Wrinkle Relaxing Treatment Consent Form

    Injection of relaxing muscles cause weakness of targeted muscles, which can last approximately 3-4 months. Small injections relax the treated muscle and can reduce facial wrinkles such as frown lines. The solution is injected with a small needle into the targeted muscle. Effects are typically seen in a few days and can take 1-2 weeks to develop fully.

    It is approved by the Food and Drug Administration for temporarily treating moderate to severe dynamic frown lines in adults aged 18-65 years and is used off-label for all other cosmetic treatment areas.

    The risk, side effects, and complications in treatment with anti-wrinkles injection on facial and neck areas include but are not limited to the following:

    • Localized burning or stinging pain during injection
    • Bruising
    • Redness
    • Tenderness
    • Swelling
    • Infection
    • Numbness or dysesthesia
    • Headache
    • Anxiety
    • Vasovagal episode with loss of consciousness
    • Facial asymmetry, alteration, or poor aesthetic results
    • Inadequate reduction of wrinkles or lack of intended effect
    • Blepharoptosis (droopy eyelid)
    • Eyebrow ptosis (droopy eyebrow)
    • Photophobia (light sensitivity)
    • Impaired eyelid closure and blink reflex
    • Ectropian (lower eyelid exposure)
    • Lagophthalmos (incomplete eyelid closure)
    • Xerophthalmia (dry eye)
    • Epiphora (tearing)
    • Diplopia (double vision) or vision changes
    • Eye trauma
    • Worsening eye bags
    • Lip ptosis with resultant smile asymmetry
    • Oral incompetence with resultant drooling and/or impaired speaking, eating, or drinking
    • Cheek flaccidity
    • Dysarthria (difficulty articulating)
    • Dysphagia (difficulty swallowing), necessitating nasogastric tube placement in severe cases
    • Hoarseness
    • Neck weakness
    • Weakening of muscles adjacent to the intended treatment area
    • Autoantibodies against anti-wrinkles relax injecting solution may be present or develop after treatments rendering treatment ineffective (1-2% of patients treated for cosmetic indications per Allergan)
    • Extremely rare, immediate hypersensitivity reaction with signs of urticaria, edema, and remote possibility of anaphylaxis
    • Case reports of side effects due to distant spread from the injection site have been reported with large doses of anti-wrinkles injecting solution, including generalized muscle weakness, ptosis, dysphagia, dysarthria, urinary incontinence, respiratory difficulties, and death due to respiratory compromise

    Postmarketing safety data suggest that injection effects may, in some cases, be observed beyond the site of local injection.

    The symptoms may include generalized muscle weakness, double vision, blurred vision, eyelid drop, difficulty swallowing, difficulty speaking, urinary incontinence, and breathing difficulties.

    These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life-threatening and there have been reports of death related to the spread of the toxin effect. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patient who have underlying conditions that would predispose them to the symptoms. No definite serious adverse event reports of distant spread of toxin effect associated with dermatologic use of cosmetic botulinum toxin at the labeled dose of 20units (for frown lines) or 100units( for underarm sweating) have been reported.

    My signature below certifies that I have fully read this consent form and understand the information provided to me regarding the proposed procedure. I have been adequately informed about the procedure including the potential benefits, limitations, and alternative treatments, and I have had all questions and concerns answered to my satisfaction.

    I understand that results are not guaranteed and I accept the risk, side effects, and possible complications inherent in undergoing wrinkles relaxing treatments.