Consent for Dermal Filler (Juvederm, Restylane, Radiesse) Injection
Indications – Dermal filler injections are given to correct facial wrinkles and/or for lip augmentation. Juvederm, Restylane (Perlane) and Radiesse have been approved by the FDA (Food and Drug Administration) for correction of facial wrinkles. I understand that the safety and effectiveness of treating facial areas other than the nasolabial folds has not been studied; however, dermal fillers have been used to enhance the appearance of lips and other areas in over 60 other countries. This “off-label” aspect of the treatment has been explained to me.
Alternatives – There are alternatives to dermal filler injections, including no treatment, collagen for lip or other facial soft tissue augmentation, and cosmetics, Botox / Dysport, laser skin resurfacing, chemical peels, or plastic surgery for wrinkle reduction.
Results – I understand that the actual degree of improvement cannot be predicted or guaranteed. Furthermore, I understand that the effect will gradually wear off and additional treatments may be necessary to maintain the desired effect.
Side effects and complications include but are not limited to:
• Potential allergic reaction. As with any product, allergies can develop during or after injection.
• Injection site reactions: a lumpy or “thick” feeling at or just under the skin, bruising, redness, itching, pain, tenderness, or slight swelling.
• Injections into the lip area could trigger a recurrence of facial cold sores (Herpes simplex infections for patients with a history of prior cold sores.
• Ulcerations secondary to arterial occlusion, and resulting scarring
Precautions and contraindications:
• Dermal fillers are not recommended for patients with severe allergies, previous history of dermal filler allergy, or a history of anaphylaxis.
• The risk of bruising or bleeding may be increased by medications with anticoagulant effects, such as aspirin and non-steroidal anti-inflammatory drugs (e.g., Ibuprofen, Aleve, Motrin, Celebrex), high doses of Vitamin E, and certain herbs (Ginkgo Biloba, St. John’s Wart).
• The safety of dermal fillers in pregnant or breast-feeding women has not been established, and is therefore not recommended for these women.
I understand the need for local anesthesia to reduce the discomfort of the procedure and consent to the topical application of anesthetic gel and/or injections for a nerve block or local infiltrative anesthesia. I understand the above, and have had the risks, benefits, and alternatives explained to me, and have had the opportunity to ask questions. No guarantees about results have been made. To the best of my knowledge, I am not pregnant, and I am not breastfeeding. I give my informed consent for Juvederm, Restylane (Perlane), or Radiesse injections today as well as future treatments as needed.
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