This is an informed-consent document which has been prepared to help us inform you concerning BOTOX or Xeomin or other Botulina Toxin A brands (Botulina Toxin Type A) 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. The word BOTOX in this consent will be used as a general name that can include other types of Botulina Toxin Type A as well as the brand name BOTOX.
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 months.
BOTOX has been used to treat certain conditions involving crossed eyes (strabismus), eyelid spasm (blepharospasm), and motor disorders of the facial nerve (VII cranial nerve). It has been used in other “off-label” uses for the treatment of facial wrinkles and neck bands caused by specific muscle groups
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 the risks involved. An individual’s choice to undergo this procedure is based on the comparison of the risk to potential benefit. Although the majority of patients do not experience the following complications, you should discuss each of them with your plastic surgeon to make sure you understand the risks, potential complications, and consequences of BOTOX injections.
Bleeding– 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. Do not take any aspirin or anti-inflammatory medications for seven days before and after BOTOX injections, as this may contribute to a greater risk of a bleeding problem.
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 in 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.
Drooping Eyelid (Ptosis)- Muscles that raise the eyelid may be affected by BOTOX, should this material migrate downward from other injection areas. Eyedrops can be given to improve this problem.
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 Eye Disorders– Functional and irritative disorders of eye structures may rarely occur following BOTOX injections.
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.
Life – Altering Headaches / Pain– Discomfort associated with BOTOX injections is usually short duration. However, rarely permanent severe headaches may occur after BOTOX injection.
Skin disorders– Skin rash and swelling may rarely occur following BOTOX injection.
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. Any and all additional injections are the financial responsibility of the patient.
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 injection. Should an infection occur, additional treatment including antibiotics may be necessary.
Long-term effects– Subsequent alterations in face and eyelid appearance may occur as the result of aging, weight loss of gain, sun exposure, 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.
Blindness– Blindness is extremely rare after BOTOX injections. However, it can be caused by internal bleeding around the eyeball or needle stick injury. The occurrence of this is very rare.
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
Most health insurance companies exclude coverage for cosmetic surgical procedures and treatments or any complications that might occur from the same
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 Additional costs of medical treatment would be your responsibility should complications develop from BOTOX injections. Rarely more botox may be necessary to accomplish the desired result. Additional injections are the financial responsibility of the patient.
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). 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 of the facts pertaining to your particular case and the 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.
I have read and understand the following Informed Consent Material for my specific procedure:
The risks, benefits, and alternatives of the procedure(s) were explained to me. I understand the specific risks in the consent material for my surgery and understand the significant risks of bleeding, infection, injury to neighboring structures, capsule contracture(if implants involved), asymmetry, pulmonary emboli, deformity, healing problems, poor scars, loss of sensation(feeling), appearance/psychological changes, unsatisfactory result, need for future revision surgery and anesthesia. I understand the anticipated results and limitations of the surgery procedure(s). I have realistic expectations and realize that there are no guarantees in plastic surgery. The following instructions were explained to me: Pre and Post procedure instructions, DVT prevention instructions, and medications to avoid instructions. I agree to follow all instructions, to follow up as directed, and to notify the office if any problems or questions arise.
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