PURPOSE AND BACKGROUND:
This document is to make you aware of the nature of this procedure, its limitations and its risks, so that you can decide whether or not to go forward with the procedure.
Bellafill® is a sterile gel composed of microscopic beads of Polymethylmethacrylate (PMMA) in a carrier of cow collagen, with dilute lidocaine (numbing), which is FDA approved for long lasting (years) filling to improve the appearance of the smile lines and facial acne scars. This product has been used successfully, worldwide, for enhancing facial appearances for over a decade. Dr. Zimmerman has injected this material successfully since 2006. It is supplied in 0.8-milliliter syringes. You can use multiple syringes per visit.
Alternatives to the use of this “PERMANENT” filler includes the use of Hyaluronic gel fillers which correct deformities for less than a year; longer lasting but temporary Radiesse ® filler; tissue activators; facial implants and/or cosmetic surgery. Bellafill® should be part of an ongoing rejuvenation program including injections of Botulinum toxin for the control of dynamic wrinkles and chemical peels, LASER and Light treatments. They work best together.
A “Test Spot” (small amount of cow collagen carrier gel) is injected under the skin of your non-dominant arm, at no charge, to verify you are not allergic to the cow collagen carrier material. If it turns red, elevates, enlarges in diameter and itches within a week of placement, please inform the office and text us a picture of come in for examination. If you choose not to confirm allergic status prior to facial injections, we will ask you to sign a waiver releasing Dr. Zimmerman/Dr. Lee and Aesthetic Revolution Las Vegas of any liability for allergy.
The treatment site(s) are washed with an antiseptic solution.
Topical or injectable anesthesia (lidocaine with/without epinephrine) may be used.
Topical cooling may be used before or after the injections.
Bellafill® is injected via a small needle or cannula, into facial tissue to re-volumize deflated areas or scars. This is done conservatively to prevent over-inflation of this “permanent” filler.
The number and sites of injections depends on the location, depth of deformity and injection technique used to build up a three-dimensional scaffolding in your tissue.
Following injection, the treatment site may be massaged to blend with the surrounding tissues and help diffuse swelling. Lumps or bumps under the skin may be felt for weeks, but should eventually go away with gentle massage. Swelling is expected. Treat it intermittently with applications of a cool gel pack or crushed ice in a Zip Lock bag.
After the first treatment establishes a foundation, additional filler(s) can be injected and other treatments done, to improve and sustain the desired results and as you age.
Please initial your understanding next to each statement:
A very thin needle or cannula is used for injections. After your treatment session, you may notice swelling, redness, slight bruising, itching and tenderness at the injection sites. This is normal and mostly subsides within a few days. Some tenderness or swelling may last for several weeks. Please call the office if you have any concerns.
Patients taking Aspirin containing products, Advil® and similar medications, garlic, gingko, ginger, fish oils, Vitamin E and other substances that reduce blood clotting are more likely to have bruising, bleeding and swelling.
Any injection carries the risk of infection. Unusual redness, pain, or swelling within several weeks of injection should be reported to the office for evaluation and possible treatment with antibiotics or anti-inflammatory medications. Rarely, superficial sloughing of tissue could occur. This could leave a scar.
Blindness secondary to unintentional injection of filler into an artery, which is part of the eye circulation, has been reported. It is rare, but a known risk.
Some temporary lumpiness may be felt (even if not visible) after an injection or as the carrier material is absorbed by the body
These products should not be used by people who have experienced hypersensitive allergic reactions to them previously (we see about 1 allergic skin test every 2 years) or who know they are allergic to cow collagen injections. It can not be injected into areas that have active inflammation or infections (e.g.: active acne, cysts, rashes and hives)
Immediately before and after treatment, you should minimize exposure of the treated areas to excessive sun, UV lamp exposure, and extreme cold weather to decrease risk of creating a biofilm infection.
While the effects of Bellafill® last years, your face will continue to age and lose volume over time, so additional procedures will be required to maintain your rejuvenation and enhancement.
Some patients may unpredictably form collections of hard tissue around an implant (called granulomas) that may need to be injected with steroids etc or removed with surgery.
Most patients are pleased with the results of their filler. However, like any cosmetic procedure, there is no guarantee that you will be completely satisfied or that you will not require additional treatments to achieve the results you seek.
Bellafill® has been shown to be safe and effective for re-volumizing deflated tissue and acne scars. It generally maintains cosmetic correction longer than other fillers and is less invasive than surgery. It can be combined with other cosmetic treatments.
Please ask any questions you may have before signing the consent part of this document.
Please initial your understanding by each line:
The nature and purpose of this procedure, risks, benefits and alternative methods of treating the volume loss on my face have been explained to my satisfaction.
I understand and consent to the use of topical and/or injectable anesthetic to decrease discomfort from the injections.
Digital pictures will be obtained for my file to help evaluate the efficacy and duration of effect of this filler. These pictures remain confidential. They may be used for education and/or advertising purposes, only with my consent. (In which case, they will be cropped to protect my identity.)
No guarantees have been made to me by anyone as to the results that may be obtained from this procedure.
I have read this informed consent on the improvement of volume loss with Bellafill®. I have had my questions answered and understand the contents in full. I have had time to evaluate and consider my options and feel I am sufficiently advised to consent to this procedure.
I hereby give my consent to the administration of anesthesia and the injection of fillers by Dr. Zimmerman/Dr. Lee and his designates.
This consent shall remain in effect for the duration of treatment(s).