Clinicopathological Analysis of 90 Cases of Polyacrylamide Hydrogel Injection for Breast Augmentation Including 2 Cases Followed by Breast Cancer

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Abstract

Background: Although polyacrylamide hydrogel (PAAG) injection for breast augmentation has been prohibited for many years, the long-term complications will be significant for a long period. Few research articles have focused on the clinicopathological analysis. Materials and Methods: We summarized clinical and pathological features of 90 cases after PAAG-injected breast augmentation, including 2 cases of breast cancer developed following PAAG injection. Results: All patients were females between the ages of 30 and 64 years (mean, 44 years). The complications included masses (75.58%), pain (45.35%), migration (22.09%), deformation (18.60%), infection (16.28%), induration (4.65%), and psychological fear (2.33%). Microscopically, the PAAG presented as purple gel pools, and the foreign body reaction was noted in all 90 patients. The proportion of fibrous component exceeded 90% in 26 cases (28.89%). Chronic and acute inflammation was noted in 70 (77.78%) and 9 (10%) patients, respectively. The mammary gland around the gel displayed atrophy in 18 cases (20.00%), adenosis in 33 cases (36.67%), ductal carcinoma in situ in 1 case (1.11%), and invasive carcinoma in 1 case (1.11%). Conclusion: The long-term complications of PAAG-injected breast augmentation are various and complex. Pathologically, these complications are associated with foreign body reaction, fibrosis, and inflammation.

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Most cited references 18

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Human exposure and internal dose assessments of acrylamide in food.

T Fennell, Jorunn M. Andersen, S P D Lalljie … (2005)

This review provides a framework contributing to the risk assessment of acrylamide in food. It is based on the outcome of the ILSI Europe FOSIE process, a risk assessment framework for chemicals in foods and adds to the overall framework by focusing especially on exposure assessment and internal dose assessment of acrylamide in food. Since the finding that acrylamide is formed in food during heat processing and preparation of food, much effort has been (and still is being) put into understanding its mechanism of formation, on developing analytical methods and determination of levels in food, and on evaluation of its toxicity and potential toxicity and potential human health consequences. Although several exposure estimations have been proposed, a systematic review of key information relevant to exposure assessment is currently lacking. The European and North American branches of the International Life Sciences Institute, ILSI, discussed critical aspects of exposure assessment, parameters influencing the outcome of exposure assessment and summarised data relevant to the acrylamide exposure assessment to aid the risk characterisation process. This paper reviews the data on acrylamide levels in food including its formation and analytical methods, the determination of human consumption patterns, dietary intake of the general population, estimation of maximum intake levels and identification of groups of potentially high intakes. Possible options and consequences of mitigation efforts to reduce exposure are discussed. Furthermore the association of intake levels with biomarkers of exposure and internal dose, considering aspects of bioavailability, is reviewed, and a physiologically-based toxicokinetic (PBTK) model is described that provides a good description of the kinetics of acrylamide in the rat. Each of the sections concludes with a summary of remaining gaps and uncertainties.

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Long-term effects of polyacrylamide hydrogel on human breast tissue.

Anna Jørgensen, Annet Aasted, Vibeke Breiting … (2003)

Polyacrylamide hydrogel is an atoxic, stable, nonresorbable sterile watery gel consisting of approximately 2.5% cross-linked polyacrylamide and nonpyrogenic water. Polyacrylamide hydrogel is widely used in ophthalmic operations, drug treatment, food packaging products, and water purification. In the former Soviet Union, polyacrylamide hydrogel has been used in plastic and aesthetic surgery for more than 10 years, and Kiev City Hospital treats approximately 300 women a year for breast augmentation using the polyacrylamide hydrogel Interfall (Contura SA, Montreux, Switzerland). Capsule shrinkage following these injections has never been observed. The authors examined breast tissue samples from a total of 27 women who had polyacrylamide hydrogel injected at Kiev City Hospital up to 8 years and 10 months earlier. Age at operation, duration of polyacrylamide hydrogel implantation, history of possible side effects to the gel injection, other intercurrent diseases, the reason for present open breast operation, and breast palpation findings before operation were in each case compared with the histological findings on samples taken from breast tissue bordering the gel. The gel presented itself as a dark violet, homogenous mass with a rounded or ragged outline in large or medium-size deposits and as elongated strands, which mimicked the extracellular matrix, in small deposits. Histological findings of the breast tissue bordering the gel showed three different patterns: large collections of gel gave rise to a thick, soft-looking cellular membrane of macrophages and foreign-body giant cells; medium-size deposits were surrounded by just a thin layer of macrophages; and small deposits were not associated with any reaction in the surrounding tissue. Projections of the cellular soft membrane, known as granulomas, were seen in six patients. The granulomas were composed of macrophages, foreign-body giant cells, lymphocytes, and blood cells. A thin layer of fibrous connective tissue was occasionally present around the foreign-body membrane, but the thick fibrous capsule, which has been described in connection with silicone implants, was completely absent. The gel changes could be correlated to neither time since gel injection nor a history of recent injury or inflammation. It is concluded that the polyacrylamide hydrogel Interfall, which has been used in the former Soviet Union, is stable over time, nondegradable, confined to the breast, and diffusion and migration resistant. When the hydrogel is injected in medium-size or large quantities a cellular foreign-body reaction occurs, but in small amounts it is capable of splitting up individual connective tissue fibers and fat cells, substituting for the extracellular connective tissue matrix without eliciting any foreign-body reaction. As far as these data are concerned, polyacrylamide hydrogel is well tolerated by the breast and does not give rise to severe fibrosis, pain, or capsule shrinkage. However, to determine safety with more certainty, a larger sample size would be necessary.

