INFORMED CONSENT - UniSkin
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INFORMED CONSENT

TREATMENT SPECIFIC INFORMATION

Have you had any dermal filler or botulinum toxin treatments? – No

Have you a history of severe allergy/anaphlyaxis to botulinum toxin type A or its excipients? – No
Do you suffer from myaesthenia gravis or Eaton Lambert syndrome? – No

Page 4

Date: 08/29/2018

Patient’s Signature: Clinician’s Signature:
Date: 08/29/2018

Botulinum Toxin Type A: Treatment Plan & Consent

UniSkin Aesthetics

Leaflet Botulinum Toxin Information Sheet, Version 1 was discussed and given to you which included the following
information:

Risks & Side Effects
Common Risks – 1 in 100 to 1 in 10
• Redness
• Swelling
• Bruising
• Allergic reaction
• Headache
• Pain
• Eyelid droop
• Eyebrow droop
• Muscle weakness
• Unsatisfactory results

Uncommon Risks – 1 in 1,000 to 1 in 100
• Infection
• Antibody formation
• Nausea
• Numbness
• Eye pain
• Skin tightness /dry skin
• Dry mouth
• Dizziness
• Asthenia (weakness of the muscle)
• Anxiety
• Paraesthesia (pins and needles)
• Blepharitis (inflamed eyelids)
• Flu like symptoms/fever
• Photosensitivity reactions
• Blurred/double vision
• Heaviness in eyelids
• Dry/watery eyes
• Nerve pain
• Muscle twitching

Rare Risks – 1 in 10,000 to 1 in 1,000
• Rash/hives
• Itching
• Serious allergic reaction (anaphylaxis)
• Hair loss
• Spread of product in the neck area affecting nearby muscles; difficulty in swallowing, pneumonia
• Decreased hearing
• Arrhythmias, MI
• Seizure

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Date: 08/29/2018

Patient’s Signature: Clinician’s Signature:
Date: 08/29/2018

Botulinum Toxin Type A: Treatment Plan & Consent

UniSkin Aesthetics

AREA SPECIFIC RELATED RISKS
Botox Around The Mouth
• Reduced ability to smoke, drink through a straw or whistle (peri-oral lines)
• Reduced smiling (gummy smile)
• Asymmetry (DAO, peri-oral, gummy smile)

Botox In The Armpit
• Non axillary sweating, hot flushes
• Myalgia and joint pain (Less Common)

Botox In Masseter
• Muscle ache
• Reduced ability to chew
• Speech disturbance

Benefits
• Improvement/reduction/eradication of facial lines (static lines require repeated treatments)
• Reduced ability to contract muscle leading to the skin remaining relaxed
• Prevention of developing or making existing wrinkles worse.
• Potential reduction in headaches
• Potential smooth/shiny skin
• Brow lift
• Reduced gummy smile
• Reduction in down turn of the mouth
• Tighter jaw line
• Reduction in platysmal bands showing
• Reduced sweating
• Reduced dimpling of chin
• Slimming of masseter muscle

Alternatives
Facial Lines
• No treatment
• Dermal filler
• PRP
• Dermabrasion
• Obagi/retinols
• Sculptra
• Medical needling
• Mesotherapy
• Surgery

Hyperhidrosis
• Antiperspirants

Page 6

Date: 08/29/2018

Patient’s Signature: Clinician’s Signature:
Date: 08/29/2018

Botulinum Toxin Type A: Treatment Plan & Consent

UniSkin Aesthetics

• Aluminium chloride hexahydrate
• Surgery

INFORMED CONSENT

I confirm that I have been informed that:

Botulinum toxin is indicated for the temporary improvement in the appearance of moderate to severe vertical lines
between the eyebrows seen at frown (glabella lines) and for the improvement of lines around the eyes (crow’s feet) in
adults <65years old, when the severity of these lines has an important psychological impact for the patient. Any use of
botulinum toxin outside of this product license is off label use and I have discussed the implications of this with my
clinician.

Like all medicines botulinum toxin can have side effects, although not everybody gets them. Approximately 1 out of 4
patients may experience side effects following a botulinum toxin injection. These adverse reactions may be related to
treatment, injection technique or both. Treatment with Botulinum Toxin is temporary, lasting approximately 3 – 6 months
but will vary depending on the condition of the skin, area treated, amount of product injected, injection technique and
lifestyle factors such as sun exposure and smoking. I also understand that to maintain the effects, further treatment is
required.

Adverse reactions possibly related to the spread of toxin distant from the site of administration have been reported very
rarely with botulinum toxin (e.g. muscle weakness, difficulty to swallow or pneumonia due to unwanted food or liquid in
airways). Injection of botulinum toxin is not recommended in patients with a history of dysphagia (difficulty to swallow)
and impaired swallowing.

In general, adverse reactions occur within the first few days following injection and are temporary. Most adverse events
reported were of mild to moderate severity. Diffusion of botulinum toxin into nearby muscles is possible when high doses
are injected, particularly in the neck area.

The chance of having a side effect is described by the following categories:

Common – More than 1 our of 100 persons and less than 1 out of 10 persons
Uncommon – More than 1 out of 1,000 persons and less than 1 out of 100 persons
Rare – More than 1 out of 10,000 persons and less than 1 out of 1,000 persons

Allergic reactions, difficulties to swallow, speak or breathe, have been reported rarely when botulinum toxin type A has
been used for other uses. Visit your Clinician immediately if such signs develop after botulinum toxin treatment. If any of
the side effects gets serious, or if you notice any side effects not listed, please tell your Clinician.

Too frequent or excessive dosing of botulinum toxin may increase the risk of antibodies in the blood which may lead to
failure of treatment with botulinum toxin when used for this and other conditions.

I confirm that my clinician, has:

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Date: 08/29/2018

Patient’s Signature: Clinician’s Signature:
Date: 08/29/2018

Botulinum Toxin Type A: Treatment Plan & Consent

UniSkin Aesthetics

– Discussed the risks, benefits and alternatives to this treatment
– Given me the opportunity to ask all remaining questions I have about the treatment
– Given me time to consider the treatment
– Received an accurate medical history and that I have not withheld any information
– Discussed and issued me with specific aftercare pertaining to this treatment.

I therefore consent to receiving the described treatment by my clinician.

AFTERCARE

1. Do not massage the treated area at all. If the area is washed, pat dry very gently with a soft towel. Do not rub the
treated area for 48 hours.

2. Do not bend excessively or lie down for at least 4 hours.

3. Do exercise the treated muscles by tensing them and relaxing them for the first hour after treatment.

4. Botulinum Toxin takes from 2 to 14 days to become effective. This is dependent on the strength of the muscles
injected and the individual response.

5. If the degree of muscle relaxation is not as you would wish, please contact your clinician.

 

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