Silicone gel breast implant failure and frequency of additional surgeries: Analysis of 35 studies reporting examination of more than 8000 explants
Identifieur interne : 001E34 ( Istex/Corpus ); précédent : 001E33; suivant : 001E35Silicone gel breast implant failure and frequency of additional surgeries: Analysis of 35 studies reporting examination of more than 8000 explants
Auteurs : James S. Marotta ; Christopher W. Widenhouse ; Mutaz B. Habal ; Eugene P. GoldbergSource :
- Journal of Biomedical Materials Research [ 0021-9304 ] ; 1999.
English descriptors
- KwdEn :
Abstract
Although it is well known that silicone gel breast implants (SGBIs) produce many “local” complications (i.e., pain, hard fibrous capsules, disfigurement, chronic inflammation, implant shell failure) and necessitate frequent surgical revisions, no large cohort retrospective quantitative analysis of clinical data has been reported to date, especially for the prevalence of failures and additional surgeries. Data from 35 different studies that encompass more than 8000 explanted SGBIs have now been analyzed and are reported here. Because examination of a prosthesis when explanted is the definitive method for determining shell integrity, the only studies that were used were ones that reported implant duration, the total number of SGBIs explanted, and the number of SGBIs for which shell rupture or failure (“not intact”) was confirmed upon surgical removal. An exponential regression plot of data indicated a direct correlation of implant duration with percent shell failure (r2 = 0.63 and r = 0.79 ). SGBI failure was found to be 30% at 5 years, 50% at 10 years, and 70% at 17 years. The failure rate was 6% per year during the first 5 years following primary implant surgery. ANOVA comparison of three implant age groups (mean implant durations of 3.9, 10.2, and 18.9 years) indicated a highly significant statistical correlation of percent failure with implant duration (p < 0.001). Complications necessitating at least one additional surgery occurred for 33% of implants within 6 years following primary implant surgery. Shell failure was found to be an order of magnitude greater than the 4 to 6% rupture prevalence suggested by the AMA Council on Scientific Affairs in 1993, the 0.2 to 1.1% cited by manufacturers at that time, and the 5% rupture that was stated to be “not a safety standard that the FDA can accept.” © 1999 John Wiley & Sons, Inc. J Biomed Mater Res (Appl Biomater) 48: 354–364, 1999
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DOI: 10.1002/(SICI)1097-4636(1999)48:3<354::AID-JBM21>3.0.CO;2-#
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ISTEX:CE2E9C6A2BB04A400A18FACFAEA3B0D63AA795CBLe document en format XML
<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Silicone gel breast implant failure and frequency of additional surgeries: Analysis of 35 studies reporting examination of more than 8000 explants</title><author><name sortKey="Marotta, James S" sort="Marotta, James S" uniqKey="Marotta J" first="James S." last="Marotta">James S. Marotta</name><affiliation><mods:affiliation>Biomaterials Center, Department of Materials Science and Engineering, University of Florida, Gainesville, Florida</mods:affiliation></affiliation></author><author><name sortKey="Widenhouse, Christopher W" sort="Widenhouse, Christopher W" uniqKey="Widenhouse C" first="Christopher W." last="Widenhouse">Christopher W. Widenhouse</name><affiliation><mods:affiliation>Biomaterials Center, Department of Materials Science and Engineering, University of Florida, Gainesville, Florida</mods:affiliation></affiliation></author><author><name sortKey="Habal, Mutaz B" sort="Habal, Mutaz B" uniqKey="Habal M" first="Mutaz B." last="Habal">Mutaz B. Habal</name><affiliation><mods:affiliation>Biomaterials Center, Department of Materials Science and Engineering, University of Florida, Gainesville, Florida</mods:affiliation></affiliation><affiliation><mods:affiliation>Tampa Bay Craniofacial and Plastic Surgery Center, Tampa, Florida</mods:affiliation></affiliation></author><author><name sortKey="Goldberg, Eugene P" sort="Goldberg, Eugene P" uniqKey="Goldberg E" first="Eugene P." last="Goldberg">Eugene P. Goldberg</name><affiliation><mods:affiliation>Biomaterials Center, Department of Materials Science and Engineering, University of