Cargando…
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...
Autores principales: | , , , , , , , , |
---|---|
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 |
_version_ | 1784729800701640704 |
---|---|
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] |
format | Online Article Text |
id | pubmed-9208825 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT glicksmancaroline impactofcapsulectomytypeonpostexplantationsystemicsymptomimprovementfindingsfromtheaserfsystemicsymptomsinwomenbiospecimenanalysisstudypart1 AT mcguirepatricia impactofcapsulectomytypeonpostexplantationsystemicsymptomimprovementfindingsfromtheaserfsystemicsymptomsinwomenbiospecimenanalysisstudypart1 AT kadinmarshall impactofcapsulectomytypeonpostexplantationsystemicsymptomimprovementfindingsfromtheaserfsystemicsymptomsinwomenbiospecimenanalysisstudypart1 AT lawrencemarisa impactofcapsulectomytypeonpostexplantationsystemicsymptomimprovementfindingsfromtheaserfsystemicsymptomsinwomenbiospecimenanalysisstudypart1 AT hawsmelinda impactofcapsulectomytypeonpostexplantationsystemicsymptomimprovementfindingsfromtheaserfsystemicsymptomsinwomenbiospecimenanalysisstudypart1 AT newbyjill impactofcapsulectomytypeonpostexplantationsystemicsymptomimprovementfindingsfromtheaserfsystemicsymptomsinwomenbiospecimenanalysisstudypart1 AT ferenzsarah impactofcapsulectomytypeonpostexplantationsystemicsymptomimprovementfindingsfromtheaserfsystemicsymptomsinwomenbiospecimenanalysisstudypart1 AT sungjames impactofcapsulectomytypeonpostexplantationsystemicsymptomimprovementfindingsfromtheaserfsystemicsymptomsinwomenbiospecimenanalysisstudypart1 AT wixtromroger impactofcapsulectomytypeonpostexplantationsystemicsymptomimprovementfindingsfromtheaserfsystemicsymptomsinwomenbiospecimenanalysisstudypart1 |