Evidence map›Paper›PMID 35980942›Full record

ArticleAesthetic surgery journal2023

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

Patricia McGuire, Caroline Glicksman, Roger Wixtrom, C James Sung, Robert Hamilton, Marisa Lawrence, Melinda Haws, Sarah Ferenz, Marshall Kadin

Open access · bronzeAbstract read
In one paragraph

Article in Aesthetic surgery journal, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
5.7field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 29 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
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  7. Silicone breast implant-associated pathologies and T cell-mediated responses.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2025
    Review
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  16. Journal of surgical case reports · 2023
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 6 institutions in 1 country.

Patricia McGuireWashington University, St Louis, MO, USA and a clinical editor for Aesthetic Surgery Journal.ORCID 0000-0003-4246-3778
Caroline GlicksmanHackensack Meridian School of Medicine, Nutley, NJ, USA and a clinical editor for Aesthetic Surgery Journal.
Roger WixtromLSCI, Springfield, VA, USA.
C James SungWarren Alpert School of Medicine of Brown University, Providence, RI, USA.
Robert HamiltonJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Marisa Lawrenceplastic surgeon in private practice, Atlanta, GA, USA.
Melinda HawsVanderbilt University, Nashville, TN, USA.
Sarah FerenzChicago Medical School, North Chicago, IL, USA.
Marshall KadinBrown University Alpert School of Medicine, Providence, RI, USA.
Brown University · USCenter for Discovery · USJohns Hopkins University · USRosalind Franklin University of Medicine and Science · USVanderbilt University · USWashington University in St. Louis · US

Funding

Aesthetic Surgery Education and Research Foundation
6 · The paper itself

Abstract

backgroundThere 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.

objectivesThe 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.

methodsA 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.

resultsNo 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.

conclusionsThis study adds to the current literature by demonstrating few identifiable biomedical markers to explain the systemic symptoms self-reported by patients with BII.

Indexed as

Breast ImplantsEnterotoxinsCytokinesFemaleHumansImmunoglobulin GProspective StudiesCytokinesEnterotoxinsImmunoglobulin G

Identifiers

PMID35980942
PMCPMC9896138
OpenAlexW4293068241

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.