Florida, Gainesville, Florida</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:CE2E9C6A2BB04A400A18FACFAEA3B0D63AA795CB</idno><date when="1999" year="1999">1999</date><idno type="doi">10.1002/(SICI)1097-4636(1999)48:3<354::AID-JBM21>3.0.CO;2-#</idno><idno type="url">https://api.istex.fr/document/CE2E9C6A2BB04A400A18FACFAEA3B0D63AA795CB/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">001E34</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Silicone gel breast implant failure and frequency of additional surgeries: Analysis of 35 studies reporting examination of more than 8000 explants</title><author><name sortKey="Marotta, James S" sort="Marotta, James S" uniqKey="Marotta J" first="James S." last="Marotta">James S. Marotta</name><affiliation><mods:affiliation>Biomaterials Center, Department of Materials Science and Engineering, University of Florida, Gainesville, Florida</mods:affiliation></affiliation></author><author><name sortKey="Widenhouse, Christopher W" sort="Widenhouse, Christopher W" uniqKey="Widenhouse C" first="Christopher W." last="Widenhouse">Christopher W. Widenhouse</name><affiliation><mods:affiliation>Biomaterials Center, Department of Materials Science and Engineering, University of Florida, Gainesville, Florida</mods:affiliation></affiliation></author><author><name sortKey="Habal, Mutaz B" sort="Habal, Mutaz B" uniqKey="Habal M" first="Mutaz B." last="Habal">Mutaz B. Habal</name><affiliation><mods:affiliation>Biomaterials Center, Department of Materials Science and Engineering, University of Florida, Gainesville, Florida</mods:affiliation></affiliation><affiliation><mods:affiliation>Tampa Bay Craniofacial and Plastic Surgery Center, Tampa, Florida</mods:affiliation></affiliation></author><author><name sortKey="Goldberg, Eugene P" sort="Goldberg, Eugene P" uniqKey="Goldberg E" first="Eugene P." last="Goldberg">Eugene P. Goldberg</name><affiliation><mods:affiliation>Biomaterials Center, Department of Materials Science and Engineering, University of Florida, Gainesville, Florida</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Journal of Biomedical Materials Research</title><title level="j" type="sub">An Official Journal of The Society for Biomaterials, The Japanese Society for Biomaterials, and The Australian Society for Biomaterials</title><title level="j" type="abbrev">J. Biomed. Mater. Res.</title><idno type="ISSN">0021-9304</idno><idno type="eISSN">1097-4636</idno><imprint><publisher>John Wiley & Sons, Inc.</publisher><pubPlace>New York</pubPlace><date type="published" when="1999">1999</date><biblScope unit="volume">48</biblScope><biblScope unit="issue">3</biblScope><biblScope unit="page" from="354">354</biblScope><biblScope unit="page" to="364">364</biblScope></imprint><idno type="ISSN">0021-9304</idno></series><idno type="istex">CE2E9C6A2BB04A400A18FACFAEA3B0D63AA795CB</idno><idno type="DOI">10.1002/(SICI)1097-4636(1999)48:3<354::AID-JBM21>3.0.CO;2-#</idno><idno type="ArticleID">JBM21</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0021-9304</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>explant analysis</term><term>failure</term><term>rupture</term><term>silicone gel breast implants</term><term>silicone implant complications</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Although it is well known that silicone gel breast implants (SGBIs) produce many “local” complications (i.e., pain, hard fibrous capsules, disfigurement, chronic inflammation, implant shell failure) and necessitate frequent surgical revisions, no large cohort retrospective quantitative analysis of clinical data has been reported to date, especially for the prevalence of failures and additional surgeries. Data from 35 different studies that encompass more than 8000 explanted SGBIs have now been analyzed and are reported here. Because examination of a prosthesis when explanted is the definitive method for determining shell integrity, the only studies that were used were ones that reported implant duration, the total number of SGBIs explanted, and the number of SGBIs for which shell rupture or failure (“not intact”) was confirmed upon surgical removal. An exponential regression plot of data indicated a direct correlation of implant duration with percent shell failure (r2 = 0.63 and r = 0.79 ). SGBI failure was found to be 30% at 5 years, 50% at 