Management of Symptomatic Patients with Textured Implants
Proper management of symptomatic textured implant patients is critical to identify and treat associated oncologic disease. Textured surface breast implants were first introduced more than 50 years ago in an effort to decrease high rates of capsular contracture and implant malposition observed with f...
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Veröffentlicht in: | Plastic and reconstructive surgery (1963) 2021-05, Vol.147 (5S), p.58S-68S |
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container_title | Plastic and reconstructive surgery (1963) |
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creator | Asaad, Malke Offodile, Anaeze C. Santanelli Di Pompeo, Fabio Bevers, Therese B. Stelly, Sharon Carew, Lori A. Barnea, Yoav Miranda, Roberto N. Butler, Charles E. Clemens, Mark W. |
description | Proper management of symptomatic textured implant patients is critical to identify and treat associated oncologic disease. Textured surface breast implants were first introduced more than 50 years ago in an effort to decrease high rates of capsular contracture and implant malposition observed with first-generation smooth surface breast implants. Textured implants were dominant over smooth devices in the United States in the late 1990s, but they fell out of favor for newer-generation smooth implants, while texture remained the dominant selling implants worldwide until recently. A class I device recall by the US Food and Drug Administration in 2019 precipitated a removal of the highest selling implant worldwide, Allergan Biocell, due to a disproportionately increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Operative strategies, such as bacterial control at the time of textured implant insertion, have not been credibly shown to affect or prevent the future development of BIA-ALCL. BIA-ALCL patients require complete surgical excision of their disease, whereas textured implant patients who are otherwise asymptomatic do not require surgical removal. For suspicious cases, diagnostic testing with CD30 immunohistochemistry should be performed before any surgical intervention. Capsules are evaluated with 12 strategic regional biopsies in a standardized approach. If surgeons are revising or exchanging textured implants, they may reasonably consider a total capsulectomy, though this is not advocated by the Food and Drug Administration or national societies, and has not been shown to mitigate future risk of BIA-ALCL. The purpose of this article is to review data on and outcomes for textured surface implants, disease-associated risk, and the management strategy for revisionary surgery and device surveillance. |
doi_str_mv | 10.1097/PRS.0000000000008047 |
format | Article |
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Textured surface breast implants were first introduced more than 50 years ago in an effort to decrease high rates of capsular contracture and implant malposition observed with first-generation smooth surface breast implants. Textured implants were dominant over smooth devices in the United States in the late 1990s, but they fell out of favor for newer-generation smooth implants, while texture remained the dominant selling implants worldwide until recently. A class I device recall by the US Food and Drug Administration in 2019 precipitated a removal of the highest selling implant worldwide, Allergan Biocell, due to a disproportionately increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Operative strategies, such as bacterial control at the time of textured implant insertion, have not been credibly shown to affect or prevent the future development of BIA-ALCL. BIA-ALCL patients require complete surgical excision of their disease, whereas textured implant patients who are otherwise asymptomatic do not require surgical removal. For suspicious cases, diagnostic testing with CD30 immunohistochemistry should be performed before any surgical intervention. Capsules are evaluated with 12 strategic regional biopsies in a standardized approach. If surgeons are revising or exchanging textured implants, they may reasonably consider a total capsulectomy, though this is not advocated by the Food and Drug Administration or national societies, and has not been shown to mitigate future risk of BIA-ALCL. The purpose of this article is to review data on and outcomes for textured surface implants, disease-associated risk, and the management strategy for revisionary surgery and device surveillance.</description><identifier>ISSN: 0032-1052</identifier><identifier>EISSN: 1529-4242</identifier><identifier>DOI: 10.1097/PRS.0000000000008047</identifier><identifier>PMID: 33890882</identifier><language>eng</language><publisher>United States: Lippincott Williams & Wilkins</publisher><subject>Breast Implantation - legislation & jurisprudence ; Breast Implants - adverse effects ; Breast Neoplasms - etiology ; Breast Neoplasms - surgery ; Device Removal - methods ; Disease Management ; Equipment Failure ; Female ; Humans ; Lymphoma, Large-Cell, Anaplastic - etiology ; Lymphoma, Large-Cell, Anaplastic - surgery ; Mammaplasty - methods ; Medical Device Recalls ; Patient Education as Topic ; Postoperative Complications - surgery ; Prosthesis Design ; Retrospective Studies ; Risk ; Silicone Gels ; Surface Properties ; Triage ; Truth Disclosure</subject><ispartof>Plastic and reconstructive surgery (1963), 2021-05, Vol.147 (5S), p.58S-68S</ispartof><rights>Lippincott Williams & Wilkins</rights><rights>Copyright © 2021 by the American Society of Plastic Surgeons.