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Informed Consent
BOTOX COSMETIC

 

INTRODUCTION

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 the muscle.  The duration of muscle paralysis lasts for approximately three months.

 

BOTOX COSMETIC has been used to treat certain conditions involving crossed eyes (strabismus), eyelid spasm (blepharospasm), motor disorders of the facial nerve (VII cranial nerve) as well as facial wrinkles and increased sweating.  Certain muscle spastic muscle disorders with the neck and colorectal areas have also been treated with this agent.

 

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.  It may also be used for hyperhidrosis (excessive sweating) in areas such as the axilla (arm-pits), palms, groin, etc.  It should be realized that 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.

 

BOTOX COSMETIC is intended to diminish dynamic wrinkling; that is, wrinkles that are produced by facial animation.  BOTOX COSMETIC will not affect static wrinkling nor will it affect fine lines. BOTOX COSMETIC usually takes 5-7 days to reach its maximal effect.

 

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 filling material, or other skin treatments.  Risks and potential complications are associated with alternative forms of medical or surgical treatment.

 

Alternative methods of treating hyperhidrosis include antiperspirants, surgical sympathectomy or no treatment at all. Risks and potential complications are associated with alternative forms of medical or surgical treatment.

 

RISKS OF BOTOX COSMETIC (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 risks 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 COSMETIC injections.

 

BLEEDING

It is possible, though unusual, to have a bleeding episode from a BOTOX COSMETIC injection.  Bruising in soft tissues may occur.  Serious bleeding around the eyeball during deeper BOTOX COSMETIC injections for crossed eyes (strabismus) has occurred.  Should you develop post-injection bleeding, it may require emergency treatment or surgery.  Do not take aspirin or anti-inflammatory medications for seven days before BOTOX COSMETIC 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

Some patients experience difficulties closing their eyelids after BOTOX COSMETIC 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 might be necessary.

 

DRY EYE

Individuals who normally have dry eyes are advised to use special caution in considering BOTOX COSMETIC injections around the eyelid region.  Your specific concerns should be address with your plastic surgeon.

 

MIGRATION OF BOTOX COSMETIC

BOTOX COSMETIC may migrate form 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 COSMETIC, should this material migrate downward from other injection areas.

 

DOUBLE VISION

Double vision may occur if the BOTOX COSMETIC material migrates into the region of muscles that control movements of the eyeball.

 

ECTROPION

Abnormal looseness of the lower eyelid can occur following BOTOX COSMETIC injection

 

OTHER EYE DISORDERS

Functional and irritative disorders of eye structures may rarely occur following BOTOX COSMETIC 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 COSMETIC injection.

 

PAIN

Discomfort associated with BOTOX COSMETIC injections is usually short in duration.

 

SKIN DISORDERS

Skin rash and swelling may rarely occur following BOTOX COSMETIC injections.

 

UNKNOWN RISKS

The long term effect of BOTOX COSMETIC on tissue is unknown. There is the possibility that additional risk factors may be discovered.

 

UNSATISFACTORY RESULT

There is the possibility of a poor or inadequate response from a BOTOX COSMETIC injection.  Additional BOTOX COSMETIC injections may be necessary.  There will be a charge for any additional BOTOX COSMETIC injection.  Surgical procedures or treatments may be needed to improve skin wrinkles, including those caused by muscle activity.

 

ALLERGIC REACTIONS

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

 

ANTIBIODIES

Presence of antibodies to BOTOX COSMETIC may reduce the effectiveness of this material in subsequent injections.  The health significance of antibodies to BOTOX COSMETIC is unknown.

 

INFECTION

Infection is extremely rare after a BOTOX COSMETIC injection.  Should an infection occur, additional treatment, including antibiotics, might be necessary.

 

LONG-TERM EFFECTS

Subsequent alterations in face and eyelid appearance may occur as a result of aging, weight loss or gain, sun exposure or other circumstances not related to BOTOX COSMETIC injections.  BOTOX COSMETIC 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 COSMETIC could produce fetal harm.  It is not known if BOTOX COSMETIC can be excreted in human milk.

 

BLINDNESS

Blindness is extremely rare after BOTOX COSMETIC injections.  However, it can be caused by internal bleeding around the eyeball or needle stick injury.

 

DRUG INTERACTIONS

The effect of BOTOX COSMETIC may be potentiated by aminoglycoside antibiotics or other drugs known to interfere with neuromuscular transmission.

 

HEALTH INSURANCE

Most health insurance companies exclude coverage for cosmetic surgical procedures and treatments, or any complications that might occur from the same.  Please carefully review your health insurance subscriber information pamphlet.

 

ADDITIONAL TREATMENT NECESSARY

There are many variable conditions in addition to risk and potential complications that may influence the long-term result of BOTOX COSMETIC injections.

 

Even though risks and complications occur infrequently, the risks cited are the ones that are particularly associated with BOTOX COSMETIC 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 warrantee, expressed or implied, on the results that may be obtained. 

 

FINANCIAL RESPONSIBILITIES

The cost of BOTOX COSMETIC 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 COSMETIC material itself.  Should you require a touch-up, an additional fee will be charged.  It is unlikely that BOTOX COSMETIC injections to treat cosmetic problems would be covered by your health insurance.  Additional costs off medical treatment would be your responsibility should complications develop from BOTOX COSMETIC injections.

 

TOUCH UP POLICY

Should the patient not attain the maximal effect, please call the office within two weeks from your last BOTOX COSMETIC injection.  You MUST be seen by your physician within that period.  At the discretion of your physician, a touch-up will be scheduled, at no additional cost.

 

DISCLAIMER

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.

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