10 years, and 70% at 17 years. The failure rate was 6% per year during the first 5 years following primary implant surgery. ANOVA comparison of three implant age groups (mean implant durations of 3.9, 10.2, and 18.9 years) indicated a highly significant statistical correlation of percent failure with implant duration (p < 0.001). Complications necessitating at least one additional surgery occurred for 33% of implants within 6 years following primary implant surgery. Shell failure was found to be an order of magnitude greater than the 4 to 6% rupture prevalence suggested by the AMA Council on Scientific Affairs in 1993, the 0.2 to 1.1% cited by manufacturers at that time, and the 5% rupture that was stated to be “not a safety standard that the FDA can accept.” © 1999 John Wiley & Sons, Inc. J Biomed Mater Res (Appl Biomater) 48: 354–364, 1999</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>James S. Marotta</name><affiliations><json:string>Biomaterials Center, Department of Materials Science and Engineering, University of Florida, Gainesville, Florida</json:string></affiliations></json:item><json:item><name>Christopher W. Widenhouse</name><affiliations><json:string>Biomaterials Center, Department of Materials Science and Engineering, University of Florida, Gainesville, Florida</json:string></affiliations></json:item><json:item><name>Mutaz B. Habal</name><affiliations><json:string>Biomaterials Center, Department of Materials Science and Engineering, University of Florida, Gainesville, Florida</json:string><json:string>Tampa Bay Craniofacial and Plastic Surgery Center, Tampa, Florida</json:string></affiliations></json:item><json:item><name>Eugene P. Goldberg</name><affiliations><json:string>Biomaterials Center, Department of Materials Science and Engineering, University of Florida, Gainesville, Florida</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>silicone gel breast implants</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>explant analysis</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>silicone implant complications</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>failure</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>rupture</value></json:item></subject><articleId><json:string>JBM21</json:string></articleId><language><json:string>eng</json:string></language><abstract>Although it is well known that silicone gel breast implants (SGBIs) produce many “local” complications (i.e., pain, hard fibrous capsules, disfigurement, chronic inflammation, implant shell failure) and necessitate frequent surgical revisions, no large cohort retrospective quantitative analysis of clinical data has been reported to date, especially for the prevalence of failures and additional surgeries. Data from 35 different studies that encompass more than 8000 explanted SGBIs have now been analyzed and are reported here. Because examination of a prosthesis when explanted is the definitive method for determining shell integrity, the only studies that were used were ones that reported implant duration, the total number of SGBIs explanted, and the number of SGBIs for which shell rupture or failure (“not intact”) was confirmed upon surgical removal. An exponential regression plot of data indicated a direct correlation of implant duration with percent shell failure (r2 = 0.63 and r = 0.79 ). SGBI failure was found to be 30% at 5 years, 50% at 10 years, and 70% at 17 years. The failure rate was 6% per year during the first 5 years following primary implant surgery. ANOVA comparison of three implant age groups (mean implant durations of 3.9, 10.2, and 18.9 years) indicated a highly significant statistical correlation of percent failure with implant duration (p > 0.001). Complications necessitating at least one additional surgery occurred for 33% of implants within 6 years following primary implant surgery. Shell failure was found to be an order of magnitude greater than the 4 to 6% rupture prevalence suggested by the AMA Council on Scientific Affairs in 1993, the 0.2 to 1.1% cited by manufacturers at that time, and the 5% rupture that was stated to be “not a safety standard that the FDA can accept.” © 1999 John Wiley & Sons, Inc. J Biomed Mater Res (Appl Biomater) 48: 354–364, 1999</abstract><qualityIndicators><score>8</score><pdfVersion>1.2</pdfVersion><pdfPageSize>612 