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3521-fc0c268470e87f6af49b60128fd823a7a7b73bcecca93de2993d691f2db521b53</citedby><cites>FETCH-LOGICAL-c3521-fc0c268470e87f6af49b60128fd823a7a7b73bcecca93de2993d691f2db521b53</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27923,27924</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33890882$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Asaad, Malke</creatorcontrib><creatorcontrib>Offodile, Anaeze C.</creatorcontrib><creatorcontrib>Santanelli Di Pompeo, Fabio</creatorcontrib><creatorcontrib>Bevers, Therese B.</creatorcontrib><creatorcontrib>Stelly, Sharon</creatorcontrib><creatorcontrib>Carew, Lori A.</creatorcontrib><creatorcontrib>Barnea, Yoav</creatorcontrib><creatorcontrib>Miranda, Roberto N.</creatorcontrib><creatorcontrib>Butler, Charles E.</creatorcontrib><creatorcontrib>Clemens, Mark W.</creatorcontrib><title>Management of Symptomatic Patients with Textured Implants</title><title>Plastic and reconstructive surgery (1963)</title><addtitle>Plast Reconstr Surg</addtitle><description>Proper management of symptomatic textured implant patients is critical to identify and treat associated oncologic disease. Textured surface breast implants were first introduced more than 50 years ago in an effort to decrease high rates of capsular contracture and implant malposition observed with first-generation smooth surface breast implants. Textured implants were dominant over smooth devices in the United States in the late 1990s, but they fell out of favor for newer-generation smooth implants, while texture remained the dominant selling implants worldwide until recently. A class I device recall by the US Food and Drug Administration in 2019 precipitated a removal of the highest selling implant worldwide, Allergan Biocell, due to a disproportionately increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Operative strategies, such as bacterial control at the time of textured implant insertion, have not been credibly shown to affect or prevent the future development of BIA-ALCL. BIA-ALCL patients require complete surgical excision of their disease, whereas textured implant patients who are otherwise asymptomatic do not require surgical removal. For suspicious cases, diagnostic testing with CD30 immunohistochemistry should be performed before any surgical intervention. Capsules are evaluated with 12 strategic regional biopsies in a standardized approach. If surgeons are revising or exchanging textured implants, they may reasonably consider a total capsulectomy, though this is not advocated by the Food and Drug Administration or national societies, and has not been shown to mitigate future risk of BIA-ALCL. The purpose of this article is to review data on and outcomes for textured surface implants, disease-associated risk, and the management strategy for revisionary surgery and device surveillance.</description><subject>Breast Implantation - legislation & jurisprudence</subject><subject>Breast Implants - adverse effects</subject><subject>Breast Neoplasms - etiology</subject><subject>Breast Neoplasms - surgery</subject><subject>Device Removal - methods</subject><subject>Disease Management</subject><subject>Equipment Failure</subject><subject>Female</subject><subject>Humans</subject><subject>Lymphoma, Large-Cell, Anaplastic - etiology</subject><subject>Lymphoma, Large-Cell, Anaplastic - surgery</subject><subject>Mammaplasty - methods</subject><subject>Medical Device Recalls</subject><subject>Patient Education as Topic</subject><subject>Postoperative Complications - surgery</subject><subject>Prosthesis Design</subject><subject>Retrospective Studies</subject><subject>Risk</subject><subject>Silicone Gels</subject><subject>Surface Properties</subject><subject>Triage</subject><subject>Truth Disclosure</subject><issn>0032-1052</issn><issn>1529-4242</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkGtLwzAUhoMobk7_gUj_QObJpU3yUYaXwcTh5ueSpombtmtJOur-vdF5w_PhHHjheeE8CJ0TGBNQ4nL-uBjDn5HAxQEakpQqzCmnh2gIwCgmkNIBOgnhBYAIlqXHaMCYVCAlHSJ1rzf62dZ20yWNSxa7uu2aWndrk8zjjnFI-nW3Spb2rdt6WybTuq10jE_RkdNVsGdfd4Sebq6Xkzs8e7idTq5m2LCUEuwMGJpJLsBK4TLtuCoyIFS6UlKmhRaFYIWxxmjFSktV3JkijpZFxIuUjRDf9xrfhOCty1u_rrXf5QTyDxN5NJH_NxGxiz3Wbovalj_Q9-u_vX1TddaH12rbW5-vrK661WdfljKOKdBoMKrDMSGEvQOjlGjG</recordid><startdate>20210501</startdate><enddate>20210501</enddate><creator>Asaad, Malke</creator><creator>Offodile, Anaeze C.</creator><creator>Santanelli Di Pompeo, Fabio</creator><creator>Bevers, Therese B.</creator><creator>Stelly, Sharon</creator><creator>Carew, Lori A.</creator><creator>Barnea, Yoav</creator><creator>Miranda, Roberto N.</creator><creator>Butler, Charles E.</creator><creator>Clemens, Mark W.