{"id":{"repo_id":"aachen","oai_identifier":"oai:publications.rwth-aachen.de:51106"},"canonical_url":"https://search.dev.ndltd.org/etd/aachen/oai:publications.rwth-aachen.de:51106","repository":{"repo_id":"aachen","name":"RWTH Aachen University","base_url":"https://publications.rwth-aachen.de/oai2d"},"display":{"title":"Charakterisierung der Biodegradation von Silikonmammaimplantaten","abstract":"Focal point of plastic-aesthetic operations is the cosmetic correction of the female breast with silicone implants. Main part of them are breast augmentations. Beside the common public interest is the use of silicone imlants in reconstructive plastic intervention and tumor aftercare. The implant material silicone, considered as inert material for lots of years, causes problems and its degradation could not be explained sufficently up to now. Implantation of a silicone implant can cause the formation of a fibrous capsule as answer of the organism to the foreign material, emersion of silicone filling material into the body (silicone bleeding) or even the total collapse of the implant (rupture). The described reactions require with every third woman an additional surgical intervention. Studies of the implant ageing are often limited to the evaluation of the implant state in vivo or at the point of explantation (ruptures or rate of fibrose capsules) without further analysis. Cause studies concerning the degradation are seldom. Furthermore research is restricted and hindered in comparability and actuality by small sample volumes, short implantation times or concentration on the implants of a single manufacturer. Mechanical ageing of explants was studied only for implants of the US-americain market. They are limited in disposability by the ban of the US-americain health administration FDA since 1992 and are restricted to selected patient panels. The study presented here arised from the question about the material causes for the ageing of 110 of the department for plastic surgery of the Klinikum rechts der Isar, München, explanted silicone implants during the years 2002 to 2005. Compared to hitherto published studies implants with implantation times of 2 weeks up to 31 years were included, containing 16 of the eldest ever studied explants. Main focus of the study was the mechanical, chemical and biological degradation of the mostly silicone filled implants with increasing implantation times. Changes of basic material properties in vivo could be shown by uniaxial tensile tests according to the americain standard ASTM 703-96. Tensile stress and elongation at break of the silicone explants decreased with increasing implantation times, whereas the module of elasticity proves itself independent of long invivo-times. Degredation of tensile stress and elongation at break could be already seen after short implantation times of about 1 year, reaching a limit after an implantation period of 10 years combined to a total loss of strength of about 30% compared to native implants. Chemical analysis of the explants exhibits diffusion processes of non crosslinked residual monomers – or oligomers of the filling material with all studied silicone filled explants, resulting in an accumulation of silicone oils in the implant shells. Extraction with the solvent Hexane showed an increase within a period of 10 years of implantation of about 8 weight per cent to a saturation value of about 18 weight per cent. Furthermore a higher silicone content of the implant shells frequently was accompanied by the incidence of higher fibrous capsule degrees. Irrespective of the implantation time fibrous capsules of baker degrees II – IV could be seen cumulatively with a silicone accumulation of ³ 15 weight per cent silicone oils in the shells. Colonisation tests demonstrated an affinity of characteristic cells of the immune system to silicone gel, but a stronger immun response in general to implants with long implantation times could not be shown. The study of the explants exhibited the role of the enrichment of the implant shells with lightly crosslinked silicone oils as reason for the biodegradation of the implants. The accumulation independent of implant typ or manufacturer showed an impact to the overall ageing of the implants. The measured degradation of strength could be concluded by a preceding elongation of the material, but did not lead to an impairment of the structure in the form of a softener. The biggest influence can be seen in the biological reaction on the implant material, expressing in a higher risk for the forming of high-grade fibrous capsules.","abstract_html":"Focal point of plastic-aesthetic operations is the cosmetic correction of the female breast with silicone implants. Main part of them are breast augmentations. Beside the common public interest is the use of silicone imlants in reconstructive plastic intervention and tumor aftercare. The implant material silicone, considered as inert material for lots of years, causes problems and its degradation could not be explained sufficently up to now. Implantation of a silicone implant can cause the formation of a fibrous capsule as answer of the organism to the foreign material, emersion of silicone filling material into the body (silicone bleeding) or even the total collapse of the implant (rupture). The described reactions require