x 792 pts (letter)</pdfPageSize><refBibsNative>true</refBibsNative><keywordCount>5</keywordCount><abstractCharCount>1911</abstractCharCount><pdfWordCount>8009</pdfWordCount><pdfCharCount>48329</pdfCharCount><pdfPageCount>11</pdfPageCount><abstractWordCount>307</abstractWordCount></qualityIndicators><title>Silicone gel breast implant failure and frequency of additional surgeries: Analysis of 35 studies reporting examination of more than 8000 explants</title><genre.original><json:string>article</json:string></genre.original><genre><json:string>article</json:string></genre><host><volume>48</volume><publisherId><json:string>JBM</json:string></publisherId><pages><total>11</total><last>364</last><first>354</first></pages><issn><json:string>0021-9304</json:string></issn><issue>3</issue><subject><json:item><value>Clinical Device Evaluation</value></json:item></subject><genre><json:string>journal</json:string></genre><language><json:string>unknown</json:string></language><eissn><json:string>1097-4636</json:string></eissn><title>Journal of Biomedical Materials Research</title><doi><json:string>10.1002/(ISSN)1097-4636</json:string></doi></host><publicationDate>1999</publicationDate><copyrightDate>1999</copyrightDate><doi><json:string>10.1002/(SICI)1097-4636(1999)48:3>354::AID-JBM21>3.0.CO;2-#</json:string></doi><id>CE2E9C6A2BB04A400A18FACFAEA3B0D63AA795CB</id><score>1</score><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/CE2E9C6A2BB04A400A18FACFAEA3B0D63AA795CB/fulltext/pdf</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/CE2E9C6A2BB04A400A18FACFAEA3B0D63AA795CB/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/CE2E9C6A2BB04A400A18FACFAEA3B0D63AA795CB/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">Silicone gel breast implant failure and frequency of additional surgeries: Analysis of 35 studies reporting examination of more than 8000 explants</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>John Wiley & Sons, Inc.</publisher><pubPlace>New York</pubPlace><availability><p>WILEY</p></availability><date>1999</date></publicationStmt><notesStmt><note type="content">*None of the authors has a financial interest in or financial relationship with any company whose product was studied in this research. One author (E.P.G.) served as a consultant in breast implant litigation both on behalf of women as plaintiffs and plastic surgeons as defendants.</note><note>University of Florida Foundation</note><note>Biomaterials Center</note><note>Department of Materials Science and Engineering</note><note>University of Florida</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Silicone gel breast implant failure and frequency of additional surgeries: Analysis of 35 studies reporting examination of more than 8000 explants</title><author><persName><forename type="first">James S.</forename><surname>Marotta</surname></persName><affiliation>Biomaterials Center, Department of Materials Science and Engineering, University of Florida, Gainesville, Florida</affiliation></author><author><persName><forename type="first">Christopher W.</forename><surname>Widenhouse</surname></persName><affiliation>Biomaterials Center, Department of Materials Science and Engineering, University of Florida, Gainesville, Florida</affiliation></author><author><persName><forename type="first">Mutaz B.</forename><surname>Habal</surname></persName><affiliation>Biomaterials Center, Department of Materials Science and Engineering, University of Florida, Gainesville, Florida</affiliation><affiliation>Tampa Bay Craniofacial and Plastic Surgery Center, Tampa, Florida</affiliation></author><author><persName><forename type="first">Eugene P.</forename><surname>Goldberg</surname></persName><note type="correspondence"><p>Correspondence: Biomaterials Center, Dept. Materials Science, 317 MAE, University of Florida, Gainsville, FL 32611</p></note><affiliation>Biomaterials Center, Department of Materials Science and Engineering, University of Florida, Gainesville, Florida</affiliation></author></analytic><monogr><title level="j">Journal of Biomedical Materials Research</title><title level="j" type="sub">An Official Journal of The Society for Biomaterials, The Japanese Society for Biomaterials, and The Australian Society for Biomaterials</title><title level="j" type="abbrev">J. Biomed. Mater. Res.