This is an informed-consent document which has been prepared to help your plastic surgeon inform you concerning BOTOX® (Botulina Toxin Type A, Allergan) injection, its risks, and alternative treatments.
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 for this procedure as proposed by your plastic surgeon and agreed upon by you.
Clostridia botulina bacteria produce a class of chemical compounds known as “toxins”. The Botulina Type A Toxin (BOTOX) 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 has been approved to treat certain conditions involving crossed eyes (strabismus), eyelid spasm (blepharospasm), cervical dystonia (spastic muscle disorder with the neck) and motor disorders of the facial nerve (VII cranial nerve). As of April 2002, it has been FDA-approved for the cosmetic treatment of forehead wrinkles caused by specific muscle groups. Other areas of the face and body such as crows feet wrinkles and neck bands may be treated in an “off-label” fashion. BOTOX has also been used to treat migraine headaches, colorectal disorders, excessive perspiration disorders of the armpit and hands, and musculoskeletal pain disorders.
BOTOX 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 cannot stop the process of aging. It can however, temporarily diminish the look of wrinkles caused by muscle groups. BOTOX injections may be performed as a singular procedure or as an adjunct to a surgical procedure.
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 filling material, or other skin treatments. Risks and potential complications are associated with alternative forms of medical or surgical treatment.
RISKS of BOTOX (Botulina Type A Toxin) 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. An individual’s choice to undergo a surgical procedure is based on the comparison of the risk to potential benefit. Although the majority of patients do not experience these complications, you should discuss each of them with your plastic surgeon to make sure you understand risks, potential complications, limitations, and consequences of BOTOX injections. Additional information concerning BOTOX may be obtained from the package-insert sheets supplied by Allergan.
Incomplete Block: It is possible to not experience a complete block of desired muscles. Additional injections to reach the desired level of block 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 BOTOX injections.
Drooping Eyelid (Ptosis): Muscles that raise the eyelid may be affected by BOTOX, should this material migrate downward from other injection areas.
Pain: Discomfort associated with BOTOX injections is usually of short duration.
Migration of BOTOX: BOTOX may migrate from its original injection site to other areas and produce temporary paralysis of other muscle groups or other unintended effects. BOTOX has been reported to cause swallowing problems in patients treated for spastic muscle disorders of the cervical region (cervical dystonia).
Bleeding and Bruising: It is possible, though unusual, to have a bleeding episode from a BOTOX injection. Bruising in soft tissues may occur. Serious bleeding around the eyeball during deeper BOTOX injections for crossed eyes (strabismus) has occurred. Should you develop post-injection bleeding, it 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 or after BOTOX injections.
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 BOTOX 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 BOTOX on tissue is unknown. The risk and consequences of accidental intravascular injection of BOTOX 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 injections around the eyelid region.
Double-Vision: Double-vision may be produced if the BOTOX material migrates into the region of muscles that control movements of the eyeball.
Eyelid Ectropion: Abnormal looseness of the lower eyelid can occur following BOTOX injections.
Other Eye Disorders: Functional and irritative disorders of eye structures may rarely occur following BOTOX injections.
Blindness: Blindness is extremely rare after BOTOX injections. However, it can be caused by internal bleeding around the eyeball or needle stick injury. In a period of 10 years of BOTOX 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 BOTOX: Presence of antibodies to BOTOX may reduce the effectiveness of this material in subsequent injections. The health significance of antibodies to BOTOX is unknown.
Infection: Infection is extremely rare after BOTOX injections. Should an infection occur, additional treatment including antibiotics may be necessary.
Skin Disorders: Skin rash, itching, and swelling may rarely occur following BOTOX injection.
Neuromuscular Disorders: Patients with peripheral motor neuropathic disorders (amyotrophic lateral sclerosis, myasthenia gravis, motor neuropathies) may be at greater risk of clinically significant side effects from BOTOX.
Migraine Headache Disorders: BOTOX has been used to treat forehead muscle groups that are involved with the migraine headache condition. Patients are advised that results of BOTOX treatments for migraine headaches may be variable and improvement in this disorder may not occur following BOTOX treatments.
