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AESTHETICS MANAGEMENT
In Association with Cosmetic Surgery Forum
Point/Counterpoint:
Is There a Role for
Permanent Fillers?
SECTION EDITOR: JOEL SCHLESSINGER, MD
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
L
et 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 treatmentrelated 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.
AUGUST 2016 PRACTICAL DERMATOLOGY 45
AESTHETICS MANAGEMENT
In Association with Cosmetic Surgery Forum
CON: Just Say No to PMMA
Permanent Fillers
Figure 1
By Kevin C. Smith, MD, FRCPC (Dermatology),
Dermatologic Surgeon at the Niagara Falls
Dermatology & Skin Care Centre, Ltd in
Niagara Falls, Ontario, Canada
M
any 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 PMMArelated 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.
46 PRACTICAL DERMATOLOGY AUGUST 2016
Figure 2
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. PMMAbased 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, longlasting (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.