with every third woman an additional surgical intervention. Studies of the implant ageing are often limited to the evaluation of the implant state in vivo or at the point of explantation (ruptures or rate of fibrose capsules) without further analysis. Cause studies concerning the degradation are seldom. Furthermore research is restricted and hindered in comparability and actuality by small sample volumes, short implantation times or concentration on the implants of a single manufacturer. Mechanical ageing of explants was studied only for implants of the US-americain market. They are limited in disposability by the ban of the US-americain health administration FDA since 1992 and are restricted to selected patient panels. The study presented here arised from the question about the material causes for the ageing of 110 of the department for plastic surgery of the Klinikum rechts der Isar, München, explanted silicone implants during the years 2002 to 2005. Compared to hitherto published studies implants with implantation times of 2 weeks up to 31 years were included, containing 16 of the eldest ever studied explants. Main focus of the study was the mechanical, chemical and biological degradation of the mostly silicone filled implants with increasing implantation times. Changes of basic material properties in vivo could be shown by uniaxial tensile tests according to the americain standard ASTM 703-96. Tensile stress and elongation at break of the silicone explants decreased with increasing implantation times, whereas the module of elasticity proves itself independent of long invivo-times. Degredation of tensile stress and elongation at break could be already seen after short implantation times of about 1 year, reaching a limit after an implantation period of 10 years combined to a total loss of strength of about 30% compared to native implants. Chemical analysis of the explants exhibits diffusion processes of non crosslinked residual monomers – or oligomers of the filling material with all studied silicone filled explants, resulting in an accumulation of silicone oils in the implant shells. Extraction with the solvent Hexane showed an increase within a period of 10 years of implantation of about 8 weight per cent to a saturation value of about 18 weight per cent. Furthermore a higher silicone content of the implant shells frequently was accompanied by the incidence of higher fibrous capsule degrees. Irrespective of the implantation time fibrous capsules of baker degrees II – IV could be seen cumulatively with a silicone accumulation of ³ 15 weight per cent silicone oils in the shells. Colonisation tests demonstrated an affinity of characteristic cells of the immune system to silicone gel, but a stronger immun response in general to implants with long implantation times could not be shown. The study of the explants exhibited the role of the enrichment of the implant shells with lightly crosslinked silicone oils as reason for the biodegradation of the implants. The accumulation independent of implant typ or manufacturer showed an impact to the overall ageing of the implants. The measured degradation of strength could be concluded by a preceding elongation of the material, but did not lead to an impairment of the structure in the form of a softener. The biggest influence can be seen in the biological reaction on the implant material, expressing in a higher risk for the forming of high-grade fibrous capsules.","abstract_has_math":false,"creators":["Janke, Andrea"],"institution":"Publikationsserver der RWTH Aachen University","degree_name":null,"degree_level":null,"degree_discipline":null,"degree_department":null,"school":null,"contributors":["Rau, Günter"],"advisors":[],"committee_chairs":[],"committee_members":[],"year":2009,"date_issued":"2009","date_published":"2009","updated_at":"2026-07-30T19:40:33Z","subjects":["info:eu-repo/classification/ddc/620","Implantat","Brust","Silicon-Polymere","Ingenieurwissenschaften","silicone","implant","breast"],"languages":["ger"],"rights":["info:eu-repo/semantics/openAccess"],"rights_urls":[],"identifier_entries":[{"key":"dc:identifier","label":"Identifier","values":["https://publications.rwth-aachen.de/search?p=id:%22RWTH-CONV-113423%22"],"render_values":[{"text":"https://publications.rwth-aachen.de/search?p=id:%22RWTH-CONV-113423%22","href":"https://publications.rwth-aachen.de/search?p=id:%22RWTH-CONV-113423%22","code":true}]}]},"links":{"outbound_url":"https://publications.rwth-aachen.de/record/51106","outbound_label":"Repository record","outbound_source":"dc:identifier"},"source_record":{"url":"https://publications.rwth-aachen.de/oai2d?verb=GetRecord&metadataPrefix=oai_dc&identifier=oai%3Apublications.rwth-aachen.de%3A51106","prefix":"oai_dc"},"metadata_groups":[{"id":"people","label":"People","entries":[{"key":"dc:contributor","label":"Contributor","values":["Rau, Günter"]},{"key":"dc:creator","label":"Author","values":["Janke, Andrea"]}]},{"id":"academic_context","label":"Academic Context","entries":[{"key":"dc:coverage","label":"Dc Coverage","values":["DE"]},{"key":"dc:date","label":"Dc Date","values":["2009"]},{"key":"dc:publisher","label":"Institution","values":["Publikationsserver der RWTH Aachen University"]},{"key":"dc:relation","label":"Dc Relation","values":["info:eu-repo/semantics/altIdentifier/urn/urn:nbn:de:hbz:82-opus-27690"]},{"key":"dc:type","label":"Dc