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Q:

Any knowledge of Bellafill causing severe problems for people many years down the road? Even if everything is done exactly right? I’m reading that facial aging may not coincide with the permanent PMMA material and you may end up looking strange later on in life. Or the spheres could “activate” somehow and it could cause complications that can only e resolved by surgery. Is a poor reaction later in life dependent upon the person, assuming everything was done by the book?

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A:

Hello and thanks for posting.

Bellafill is a combination of bovine (cow) collagen and PMMA. The PMMA microspheres are the permanent component of Bellafill. Bellafill is currently approved for naso-labial folds and acne scars, but has been safely used in “off-label” locations since it was approved in 2006.

The main safety issue with Bellafill in the risk of late granuloma formation. Granulomas are late development of nodules in the areas of injection. When Bellafill was approved by the FDA a 5 year post-marketing safety study was mandated. This study showed that there was a 1.7% risk of granuloma formation over 5 years (17 of 1000 patients developed granulomas in this study). Granulomas are not related to injection technique, but represent an aberrant immune response to the PMMA.

Granulomas are manageable, a series of injections of triamcinolone and 5FU reliably shrinks the nodules down. There are also data from Europe and China suggesting that deep injection of PMMA onto bone further lessens the risk of granuloma formation because of the scarcity of immunologic cells in this anatomic location. Surgery is almost never indicated for management of granulomas.

Another potential complication from Bellafill are nodules, these tend to be related to sub-optimal injection technique and represent a clump of injected Bellafill. Nodules will often improve with injection of triamcinolone was well.

With regard to Bellafill looking odd as the tissues age around it, this has not been a problem, although this product has only been available for just over 10 years.

Bellafill is a safe and effective long-term filler and has benefits over short-term fillers. That said, it should only be injected by highly experienced facial injectors who understand the potential for rare, but significant late complications.

I hope that this information helps and best of luck to you!

Regards,
Dr. Pierone

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