Silicone gel breast implant failure and frequency of additional surgeries: Analysis of 35 studies reporting examination of more than 8000 explants
Identifieur interne : 008155 ( Main/Exploration ); précédent : 008154; suivant : 008156Silicone gel breast implant failure and frequency of additional surgeries: Analysis of 35 studies reporting examination of more than 8000 explants
Auteurs : James S. Marotta [États-Unis] ; Christopher W. Widenhouse [États-Unis] ; Mutaz B. Habal [États-Unis] ; Eugene P. Goldberg [États-Unis]Source :
- Journal of Biomedical Materials Research [ 0021-9304 ] ; 1999.
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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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<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></author><author><name sortKey="Widenhouse, Christopher W" sort="Widenhouse, Christopher W" uniqKey="Widenhouse C" first="Christopher W." last="Widenhouse">Christopher W. Widenhouse</name></author><author><name sortKey="Habal, Mutaz B" sort="Habal, Mutaz B" uniqKey="Habal M" first="Mutaz B." last="Habal">Mutaz B. Habal</name></author><author><name sortKey="Goldberg, Eugene P" sort="Goldberg, Eugene P" uniqKey="Goldberg E" first="Eugene P." last="Goldberg">Eugene P. 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Habal</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Floride</region></placeName><wicri:cityArea>Biomaterials Center, Department of Materials Science and Engineering, University of Florida, Gainesville</wicri:cityArea></affiliation><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Floride</region></placeName><wicri:cityArea>Tampa Bay Craniofacial and Plastic Surgery Center, Tampa</wicri:cityArea></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 wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Floride</region></placeName><wicri:cityArea>Biomaterials Center, Department of Materials Science and Engineering, University of Florida, Gainesville</wicri:cityArea></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><affiliations><list><country><li>États-Unis</li></country><region><li>Floride</li></region></list><tree><country name="États-Unis"><region name="Floride"><name sortKey="Marotta, James S" sort="Marotta, James S" uniqKey="Marotta J" first="James S." last="Marotta">James S. Marotta</name></region><name sortKey="Goldberg, Eugene P" sort="Goldberg, Eugene P" uniqKey="Goldberg E" first="Eugene P." last="Goldberg">Eugene P. Goldberg</name><name sortKey="Habal, Mutaz B" sort="Habal, Mutaz B" uniqKey="Habal M" first="Mutaz B." last="Habal">Mutaz B. Habal</name><name sortKey="Habal, Mutaz B" sort="Habal, Mutaz B" uniqKey="Habal M" first="Mutaz B." last="Habal">Mutaz B. Habal</name><name sortKey="Widenhouse, Christopher W" sort="Widenhouse, Christopher W" uniqKey="Widenhouse C" first="Christopher W." last="Widenhouse">Christopher W. Widenhouse</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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