Commentary on “Late complications after application of polyacrylamide hydrogel” by Evstatiev

Commentary on “Late complications after application of polyacrylamide hydrogel” by Evstatiev Eur J Plast Surg (2006) 29: 139 DOI 10.1007/s00238-006-0059-9 INVITED COMMENTARY R. Schmidt Commentary on “Late complications after application of polyacrylamide hydrogel” by Evstatiev Published online: 30 May 2006 # Springer-Verlag 2006 Abstract The filling material described should be prop- and lasting augmentation; otherwise, some details about erly identified and/or correctly cited. pH is missing a value. using the 5% hydrogel directly would be appreciated. The hydrogel is claimed to contain tetramethylenediamine, which from a chemistry point of view is questionable; it probably should be N, N, N′, N′-tetramethylethylenedia- Discussion mine, which may be used as initiator in polyacrylamide systems. The author claims (pp. 8–9) that complications are not limited to certain producers because the ingredients of the material (polyacrylamide hydrogels?) are always the same, Introduction no matter who produces it. This is an oversimplified statement indicating lack of any knowledge of polymer In this study, the hydrogel is claimed to be from Interfall, chemistry and processing insight. Cross-linked polyacryl- Ukraine. This hydrogel is stated to be 5% (dry solids), amide may be processed based on the same ingredients, but which may be difficult to inject directly; therefore, a different processing conditions will influence the final common practice by physicians is to further dilute the product’s performance drastically. By complying with the hydrogel by introducing sterile isotonic water (sometimes regulatory requirements as for instance to get a CE mark, with a water-soluble analgetic) and mix it in the vial or such a producer is expected to demonstrate documented syringe before injecting. Any such practice is not men- and well-controlled processing facilities and batch records, tioned, but if used, it may influence the success for correct and in particular ensure product sterility, repeatably. Furthermore, some producers have developed rational technologies that provide more consistent hydrogels than others in terms of smaller batch-to-batch variation in hydrogel characteristics, such as pH, dry solids, and rhe- ological performance. There are technologies that provide This commentary refers to the article http://dx.doi.org/10.1007/ s00238-006-0055-0. consistent cross-linking of polyacrylamide hydrogels. This means that despite having the same ingredients, some R. Schmidt (*) producers appreciate the value of obtaining a high level of Chempilots a/s, production control and to supply hydrogels with consistent Farum, Denmark e-mail: rs@chempilots.dk structure and properties. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png European Journal of Plastic Surgery Springer Journals

Commentary on “Late complications after application of polyacrylamide hydrogel” by Evstatiev

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Publisher
Springer-Verlag
Copyright
Copyright © 2006 by Springer-Verlag
Subject
Medicine & Public Health; Plastic Surgery
ISSN
0930-343X
eISSN
1435-0130
D.O.I.
10.1007/s00238-006-0059-9
Publisher site
See Article on Publisher Site

Abstract

Eur J Plast Surg (2006) 29: 139 DOI 10.1007/s00238-006-0059-9 INVITED COMMENTARY R. Schmidt Commentary on “Late complications after application of polyacrylamide hydrogel” by Evstatiev Published online: 30 May 2006 # Springer-Verlag 2006 Abstract The filling material described should be prop- and lasting augmentation; otherwise, some details about erly identified and/or correctly cited. pH is missing a value. using the 5% hydrogel directly would be appreciated. The hydrogel is claimed to contain tetramethylenediamine, which from a chemistry point of view is questionable; it probably should be N, N, N′, N′-tetramethylethylenedia- Discussion mine, which may be used as initiator in polyacrylamide systems. The author claims (pp. 8–9) that complications are not limited to certain producers because the ingredients of the material (polyacrylamide hydrogels?) are always the same, Introduction no matter who produces it. This is an oversimplified statement indicating lack of any knowledge of polymer In this study, the hydrogel is claimed to be from Interfall, chemistry and processing insight. Cross-linked polyacryl- Ukraine. This hydrogel is stated to be 5% (dry solids), amide may be processed based on the same ingredients, but which may be difficult to inject directly; therefore, a different processing conditions will influence the final common practice by physicians is to further dilute the product’s performance drastically. By complying with the hydrogel by introducing sterile isotonic water (sometimes regulatory requirements as for instance to get a CE mark, with a water-soluble analgetic) and mix it in the vial or such a producer is expected to demonstrate documented syringe before injecting. Any such practice is not men- and well-controlled processing facilities and batch records, tioned, but if used, it may influence the success for correct and in particular ensure product sterility, repeatably. Furthermore, some producers have developed rational technologies that provide more consistent hydrogels than others in terms of smaller batch-to-batch variation in hydrogel characteristics, such as pH, dry solids, and rhe- ological performance. There are technologies that provide This commentary refers to the article http://dx.doi.org/10.1007/ s00238-006-0055-0. consistent cross-linking of polyacrylamide hydrogels. This means that despite having the same ingredients, some R. Schmidt (*) producers appreciate the value of obtaining a high level of Chempilots a/s, production control and to supply hydrogels with consistent Farum, Denmark e-mail: rs@chempilots.dk structure and properties.

Journal

European Journal of Plastic SurgerySpringer Journals

Published: Sep 1, 2006

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