Type","values":["info:eu-repo/semantics/doctoralThesis","info:eu-repo/semantics/publishedVersion"]}]},{"id":"subjects_keywords","label":"Subjects and Keywords","entries":[{"key":"dc:subject","label":"Dc Subject","values":["info:eu-repo/classification/ddc/620","Implantat","Brust","Silicon-Polymere","Ingenieurwissenschaften","silicone","implant","breast"]}]},{"id":"language_rights","label":"Language and Rights","entries":[{"key":"dc:language","label":"Dc Language","values":["ger"]},{"key":"dc:rights","label":"Dc Rights","values":["info:eu-repo/semantics/openAccess"]}]},{"id":"identifiers","label":"Identifiers","entries":[{"key":"dc:identifier","label":"Identifier","values":["https://publications.rwth-aachen.de/record/51106","https://publications.rwth-aachen.de/search?p=id:%22RWTH-CONV-113423%22"]}]},{"id":"additional","label":"Additional Metadata","entries":[{"key":"dc:description","label":"Description","values":["Focal point of plastic-aesthetic operations is the cosmetic correction of the female breast with silicone implants. Main part of them are breast augmentations. Beside the common public interest is the use of silicone imlants in reconstructive plastic intervention and tumor aftercare. The implant material silicone, considered as inert material for lots of years, causes problems and its degradation could not be explained sufficently up to now. Implantation of a silicone implant can cause the formation of a fibrous capsule as answer of the organism to the foreign material, emersion of silicone filling material into the body (silicone bleeding) or even the total collapse of the implant (rupture). The described reactions require with every third woman an additional surgical intervention. Studies of the implant ageing are often limited to the evaluation of the implant state in vivo or at the point of explantation (ruptures or rate of fibrose capsules) without further analysis. Cause studies concerning the degradation are seldom. Furthermore research is restricted and hindered in comparability and actuality by small sample volumes, short implantation times or concentration on the implants of a single manufacturer. Mechanical ageing of explants was studied only for implants of the US-americain market. They are limited in disposability by the ban of the US-americain health administration FDA since 1992 and are restricted to selected patient panels. The study presented here arised from the question about the material causes for the ageing of 110 of the department for plastic surgery of the Klinikum rechts der Isar, München, explanted silicone implants during the years 2002 to 2005. Compared to hitherto published studies implants with implantation times of 2 weeks up to 31 years were included, containing 16 of the eldest ever studied explants. Main focus of the study was the mechanical, chemical and biological degradation of the mostly silicone filled implants with increasing implantation times. Changes of basic material properties in vivo could be shown by uniaxial tensile tests according to the americain standard ASTM 703-96. Tensile stress and elongation at break of the silicone explants decreased with increasing implantation times, whereas the module of elasticity proves itself independent of long invivo-times. Degredation of tensile stress and elongation at break could be already seen after short implantation times of about 1 year, reaching a limit after an implantation period of 10 years combined to a total loss of strength of about 30% compared to native implants. Chemical analysis of the explants exhibits diffusion processes of non crosslinked residual monomers – or oligomers of the filling material with all studied silicone filled explants, resulting in an accumulation of silicone oils in the implant shells. Extraction with the solvent Hexane showed an increase within a period of 10 years of implantation of about 8 weight per cent to a saturation value of about 18 weight per cent. Furthermore a higher silicone content of the implant shells frequently was accompanied by the incidence of higher fibrous capsule degrees. Irrespective of the implantation time fibrous capsules of baker degrees II – IV could be seen cumulatively with a silicone accumulation of ³ 15 weight per cent silicone oils in the shells. Colonisation tests demonstrated an affinity of characteristic cells of the immune system to silicone gel, but a stronger immun response in general to implants with long implantation times could not be shown. The study of the explants exhibited the role of the enrichment of the implant shells with lightly crosslinked silicone oils as reason for the biodegradation of the implants. The accumulation independent of implant typ or manufacturer showed an impact to the overall ageing of the implants. The measured degradation of strength could be concluded by a preceding elongation of the material, but did not lead to an impairment of the structure in the form of a softener. The biggest influence can be seen in the biological reaction on the implant material, expressing in a higher risk for the forming of high-grade fibrous capsules."]