Bellafill® is a unique, injectable collagen filler with microspheres, most commonly used for wrinkle treatment, that can instantly smooth facial wrinkles and restore lost volume for beautiful, natural-looking correction that lasts.
In the world of injectables, Bellafill® is distinctive. It has been approved for the correction of nasolabial folds or “smile lines” since 2006. In December 2014, Bellafill® was also approved by the FDA for the correction of certain types of moderate to severe acne scars in patients over 21.
Bellafill® isn’t just an exceptional cosmetic treatment option. It was proven safe through 5 years in the largest and longest prospective dermal filler study ever completed.
Bellafill® is a polymethylmethacrylate (PMMA) collagen filler. The collagen in Bellafill® provides immediate volume and lift, while the PMMA microspheres remain in place and create a matrix that supports collagen production in your skin for lasting improvement. The syringe also contains 0.3% lidocaine to make the injection more comfortable. The bovine collagen used in Bellafill is sourced from a herd in the United States that is controlled, bred, and monitored according to FDA, ISO and USDA guidelines. The collagen is highly purified.
“I usually tell my clients to think of Bellafill® as ‘Part dermal filler, Part implant’. I think that best describes how it is different from the hyaluronic acid dermal fillers. Thinking of each syringe as a ‘building block’ is also a useful analogy. So, each time a syringe is injected, they get a population of PMMA microspheres, the building block so to speak, which will remain for good and stimulate the production of collagen in the region. Over time, the correction lasts longer and longer and clients go longer and longer in between dermal filler appointments. It is important to understand though that Bellafill® is not the ideal filler for all regions. I do not believe in placing this dermal filler in areas such as the lips or the tear troughs, for example, as these are delicate regions that are better suited to the more traditional dermal fillers. It is also important to know when to ‘stop’ when it comes to volume. I see many over plumped faces and it is just not my idea of a great aesthetic goal. At Renew MediSpa we use volume to the point of correcting the volume that was lost. After that, if more lift is desired it is important to stop plumping and start exploring other treatment options such as collagen induction procedures or thread lifting so that you can achieve the lift without distorting the anatomy into something that looks unnatural. ” – Dr. Lisa Vuich
Safety and Patient Satisfaction
PMMA is a synthetic material which has been used in the operating room since 1949. Bellafill® is composed of millions of symmetric, identical microscopic spheres of PMMA. The microspheres are suspending in bovine collagen which is absorbed by the body over the course of several months.
Bovine collagen has been and FDA approved dermal filler since 1981. For more than two decades, collagen fillers were the most popular injectable implants in the United States until hyaluronic acid products (ex: Juvéderm®, Restylane® and many others) entered the market at the beginning of the 21st century.
A skin test is available to check for the possibility of allergic reaction to the bovine collagen component. This skin test is available at Renew MediSpa at no cost to the client. Bovine collagen allergy is rare, and its presence is not 100% ruled out by a negative skin test. Allergic reactions if they occur tend to consist of redness, itchiness, and swelling which generally resolves spontaneously but can also be treated with medication.
The correction obtained by the Bellafill® is long lasting because the body can’t break down the PMMA. As the body digests the bovine collagen, it is creating its own collagen in response to the PMMA spheres.
Bellafill® was previously known as ArteFill®. ArteFill® was approved by the FDA in October 2006 specifically for the correction of nasolabial folds. Over the development period of 20 years most of its side effects have been eliminated to achieve the same safety standard as today’s hyaluronic acid products.
Bellafill® has five-year safety and efficacy data from the largest and longest prospective dermal filler study ever conducted through the FDA. There has been extensive clinical testing and 5 and 10 year post market surveillance. When taking a closer look at the 10 years post market surveillance, from 2007 to December 2016, approximately 600,000 syringes were sold in that time frame, with a remarkable 0.11% of total adverse events reported.
Who is a candidate for Bellafill® Wrinkle Treatment?
“Bellafill® is a great option for those who have past experience with dermal fillers and are looking for a longer lasting alternative. Clients who love the look of “full correction” achieved with their dermal fillers can sometimes be disappointed when even 30 or 50% of the correction is gone in 6 months. This can happen with the more traditional dermal fillers which are hyaluronic acid based. The rate of loss of the correction depends on the amount of product placed but also on things we cannot really control- like your rate of metabolism, the level of hyaluronidase in your body (genetics), and the amount of muscle movement that occurs in the area where the filler is placed- so called “mechanical wear and tear”. If a client feels the need to come in 3 times a year to “top off” their volume, to maintain that full correction, it can sometimes feel like they are ‘chasing their cheeks’ for example. By gradually switching over to Bellafill® in certain areas where it can be used, the need for future adjustments in volume drops significantly. What I tell my clients is this- although up front it is a higher price per syringe, in the end it is the most economical of all the fillers we carry because of its duration of action.” –Dr. Lisa Vuich
- Indications are similar to those for hyaluronic acid fillers.
- Aesthetic correction with Bellafill® appears to be sustained for many years because the PMMA microspheres cannot be broken down by enzymes or removed by phagocytosis.
- Biocompatibility, safety, and stability at the implantation site persist indefinitely.
- Maintenance of volume and pliability appear to be a product of natural and continuous connective tissue turnover and collagen deposition.
- No migration, dislocation, or erosion through the skin has resulted, coincident with the complete encapsulation of the PMMA microspheres.
- There is minimal foreign body reaction as a result of the smooth surface of the microspheres and their uniform size.
Patients must be 21 years of age or older, and per FDA recommendations receive the required negative skin test prior to treatment.
In clinical studies, Bellafill® was shown to work in all skin types, and in men and women.
If you have had a positive reaction to the Bellafill® Skin Test, have a history of severe allergies (anaphylaxis), have known bovine collagen allergies, are allergic to lidocaine, have severe bleeding disorders, or are prone to thick scar formation and/or excessive scarring, you should not receive Bellafill®. The same cautions apply to the use of other dermal fillers, though bovine collagen is unique to the Bellafill®.
As with other dermal fillers, safety of use in pregnant or breastfeeding women has not been established because they were not enrolled in the studies which led to FDA approval of the product.
Where can Bellafill® be used?
Bellafill is commonly used in the nasolabial folds/ “smile lines”, and also with subscision placed into certain types of acne scars. There are also “off label” uses of Bellafill which are common- the cheeks, the marionette region, and the hands for example. “Off label” means the use of the filler in this region has not been specifically evaluated by the FDA.
“Off label use of medical devices such as dermal fillers, of prescription and non- prescription drugs, and of other aesthetic devices is quite commonplace both in and out of the aesthetic field. It is up to the clinical provider to use his or her medical judgement and experience, as well as the experience of colleagues gleaned through study of the available literature, in deciding where to use any injectable product.” – Dr. Lisa Vuich