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BREAKING NEWS
Source: Thailand Medical News  Oct 25, 2019
Latest Aesthetics Trend In Asia: BellaFill, The Only US FDA Permanent Filler
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Latest Aesthetics Trend In Asia: BellaFill, The Only US FDA Permanent Filler
Source: Thailand Medical News  Oct 25, 2019
BellaFill is  the only US FDA-approved dermal filler for permanent implantation into the skin for the correction of nasolabial folds, or smile lines. It can be used in both women and men. Bellafill is a non-resorbable dermal filler, unlike many other dermal fillers that are absorbed and require reinjection. BellaFill is also approved for the correction of moderate to severe facial acne scars on the cheeks in patients over the age of 21 years. Its currently one of the most sought after Aesthetic procedure in Asia and Globally.


 
The FDA announced several months ago that BellaFill is now approved for treating acne scars, which are moderate-to-severe, particularly on the face. This is indeed great news for the more than 320 million individuals globally who suffer from acne scars.
 
Dermatologists are especially hopeful because BellaFill can help people who haven’t responded to topical medications such as Retin-A which only improve the appearance of superficial acne scars, and which can take months to show results.
 
And, it turns out that BellaFill is also an excellent alternative for people who don’t want to undergo chemical peels, which can be irritating to the skin and generally require a series of four or more treatments.
 
In comparison, dermatologists have learned that the BellaFill therapy generally requires only one or two treatments. Best of all, unlike Retin-A and some other treatments, the dermal filler treatment offers hope for permanent results.
 
BellaFill is a combination of microsphere enhanced bovine collagen with the local anesthetic lidocaine. The microspheres are produced from a synthetic implant material called polymethylmethacrylate (PMMA) in accordance with FDA and USDA guidelines and are roughly 30 to 50 microns in size, barely visible to the naked eye. An allergy skin test is required prior to first use.
 
BellaFill should only be administered under the supervision of a licensed practitioner or dermatologists.
 
How does it work?
BellaFill  combines collagen together with polymethylmethacrylate (PMMA) contained in microspheres. Whether it’s used to treat wrinkling, volume or scarring, the collagen provides immediate replacement filler for volume loss, so the surface of the skin becomes smooth again.
 
While adding immediate volume to fill and smooth facial wrinkles and acne scars, the treatment provides a firmer structure upon which the body can create its own new collagen, which builds beautiful, more-youthful skin. Over time, the collagen in the mixture is absorbed by the body, leaving the tiny microspheres behind as permanent filler.
 
Bellafill Clinical Trials
A 12-month U.S. clinical trial in over 250 patients was completed in support of the approved uses for BellaFill. These trials evaluated the safety and effectiveness of BellaFill compared to another collagen control (Zyplast) for nasolabial folds. At the 6-month evaluation period, wrinkle correction with BellaFill persisted while patients treated with the collagen control returned to their pretreatment status. Wrinkle control effectiveness at one year was similar to 6 months. Safety was comparable among products.
 
In clinical trials for acne scars, the primary effectiveness endpoint was proven superior for subjects treated with BellaFill compared to a control at 6 months. A responder was defined as a subject who had 50% or more of treated acne scars improve by two or more points on a validated 4-point Acne Scar Rating Scale (ASRS). At 6 months, the response rate for BellaFill was 64% vs. 33% for control (p=.0005). BellaFill continued to show effectiveness by an unblinded assessment at 12 months (71%).

Do not use BellaFill in patients with:
-a positive reaction to the BellaFill allergy skin test
-a history of severe allergies, hypersensitivity, or anaphylaxis
-an allergy to the anesthetic (lidocaine) in BellaFill
-a history of allergies to any bovine collagen product
-a tendency for thick scar formation (hypertrophic scars) and/or excessive scar formations (keloid scars)
-current or planned desensitization injections to meat products
-BellaFill is contraindicated for use in lip augmentation and injection into the vermilion or wet mucosa of the lip.

BellaFill Side Effects
As with any injectable filler, temporary (< 24 hours) mild swelling and redness may occur at the treatment site. Bruising is usually mild and usually lasts 3 to 7 days.
 
-Bruising
-Redness
-Swelling
-Pain/Soreness
-Tenderness
-Itching
 
Less common side effects:
 
-Rash and itching after 48 hours
-Persistent swelling or redness
-Injection site sensitivity
-Lumps and/or granulomas

What is BellaFill used for?
BellaFill is used to smooth moderate to severe facial folds and wrinkles from the nose to the corners of the mouth (nasolabial folds). BellaFill is meant to be a permanent wrinkle solution. It has been found to be a safe dermal filler that restores volume and fullness to the skin. It is also used to correct acne scars on the cheeks in those over 21 years of age.
 
