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Aesthetic
Surgery Journal
May/June
2003; Volume 23; Number 3 pp: 221 -224
Practice
Forum: Hot Topics:
Facial fillers and their complications
Ziya Saylan, MD
Abstract:
A number of facial filler materials that have not yet been approved
by the Food and Drug Administration for use in the United States have
been employed by physicians in Europe for several years. Although these
products have proved efficacious, some complications events have been
associated with their injection or inappropriate application. Moreover,
the long-term effects of injecting into the face materials that often
cannot be removed without surgical intervention is an issue that deserves
serious consideration by both physicians and patients. (Aesthestic Surg
J 2003;23:221-224.)
Ziya Saylan,
MD, Dusseldorf, Germany, is a general surgeon.
Several facial-filler materials not yet approved by the Food and Drug
Administration for use in the United States have been marketed in Europe
for several years. Their introduction has resulted in a dramatic decrease
in the use of fat injections for facial filling in Europe. The new products
include: Hyaluronic acid (Restylane, Juvederm, Fineline: Q-Med AB, Uppsala,
Sweden; Juvederm: Corneal, Hallbergmoos, Germany; Hylaform: Inamed,
Düsseldorf, Germany); Hyaluronic acid and collagen combined with
polymethylmethacrylate (PMMA) or hydroxyethylmethacrylate (HEMA) (Artecoll:
Rofil Medro, Düsseldorf, Germany; DermaLive and DermaDeep: Dermatech
SARL, Paris, France); Polylactic acid (PLA: New Fill, European Aesthetics
GmbH, Ismaning, Germany); and others (polyacryl injections: Amazingel,
Fuhua Medical Co. Ltd., Shenzhen, China; Aqua-Mid, Bexbach, Germany).
I do not use these latter 2 substances because the material injected
has not been completely evaluated for possible toxicity. Hyaluronic
acid eventually dissolves after injection; the duration of its effects
varies, depending on the thickness of the acid. The other filler materials
remain permanently in the body's tissues.
Hyaluronic
acid:
There are three different thicknesses of hyaluronic acid. Low-density
hyaluronic acid products (Fineline, Juvederm18, and Hylaform Fineline)
are designed to fill "smoker lines" of the upper lips, as
well as crow's feet; they dissolve after 2 to 3 months. Medium-density
hyaluronic acid products (Restylane, Juvederm24, and Hylaform) are applied
to the lips and generally last 4 to 6 months.
High-density
hyaluronic acid products (Perlane, Juvederm 30, and Hylaform Plus) are
applied in the nasolabial folds and may last up to 12 months if injected
properly. A new version of hyaluronic acid with even larger molecules,
called Macrolane (Q-Med) has been announced by the manufacturer but,
as of January 2003, is not yet on the market. Macrolane is intended
for deep implantations such as correction of breast surgery complications
(filling rippling and dents) and the direct augmentation of the cheek
and chin.
We have
treated 500 patients with hyaluronic acid facial injections and found
that it provided longer-lasting results than bovine collagen products
for volume augmentation of the lips, wrinkles, and folds. In contrast
to collagen, hyaluronic acid contains no products of animal origin.
Consequently, no skin pretesting is necessary. We prefer to work with
the thicker hyaluronic acid fillers because we have obtained more satisfactory
results with them.
Hyaluronic
acid must be injected properly into the lower levels of the dermis and
upper levels of subcutaneous tissue. Intradermal injection will cause
irritation and adverse reactions. Intramuscular or periosteal injections
should be avoided because the material will be absorbed as result of
the rich blood circulation in these areas. Also, areas subject to significant
muscle movement, such as the perioral and mouth angle folds, are not
well suited for hyaluronic acid injections because motion will cause
rapid dissolution of the filler and reappearance of the folds.
Our clinical
experience has revealed a 0.4% incidence of inflammatory local reactions
to all hyaluronic acid fillers, appearing 1 to 14 days after treatment
(Figure 1).
Fig. 1.
This patient experienced an allergic reaction to a hyaluronic acid injection.
In comparison, there is a reported 4% incidence of allergic reactions
among patients injected with bovine collagen.1 The adverse reactions
that occurred in our series resolved after a few days of corticoid and
antihistamine treatment.
