www.elsevier.com/locate/jmbbm Available online at www.sciencedirect.com Research Paper New biomaterial as a promising alternative to silicone breast implants $ Goy Teck Lim a,1 , Stephanie A. Valente b , Cherie R. Hart-Spicer c , Mary M. Evancho-Chapman d , Judit E. Puskas a,e , Walter I. Horne f , Steven P. Schmidt d,n a Department of Chemical and Biomolecular Engineering, University of Akron, Akron, OH 44325, USA b Department of Surgery, Summa Health System, Akron City Hospital, 525 East Market Street, Akron, OH 44304, USA c Department of Pathology and Laboratory Medicine, Summa Health System, Akron City Hospital, 525 East Market Street, Akron, OH 44304, USA d Division of Surgical Education and Research, Department of Surgery, Summa Health System, Akron City Hospital, 525 East Market Street, Akron, OH 44304, USA e Department of Polymer Science, University of Akron, Akron, OH 44325, USA f Comparative Medicine Unit, Northeast Ohio Medical University (formerly Northeastern Ohio Universities Colleges of Medicine and Pharmacy), 4209 State Route 44, Rootstown, OH 44272, USA article info Article history: Received 11 November 2012 Received in revised form 20 January 2013 Accepted 28 January 2013 Available online 9 February 2013 Keywords: Breast implants Biopolymers SIBS Mechanical properties In vivo biocompatibility Histological study abstract One in eight American women develops breast cancer. Of the many patients requiring mastectomy yearly as a consequence, most elect some form of breast reconstruction. Since 2006, only silicone breast implants have been approved by the FDA for the public use. Unfortunately, over one-third of women with these implants experience complications as a result of tissue-material biocompatibility issues, which may include capsular contrac- ture, calcification, hematoma, necrosis and implant rupture. Our group has been working on developing alternatives to silicone. Linear triblock poly(styrene-b-isobutylene-b- styrene) (SIBS) polymers are self-assembling nanostructured thermoplastic rubbers, already in clinical practice as drug eluting stent coatings. New generations with a branched (arborescent or dendritic) polyisobutylene core show promising potential as a biomaterial alternative to silicone rubber. The purpose of this pre-clinical research was to evaluate the material-tissue interactions of a new arborescent block copolymer (TPE1) in a rabbit implantation model compared to a linear SIBS (SIBSTAR 103T) and silicone rubber. This study is the first to compare the molecular weight and molecular weight distribution, tensile properties and histological evaluation of arborescent SIBS-type materials with silicone rubber before implantation and after explantation. & 2013 Elsevier Ltd. All rights reserved. 1751-6161/$ - see front matter & 2013 Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.jmbbm.2013.01.025 $ Selected parts of this work were presented at the 2008 Annual Meeting of Society for Biomaterials and the 17th Annual Postgraduate Day at the Summa Health System, 2009. n Corresponding author. Tel.: þ1 330 375 3693; fax: þ1 330 375 4648. E-mail address: [email protected] (S.P. Schmidt). 1 Presentaddress: Exponent Science and Technology Consulting Co. Ltd, You You International Plaza, Suite 2305-2306, 76 Pujian Road, Shanghai 200127, China. journal of the mechanical behavior of biomedical materials 21 (2013) 47–56
10
Embed
New biomaterial as a promising alternative to …promesi.med.auth.gr/mathimata/05. New biomaterial as... Available online at Research Paper New biomaterial as a promising alternative
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
Available online at www.sciencedirect.com
www.elsevier.com/locate/jmbbm
j o u r n a l o f t h e m e c h a n i c a l b e h a v i o r o f b i o m e d i c a l m a t e r i a l s 2 1 ( 2 0 1 3 ) 4 7 – 5 6
1751-6161/$ - see frohttp://dx.doi.org/10
$Selected parts oDay at the Summa
nCorresponding autE-mail address:
1Present addressShanghai 200127, C
Research Paper
New biomaterial as a promising alternative to siliconebreast implants$
