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Microbes, Histology, Blood Analysis, Enterotoxins, and Cytokines: Findings From the ASERF Systemic Symptoms in Women–Biospecimen Analysis Study: Part 3

BACKGROUND: There has been an increasing need to acquire rigorous scientific data to answer the concerns of physicians, patients, and the FDA regarding the self-reported illness identified as breast implant illness (BII). There are no diagnostic tests or specific laboratory values to explain the rep...

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Autores principales: McGuire, Patricia, Glicksman, Caroline, Wixtrom, Roger, Sung, C James, Hamilton, Robert, Lawrence, Marisa, Haws, Melinda, Ferenz, Sarah, Kadin, Marshall
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9896138/
https://www.ncbi.nlm.nih.gov/pubmed/35980942
http://dx.doi.org/10.1093/asj/sjac225
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author McGuire, Patricia
Glicksman, Caroline
Wixtrom, Roger
Sung, C James
Hamilton, Robert
Lawrence, Marisa
Haws, Melinda
Ferenz, Sarah
Kadin, Marshall
author_facet McGuire, Patricia
Glicksman, Caroline
Wixtrom, Roger
Sung, C James
Hamilton, Robert
Lawrence, Marisa
Haws, Melinda
Ferenz, Sarah
Kadin, Marshall
author_sort McGuire, Patricia
collection PubMed
description BACKGROUND: There has been an increasing need to acquire rigorous scientific data to answer the concerns of physicians, patients, and the FDA regarding the self-reported illness identified as breast implant illness (BII). There are no diagnostic tests or specific laboratory values to explain the reported systemic symptoms described by these patients. OBJECTIVES: The aim of this study was to determine if there are quantifiable laboratory findings that can be identified in blood, capsule tissue pathology, or microbes that differentiate women with systemic symptoms they attribute to their implants from 2 control groups. METHODS: A prospective blinded study enrolled 150 subjects into 3 cohorts: (A) women with systemic symptoms they attribute to implants who requested implant removal; (B) women with breast implants requesting removal or exchange who did not have symptoms attributed to implants; and (C) women undergoing cosmetic mastopexy who have never had any implanted medical device. Capsule tissue underwent detailed analysis and blood was sent from all 3 cohorts to evaluate for markers of inflammation. RESULTS: No significant histologic differences were identified between the cohorts, except there were more capsules with synovial metaplasia in the non-BII cohort. There was no statistical difference in thyroid-stimulating hormone, vitamin D levels, or complete blood count with differential between the cohorts. Next-generation sequencing revealed no statistically significant difference in positivity between Cohort A and B. Of the 12 cytokines measured, 3 cytokines, interleukin (IL)-17A, IL-13, and IL-22, were found to be significantly more often elevated in sera of subjects in Cohort A than in Cohorts B or C. The enterotoxin data demonstrated an elevation in immunoglobulin G (IgG) anti–Staphylococcus aureus enterotoxin A in Cohort A. There was no correlation between the presence of IgE or IgG anti-Staphylococcal antibody and a positive next-generation sequencing result. CONCLUSIONS: This study adds to the current literature by demonstrating few identifiable biomedical markers to explain the systemic symptoms self-reported by patients with BII.
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spelling pubmed-98961382023-02-06 Microbes, Histology, Blood Analysis, Enterotoxins, and Cytokines: Findings From the ASERF Systemic Symptoms in Women–Biospecimen Analysis Study: Part 3 McGuire, Patricia Glicksman, Caroline Wixtrom, Roger Sung, C James Hamilton, Robert Lawrence, Marisa Haws, Melinda Ferenz, Sarah Kadin, Marshall Aesthet Surg J Original Article BACKGROUND: There has been an increasing need to acquire rigorous scientific data to answer the concerns of physicians, patients, and the FDA regarding the self-reported illness identified as breast implant illness (BII). There are no diagnostic tests or specific laboratory values to explain the reported systemic symptoms described by these patients. OBJECTIVES: The aim of this study was to determine if there are quantifiable laboratory findings that can be identified in blood, capsule tissue pathology, or microbes that differentiate women with systemic symptoms they attribute to their implants from 2 control groups. METHODS: A prospective blinded study enrolled 150 subjects into 3 cohorts: (A) women with systemic symptoms they attribute to implants who requested implant removal; (B) women with breast implants requesting removal or exchange who did not have symptoms attributed to implants; and (C) women undergoing cosmetic mastopexy who have never had any implanted medical device. Capsule tissue underwent detailed analysis and blood was sent from all 3 cohorts to evaluate for markers of inflammation. RESULTS: No significant histologic differences were identified between the cohorts, except there were more capsules with synovial metaplasia in the non-BII cohort. There was no statistical difference in thyroid-stimulating hormone, vitamin D levels, or complete blood count with differential between the cohorts. Next-generation sequencing revealed no statistically significant difference in positivity between Cohort A and B. Of the 12 cytokines measured, 3 cytokines, interleukin (IL)-17A, IL-13, and IL-22, were found to be significantly more often elevated in sera of subjects in Cohort A than in Cohorts B or C. The enterotoxin data demonstrated an elevation in immunoglobulin G (IgG) anti–Staphylococcus aureus enterotoxin A in Cohort A. There was no correlation between the presence of IgE or IgG anti-Staphylococcal antibody and a positive next-generation sequencing result. CONCLUSIONS: This study adds to the current literature by demonstrating few identifiable biomedical markers to explain the systemic symptoms self-reported by patients with BII. Oxford University Press 2022-08-18 /pmc/articles/PMC9896138/ /pubmed/35980942 http://dx.doi.org/10.1093/asj/sjac225 Text en © The Author(s) 2022. Published by Oxford University Press on behalf of The Aesthetic Society. https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Original Article
McGuire, Patricia
Glicksman, Caroline
Wixtrom, Roger
Sung, C James
Hamilton, Robert
Lawrence, Marisa
Haws, Melinda
Ferenz, Sarah
Kadin, Marshall
Microbes, Histology, Blood Analysis, Enterotoxins, and Cytokines: Findings From the ASERF Systemic Symptoms in Women–Biospecimen Analysis Study: Part 3
title Microbes, Histology, Blood Analysis, Enterotoxins, and Cytokines: Findings From the ASERF Systemic Symptoms in Women–Biospecimen Analysis Study: Part 3
title_full Microbes, Histology, Blood Analysis, Enterotoxins, and Cytokines: Findings From the ASERF Systemic Symptoms in Women–Biospecimen Analysis Study: Part 3
title_fullStr Microbes, Histology, Blood Analysis, Enterotoxins, and Cytokines: Findings From the ASERF Systemic Symptoms in Women–Biospecimen Analysis Study: Part 3
title_full_unstemmed Microbes, Histology, Blood Analysis, Enterotoxins, and Cytokines: Findings From the ASERF Systemic Symptoms in Women–Biospecimen Analysis Study: Part 3
title_short Microbes, Histology, Blood Analysis, Enterotoxins, and Cytokines: Findings From the ASERF Systemic Symptoms in Women–Biospecimen Analysis Study: Part 3
title_sort microbes, histology, blood analysis, enterotoxins, and cytokines: findings from the aserf systemic symptoms in women–biospecimen analysis study: part 3
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9896138/
https://www.ncbi.nlm.nih.gov/pubmed/35980942
http://dx.doi.org/10.1093/asj/sjac225
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