An increasing number of
soft tissue filler substances have been introduced to the European beauty
market, which lack experimental and clinical data in support of their claim.
Ten commercially available filler substances were examined for
biocompatibility and durability: 0.1 cc of each substance was injected
subdermally into the volar forearm of the authors and observed for clinical
reaction and permanence. At 1, 3, 6, and 9 months the test sites were
excised, histologically examined, and graded according to a foreign body
reactions classification (Duranti).
The filler depots of
collagen (Zyplast) and hyaluronic acid (Restylane) disappeared clinically at
4 months and werephagocytosed at 6 months.
PMMAmicrospheres (Artecoll)
remained unchanged and were encapsulated with connective tissue,
macrophages, and sporadic giant cells.
Silicone oil (PMS 350) was
clinically inconspicuous but dissipated into the tissue, causing a chronic
foreign bodyreaction.
Polylactic acid
microspheres (New-Fill) induced a mild inflammatory response and had
disappeared clinically at 4 months.
Dextran microspheres (Reviderm
intra) induced a pronounced foreign body reaction and had disappeared at 6
months.
Polyethylmethacrylate (HEMA)
particles (Dermalive) induced the lowest cellular reaction but had
disappeared clinically at 6 months.
Polyacrylamide gel (Aquamid)
was well tolerated but slowly absorbed and remained palpable to a lessening
degree over the entire testing period. Histologically, it dissipated more
slowly than silicone oil and was kept in placethrough fine fibrous capsules.
Polyvinyl microspheres
suspended in acrylamide (Evolution) were well tolerated, clinically and
histologically slowly diminishing over 9 months.
Calciumhydroxylapatite
microspheres (Radiance FN) appeared white beneath thin skin, induced almost
no foreign body reaction, but were absorbed at 12 months.
The clinical persistence of
an injectable and its effect on wrinkles is depending on the amount, depth
and shape of the implant: A thin strand applied beneath a constantly moving
wrinkle is even faster absorbed than a round depot in the skin of the
forearm. The carrier substance, whether fast or slowly resorbable, may play
an important role on persistence as well. None of the implants - with the
exception of Artecoll - was palpable longer than 6 and 9 months,
respectively.
Host defense mechanisms
react differently to the various filler materials, but all substances -
resorbable or non-resorbable - appeared to be clinically and histologically
safe, although all may exhibit undesirable clinical side effects. Since the
mechanism of late inflammation or granuloma formation is still unknown,
early histological findings are not useful in predicting possible late
reactions to filler substances. These can be verified in exact clinical long
term-studies and in a centralized European implant registry.
In summary, patients who
are thinking for the first time of a wrinkle treatment should try collagen
or hyaluronic acids in order to experience its effect. Restylane, Hylaform
or Juvederm do not last longer than Zyderm or Zyplast: all about 4 to 6
months. If they are satisfied but do not want to repeat the treatment every
6 months, they should consider a long lasting injectable like Artecoll. Its
side effects from the early nineties have been abolished significantly by
purification of the microspheres.
The effect of silicone oils
and acrylamide gels on wrinkles has not been tested thoroughly. In larger
quantities, both are followed by a high incidence of late complications.
New-Fill and Radiance appear to be safe and effective in larger quantities
in facial defects like facial lipodystrophy - but do not last longer than
6-9 months beneath wrinkles.
Most side effects occur
after lip augmentation in form of palpable or even visible nodules. Lip
augmentation should be approached very carefully, preferably by the
micro-droplet technique.
Abstract from:
Lemperle G, Morhenn V,
Charrier U. Human Histology and Persistence of Various Injectable Filler
Substances for Soft Tissue Augmentation. Aesthetic Plast Surg. 27: 2003 Dec
4.
Gottfried Lemperle
302 Prospect Street
La jolla, CA 92037-4691,
USA
Tel: ++1 858 551 7696
e-mail:
glemperle@aol.com