Unsatisfactory Result: There is the possibility of a poor or inadequate response from BOTOX injections. Additional BOTOX injections may be necessary. Surgical procedures or treatments may be needed to improve skin wrinkles including those caused by muscle activity.
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 BOTOX injections. BOTOX injections do not arrest the aging process or produce permanent tightening of the eyelid region. Future surgery or other treatments may be necessary.
Pregnancy and Nursing Mothers: Animal reproduction studies have not been performed to determine if BOTOX could produce fetal harm. It is not known if BOTOX can be excreted in human milk. It is not recommended that pregnant women or nursing mothers receive BOTOX treatments.
Drug Interactions: The effect of BOTOX may be potentiated by aminoglycoside antibiotics or other drugs known to interfere with neuromuscular transmission.
Bleeding: It is possible, though unusual, to experience a bleeding episode during or after surgery. Should post-operative bleeding occur, it may require emergency treatment to drain accumulated blood or you may require a blood transfusion, though such occurrences are rare. Increased activity too soon after surgery can lead to increased chance of bleeding and additional surgery. It is important to follow postoperative instructions and limit exercise and strenuous activity for the instructed time. Do not take any aspirin or anti-inflammatory medications for at least ten days before or after surgery, as this may increase the risk of bleeding. Non-prescription “herbs” and dietary supplements can increase the risk of surgical bleeding. Hematoma can occur at any time, usually in the first three weeks following injury to the operative area. If blood transfusions are necessary to treat blood loss, there is the risk of blood-related infections such as hepatitis and HIV (AIDS). Heparin medications that are used to prevent blood clots in veins can produce bleeding and decreased blood platelets.
Infection: Infection is unusual after surgery. Should an infection occur, additional treatment including antibiotics, hospitalization, or additional surgery may be necessary. It is important to tell your surgeon of any other infections, such as ingrown toenail, insect bite, or urinary tract infection. Remote infections, infections in other parts of the body, may lead to an infection in the operated area.
Female Patient Information: It is important to inform your plastic surgeon if you use birth control pills, estrogen replacement, or if you suspect you may be pregnant. Many medications including antibiotics may neutralize the preventive effect of birth control pills, allowing for conception and pregnancy.
Mental Health Disorders and Elective Surgery: It is important that all patients seeking to undergo elective surgery have realistic expectations that focus on improvement rather than perfection. Complications or less than satisfactory results are sometimes unavoidable, may require additional surgery and often are stressful. Please openly discuss with your surgeon, prior to surgery, 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 surgery, effects on mental health cannot be accurately predicted.
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 surgeon and either delay treatment, or avoid tanning until the surgeon says it is safe to resume. The damaging effect of sun exposure occurs even with the use sun block or clothing coverage.
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 clotting and can cause more bleeding. These include non-steroidal anti-inflammatories such as Motrin, Advil, and Alleve. It is very important not to stop drugs that interfere with platelets, such as Plavix, which is used after a stent. It is important if you have had a stent and are taking Plavix that you inform the plastic surgeon. Stopping Plavix may result in a heart attack, stroke and even death. Be sure to check with your physician about any drug interactions that may exist with medications which you are already taking. If you have an adverse reaction, stop the drugs immediately and call your plastic surgeon for further instructions. If the reaction is severe, go immediately to the nearest emergency room. When taking the prescribed pain medications after surgery, realize that they can affect your thought process and coordination. Do not drive, do not operate complex equipment, do not make any important decisions and do not drink any alcohol while taking these medications. Be sure to take your prescribed medication only as directed.
Travel Plans: Any surgery holds the risk of complications that may delay healing and delay your return to normal life. Please let the surgeon know of any travel plans, important commitments already scheduled or planned, or time demands that are important to you, so that appropriate timing of surgery can occur. There are no guarantees that you will be able to resume all activities in the desired time frame.
