not treating the skin wrinkles by any means.  Improvement of skin wrinkles may be accomplished by other treatments or alternative types of  surgery such as a blepharoplasty, face or brow lift when indicated. Other forms of eyelid surgery  may be needed should you have intrinsic disorders affecting the function of the eyelid such as  drooping eyelids from muscle problems (eyelid ptosis) or looseness between the eyelid and  eyeball (ectropion). Minor skin wrinkling may be improved through chemical skin peels, lasers,  injection of fillers or fat, or other skin treatments. Risks and potential complications are  associated with alternative forms of medical or surgical treatment.  

INHERENT RISKS OF BTA INJECTIONS 

Every procedure involves a certain amount of risk and it is important that you understand these  risks and the possible complications associated with them. In addition, every procedure has  limitations. Although the majority of patients do not experience these complications, you should  discuss each of them with your provider to make sure you understand risks, potential  complications, limitations, and consequences of Botox® Cosmetic injections. Additional  information concerning Botox® Cosmetic may be obtained from the package-insert sheets  supplied by Allergan. Tell your doctor if you have received any other botulinum toxin product in  the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or  Xeomin® in the past (tell your doctor exactly which product you received); have recently  received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take  a sleep medicine; take aspirin-like products or blood thinners.   

SPECIFIC RISKS OF BOTOX®COSMETIC (BOTULINA TYPE A TOXIN) INJECTIONS 

WARNING: DISTANT SPREAD OF TOXIN EFFECT  

Postmarketing reports indicate that the effects of BOTOX® Cosmetic and all botulinum toxin  products may spread from the area of injection to produce symptoms consistent with botulinum  toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis,  dysphagia, dysphonia, dysarthria, 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. The risk of symptoms is  probably greatest in children treated for spasticity but symptoms can also occur in adults treated  for spasticity and other conditions, particularly in those patients who have an underlying  condition that would predispose them to these symptoms. In unapproved uses, including  spasticity in children, and in approved indications, cases of spread of effect have been reported at  doses comparable to those used to treat cervical dystonia and upper limb spasticity and at lower  doses.  

Incomplete Result:  

It is possible to not experience a complete result of targeted muscles. Additional injections to reach the  desired level of result can be performed until the goal is achieved.  

Asymmetry:  

The human face and eyelid region is normally asymmetrical with respect to structural anatomy and  function. There can be a variation from one side to the other in terms of the response to BTA injection.  

Drooping Eyelid (Ptosis):  

Muscles that raise the eyelid may be affected by BTA, should this material migrate downward from other  injection areas. Should this problem occur, it is temporary and additional treatments such as eye drops  may be necessary.  

Pain:  

Discomfort associated with BTA injections is usually of short duration.  

Migration of BTA:  

BTA may migrate from its original injection site to other areas and produce temporary weakness of other  muscle groups or other unintended effects. BTA has been reported to cause swallowing problems in  patients treated for spastic muscle disorders of the neck region (cervical dystonia).  

Bleeding and Bruising:  

It is possible, though unusual, to have a bleeding episode from a BTA injection. Bruising in soft tissues  may occur. Serious bleeding around the eyeball during deeper BTA injections for crossed eyes  (strabismus) has occurred. Should you develop post-injection bleeding, you may require emergency  treatment or surgery. Aspirin, anti-inflammatory medications, platelet inhibitors, anticoagulants, Vitamin E,  ginkgo biloba, and other “herbs / homeopathic remedies” may contribute to a greater risk of a bleeding  problem. Do not take these for ten days before BTA injections. If you are taking these medications, please  inform your provider prior to proceeding.  

Damage to Deeper Structures: ​Deeper structures such as nerves, blood vessels, and the eyeball may  be damaged during the course of injection. Injury to deeper structures may be temporary or permanent.   

Corneal Exposure Problems​:  

Some patients experience difficulties closing their eyelids after BTA injections and problems may occur in  the cornea due to dryness. Should this rare complication occur, additional treatments, protective eye  drops, contact lenses, or surgery may be necessary.  

Unknown Risks:​ The long-term effect of BTA on tissue is unknown. The risk and consequences of  accidental intravascular injection of BTA is unknown and not predictable. There is the possibility that  additional risk factors may be discovered.  

Dry Eye Problems:​ Individuals who normally have dry eyes may be advised to use special caution in  considering BOTOX® Cosmetic injections around the eyelid region.  

Double-Vision:​ Double-vision may be produced if the BTA material migrates into the region of muscles  that control movements of the eyeball.  

Eyelid Ectropion:​ Abnormal looseness of the lower eyelid can occur following BTA injection.  

Other Eye Disorders: Functional and irritive disorders of eye structures may rarely occur following BTA  injections.  

Blindness:​ Blindness is extremely rare after BTA injections. However, it can be caused by internal  bleeding around the eyeball or needle stick injury. In a period of 10 years of Botox® Cosmetic  administration, complications of blurred vision, retinal vein occlusion, and glaucoma have been reported  in three patients. The occurrence of eye problems appears to be very rare.  

Allergic Reactions:​ As with all biologic products, allergic and systemic anaphylactic reactions may occur.  Allergic reactions may require additional treatment.  

Antibodies to BTA​: Presence of antibodies to Botox® Cosmetic may reduce the effectiveness of this  material in subsequent injections. The health significance of antibodies to BTA is unknown.  

Infection: ​Infection is extremely rare after BTA injection. Should an infection occur, additional treatment  including antibiotics may be necessary.  

Skin Disorders:​ Skin rash, itching, and swelling may rarely occur following BTA injection.  