</title><idno type="pISSN">0021-9304</idno><idno type="eISSN">1097-4636</idno><idno type="DOI">10.1002/(ISSN)1097-4636</idno><imprint><publisher>John Wiley & Sons, Inc.</publisher><pubPlace>New York</pubPlace><date type="published" when="1999"></date><biblScope unit="volume">48</biblScope><biblScope unit="issue">3</biblScope><biblScope unit="page" from="354">354</biblScope><biblScope unit="page" to="364">364</biblScope></imprint></monogr><idno type="istex">CE2E9C6A2BB04A400A18FACFAEA3B0D63AA795CB</idno><idno type="DOI">10.1002/(SICI)1097-4636(1999)48:3<354::AID-JBM21>3.0.CO;2-#</idno><idno type="ArticleID">JBM21</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>1999</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>Although it is well known that silicone gel breast implants (SGBIs) produce many “local” complications (i.e., pain, hard fibrous capsules, disfigurement, chronic inflammation, implant shell failure) and necessitate frequent surgical revisions, no large cohort retrospective quantitative analysis of clinical data has been reported to date, especially for the prevalence of failures and additional surgeries. Data from 35 different studies that encompass more than 8000 explanted SGBIs have now been analyzed and are reported here. Because examination of a prosthesis when explanted is the definitive method for determining shell integrity, the only studies that were used were ones that reported implant duration, the total number of SGBIs explanted, and the number of SGBIs for which shell rupture or failure (“not intact”) was confirmed upon surgical removal. An exponential regression plot of data indicated a direct correlation of implant duration with percent shell failure (r2 = 0.63 and r = 0.79 ). SGBI failure was found to be 30% at 5 years, 50% at 10 years, and 70% at 17 years. The failure rate was 6% per year during the first 5 years following primary implant surgery. ANOVA comparison of three implant age groups (mean implant durations of 3.9, 10.2, and 18.9 years) indicated a highly significant statistical correlation of percent failure with implant duration (p < 0.001). Complications necessitating at least one additional surgery occurred for 33% of implants within 6 years following primary implant surgery. Shell failure was found to be an order of magnitude greater than the 4 to 6% rupture prevalence suggested by the AMA Council on Scientific Affairs in 1993, the 0.2 to 1.1% cited by manufacturers at that time, and the 5% rupture that was stated to be “not a safety standard that the FDA can accept.” © 1999 John Wiley & Sons, Inc. J Biomed Mater Res (Appl Biomater) 48: 354–364, 1999</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>keywords</head><item><term>silicone gel breast implants</term></item><item><term>explant analysis</term></item><item><term>silicone implant complications</term></item><item><term>failure</term></item><item><term>rupture</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>article-category</head><item><term>Clinical Device Evaluation</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="1998-11-02">Received</change><change when="1999-02-23">Registration</change><change when="1999">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/CE2E9C6A2BB04A400A18FACFAEA3B0D63AA795CB/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Wiley, elements deleted: body"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="yes"</istex:xmlDeclaration><istex:document><component version="2.0" type="serialArticle" xml:lang="en"><header><publicationMeta level="product"><publisherInfo><publisherName>John Wiley & Sons, Inc.</publisherName><publisherLoc>New York</publisherLoc></publisherInfo><doi registered="yes">10.1002/(ISSN)1097-4636</doi><issn type="print">0021-9304</issn><issn type="electronic">1097-4636</issn><idGroup><id type="product" value="JBM"></id></idGroup><titleGroup><title type="main" xml:lang="en" sort="JOURNAL OF BIOMEDICAL MATERIALS RESEARCH">Journal of Biomedical Materials Research</title><title type="subtitle">An Official Journal of The Society for Biomaterials, The Japanese Society for Biomaterials, and The Australian Society for Biomaterials</title><title type="short">J. 