Radiesse is a resorbable implant product approved by the United States Food and Drug Administration for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.
Risks and complications that may be associated with Radiesse and the implant procedure include, but are not limited to:
1. Facial Bruising, Redness, Swelling, Itching and Pain: I understand that there is a risk of bruising, redness, swelling, itching 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, or 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 material collecting in one area. I also understand that I may be able to feel the Radiesse 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, 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 Radiesse should not be used in patients with severe allergies, a history of anaphylaxis, or history or presence of multiple severe allergies or hypersensitivity to any of the ingredients in Radiesse.
6. Keloids/Scarring: I understand that the safety of Radiesse 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 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 is radiopaque 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 will vary among patients. In some instances, additional treatments may be necessary to achieve the desired outcome.
No studies of interactions of Radiesse with drugs or other substances or implants have been conducted. This above list is not meant to be inclusive of all possible risks associated with Radiesse 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.
The safety of Radiesse for use during pregnancy or in breastfeeding women has not been established.