Lemperle compares injectable implants

[Guest guest]

Abstract by G. Lemperle (artecoll patent holder) comparing various

fillers over a period of time (would be nice if somebody who has

access could post the full article). Silicone oil causes chronic

foreign body reaction, polyacrylamide (aquamid) is well tolerated and

held best till the last date measured (9 mos). Bioalcamid not

included. Seems inconsistent since US availability is stated as

inclusion criterion but aquamid is

(www.lipaugmentation.com/microplants.htm states that some docs have

been using it even though not approved). Aquamid sounds like a very

viable alternative based on results of this study, plus it is

available from a Danish company with 1000 patents (Ferrosan) and has

CE mark and is also removable. In use up to 9 years without

degradation and safety problems, several clinical trials published,

including one in Brazil for poz (www.aquamid.com). How much is it?

Aesthetic Plastic Surgery

Publisher: Springer-Verlag New York

ISSN: 0364-216X

DOI: 10.1007/s00-1

Issue: Online First

Human Histology and Persistence of Various Injectable Filler

Substances for Soft Tissue Augmentation

Gottfried Lemperle M.D., Ph.D.1 , Vera Morhenn M.D.2 and Ulrich

Charrier

M.D3

(1) Division of Plastic Surgery, University of California, San

Diego, CA, USA

(2) Division of Dermatology, University of California, San Diego,

CA, USA

(3) Institute of Pathology, furt, Germany

Published online: 4 December 2003

Abstract An increasing number of soft tissue filler substances have

been introduced to the beauty market outside the U.S. 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 deep intradermally into the volar forearm of one 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 foreign body reactions

classification. Collagen (Zyplast) was phagocytosed at 6 months and

hyaluronic acid (Restylane) at 9 months. PMMA microspheres (Artecoll)

had 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 body reaction.

Polylactic acid microspheres (New-Fill) induced amild 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. Polymethylacrylate particles

(Dermalive) induced the lowest cellular reaction but had disappeared

clinically at 6 months. Polyacrylamide (Aquamid) was well tolerated

and remained palpable to a lessening degree over the entire testing

period. Histologically, it dissipated more slowly and was kept in

place through fine fibrous capsules. Polyvinylhydroxide microspheres

suspended in acrylamide (Evolution) were well tolerated, slowly

diminishing over 9 months. Calcium hydroxylapatite microspheres

(Radiance FN) induced almost no foreign body reaction but were

absorbed by the skin at 12 months. Host defense mechanisms react

differently to the various filler materials, but all substances-

resorbable or nonresorbable-appeared to be clinically and

histologically safe, although all exhibit undesirable 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.

Keywords Dermal filler substances - Soft tissue augmentation -

Aquamid - Artecoll - Dermalive - Evolution - New-Fill-Radiance FN -

Restylane - Reviderm intra

Presented at the 33rd Annual Meeting of the Association of German

Plastic Surgeons in Heidelberg, Germany, September 21, 2002

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Gottfried Lemperle

Email: glemperle@...