},{"key":"dc:source","label":"Dc Source","values":["Aachen : Publikationsserver der RWTH Aachen University 161 S. : Ill., graph. Darst. (2009). = Aachen, Techn. Hochsch., Diss., 2008"]},{"key":"dc:title","label":"Title","values":["Charakterisierung der Biodegradation von Silikonmammaimplantaten"]}]}],"canonical_facts":{"dc:contributor":["Rau, Günter"],"dc:coverage":["DE"],"dc:creator":["Janke, Andrea"],"dc:date":["2009"],"dc:description":["Focal point of plastic-aesthetic operations is the cosmetic correction of the female breast with silicone implants. Main part of them are breast augmentations. Beside the common public interest is the use of silicone imlants in reconstructive plastic intervention and tumor aftercare. The implant material silicone, considered as inert material for lots of years, causes problems and its degradation could not be explained sufficently up to now. Implantation of a silicone implant can cause the formation of a fibrous capsule as answer of the organism to the foreign material, emersion of silicone filling material into the body (silicone bleeding) or even the total collapse of the implant (rupture). The described reactions require with every third woman an additional surgical intervention. Studies of the implant ageing are often limited to the evaluation of the implant state in vivo or at the point of explantation (ruptures or rate of fibrose capsules) without further analysis. Cause studies concerning the degradation are seldom. Furthermore research is restricted and hindered in comparability and actuality by small sample volumes, short implantation times or concentration on the implants of a single manufacturer. Mechanical ageing of explants was studied only for implants of the US-americain market. They are limited in disposability by the ban of the US-americain health administration FDA since 1992 and are restricted to selected patient panels. The study presented here arised from the question about the material causes for the ageing of 110 of the department for plastic surgery of the Klinikum rechts der Isar, München, explanted silicone implants during the years 2002 to 2005. Compared to hitherto published studies implants with implantation times of 2 weeks up to 31 years were included, containing 16 of the eldest ever studied explants. Main focus of the study was the mechanical, chemical and biological degradation of the mostly silicone filled implants with increasing implantation times. Changes of basic material properties in vivo could be shown by uniaxial tensile tests according to the americain standard ASTM 703-96. Tensile stress and elongation at break of the silicone explants decreased with increasing implantation times, whereas the module of elasticity proves itself independent of long invivo-times. Degredation of tensile stress and elongation at break could be already seen after short implantation times of about 1 year, reaching a limit after an implantation period of 10 years combined to a total loss of strength of about 30% compared to native implants. Chemical analysis of the explants exhibits diffusion processes of non crosslinked residual monomers – or oligomers of the filling material with all studied silicone filled explants, resulting in an accumulation of silicone oils in the implant shells. Extraction with the solvent Hexane showed an increase within a period of 10 years of implantation of about 8 weight per cent to a saturation value of about 18 weight per cent. Furthermore a higher silicone content of the implant shells frequently was accompanied by the incidence of higher fibrous capsule degrees. Irrespective of the implantation time fibrous capsules of baker degrees II – IV could be seen cumulatively with a silicone accumulation of ³ 15 weight per cent silicone oils in the shells. Colonisation tests demonstrated an affinity of characteristic cells of the immune system to silicone gel, but a stronger immun response in general to implants with long implantation times could not be shown. The study of the explants exhibited the role of the enrichment of the implant shells with lightly crosslinked silicone oils as reason for the biodegradation of the implants. The accumulation independent of implant typ or manufacturer showed an impact to the overall ageing of the implants. The measured degradation of strength could be concluded by a preceding elongation of the material, but did not lead to an impairment of the structure in the form of a softener. The biggest influence can be seen in the biological reaction on the implant material, expressing in a higher risk for the forming of high-grade fibrous capsules."],"dc:identifier":["https://publications.rwth-aachen.de/record/51106","https://publications.rwth-aachen.de/search?p=id:%22RWTH-CONV-113423%22"],"dc:language":["ger"],"dc:publisher":["Publikationsserver der RWTH Aachen University"],"dc:relation":["info:eu-repo/semantics/altIdentifier/urn/urn:nbn:de:hbz:82-opus-27690"],"dc:rights":["info:eu-repo/semantics/openAccess"],"dc:source":["Aachen : Publikationsserver der RWTH Aachen University 161 S. : Ill., graph. Darst. (2009). = Aachen, Techn. Hochsch., Diss., 2008"],"dc:subject":["info:eu-repo/classification/ddc/620","Implantat","Brust","Silicon-Polymere","Ingenieurwissenschaften","silicone","implant","breast"],"dc:title":["Charakterisierung der Biodegradation von Silikonmammaimplantaten"],"dc:type":["info:eu-repo/semantics/doctoralThesis","info:eu-repo/semantics/publishedVersion"]},"updated_at":"2026-07-30T19:40:33Z"}