Consent for Treatment with Sculptra
SculptraAesthetic® is an injectable implant that contains micro particles of L-Poly-Lactic Acid, a biocompatible, biodegradable synthetic polymer from the alpha hydroxy acid family.
- I understand that I should not use this product if I am allergic to subcutaneous, absorbable suture material.
- I understand that the injection procedure reactions are: bruising, hematoma formation, discomfort and erythema.
- I understand that the risks of these injection procedure reactions are greater if I have been drinking any alcohol, taking any aspirin (Advil, Motrin, Ibuprofen, Naproxen, Aleve, etc.), or taking large doses of Gingko Biloba or more than 400 IU of Vitamin E per day.
- I understand that the most common device related adverse effect is the delayed occurrence of subcutaneous papules, which were confined to the injection site and were typically palpable (could be felt), asymptomatic and non-visible.
- I understand that it takes several weeks to see the effects of this treatment, and the appropriate way to do this is to "treat, wait and reassess" in 4-6 weeks.
- I understand that several vials of SculptraAesthetic® may be necessary to achieve the results I desire.
- I understand that SculptraAesthetic® should not be injected while you have an active skin infection or inflammation in the treatment area and should not be injected into the red area of the lip. Use in the skin near the eyes is not recommended.
- I understand the side effects may include injections site discomfort, redness, bruising, bleeding, itching and swelling. Other side effects may include small lumps under the skin that are sometimes noticeable when pressing on the treated area. Larger lumps, some with delayed onset with or without inflammation or skin discoloration. In clinical study the numbers of small and large lumps were low and most resolved without treatment.