BOTOX® INFORMED CONSENT

Botox is a Botulinum Toxins Type A, a protein produced by the bacteria Clostridium Botulinum. Small doses will weaken the muscle where they are injected. These can be used to smooth wrinkles caused by muscle activity and can be used in the face to diminish the appearance of aging. They will not stop the process of aging. They may be used alone or in combinations with other surgical and non-surgical treatments. They can also be used in some instances to reduce the incidence of migraine headaches. These effects are temporary and typically last about three months. Repeated treatments would be required for continued effects.

The details of the procedure have been explained to me in terms I understand including but not limited to:

• Injection Type: The specific material used will be determined in consultation with my provider.

• Pain: There may be mild pain during the injections, but small needles are used. Some sensitive areas can be treated with topical numbing cream or nerve blocks prior to injection.

• Activity: I will avoid exercise or strenuous activity for the first 24 hours after the injection to reduce the risk of bruising.

• Alternative Option for This Treatment: If used for wrinkle correction, is to have surgical skin tightening procedures, fillers, fat transfers, or skin resurfacing procedures such as laser or dermabrasion.

Referral(s) can be made.

Delay in onset of the effect may take up to seven to ten days. Until that time I may not see any change in my muscle activity.

I understand and accept the most likely risks and complications include but are not limited to:

• Temporary effects include swelling, redness, visible needle marks, acne-like skin eruptions, bruising and pain at the injection site are usually mild. These usually resolve within 48 hours.

• Asymmetry, or differences in shape, between my sides of the face can occur after injection. This might require additional injection.

• Paralysis of nearby muscles can result in drooping of the eyelid, impaired speech or swallowing. This is rare and will completely go away on its own, but may take three to four months.

• Damage to deeper structures such as nerves, blood vessels, and the eye can occur as a result of the injection. These may cause temporary or permanent injury or disability.

• Other muscle effects. There might be paralysis of the muscles of breathing or other life threatening effects. This has not occurred when these medicines are administered as recommended.

• Disappointment with results is possible after Botox. The results may be more or less than was expected. Sometimes additional treatments are needed to see the optimal results, or to conclude that I am not a good candidate for these treatments.

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). 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. 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.

Injection of this material into the muscles causes those specific muscles to halt their function (be paralyzed), thereby improving the appearance of the wrinkles. This paralysis is temporary, and reinjection is necessary within three to ten months. 

Options for alternative treatment include doing nothing, injection of either collagen or fat, or the surgical excision of the muscles.

Complications are rare but may include paralysis of a nearby muscle resulting in its temporary loss of function (e.g., a drooping eyelid). The effects of the BOTOX may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those symptoms include swallowing and breathing difficulties that can be life-threatening. There has not been a confirmed serious case of toxin spread when BOTOX has been used at the recommended dose for the approved indications.

CONSENT

• I understand that Consent - Provider will inject BOTOX or DYSPORT into the muscles around facial wrinkles to paralyze these muscles temporarily.

• I understand the goal is to decrease the wrinkles in that area. I understand that complications are rare but may include paralysis of other nearby muscles, headaches, local numbness, swelling, rash and bruising.

• I understand there is no guarantee of results of any treatment.

• I understand the FDA has approved BOTOX for other problems concerning the eye and face, and for limited cosmetic use.

• I understand that there has not been FDA approval for other cosmetic areas.

  It is important that you read the above information carefully and have all of your questions answered before signing this consent.

I have read the foregoing consent and hereby confirm that I have 1) had each item explained to me, 2) was given an opportunity to ask questions, and 3) had all of my questions answered. 

I hereby authorize Consent - Provider to perform the procedure of Botox injections.