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Histological Characterization of Human Breast Implant Capsules

Janine M. Bui, TracyAnn Perry, Cindy Ren … (2015)

Background This study investigated the relationships between histomorphological aspects of breast capsules, including capsule thickness, collagen fiber alignment, the presence of α-smooth muscle actin (α-SMA)–positive myofibroblasts, and clinical observations of capsular contracture. Methods Breast capsule samples were collected at the time of implant removal in patients undergoing breast implant replacement or revision surgery. Capsular contracture was scored preoperatively using the Baker scale. Histological analysis included hematoxylin and eosin staining, quantitative analysis of capsule thickness, collagen fiber alignment, and immunohistochemical evaluation for α-SMA and CD68. Results Forty-nine samples were harvested from 41 patients. A large variation in histomorphology was observed between samples, including differences in cellularity, fiber density and organization, and overall structure. Baker I capsules were significantly thinner than Baker II, III, and IV capsules. Capsule thickness positively correlated with implantation time for all capsules and for contracted capsules (Baker III and IV). Contracted capsules had significantly greater collagen fiber alignment and α-SMA–positive immunoreactivity than uncontracted capsules (Baker I and II). Capsules from textured implants had significantly less α-SMA–positive immunoreactivity than capsules from smooth implants. Conclusion The histomorphological diversity observed between the breast capsules highlights the challenges of identifying mechanistic trends in capsular contracture. Our findings support the role of increasing capsule thickness and collagen fiber alignment, and the presence of contractile myofibroblasts in the development of contracture. These changes in capsule structure may be directly related to palpation stiffness considered in the Baker score. Approaches to disrupt these processes may aid in decreasing capsular contracture rates. Level of Evidence III This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

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Author and article information

Journal

Journal ID (publisher-id): BRC

Journal ID (pmc): BRC

Journal ID (doi): 10.1159/issn.1661-3791

Title: Breast Care

Publisher: S. Karger AG

ISSN (Print): 1661-3791

ISSN (Electronic): 1661-3805

Publication date Subscription-year: 2020

Publication date (Print): February 2020

Publication date (Electronic): 29 May 2019

Volume: 15

Issue: 1

Pages: 38-44

Affiliations

[_a] _aDepartment of Pathology, The First Affiliated Hospital of Kunming Medical University, Kunming, China

[_b] _bDepartment of Breast Surgery, The First Affiliated Hospital of Kunming Medical University, Kunming, China

[_c] _cDepartment of Plastic Surgery, The First Affiliated Hospital of Kunming Medical University, Kunming, China

[_d] _dDepartment of Radiology, The First Affiliated Hospital of Kunming Medical University, Kunming, China

Author notes

*Liu Liu, MD, PhD, Department of Plastic Surgery, The First Affiliated Hospital of Kunming Medical University, 295, Xichang Road, Kunming, Yunnan 650032 (China), E-Mail liuliu3939@126.com

Article

Publisher ID: 499832 Other ID: Breast Care 2020;15:38–43

DOI: 10.1159/000499832

PMC ID: 7098307

PubMed ID: 32231496

SO-VID: 6a572986-cde8-44e7-ab19-7cf45bf39a62

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Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

History

Date received : 13 June 2018

Date accepted : 17 March 2019

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Figures: 3, Tables: 1, Pages: 7

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Clinicopathological Analysis of 90 Cases of Polyacrylamide Hydrogel Injection for Breast Augmentation Including 2 Cases Followed by Breast Cancer

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Abstract

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Karger: Oncology

Most cited references 18

Human exposure and internal dose assessments of acrylamide in food.

Long-term effects of polyacrylamide hydrogel on human breast tissue.

Histological Characterization of Human Breast Implant Capsules

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