TY - JOUR
T1 - Interspecies differences in reaction to a biodegradable subcutaneous tissue filler
T2 - Severe inflammatory granulomatous reaction in the sinclair minipig
AU - Ramot, Yuval
AU - Touitou, Dan
AU - Levin, Galit
AU - Ickowicz, Diana E.
AU - Zada, Moran Haim
AU - Abbas, Randa
AU - Yankelson, Lior
AU - Domb, Abraham J.
AU - Nyska, Abraham
N1 - Publisher Copyright:
© 2014 by The Author(s).
PY - 2015/2/15
Y1 - 2015/2/15
N2 - Soft tissue filler products have become very popular in recent years, with ever-increasing medical and aesthetic indications. While generally considered safe, the number of reported complications with tissue fillers is growing. Nevertheless, there is no specific animal model that is considered as the gold standard for assessing safety or efficacy of tissue fillers, and there are very little data on interspecies differences in reaction to these products. Here, we report on interspecies differences in reaction to a subcutaneous injectable co-polyester, composed of castor oil and citric acid. Comparison of the histopathological local tissue changes following 1-month postimplantation, indicated that in rats the reaction consisted of cavities, surrounded by relatively thin fibrotic enveloping capsule. In contrast, an unexpected severe inflammatory granulomatous reaction was noticed in Sinclair minipigs. To our knowledge, this is the first report on significant interspecies differences in sensitivity to tissue fillers. It emphasizes the importance of using the appropriate animal model for performing preclinical biocompatibility assays for biodegradable polymers, tissue fillers, and implanted medical devices in general. It also makes the Sinclair minipig subject for scrutiny as an animal model in future biocompatibility studies.
AB - Soft tissue filler products have become very popular in recent years, with ever-increasing medical and aesthetic indications. While generally considered safe, the number of reported complications with tissue fillers is growing. Nevertheless, there is no specific animal model that is considered as the gold standard for assessing safety or efficacy of tissue fillers, and there are very little data on interspecies differences in reaction to these products. Here, we report on interspecies differences in reaction to a subcutaneous injectable co-polyester, composed of castor oil and citric acid. Comparison of the histopathological local tissue changes following 1-month postimplantation, indicated that in rats the reaction consisted of cavities, surrounded by relatively thin fibrotic enveloping capsule. In contrast, an unexpected severe inflammatory granulomatous reaction was noticed in Sinclair minipigs. To our knowledge, this is the first report on significant interspecies differences in sensitivity to tissue fillers. It emphasizes the importance of using the appropriate animal model for performing preclinical biocompatibility assays for biodegradable polymers, tissue fillers, and implanted medical devices in general. It also makes the Sinclair minipig subject for scrutiny as an animal model in future biocompatibility studies.
KW - biocompatibility studies
KW - interspecies differences
KW - sinclair minipig
KW - soft tissue augmentation
UR - http://www.scopus.com/inward/record.url?scp=84924750446&partnerID=8YFLogxK
U2 - 10.1177/0192623314534995
DO - 10.1177/0192623314534995
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C2 - 24862796
AN - SCOPUS:84924750446
SN - 0192-6233
VL - 43
SP - 267
EP - 271
JO - Toxicologic Pathology
JF - Toxicologic Pathology
IS - 2
ER -