Granulomas
occurred in 2% of patients but resolved after the injection of corticoids
and topical application of antihistamine creams. Molding the granulomas
and applying digital pressure also helped dissolve them. Patients can
do this for themselves at home with good results.
Artecoll:
Artecoll is a mixture of collagen and acryl particles (PMMA) that was
developed by Dr. Gottfried Lemperle2 and introduced in Europe in 1992.
It is designed to achieve augmentation by provoking fibrotic granulation
under the skin through foreign-body reactions. The collagen in the material
expedites the transportation of the acryl particles but does not act
directly as a filler. Because Artecoll contains collagen, a skin pretest
is always required.
Artecoll
injection requires careful technique. It must be injected into the upper
levels of the subdermis. Intradermal placement can result in beading
or ridging caused by the foreign-body reaction; injection into muscle
may lead to nodule formation. In several reports, it has been noted
that complications correctable only by surgical excision can result
from incorrect technique.3-5 Pollack has warned that Artecoll treatment
involves a learning curve extending over the first few dozen treatments
and recommends a highly conservative approach with respect to the amount
used and the interval between treatments. (I have found that an interval
of at least 1 month between injections is necessary to allow encapsulation
and to assess results; Pollack recommends 6 to 8 weeks.)
The most
serious complication associated with Artecoll is granuloma (Figures
2 and 3).
Fig. 2.
Too-superficial injection of Artecoll resulted in granuloma formation
9 months after treatment.
Fig. 3.
A granuloma formed in this patient 2 months after injection of Artecoll
into the nasolabial fold.
Lemperle reported that an early form of Artecoll and its predecessor,
Arteplast, were associated with a 3% to 5% incidence of granuloma because
the microspheres of which the product was composed did not have absolutely
smooth surfaces. Consequently, electrostatic charging caused the adherence
of very small particles to the surfaces of some microspheres. This problem
was resolved after multiple washings were implemented in 1994.6-8 A
1998 study reported a low (1:1000) incidence of granuloma after 2 years'
follow-up, although the rare occurrence of granuloma as a late side
effect of unknown cause was noted.4 In addition, granuloma can result
from overly aggressive treatment in which too much material is injected.3
I have
encountered granuloma as a late side effect of Artecoll injection in
my own practice. In my cases, the incidence of nodule formation was
higher than that reported above and led to complaints from patients
3 to 4 years after treatment.
DermaLive
and DermaDeep:
DermaLive
and DermaDeep have been available in Europe and South America for the
past 5 years. Their mechanism of action is similar to that of Artecoll,
except that instead of collagen, a hyaluronic acid/hydrogel solution
is mixed with acryl particles (HEMA) and acts as a carrier to transport
the acryl-hydrogel particles into the treated tissue. This solution
is absorbed after a few months. DermaDeep contains more acryl particles
than DermaLive and is designed to be implanted only in deeper layers,
close to the bones (periosteum). No skin pretesting is required for
these products.
We use
DermaDeep to augment the bony structures of the face, implanting it
only sub- or epiperiosteally. It must be injected over a solid base.
It is effective in filling the fossa canine of the nasolabial region
and for the augmentation of the chin and cheek. However, when used to
fill defects not located over a bony or otherwise solid base (e.g.,
the chin and the cheekbones), the particles and their capsules form
a compact unit that can be detected on palpation and is sometimes visible
(Figure 4).
Fig. 4.
An infected granuloma developed in this patient 6 months after injection
of DermaLive.
Bergeret-Galley et al9 reported a low rate (1.2:1000) of long-term side
effects associated with these products. The main complication they noted
was the appearance of palpable nodules approximately 6 months after
treatment; these were treated successfully with corticoid injections.
In our
clinical experience, both DermaLive and DermaDeep can cause dramatic
hardening if injected into the muscle or deep mucosa of the lips, or
intradermally. In our series of 200 patients, 22 (11%) complained of
hardening at 1-year follow-up. At 2-year follow-up, 51 patients (25.5%)
complained of hardening. We also encountered 11 cases of granuloma (5.5%)
in long-term (more than 2 years) follow-up, some of which required surgical
excision.