</creator><general>Lippincott Williams & Wilkins</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>20210501</creationdate><title>Management of Symptomatic Patients with Textured Implants</title><author>Asaad, Malke ; Offodile, Anaeze C. ; Santanelli Di Pompeo, Fabio ; Bevers, Therese B. ; Stelly, Sharon ; Carew, Lori A. ; Barnea, Yoav ; Miranda, Roberto N. ; Butler, Charles E. ; Clemens, Mark W.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3521-fc0c268470e87f6af49b60128fd823a7a7b73bcecca93de2993d691f2db521b53</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Breast Implantation - legislation & jurisprudence</topic><topic>Breast Implants - adverse effects</topic><topic>Breast Neoplasms - etiology</topic><topic>Breast Neoplasms - surgery</topic><topic>Device Removal - methods</topic><topic>Disease Management</topic><topic>Equipment Failure</topic><topic>Female</topic><topic>Humans</topic><topic>Lymphoma, Large-Cell, Anaplastic - etiology</topic><topic>Lymphoma, Large-Cell, Anaplastic - surgery</topic><topic>Mammaplasty - methods</topic><topic>Medical Device Recalls</topic><topic>Patient Education as Topic</topic><topic>Postoperative Complications - surgery</topic><topic>Prosthesis Design</topic><topic>Retrospective Studies</topic><topic>Risk</topic><topic>Silicone Gels</topic><topic>Surface Properties</topic><topic>Triage</topic><topic>Truth Disclosure</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Asaad, Malke</creatorcontrib><creatorcontrib>Offodile, Anaeze C.</creatorcontrib><creatorcontrib>Santanelli Di Pompeo, Fabio</creatorcontrib><creatorcontrib>Bevers, Therese B.</creatorcontrib><creatorcontrib>Stelly, Sharon</creatorcontrib><creatorcontrib>Carew, Lori A.</creatorcontrib><creatorcontrib>Barnea, Yoav</creatorcontrib><creatorcontrib>Miranda, Roberto N.</creatorcontrib><creatorcontrib>Butler, Charles E.</creatorcontrib><creatorcontrib>Clemens, Mark W.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><jtitle>Plastic and reconstructive surgery (1963)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Asaad, Malke</au><au>Offodile, Anaeze C.</au><au>Santanelli Di Pompeo, Fabio</au><au>Bevers, Therese B.</au><au>Stelly, Sharon</au><au>Carew, Lori A.</au><au>Barnea, Yoav</au><au>Miranda, Roberto N.</au><au>Butler, Charles E.</au><au>Clemens, Mark W.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Management of Symptomatic Patients with Textured Implants</atitle><jtitle>Plastic and reconstructive surgery (1963)</jtitle><addtitle>Plast Reconstr Surg</addtitle><date>2021-05-01</date><risdate>2021</risdate><volume>147</volume><issue>5S</issue><spage>58S</spage><epage>68S</epage><pages>58S-68S</pages><issn>0032-1052</issn><eissn>1529-4242</eissn><abstract>Proper management of symptomatic textured implant patients is critical to identify and treat associated oncologic disease. Textured surface breast implants were first introduced more than 50 years ago in an effort to decrease high rates of capsular contracture and implant malposition observed with first-generation smooth surface breast implants. Textured implants were dominant over smooth devices in the United States in the late 1990s, but they fell out of favor for newer-generation smooth implants, while texture remained the dominant selling implants worldwide until recently. A class I device recall by the US Food and Drug Administration in 2019 precipitated a removal of the highest selling implant worldwide, Allergan Biocell, due to a disproportionately increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Operative strategies, such as bacterial control at the time of textured implant insertion, have not been credibly shown to affect or prevent the future development of BIA-ALCL. BIA-ALCL patients require complete surgical excision of their disease, whereas textured implant patients who are otherwise asymptomatic do not require surgical removal. For suspicious cases, diagnostic testing with CD30 immunohistochemistry should be performed before any surgical intervention. Capsules are evaluated with 12 strategic regional biopsies in a standardized approach. If surgeons are revising or exchanging textured implants, they may reasonably consider a total capsulectomy, though this is not advocated by the Food and Drug Administration or national societies, and has not been shown to mitigate future risk of BIA-ALCL. The purpose of this article is to review data on and outcomes for textured surface implants, disease-associated risk, and the management strategy for revisionary surgery and device surveillance.</abstract><cop>United States</cop><pub>Lippincott Williams & Wilkins</pub><pmid>33890882</pmid><doi>10.1097/PRS.0000000000008047</doi></addata></record> |
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subjects | Breast Implantation - legislation & jurisprudence Breast Implants - adverse effects Breast Neoplasms - etiology Breast Neoplasms - surgery Device Removal - methods Disease Management Equipment Failure Female Humans Lymphoma, Large-Cell, Anaplastic - etiology Lymphoma, Large-Cell, Anaplastic - surgery Mammaplasty - methods Medical Device Recalls Patient Education as Topic Postoperative Complications - surgery Prosthesis Design Retrospective Studies Risk Silicone Gels Surface Properties Triage Truth Disclosure |
title | Management of Symptomatic Patients with Textured Implants |
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