Goy Teck Lima,1, Stephanie A. Valenteb, Cherie R. Hart-Spicerc,Mary M. Evancho-Chapmand, Judit E. Puskasa,e, Walter I. Hornef, Steven P. Schmidtd,n
aDepartment of Chemical and Biomolecular Engineering, University of Akron, Akron, OH 44325, USAbDepartment of Surgery, Summa Health System, Akron City Hospital, 525 East Market Street, Akron, OH 44304, USAcDepartment of Pathology and Laboratory Medicine, Summa Health System, Akron City Hospital, 525 East Market Street, Akron,
OH 44304, USAdDivision of Surgical Education and Research, Department of Surgery, Summa Health System, Akron City Hospital, 525 East Market Street,
Akron, OH 44304, USAeDepartment of Polymer Science, University of Akron, Akron, OH 44325, USAfComparative Medicine Unit, Northeast Ohio Medical University (formerly Northeastern Ohio Universities Colleges of Medicine and
Pharmacy), 4209 State Route 44, Rootstown, OH 44272, USA
a r t i c l e i n f o
Article history:
Received 11 November 2012
Received in revised form
20 January 2013
Accepted 28 January 2013
Available online 9 February 2013
Keywords:
Breast implants
Biopolymers
SIBS
Mechanical properties
In vivo biocompatibility
Histological study
nt matter & 2013 Elsevie.1016/j.jmbbm.2013.01.02
f this work were presenteHealth System, 2009.hor. Tel.: þ1 330 375 3693schmidts@summahealth: Exponent Science and Thina.
a b s t r a c t
One in eight American women develops breast cancer. Of the many patients requiring
mastectomy yearly as a consequence, most elect some form of breast reconstruction. Since
2006, only silicone breast implants have been approved by the FDA for the public use.
Unfortunately, over one-third of women with these implants experience complications as
a result of tissue-material biocompatibility issues, which may include capsular contrac-
ture, calcification, hematoma, necrosis and implant rupture. Our group has been working
on developing alternatives to silicone. Linear triblock poly(styrene-b-isobutylene-b-
styrene) (SIBS) polymers are self-assembling nanostructured thermoplastic rubbers,
already in clinical practice as drug eluting stent coatings. New generations with a branched
(arborescent or dendritic) polyisobutylene core show promising potential as a biomaterial
alternative to silicone rubber. The purpose of this pre-clinical research was to evaluate the
material-tissue interactions of a new arborescent block copolymer (TPE1) in a rabbit
implantation model compared to a linear SIBS (SIBSTAR 103T) and silicone rubber. This
study is the first to compare the molecular weight and molecular weight distribution,
tensile properties and histological evaluation of arborescent SIBS-type materials with
silicone rubber before implantation and after explantation.
& 2013 Elsevier Ltd. All rights reserved.
r Ltd. All rights reserved.5
d at the 2008 Annual Meeting of Society for Biomaterials and the 17th Annual Postgraduate
; fax: þ1 330 375 4648..org (S.P. Schmidt).echnology Consulting Co. Ltd, You You International Plaza, Suite 2305-2306, 76 Pujian Road,
Greensmith, H.W., Mullins, L., Thomas, A.G., 1963. Strength ofrubbers. In: Bateman, L. (Ed.), The Chemistry and Physics ofRubber-Like Substances. John Wiley & Sons, New York, pp. 249.
Harkness, J.E., Wagner, J.E., 1995. The Biology and Medicine ofRabbits and Rodents. Williams & Wilkins, Philadelphia, pp. 28.
Ikeda, D.M., Borofsky, H.B., Herfkens, R.J., Sawyer-Glover, A.M.,Birdwell, R.L., Glover, G.H., 1999. Silicone breast implantrupture: pitfalls of magnetic resonance imaging and relativeefficacies of magnetic resonance, mammography, andultrasound. Plastic and Reconstructive Surgery 104 (7), 2054–2062.
Kaszas, G., 1993. Basic physical properties/structure of polystyrene–polyisobutylene–polystyrene triblock copolymers. PolymericMaterials Science and Engineering 68, 325–326.
Kennedy, J.P., Puskas, J.E., Kaszas, G., Hager, W.G., 1990. Thermo-plastic elastomers of isobutylene and process of preparation.United States Patent US 4946899.
Kennedy, J.P., Puskas, J.E., 2004. Thermoplastic elastomers bycarbocationic polymerization. In: Holden, G., Kricheldorf,H.R., Quirk, R. (Eds.), Thermoplastic Elastomers third ed.Hanser Publishers, Munich, pp. 285–321.
