PRO: Say Yes to Permanent Fillers (Sometimes)

By Michael H. Gold, MD, Founder of Gold Skin Care Center, Advanced Aesthetics Medical Spa, The Laser & Rejuvenation Center, and Tennessee Clinical Research Center in Nashville

Let me start by saying this: I am 99.9 percent against the use of permanent facial fillers. That said, this stance does provide a degree of wiggle room, and there remains a place for Suneva Medical, Inc.’s Bellafill. This filler is approved for the correction of nasolabial folds and the moderate-to-severe, atrophic, distensible facial acne scars on the cheek in patients older than 21.

The problems that occurred using some of the earlier iterations of Bellafill, namely migration and granuloma formation, are real, but the company has made many improvements to the product formerly known as Artefill. These include changes in the production process and the development of uniform shapes of Polymethyl methacrylate (PMMA) microspheres.

We have more safety and efficacy data for Bellafill than for any other filler on the market. It is the only filler to have been studied for five years. Of 1,008 patients enrolled across 23 study sites, 83 percent were “satisfied” to “very satisfied” with the treatment outcome at five years. There were no treatment-related serious adverse events or unanticipated adverse events seen in the study. The incidence of treatment-related adverse events was 11.7 percent. The majority of these were classified as mild in severity and resolved by the study’s conclusion. The most commonly reported adverse events were lumpiness and redness at the injection site. Of note, the incidence of granulomas was miniscule (1.7 percent).

Many of my colleagues may have preconceived notions about Bellafill due to their experience with the earlier versions of Artefill, but this is akin to comparing apples to oranges. Bellafill is safe and effective when used appropriately by skilled injectors in the right places and in the right patient. It is when practitioners use the product inappropriately that problems develop.

Patient selection is key. Bellafill is one of my go-to’s for acne scars that have been there for a while, especially when combined with microneedling. I won’t treat lips or tear troughs with Bellafill, as there are enough alternatives available. For nasolabial folds, I would not use Bellafill in filler-naive patients, but if a mature patient has had filler previously and likes the results, but not the regular maintenance, I may suggest Bellafill.

Other contraindications to Bellafill include positive reaction to the skin test, a history of anaphylaxis, and allergy to lidocaine or any bovine collagen products. Patients who are prone to hypertrophic or keloid scars as well as those undergoing or planning to undergo desensitization injections to meat products are also not candidates for Bellafill.

In summary, Bellafill is new and improved and has passed FDA scrutiny with flying colors. Is it for everyone? No, but in the right patient and injected by the right doctor, it certainly has its place.

CON: Just Say No to PMMA Permanent Fillers

By Kevin C. Smith, MD, FRCPC (Dermatology), Dermatologic Surgeon at the Niagara Falls Dermatology & Skin Care Centre, Ltd in Niagara Falls, Ontario, Canada

Many of us practicing outside the United States have 10-20 years of experience injecting patients with PMMA (polymethylmethacrylate)-based permanent fillers—and many of us have years of experience dealing with the chronic and sometimes intractable problems that can result from the use of these fillers. I injected more than 3,800 syringes of PMMA fillers between 2002 and 2013, and have lectured and written on the subject. I have been a consultant for Suneva, the company that is selling Bellafill (PMMA filler) in Canada and the United States. I was also the medical expert for the plaintiffs in a class action lawsuit against the distributor of Dermalive/Dermdeep (an unrelated permanent filler).

There have been several generations of PMMA fillers, starting with Arteplast (which frequently caused severe granulomatous inflammatory reactions, Figure 1), then Artecoll (which was more refined and caused a smaller number of problems), then Artefill (even more refined, but still caused quite a large number of serious problems, Figure 2.) As each new generation of PMMA filler was introduced, we were told: “This time it will be different!”—but we saw the same old problems, just at a lower frequency. Now, we look in horror as Bellafill, a “new” PMMA filler almost identical to Artefill is being introduced in the United States.

“This time it will be different?”

The difference this time is that injectors in the United States will be confronted with a large body of medical evidence and litigation experience used in other jurisdictions when injectors in the United States are sued for PMMA-related complications. United States injectors can also expect at least reputational damage in cases where there are PMMA-related problems. Beyond that, patients will Google PMMA and quickly discover that this class of filler has a long and nasty track record of serious problems.

Reactions to PMMA may not develop for five-10 years after the product is injected, and there is no way to predict who is at risk or to prevent these problems from arising. Many sessions of injection with Kenalog and/or 5-fluorouracil may be needed to get the problem under control; and because the PMMA cannot be removed except by surgery, the reaction may flare up again in the future. In some cases systemic treatment with very expensive agents like infliximab may be needed to control (not cure) the problem. In other cases complications cannot be adequately corrected by any intervention.

My observation has been that Artesense and other members of that family can migrate after a number of years to locations up to 2cm away from the intended injection site (e.g., nasolabial folds or melomental lines). PMMA is PERMANENT, even though the duration of cosmetic benefit may be only five years or so.

Because PMMA cannot be reversed, accidental intravascular injections (or even perivascular injections) are likely to be much more severe and also more difficult to manage than if a hyaluronic acid (HA) filler had been used. PMMA-based fillers are composed of particles so there is more risk of embolization to sites distant from the site of intravascular injection. By contrast, HA fillers are (to varying degrees) cohesive, and less likely to embolize to tissue distant from the site of an intravascular injection.

I strongly encourage practitioners to develop mastery of a range of HA fillers that can provide a broad spectrum of excellent, long-lasting outcomes, have limited complications that are readily managed, and consistently produce a high degree of patient satisfaction. The biocompatibility, long-lasting (but not permanent) effects of cohesive gel HA fillers, low incidence of adverse experiences, reversibility, and versatility make them an excellent and secure foundation for the aesthetic soft tissue-filling practice. n

The above debate was part of a panel held during the 2015 Cosmetic Surgery Forum in Las Vegas. To learn more about CSF, and to see the 2016 Program, visit CosmeticSurgeryForum.com.