In our
experience, the results of injection with Artecoll, DermAlive, and DermaDeep
did not stabilize after 3 months, as claimed by these products' manufacturers.
We observed further macroscopic enlargement as long as 24 months after
treatment.
PLA
injections:
New Fill
is a PLA described as a biocompatible, bioabsorbable synthetic polymer
belonging to the family of aliphatic polyesters. The L-PLA is in the
form of microspheres, ranging in diameter from 40 to 60 m, held in suspension
in a gel. The microspheres are more than 10 m in diameter, to avoid
immediate phagocytosis by macrophages, and more than 30 m, to avoid
intracapillary dispersal; however, they measure less than 100 m, guaranteeing
ease of injection through fine intradermal needles.
In our
experience, particles of this size may cause a granulated appearance
and can also result in granulomas. We have injected PLA in 100 cases
and have observed 5 cases of infection and 12 cases of granuloma formation
(Figure 5).
Fig. 5.
A granuloma developed in this patient 2 months after injection of PLA
filler. Secondary infection developed several months later.
In addition, 3 cases of long-term allergic reaction have occurred; these
are still under investigation.
Conclusion:
The development of facial-filler material designed for permanent implantation
offers obvious benefits to patients and physicians in terms of convenience
and cost. However, I believe that a prudent approach to their use is
called for; my own clinical experience and reports in the literature
indicate the possibility of long-term complications after injection
of these materials.
In addition,
the long-term aesthetic consequences of using permanent or long-lasting
facial-filling material merit careful consideration. Facial contours
change over time; in particular, the soft tissues can shrink as the
patient grows older. Permanent fillers that provide satisfactory results
at first may become more visible or create an unnatural appearance as
aging progresses. Precisely because these products are so long-lasting,
such untoward consequences would be difficult or impossible to correct
without surgical intervention. Given these problems, in my opinion,
it is legitimate to question the necessity for such permanent fillers.
References:
1. Lemperle G., PMMA Microspheres for intradermal implantation, animal
research. Ann Plast Surg 1991;26:57-63.
2. Klein,
A. Tissue Augmentation in Clinical Practice: Injectable Bovine Collagen.
New York, NY: Marcel Dekker; 1998:125-144.
3. Pollack
S. Some new injectable dermal filler materials: Hylaform, Restylane,
and Artecoll. J Cutan Med Surg 1999;3(suppl 4):S27-S35.AQ11
4. Lemperle
G, Gauthier-Hazan N, Lemperle M. PMMA-microspheres (Artecoll) for long-lasting
correction of wrinkles: refinements and statistical results. Aesthetic
Plast Surg 1998;22:356-365.
5. Rudolph
CM, Soyer HP, Schuller-Petrovic S, Kerl H. Foreign body granulomas due
to injectable aesthetic microimplants. Am J Surg Pathol 1999;23:113-117.
6. Kessels
R, Santachè P. Commentary on Lemperle G, Gauthier-Hazan N, Lemperle
M. PMMA-microspheres (Artecoll) for long-lasting correction of wrinkles:
refinements and statistical results. Aesthetic Plast Surg 2000;24:73.
7. Lemperle
G, Larson F. Reply to Kessels R, SantachèAQ13 P. Commentary on
Lemperle G, Gauthier-Hazan N, Lemperle M. PMMA-microspheres (Artecoll)
for long-lasting correction of wrinkles: refinements and statistical
results. Aesthetic Plast Surg 2000;24:74-75.
8. Lemperle
G. Reported side effects of Artecoll. ARSIS Medical Web site. 216.239.33.100/search?q=cac…artecoll,+granuloma&hl=en&hl=en&ie=UTF-8.
Accessed February 25, 2003.
9. Bergeret-Galley
C, Latouche X, Illouz YG. The value of a new filler material in corrective
and cosmetic surgery: DermaLive and DermaDeep. Aesthetic Plast Surg
2001;25:249-255.
Publishing and Reprint Information:
Reprint requests: Ziya Saylan, MD, Konigsallee 22, Dusseldorf 40212,
Germany;
e-mail: saylan@aol.com .
Copyright & copy; 2003 by The American Society for Aesthetic Plastic
Surgery, Inc.
1090-820X/2003/$30.00 + 0
doi:10.1067/maj.2003.45
