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.
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. Aspinn, 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.
Dry Eye Problems- Individuals who normally have dry eyes may be advised to use special caution ¡n considering BOTOX injections around the eyelid region.
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).
Drooping Eyelid (Ptosis) - Muscles that raise the eyelid may be affected by BOTOX, should this material migrate downward from other injection areas.
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 injection.
Other Eve 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.
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 injection.
Pain- Discomfort associated with BOTOX injections is usually short duration.
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 ¡s unknown.
Infection- Infection is extremely rare after BOTOX injection. 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 treatment 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 injection. 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,npregnancy, menopause, or other circumstances not related to BOTOX injections. BOTOX injection does 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.
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 of additional risk factors may be discovered.