BellaFill is injected into the skin with an ultrafine needle. BellaFill plumps the skin to smooth away wrinkles and folds. BellaFill is composed of nonabsorbable microsphere collagen which acts to provide support for a longer-lasting wrinkle correction. Most patients see results within one or two treatments. Allergy pre-testing is required.

How long does Bellafill last?
Bellafill is a non-resorbable dermal filler, unlike many other dermal fillers that are absorbed and require reinjection. Results are permanent and surgical removal of the collagen is required for reversal of effects.

What are the warnings or side effects to consider?
The use of BellaFill at sites with skin sores, pimples, rashes, hives, cysts, or infections should be postponed until healing is complete. Use of BellaFill in these instances could delay healing or make your skin problems worse.
 
BellaFill must not be implanted into blood vessels. Implantation of BellaFill into dermal vessels may cause vascular occlusion, infarction or emboli.
 
If you are taking aspirin or anti-inflammatory drugs (NSAIDs) 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 your doctor if you:
 
-have had any dermal filler treatments in the last 6 months
-are receiving UV light therapy
-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, cancer, or other conditions.)
 
What are some risks or side effects that may be experienced?
 
As with any injectable dermal filler, you can expect mild swelling and redness at the treatment site. These side effects are usually temporary.
 
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 are lumps and granulomas, both of which can be treated by your physician. Be sure to call your doctor immediately if you notice any unusual skin reactions around the treatment area.
 
What should patients do prior to treatment?
An allergy skin test is required 4 weeks prior to first use. The skin test is a safety precaution to ensure that you are not allergic to the collagen in BellaFill. Talk to your doctor about other treatment options, if needed.
 
Do the injections hurt?
BellaFill is formulated with an anesthetic (lidocaine) for patient comfort. For additional comfort, the doctor may numb the treatment area with additional topical or local anesthetic agent.
 
What should I call my doctor about after the treatment?
 
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 3 to 7 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.

Be sure to call your doctor immediately if you notice any unusual skin reactions around the treatment area.

What is the dose of BellaFill?
The amount used depends on your face and what you would like to have treated. The safety of injecting greater amounts than 3.5 cc per treatment site or 8.9 cc overall has not been established for wrinkles. Doses may be different for acne scars. Your healthcare provider will determine the appropriate amount to be injected. Larger amounts are injected based on the level of wrinkle being corrected. Most people require more than one treatment to reach the level of correction that they want.
 
BellaFill Study
 
A study of the injectable dermal filler BellaFill showed that more than 80 percent of patients were satisfied with the results five years after finishing treatment, maker Suneva Medical said.
 
The dermal filler, made primarily of bovine collagen, has been approved by the U.S. Food and Drug Administration for smoothening “laugh lines” since 2006 and for treating acne scarring of the cheek since January this year. The current versions have been further refined and enhanced.
 
The study was the longest and largest post-approval trial of its kind, privately owned Suneva said, noting that such products are typically tracked for only up to a year after treatment.
 
In 2018 alone, there were more than 3.8 million injectable filler procedures in the United States, according to the American Society of Plastic Surgeons, making it the second most popular minimally invasive cosmetic procedure in the country.
 
Dermal fillers, which are also used for lip, cheek and hand augmentation, are injected into the skin to fill in wrinkles.
 
Allergan Inc’s Botox, on the other hand, targets muscles that form wrinkles by relaxing them and typically lasts three to six months.
 
While the duration of a filler’s effect depends on the material used and the area where it is injected, most products are temporary as they are absorbed by the body over time. This tends to frustrate consumers as the cost of repeated treatments add up.
 
Suneva said that in its 1,008-patient study, users experienced a retention rate of 87 percent.
 
Other dermal fillers on the market have been evaluated for much shorter periods, or studies are ongoing.
 
The long-term safety and effectiveness of Restylane Lyft, sold by Galderma, unit of Nestle SA, has not been established beyond one year while Galderma’s Sculptra has not been evaluated beyond 25 months after the last injection.
In a tiny study of Allergan’s Juvederm Ultra, seven of nine patients demonstrated improvement in laugh lines a year after being treated but only for a short while unlike BellaFill.
 
Earlier this year, the U.S. Food and Drug Administration asked manufacturers of dermal fillers to update their labeling to reflect the risk of serious injuries caused by unintentional injection into the blood vessels in the face.
 
In Thailand, BellaFill is only carried by higher-end clinics catering for customers who want something better and willing to pay more as the products itself is more expensive that botox or hyaluronic fillers that do not last more than 2 to 3  months.
 
Thailand Medical News advices that all prospective patients check the clinics that they are planning to check in to  see if the clinic really uses the original branded and FDA cleared imports and not some cheap Chinese or Korean knockoffs and also to check on the credentials of the doctor as some aesthetic clinics are run by ordinary GPs and not really qualified dermatologists and plastic surgeons. For more details, do not hesitate to use the live chats functions of Thailand Medical news provided you provide the real email address and our staff will revert back within 48 hours for any queries.