RADIESSE® Treatment Informed Consent
RADIESSE dermal filler is a resorbable implant product approved by 1he United States Food and Drug Administration for the correction or moderate to severe facial wrinkles and folds, such as nasolabial folds.
Risks and complications that may be associated with RADIESSE dermal filler and the implant procedure include, but are not limited to:
I. Facial Bruising, Redness, Swelling, Itching and Pain: I understand that there is a risk of bruising, redness, swelling, i1ching and pain associated with the procedure. These symptoms are usually mild and last less than a week but can last longer. Patients who are using medications that can prolong bleeding, such as aspirin, warfarin, ur certain vitamins and supplements, may experience increased bruising or bleeding at the injection site.
2. Nodules, and palpable material: I understand that there is a risk that small lumps may form under my skin due to the RADIESSE filler material collecting in one area. I also understand that I may be able to feel the RADIESSE filler material in the area where the material has been injected. Any foreign material injected into the body may create the possibility of swelling or other local reactions to a filler material.
3. Migration: I understand that the RADIESSE dermal filler, as with any filler material, may move from the place where it was injected.
4. Infection: As with all transcutaneous procedures, I understand that injection of any filler material carries the risk of infection.
5. Allergic Reactions: I understand that RADlESSE dermal filler should not be used in patients with severe allergies, a his1ory of anaphylaxis, or history or presence of multiple severe allergies or hypersensitivity to any of the ingredients in RADIESSE filler.
6. Keloids/Scarring: I understand that the safety of RADIESSE dermal filler in patients with known susceptibility to keloid formation or hypertrophic scarring has not been studied.
7. Accidental Injection into a Blood Vessel: I understand that RADIESSE dermal filler can be accidentally injected into a blood vessel, which may block the blood vessel and cause local tissue damage, or potentially even a heart attack or stroke.
8. Radio-opacity: I understand that RADIESSE dermal filler is radio-opaque and is visible on CT Scans and may be visible in x-rays.
9. Duration of Effect: I understand that the outcome of treatment with RADIESSE dermal filler will vary among patients. In some instances, additional treatments may be necessary to achieve the desired outcome.
No studies or interactions of RADIESSE dermal filler with drugs or other substances or implants have been conducted.
The above list is not meant to be inclusive of all possible risks associated with RADIESSE dermal filler or dermal fillers in general, as there are both known and unknown side effects and complications associated with any medication or dermal filler injection procedure. I understand that medical attention may be required to resolve complications associated with my injection.
I understand that I should minimize exposure of the treated area to the sun or heat for approximately 24 hours after treatment or un1il any initial swelling or redness goes away.
The safety of RADIESSE dermal filler for use during pregnancy or in breastfeeding women has not been established.