I'm considering Bellafill for hollow temples and nasolabial folds. How common are longterm complications?

Hello,     Thank you for your question. I understand that you are 32 years old and you are considering Bellafill for hollow temples and to improve deeper nasolabial folds. I also understand that you have previous experience using other temporary fillers.  Because of the temporary results and the requirement that you refill frequently to maintain your appearance is expensive you’re considering replacing the temporary fillers with a permanent option.  I assume you have been satisfied with the cosmetic results from the other fillers you’ve used and I think this in part makes you a good candidate to use Bellafill now.   You know first hand how fillers work and appear when injected into your areas of concern.   Unless I am treating acne scars, I usually recommend for a patient who has never used any volume replacement to at least try a temporary filler first to make sure that he or she is satisfied with the filler experience and appearance of having a filler placed into his or her face as opposed to starting out with a permanent option such as Bellafill.     I have been injecting Bellafill for quite a few years and I am satisfied with the filler overall and my patients have also been satisfied with the filler. I have had very few complaints, none have been overfilling or significant appearing nodule issues. I think that the long-term safety of the Bellafill is very good. The long-term results, long-term safety and efficacy of Bellafill through multiple clinical studies and post market surveillance indicates clear evidence of the long-term safety with Bellafill through 12 years. Bellafill was approved by the FDA to treat nasal labial folds in October 2006 under the trade name of Artefill and I know it’s popularity is steadily increasing for patients in your position.  whatever it is we read from the company regarding Bellafill is in terms of injecting it into the nasal labial folds and not into other off-label regions.      Bellafill is FDA approved for nasal labial folds as well as acne scars and you should be aware that using the filler in your temples would be an off label use. I would like to mention possibly a better option for the hollow temples and that would be silicone implants. There is a temporal shell implant made by Implantech which is an ideal, permanent solution for temporal hollowness due to genetics or trauma. It’s soft and flexible and the silicone temporal shell provides soft-tissue volume (muscle enhancement) for an aesthetically pleasing appearance. They come in various sizes and they can be trimmed or customized by your surgeon during the procedure so they fit you just right. These implants are very nice and they are safe. They are inserted through a small temporal incision and they can always be removed relatively easily if for some reason you decide you don’t want them anylonger.   Bellafill however is another option and it would need to be injected smoothly and carefully in this region.  Personally I would dilute it and have my patient treat post-injection similar to Sculptra.  What you are worried about in your question is a delayed onset nodule (DON). Lumps, masses, nodules, regions of induration, delayed hypersensitivity reactions, sterile abscesses and granulomas are all terms used to describe a delayed onset nodule. A granuloma is actually a histological diagnosis and no lump or nodule should be named is this unless there is histological evidenece.  Delayed onset nodules are more common in immune reactive patients and particularly those with active autoimmune diseases.     It is important that you choose the correct practitioner to inject this particular filler because the complication rate is greater for less experience practitioners.   If a patient develops a delayed onset nodule the treatment varies.  If it’s only palpable but not visible you might want leave it alone with careful watching and waiting. If you do develop a significant nodule or an inflamed nodule that requires treatment, various options exist to treat the nodule depending upon the time of presentation of the nodule after the filler was injected as well as its visibility and inflammation type.  I am going to state with an educated opinion but little personal experience with D.O.N. that you have at most a 1% chance of developing a significant nodule sometime in the future after the injection of Bellafill.       I hope this information provides you with some guidance in going forward with your desires regarding permanent options for restoring facial volume. I think you should certainly research silicone temple implants before you choose to put Bellafill in this region. Bellafill can always be used in the future but it is very difficult to remove. Silicone implants are not difficult to place in this region and they are relatively easy to remove.       If you have any questions please reach out to me at anytime.Best regards,Dr  Ryan Mitchell  

Surveys of complications from Bellafill have demonstrated it to have amongst the lowest rate ( at an incidence of Radiesse ) of all fillers.Personally, my experience has been from the beginning, having published the article describing the first 20 patients treated in the U.S. with Artecoll- Bellafill's original name & having participated in all phases of the FDA trials. leading to its approval. I have seen no late onset side effects ever in almost 20 years of use.

Complications are possible with any injectable filler, including Bellafill, but long term complications are not common.  So far, I have not seen any long term complications in patients that I have treated with Bellafill.  If you decide to have the treatment, I would make sure you are seeing someone who has experience with Bellafill though.