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 physician believes it to be safe and effective. Examples of commonly accepted “Off-Label” use of drugs or devices include the use of aspirin for prevention of heart disease, retinoids for skin care, and injection of botulinum toxin for wrinkles around the eyes. Botox® is approved for Glabellar frown lines, Blepharospasm, and would be Off-Label for all other uses.
____ I acknowledge that I have been informed about the Off-Label FDA status of Botox®, and I understand it is not experimental and accept its use.
Most health insurance companies exclude coverage for cosmetic surgical operations or any resulting complications. Please carefully review your health insurance subscriber-information pamphlet. Most insurance plans exclude coverage for secondary or revisionary surgery due to complications of cosmetic surgery.
ADDITIONAL TREATMENT NECESSARY
There are many variable conditions in addition to risk and potential complications that may influence the long-term result of BOTOX injections. Even though risks and complications occur infrequently, the risks cited are the ones that are particularly associated with BOTOX injections. Other complications and risks can occur but are even more uncommon. Should complications occur, additional 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.
The cost of BOTOX injection may involve several charges. This includes the professional fee for the injections, follow-up visits to monitor the effectiveness of the treatment, and the cost of the BOTOX material itself. It is unlikely that BOTOX injections to treat cosmetic problems would be covered by your health insurance. 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. Additional costs may occur should complications develop from the injections and will also be your responsibility. In signing the consent for this surgery/procedure, you acknowledge that you have been informed about its risks and consequences and accept responsibility for the clinical decisions that were made along with the financial costs of all future treatments.
___ I understand and unconditionally and irrevocably accept this.
Informed-consent documents are used to communicate information about the proposed surgical treatment of a disease or condition along with disclosure of risks and alternative forms of treatment(s), including no surgery. 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 plastic surgeon 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.
It is important that you read the above information carefully and have all of your questions answered before signing the consent on the next page.
CONSENT FOR SURGERY/ PROCEDURE or TREATMENT
- I hereby authorize Dr.__________________ and such assistants as may be selected to perform the following procedure or treatment: BOTOX INJECTION
(list the anatomic areas where BOTOX will be injected i.e. frontalis and corrugator muscles)
I have received the following information sheet:
INFORMED CONSENT – BOTOX INJECTION
- I recognize that during the course of the procedure and medical treatment or anesthesia, unforeseen conditions may necessitate different procedures than those above. I therefore authorize the above physician and assistants or designees to perform such other procedures that are in the exercise of his or her professional judgment necessary and desirable. The authority granted under this paragraph shall include all conditions that require treatment and are not known to my physician at the time the procedure is begun.
- I consent to the administration of such anesthetics considered necessary or advisable. I understand that all forms of anesthesia involve risk and the possibility of complications, injury, and sometimes death.
- I understand what my surgeon can and cannot do, and I understand there are no warranties or guarantees, implied or specific about my outcome. I have had the opportunity to explain my goals and understand which desired outcomes are realistic and which are not. All of my questions have been answered, and I understand the inherent (specific) risks of the procedures I seek, as well as those additional risks and complications, benefits, and alternatives. Understanding all of this, I elect to proceed.
- I consent to be photographed or televised before, during, and after the operation(s) or procedure(s) to be performed, including appropriate portions of my body, for medical, scientific or educational purposes, provided my identity is not revealed by the pictures.
- For purposes of advancing medical education, I consent to the admittance of observers to the treatment room.
- I authorize the release of my Social Security number to appropriate agencies for legal reporting and medical-device registration, if applicable.
- I understand that the surgeon’s fees are separate from the anesthesia and hospital charges, and the fees are agreeable to me. If a secondary procedure is necessary, further expenditure will be required.
- I realize that not having the operation is an option.
- IT HAS BEEN EXPLAINED TO ME IN A WAY THAT I UNDERSTAND:
- THE ABOVE TREATMENT OR PROCEDURE TO BE UNDERTAKEN
- THERE MAY BE ALTERNATIVE PROCEDURES OR METHODS OF TREATMENT
- THERE ARE RISKS TO THE PROCEDURE OR TREATMENT PROPOSED