Q: What is the Bellafill?
A: Bellafill is the long lasting solution for wrinkle correction. Bellafill consists of a combination of microsphere enhanced collagen and lidocaine for comfort.
Q: How does the Bellafill work?
A: The collagen gel acts as a carrier for the microspheres in Bellafill. Gradually, your body absorbs the collagen while the microspheres remain to provide a long lasting support structure below the wrinkle to sustain wrinkle correction.
Q: Is Bellafill safe?
A: Yes. Bellafill has proven to be a safe and effective dermal filler for the correction of wrinkles and was approved by the U.S. FDA in October 2006. In clinical testing, Bellafill was as safe as the control temporary filler.
Since the launch of Bellafill in 2007, thousands of patients have been safely treated with Bellafill and there have been no product recalls and no reported medical device events.
Q: How does Bellafill differ from temporary fillers?
A: Temporary dermal fillers are made of different kinds of natural or synthetic materials that are completely absorbed by the body over time and as a result, wrinkle correction usually lasts for only 3-9 months.
The microsphere enhanced collagen in Bellafill remains intact at the treatment site and provides structural support to keep your wrinkle from returning.
Q: Can anyone have Bellafill treatments?
A: No. Some people are not good candidates for Bellafill.
The Bellafill is contraindicated in those who:
- have a positive reaction to the Bellafill skin test
- have a history of severe allergies and hypersensitivity (anaphylaxis)
- are allergic to the anesthetic (lidocaine) in Bellafill
- have a history of allergies to any collagen products
- are prone to thick scarring (hypertrophic) formation and/or excessive scarring (keloid)
- are undergoing or planning to undergo desensitization injections to meat products
Q: Are there any other treatment concerns with the Bellafill?
A: Yes. If you have any skin outbreaks (e.g. cysts, pimples, rashes, hives, infection) near the injection site, you should postpone treatment until they clear. If you are taking aspirin (NSAIDs) or anti-inflammatory drugs or have any medical condition that affects your blood, you may experience increased bruising or bleeding at the injection sites.
In addition, you should inform us if:
- you have had any treatments for smile lines in the last 6 months
- you are receiving UV light therapy
- you are currently on immunosuppressive therapy (medication commonly prescribed for those who have undergone an organ transplant, or are suffering
- from rheumatoid arthritis, psoriasis, inflammatory bowel disease, or cancer)
Q: Are there any further precautions with the Bellafill?
A: Yes, you should know that Bellafill contains microspheres that help provide the support for wrinkle correction- the microspheres can only be surgically removed. The safety of Bellafill in pregnant or breastfeeding women, and individuals under 18, has not been established. As with any injectable filler, there is always a risk of infection.
Q: Are there any possible side effects with the Bellafill?
A: As with any injectable wrinkle filler, you can expect mild swelling and reddening at the treatment site. These side effects are usually gone within 24 hours. Occasionally, there is mild bruising that typically disappears in three to seven days. Less common side effects include rash and itching more than 48 hours after treatment, persistent swelling or redness, and increased sensitivity at some or all injection sites. Two other rare potential side effects of all dermal fillers may be lumps and granulomas, both of which can be treated by your physician.
Q: When will I see results with the Bellafill and how long will the results last?
A: You will see results immediately. In the U.S. clinical study, full wrinkle correction was maintained for up to one year.
Q: Is one treatment enough to get the look I want?
A: Most people get the results they want with one or two treatments, depending on the depth of their wrinkles and folds. When you have your follow-up appointment in four to six weeks, you can decide if you would like to further enhance your results.
Q: How will my face feel following treatment?
A: With proper placement, Bellafill may not be felt after treatment. You will see the results immediately and be able to return to your normal daily activities.
Q: How will I look as my skin ages after treatment with the Bellafill?
A: Studies have shown that patients injected with microsphere-enhanced collagen, still reflect a natural appearance in both their overall facial appearance as well as in the area treated 5 years from their initial treatment. These patients were surveyed and had a 90% satisfaction rating related to their wrinkle correction and experience with Bellafill.
Q: Why is a skin test required before treatment with the Bellafill?
A: The skin test is a safety precaution to ensure that you are not allergic to the collagen or anesthetic in Bellafill.
Q: What process did the Bellafill go through before it was FDA approved?
A: Several clinical studies were conducted in the United States to demonstrate the safety and effectiveness of the microsphere dermal filler technology. The data from our clinical trials were subject to a full and open review in a public hearing by an FDA review panel. Bellafill was approved by the FDA in October 2006.
Q: What is the long term safety of microsphere-enhanced collagen treatments?
A: A follow-up study of patients from the controlled clinical study were followed over a 5-year period after treatment. Independent expert observers rated photographs of patient wrinkles at five years compared to before treatment and six months after treatment. The physician investigators of this follow-up study concluded that the treatment safely maintains significant correction of smile lines for at least five (5) years post-treatment.
Q: Are there any current studies being conducted on the Bellafill?
A: Yes. A post-approval marketing study was initiated in October 2007 to evaluate the long term safety of Bellafill. The study will follow 1,000 patients treated with Bellafill for a period of five years.
Q: How many patients have been treated with the product?
A: To date, thousands of patients in the U.S. have been treated successfully with Bellafill.
Q: I have heard some patients develop persistent lumps in their skin after treatment with the Bellafill, is this true?
A: Persistent lumps are a rare potential side effect of all dermal fillers, including Bellafill, and can be treated effectively.
Q: If I have had a negative collagen skin test previously, do I need to have another skin test with the Bellafill?
A: Yes, an Bellafill skin test is required prior to treatment to make sure that you are not allergic to the collagen in Bellafill.
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