Neuromuscular Disorders:​ Patients with peripheral motor neuropathic disorders (amyotrophic lateral  sclerosis, myasthenia gravis, and motor neuropathies) may be at greater risk of clinically significant side  effects from BTA.  

Migraine Headache Disorders:​ Headaches are possible and usually last one day but may persist longer  in a very small percentage of patients. Botox® Cosmetic has been used to treat forehead muscle groups  that are involved with the migraine headache condition. Patients are advised that results of BTA treatment  for migraine headaches may be variable and improvement in this disorder may not occur following BTA  treatments.  

Unsatisfactory Result:​ There is the possibility of a poor or inadequate response from BTA injection.  Additional BTA injections may be necessary. Surgical procedures or treatments may be needed to  improve skin wrinkles including those caused by muscle activity. Unsatisfactory results may NOT improve  with each additional treatment.   

Long-Term Effects:​ Subsequent alterations in face and eyelid appearance may occur as the result of  aging, weight loss, weight gain, sun exposure, pregnancy, menopause, or other circumstances not related  to BTA injections. BTA injection does not stop the aging process or produce permanent tightening of skin.  Future surgery or other treatments may be necessary  

Pregnancy and Nursing Mothers:​ Animal reproduction studies have not been performed to determine if  BTA could produce fetal harm. It is not known if BTA can be excreted in human milk. It is not  recommended that pregnant women or nursing mothers receive BTA treatments. Please inform your  provider prior to proceeding if you are pregnant or think you could be or if you are nursing.  

Drug Interactions:​ The effect of BTA may be potentiated by aminoglycoside antibiotics or other drugs  known to interfere with neuromuscular transmission.  

OFF-LABEL FDA ISSUES:​ There are many devices, medications and injectable fillers and botulinum  toxins that are approved for specific use by the FDA, but this proposed use is “Off-Label”, that is not  specifically approved by the FDA. It is important that you understand this proposed use is not  experimental and your provider believes it to be safe and effective.  

ADDITIONAL ADVISORIES 

Medications and Herbal Dietary Supplements:​ There are potential adverse reactions that occur as the  result of taking over-the-counter, herbal, and/or prescription medications. Aspirin and medications that  contain aspirin interfere with forming blood clots, and therefore may contribute to more bleeding issues. If  you have a medical condition (such as heart arrhythmia, heart stent, blood vessels with blockages, or  blood clots) and are taking medications to thin your blood and prevent clotting such as Plavix, Warfarin,  Coumadin, Xarelto, Effient or Pradaxa, discuss management of these medications around the time of  treatment with your provider. If you have an adverse reaction, stop the drugs immediately and call your  provider for further instructions. If the reaction is severe, go immediately to the nearest emergency room.  

Sun Exposure – Direct or Tanning Salon:​ The effects of the sun are damaging to the skin. Exposing  the treated areas to sun may result in increased scarring, color changes, and poor healing. Patients who  tan, either outdoors or in a salon, should inform their provider and either delay treatment, or avoid tanning  until the provider says it is safe to resume. The damaging effect of sun exposure occurs even with the use  sun block or clothing coverage.  

Important Commitments/Travel Plans:​ Any treatment holds the risk of complications that may delay  healing and your return to normal life. Please let the provider know of any travel plans, important  commitments already scheduled or planned, or time demands that are important to you, so that  appropriate timing of treatment can occur. There are no guarantees that you will be able to resume all  activities in the desired time frame.  

Female Patient Information: ​It is important to inform your provider if you use birth control pills, estrogen  replacement, or if you suspect you may be pregnant.  

Mental Health Disorders and Elective Treatment:​ It is important that all patients seeking to undergo  elective treatment have realistic expectations that focus on improvement rather than perfection.  Complications or less than satisfactory results are sometimes unavoidable, may require additional  treatment and often are stressful. Please openly discuss with your provider, 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 treatment, effects on mental health  cannot be accurately predicted.   

PATIENT COMPLIANCE​ Follow all physician instructions carefully; this is essential for the success of  your outcome. Personal and vocational activity may need to be restricted.  

DISCLAIMER ​Informed-consent documents are used to communicate information about the proposed  treatment of a disease or condition along with disclosure of risks and alternative forms of treatment(s),  including a decision not to proceed with treatment. This document is based on a thorough evaluation of  scientific literature and relevant clinical practices to describe a range of generally acceptable risks and  alternative forms of management of a particular disease or condition. 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 provider may provide you with additional or  different information which is based on all the facts in 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.   

AUTHORIZATION (S): 

• I acknowledge that I have been informed about the Off-Label FDA status of BOTOX® (Botulina Toxin  Type A, Allergan) and I understand it is not experimental and accept its use.  

• For women: I confirm that I am not pregnant or breastfeeding and do not intend to become pregnant  anytime during the course of treatment.  

• Before and after treatment instructions have been discussed with me. The procedure, potential benefits  and risks, and alternative treatment options have been explained to my satisfaction.  

• I understand that the procedure is purely elective, that the results may vary with each individual, and  multiple treatments may be necessary.  

• I have read and understand all information presented to me before consenting to treatment.  • I have had all my questions answered. I freely consent to the proposed treatment.  

I, hereby authorize above provider to perform BOTOX® Cosmetic injection on me. I understand that I am  a patient of Medical Aesthetics Associates, PC, a medical practice led by a Harvard trained Board  Certified Plastic Surgeon with over two decades of medical aesthetic experience, and that my licensed  provider is an employee of the practice.