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Impact of Capsulectomy Type on Post-Explantation Systemic Symptom Improvement: Findings From the ASERF Systemic Symptoms in Women-Biospecimen Analysis Study: Part 1

BACKGROUND: Breast Implant Illness (BII) is a term used to describe a variety of symptoms by patients with breast implants for which there are no abnormal physical or laboratory findings to explain their symptoms. There currently exists a difference of opinion among clinicians and patients concernin...

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Autores principales: Glicksman, Caroline, McGuire, Patricia, Kadin, Marshall, Lawrence, Marisa, Haws, Melinda, Newby, Jill, Ferenz, Sarah, Sung, James, Wixtrom, Roger
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9208825/
https://www.ncbi.nlm.nih.gov/pubmed/34915566
http://dx.doi.org/10.1093/asj/sjab417
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author Glicksman, Caroline
McGuire, Patricia
Kadin, Marshall
Lawrence, Marisa
Haws, Melinda
Newby, Jill
Ferenz, Sarah
Sung, James
Wixtrom, Roger
author_facet Glicksman, Caroline
McGuire, Patricia
Kadin, Marshall
Lawrence, Marisa
Haws, Melinda
Newby, Jill
Ferenz, Sarah
Sung, James
Wixtrom, Roger
author_sort Glicksman, Caroline
collection PubMed
description BACKGROUND: Breast Implant Illness (BII) is a term used to describe a variety of symptoms by patients with breast implants for which there are no abnormal physical or laboratory findings to explain their symptoms. There currently exists a difference of opinion among clinicians and patients concerning the diagnosis and treatment of patients self-reporting BII. OBJECTIVES: The first aim of this study was to determine if there is a valid indication for “en bloc” capsulectomy in patients self-reporting BII and if the type of capsulectomy performed alters long-term symptom improvement. The second goal was to identify any clinical laboratory differences between the cohorts. This study was funded by the Aesthetic Surgery Education and Research Foundation (ASERF). METHODS: A prospective blinded study enrolled 150 consecutive subjects divided equally into 3 cohorts: (A) women with systemic symptoms they attribute to their implants who requested implant removal; (B) women with breast implants requesting removal or exchange who do not have symptoms they attribute to their implants; and (C) women undergoing cosmetic mastopexy who have never had any implanted medical device. The subject’s baseline demographic data and a systemic symptoms survey, including PROMIS validated questionnaires, was obtained before surgery and at 3-6 weeks, 6 months, and 1 year. Blood was collected from all 3 cohorts and implant capsules were collected from Cohorts A and B. RESULTS: 150 patients were enrolled between 2019-2021. Follow-up at 3-6 weeks for all 3 cohorts was between 98%-100%, 78%-98% at 6-months, and 1 year data is currently at 80%. The type of capsulectomy; intact total, total, or partial all showed similar symptom improvement with no statistical difference in the reduction of symptoms based on the type of capsulectomy. CONCLUSIONS: This study addresses one of the most discussed questions by plastic surgeons, patients, their advocates, and social media. The findings show that patients who self-report BII demonstrate a statistically significant improvement in their symptoms after explantation and that this improvement persists for at least 6 months. This improvement in self-reported systemic symptoms was seen regardless of the type of capsulectomy performed. LEVEL OF EVIDENCE: 2: [Image: see text]
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spelling pubmed-92088252022-06-21 Impact of Capsulectomy Type on Post-Explantation Systemic Symptom Improvement: Findings From the ASERF Systemic Symptoms in Women-Biospecimen Analysis Study: Part 1 Glicksman, Caroline McGuire, Patricia Kadin, Marshall Lawrence, Marisa Haws, Melinda Newby, Jill Ferenz, Sarah Sung, James Wixtrom, Roger Aesthet Surg J Research BACKGROUND: Breast Implant Illness (BII) is a term used to describe a variety of symptoms by patients with breast implants for which there are no abnormal physical or laboratory findings to explain their symptoms. There currently exists a difference of opinion among clinicians and patients concerning the diagnosis and treatment of patients self-reporting BII. OBJECTIVES: The first aim of this study was to determine if there is a valid indication for “en bloc” capsulectomy in patients self-reporting BII and if the type of capsulectomy performed alters long-term symptom improvement. The second goal was to identify any clinical laboratory differences between the cohorts. This study was funded by the Aesthetic Surgery Education and Research Foundation (ASERF). METHODS: A prospective blinded study enrolled 150 consecutive subjects divided equally into 3 cohorts: (A) women with systemic symptoms they attribute to their implants who requested implant removal; (B) women with breast implants requesting removal or exchange who do not have symptoms they attribute to their implants; and (C) women undergoing cosmetic mastopexy who have never had any implanted medical device. The subject’s baseline demographic data and a systemic symptoms survey, including PROMIS validated questionnaires, was obtained before surgery and at 3-6 weeks, 6 months, and 1 year. Blood was collected from all 3 cohorts and implant capsules were collected from Cohorts A and B. RESULTS: 150 patients were enrolled between 2019-2021. Follow-up at 3-6 weeks for all 3 cohorts was between 98%-100%, 78%-98% at 6-months, and 1 year data is currently at 80%. The type of capsulectomy; intact total, total, or partial all showed similar symptom improvement with no statistical difference in the reduction of symptoms based on the type of capsulectomy. CONCLUSIONS: This study addresses one of the most discussed questions by plastic surgeons, patients, their advocates, and social media. The findings show that patients who self-report BII demonstrate a statistically significant improvement in their symptoms after explantation and that this improvement persists for at least 6 months. This improvement in self-reported systemic symptoms was seen regardless of the type of capsulectomy performed. LEVEL OF EVIDENCE: 2: [Image: see text] Oxford University Press 2021-12-16 /pmc/articles/PMC9208825/ /pubmed/34915566 http://dx.doi.org/10.1093/asj/sjab417 Text en © The Author(s) 2021. Published by Oxford University Press on behalf of The Aesthetic Society. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research
Glicksman, Caroline
McGuire, Patricia
Kadin, Marshall
Lawrence, Marisa
Haws, Melinda
Newby, Jill
Ferenz, Sarah
Sung, James
Wixtrom, Roger
Impact of Capsulectomy Type on Post-Explantation Systemic Symptom Improvement: Findings From the ASERF Systemic Symptoms in Women-Biospecimen Analysis Study: Part 1
title Impact of Capsulectomy Type on Post-Explantation Systemic Symptom Improvement: Findings From the ASERF Systemic Symptoms in Women-Biospecimen Analysis Study: Part 1
title_full Impact of Capsulectomy Type on Post-Explantation Systemic Symptom Improvement: Findings From the ASERF Systemic Symptoms in Women-Biospecimen Analysis Study: Part 1
title_fullStr Impact of Capsulectomy Type on Post-Explantation Systemic Symptom Improvement: Findings From the ASERF Systemic Symptoms in Women-Biospecimen Analysis Study: Part 1
title_full_unstemmed Impact of Capsulectomy Type on Post-Explantation Systemic Symptom Improvement: Findings From the ASERF Systemic Symptoms in Women-Biospecimen Analysis Study: Part 1
title_short Impact of Capsulectomy Type on Post-Explantation Systemic Symptom Improvement: Findings From the ASERF Systemic Symptoms in Women-Biospecimen Analysis Study: Part 1
title_sort impact of capsulectomy type on post-explantation systemic symptom improvement: findings from the aserf systemic symptoms in women-biospecimen analysis study: part 1
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9208825/
https://www.ncbi.nlm.nih.gov/pubmed/34915566
http://dx.doi.org/10.1093/asj/sjab417
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