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Data from 35 different studies that encompass more than 8000 explanted SGBIs have now been analyzed and are reported here. Because examination of a prosthesis when explanted is the definitive method for determining shell integrity, the only studies that were used were ones that reported implant duration, the total number of SGBIs explanted, and the number of SGBIs for which shell rupture or failure (“not intact”) was confirmed upon surgical removal. An exponential regression plot of data indicated a direct correlation of implant duration with percent shell failure (<i>r</i><sup>2</sup> = 0.63 and <i>r</i> = 0.79 ). SGBI failure was found to be 30% at 5 years, 50% at 10 years, and 70% at 17 years. The failure rate was 6% per year during the first 5 years following primary implant surgery. ANOVA comparison of three implant age groups (mean implant durations of 3.9, 10.2, and 18.9 years) indicated a highly significant statistical correlation of percent failure with implant duration (<i>p</i> < 0.001). Complications necessitating at least one additional surgery occurred for 33% of implants within 6 years following primary implant surgery. Shell failure was found to be an order of magnitude greater than the 4 to 6% rupture prevalence suggested by the AMA Council on Scientific Affairs in 1993, the 0.2 to 1.1% cited by manufacturers at that time, and the 5% rupture that was stated to be “not a safety standard that the FDA can accept.” © 1999 John Wiley & Sons, Inc. J Biomed Mater Res (Appl Biomater) 48: 354–364, 1999</p></abstract></abstractGroup></contentMeta><noteGroup><note xml:id="fn1"><p>None of the authors has a financial interest in or financial relationship with any company whose product was studied in this research. One author (E.P.G.) served as a consultant in breast implant litigation both on behalf of women as plaintiffs and plastic surgeons as defendants.</p></note></noteGroup></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Silicone gel breast implant failure and frequency of additional surgeries: Analysis of 35 studies reporting examination of more than 8000 explants</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Silicone breast implant failure and additional surgeries</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Silicone gel breast implant failure and frequency of additional surgeries: Analysis of 35 studies reporting examination of more than 8000 explants</title></titleInfo><name type="personal"><namePart type="given">James S.</namePart><namePart type="family">Marotta</namePart><affiliation>Biomaterials Center, Department of Materials Science and Engineering, University of Florida, Gainesville, Florida</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Christopher W.</namePart><namePart type="family">Widenhouse</namePart><affiliation>Biomaterials Center, Department of Materials Science and Engineering, University of Florida, Gainesville, Florida</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Mutaz B.</namePart><namePart type="family">Habal</namePart><affiliation>Biomaterials Center, Department of Materials Science and Engineering, University of Florida, Gainesville, Florida</affiliation><affiliation>Tampa Bay Craniofacial and Plastic Surgery Center, Tampa, Florida</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Eugene P.</namePart><namePart type="family">Goldberg</namePart><affiliation>Biomaterials Center, Department of Materials Science and Engineering, University of Florida, Gainesville, Florida</affiliation><description>Correspondence: Biomaterials Center, Dept. Materials Science, 317 MAE, University of Florida, Gainsville, FL 32611</description><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="article" displayLabel="article"></genre><originInfo><publisher>John Wiley & Sons, Inc.</publisher><place><placeTerm type="text">New York</placeTerm></place><dateIssued encoding="w3cdtf">1999</dateIssued><dateCaptured encoding="w3cdtf">1998-11-02</dateCaptured><dateValid encoding="w3cdtf">1999-02-23</dateValid><copyrightDate encoding="w3cdtf">1999</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType><extent unit="figures">1</extent><extent unit="tables">3</extent><extent unit="references">71</extent><extent unit="words">8996</extent></physicalDescription><abstract lang="en">Although it is well known that silicone gel breast implants (SGBIs) produce many “local” complications (i.e., pain, hard fibrous capsules, disfigurement, chronic