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.