DERMAPEN 4 - 10 - Warnings and Considerations; 10.1-10.3 - Contraindications, Side-Effects, and Complications

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10 - WARNINGS & CONSIDERATIONS
10.1 - Possible Contraindications
Patients experiencing any of the following active conditions should not proceed with a
Dermapen 4™ clinical treatment without doctors’ consent:
• Papulopustular rosacea
• Acne vulgaris stage III-IV
• Herpes simplex
• Warts
• Scleroderma
• Bacterial/fungal infections
• Open lesions
• Solar keratosis
• Skin cancer
• Haemophilia
Topical Local Anaesthetic (TLA) should not be applied on patients experiencing any of
the following active conditions, practices or medications. Treatment however may proceed
without TLA application. In our experience most
Dermapen 4™ treatments are conducted
without TLA.
• Pregnancy
• Breastfeeding
• Hepatic disease
• Pseudo cholinesterase defi ciency
• P-aminobenzoic acid (PABA) allergies
• Sulphonamide allergies
• Congenial or idiopathic methaemoglobinaemia
• Arrhythmia medications
10.2 - Possible Side-E ects of Microneedling
• Allergic reaction on patients who su er from cutaneous allergy to metallic products.
• Bacterial infection if the skin is not adequately disinfected before, during and after each
treatment.
• Post-infl ammatory hyperpigmentation in high-risk patients who have been over-treated
while using the Dermapen 4™ on the skin.
• Irregular fi brous tissue deposits in high-risk patients who have not undertaken appropriate
treatment measures.
10.3 - Possible Complications
Possible complications arising from the use of the Dermapen 4™ include:
• Cutaneous eruptions
• Infl ammation, erythema
• Itching and burning sensations
• Cold sore eruption (herpes simplex)