Biologics of Bellafill - what are the long term risks of granulomas, nodules, inflammation?

Question

Can someone explain the biologics of bellafill? Do PMMA spheres remain unexposed forever? What causes late stage granuloma formation? I’ve had 1.6cc bellafill a year ago. Wondering how to prevent long term complications. Was not aware the spheres were permanent bone cement. Is my immune system hyper reactive because I’m 24? Run more risks with age?

Raffy Karamanoukian, MD, FACS · Answer

We see Bellafill complications almost weekly in my national referral center for soft tissue filler complications. I would not suggest placing a permanent filler into the soft tissue unless you can tolerate longterm complications including granuloma and edema.

Best,
Dr. Karamanoukian
Realself100 Surgeon

Best, 
Dr. Karamanoukian
Realself100 Surgeon

Nelson Lee Novick, MD · Answer

My regular followers are well aware that I have been cautioning about the use of permanent fillers now for many years going back to the use of liquid silicone, a substance foreign to the body (essentially liquid glass), which even up to today has never received approval for use as a filler. And Bellafil is a methacrylate and so is Super Glue. I certainly understand that the word permanent is enticing and suggests that once treatment is done it is "one and done."  Unfortunately, this is most often not so for a variety of reasons even under the best of circumstances, not the least of which is that with the volumetric and structural changes that continue to take place with aging that typically necessitate further treatments--nonsurgical and/or surgical--of one kind or another--in order to keep up with the aging process. Unfortunaely, there are no dissolving medications for permanent fillers, and since the permanent fillers essentially work by stimulating fibrous tissue production in the skin to essentially "wall off" these foreign bodies, the problem is that if sometime down the road, be it soon or even five, ten or twenty+ years down the road, some aggressive manipulation of the skin takes place that shakes things up, such as the use of additional fillers in the same area of one kind or another (even natural ones, like HA fillers), or aggressive dental work that necessitates forceful manipulation of the overlying skin, the particles may spill out within the skin and promote the development of nodules and granulomas. So, it would be wise to keep this in mind going forward and be sure to tell any future injectors of the prior treatment received with a permanent filler. I hope this helps to clarity the issue and serves to alert to some ways to minimize the chances for any subsequent adverse issues. Should granulomas or nodules or thickening and skin rigidity occur, I have had success in treating these issue using an algortthm of intralesional anti-inflammatory agents. Best of luck.

Milan Shah, MD · Answer

While Bellafill, a dermal filler, is generally considered safe, there are potential long-term risks, including the formation of granulomas, nodules, or inflammation at the injection site. Granulomas are small, localized inflammatory nodules that can develop. It’s essential to consult with a skilled healthcare professional who can provide recommendations based on your medical history and assess the potential risks and benefits of Bellafill for your specific case.

Biologics of Bellafill - what are the long term risks of granulomas, nodules, inflammation?

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