inflammation, implant shell failure) and necessitate frequent surgical revisions, no large cohort retrospective quantitative analysis of clinical data has been reported to date, especially for the prevalence of failures and additional surgeries. Data from 35 different studies that encompass more than 8000 explanted SGBIs have now been analyzed and are reported here. Because examination of a prosthesis when explanted is the definitive method for determining shell integrity, the only studies that were used were ones that reported implant duration, the total number of SGBIs explanted, and the number of SGBIs for which shell rupture or failure (“not intact”) was confirmed upon surgical removal. An exponential regression plot of data indicated a direct correlation of implant duration with percent shell failure (r2 = 0.63 and r = 0.79 ). SGBI failure was found to be 30% at 5 years, 50% at 10 years, and 70% at 17 years. The failure rate was 6% per year during the first 5 years following primary implant surgery. ANOVA comparison of three implant age groups (mean implant durations of 3.9, 10.2, and 18.9 years) indicated a highly significant statistical correlation of percent failure with implant duration (p < 0.001). Complications necessitating at least one additional surgery occurred for 33% of implants within 6 years following primary implant surgery. Shell failure was found to be an order of magnitude greater than the 4 to 6% rupture prevalence suggested by the AMA Council on Scientific Affairs in 1993, the 0.2 to 1.1% cited by manufacturers at that time, and the 5% rupture that was stated to be “not a safety standard that the FDA can accept.” © 1999 John Wiley & Sons, Inc. J Biomed Mater Res (Appl Biomater) 48: 354–364, 1999</abstract><note type="content">*None of the authors has a financial interest in or financial relationship with any company whose product was studied in this research. One author (E.P.G.) served as a consultant in breast implant litigation both on behalf of women as plaintiffs and plastic surgeons as defendants.</note><note type="funding">University of Florida Foundation</note><note type="funding">Biomaterials Center</note><note type="funding">Department of Materials Science and Engineering</note><note type="funding">University of Florida</note><subject lang="en"><genre>keywords</genre><topic>silicone gel breast implants</topic><topic>explant analysis</topic><topic>silicone implant complications</topic><topic>failure</topic><topic>rupture</topic></subject><relatedItem type="host"><titleInfo><title>Journal of Biomedical Materials Research</title><subTitle>An Official Journal of The Society for Biomaterials, The Japanese Society for Biomaterials, and The Australian Society for Biomaterials</subTitle></titleInfo><titleInfo type="abbreviated"><title>J. Biomed. Mater. Res.</title></titleInfo><genre type="journal">journal</genre><subject><genre>article-category</genre><topic>Clinical Device Evaluation</topic></subject><identifier type="ISSN">0021-9304</identifier><identifier type="eISSN">1097-4636</identifier><identifier type="DOI">10.1002/(ISSN)1097-4636</identifier><identifier type="PublisherID">JBM</identifier><part><date>1999</date><detail type="volume"><caption>vol.</caption><number>48</number></detail><detail type="issue"><caption>no.</caption><number>3</number></detail><extent unit="pages"><start>354</start><end>364</end><total>11</total></extent></part></relatedItem><relatedItem type="preceding"><titleInfo><title>Journal of Applied Biomaterials</title></titleInfo><identifier type="ISSN">1045-4861</identifier><part><date point="end">1995</date><detail type="volume"><caption>last vol.</caption><number>6</number></detail><detail type="issue"><caption>last no.</caption><number>4</number></detail></part></relatedItem><identifier type="istex">CE2E9C6A2BB04A400A18FACFAEA3B0D63AA795CB</identifier><identifier type="DOI">10.1002/(SICI)1097-4636(1999)48:3<354::AID-JBM21>3.0.CO;2-#</identifier><identifier type="ArticleID">JBM21</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 1999 John Wiley & Sons, Inc.</accessCondition><recordInfo><recordContentSource>WILEY</recordContentSource><recordOrigin>John Wiley & Sons, Inc.</recordOrigin></recordInfo></mods></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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