Marotta, J.S., Goldberg, E.P., Habal, M.B., Amery, D.P., Martin, P.J.,Urbaniak, D.J., Widenhouse, C.W., 2002. Silicone gel breastimplant failure: evaluation of properties of shells and gels forexplanted prostheses and meta-analysis of literature rupturedata. Annals of Plastic Surgery 49 (3), 227–242.
Munoz-Robledo, L.G., Porosky, S.E., Evancho-Chapman, M.,Schmidt, S.P., Puskas, J.E., 2009. Proliferation of aorticadventitial fibroblasts on three novel polyisobutylene (PIB)-based thermoplastic elastomers (TPEs). ACS Polymer Preprints50 (1), 533–534.
National Research Center for Women & Families, 2006. Decisionsin the Dark: The FDA, Breast Cancer Survivors, and SiliconeImplants. National Research Center for Women & Families,Washington, DC.
Peters, V., Smith, D., Lugowski, S., 1999. Silicon assays in womenwith and without silicone gel breast implants—a review.Annals of Plastic Surgery 43 (3), 324–330.
Pinchuk, L., Wilson, G.J., Barry, J.J., Schoephoerster, R.T., Parel,J.M., Kennedy, J.P., 2008. Medical applications of poly(styrene-block-isobutylene-block-styrene) (‘‘SIBS’’). Biomaterials 29,448–460.
Piza-Katzer, H., Pulzl, P., Balogh, B., Wechselberger, G., 2002.Long-term results of MISTI gold breast implants: aretrospective study. Plastic and Reconstructive Surgery 110 (6),1455–1459.
Puskas, J.E., Chen, Y., 2004. Biomedical application of commercialpolymers and novel polyisobutylene-based thermoplasticelastomers for soft tissue replacement. Biomacromolecules 5(4), 1141–1154.
Puskas, J.E., Kwon, Y.M., 2006. Biomacromolecular engineering:design, synthesis and characterization. One-pot synthesis ofblock copolymers of arborescent polyisobutylene andpolystyrene. Polymers for Advanced Technologies 17 (9–10),615–620.
Puskas, J.E., Antony, P., Kwon, Y., Paulo, C., Kovar, M., Norton, P.R.,Kaszas, G., Altstadt, V., 2001. Macromolecular engineering viacarbocationic polymerization: branched and hyperbranchedstructures, block copolymers and nanostructures.Macromolecular Materials and Engineering 286 (10), 565–582.
j o u r n a l o f t h e m e c h a n i c a l b e h a v i o r o f b i o m e d i c a l m a t e r i a l s 2 1 ( 2 0 1 3 ) 4 7 – 5 656
Puskas, J.E., Chen, Y.H., Dahman, Y., Padavan, D., 2004a.Polyisobutylene-based biomaterials. Journal of PolymerScience Part A: Polymer Chemistry 42, 3091–3109.
Puskas, J.E., Paulo, C., Antony, P., 2004b. Arborescent thermo-plastic elastomers and products therefrom. United StatesPatent US 6747098.
Puskas, J.E., Kwon, Y., Antony, P., Bhowmick, A.K., 2005. Synthesisand characterization of novel dendritic (arborescent,hyperbranched) polyisobutylene–polystyrene blockcopolymers. Journal of Polymer Science Part A: PolymerChemistry 43, 1811–1826.
Puskas, J.E., Dos Santos, L.M., Kaszas, G., 2006. Innovation inmaterial science: the chameleon block copolymer. Journal ofPolymer Science Part A: Polymer Chemistry 44 (21), 6494–6497.
Puskas, J.E., Dos Santos, L.M., Sen, M.Y., Kaszas, G., 2007. Effect ofarchitecture on the properties of polyisobutylene-based TPEmaterials. Rubber Chemistry and Technology 80 (3), 671–681.
Puskas, J.E., Dos Santos, L.M., Kaszas, G., Kulbaba, K., 2009a. Novelthermoplastic elastomers based on arborescent (dendritic)polyisobutylene with short copolymer end sequences. Journalof Polymer Science Part A: Polymer Chemistry 47 (4),1148–1158.
Puskas, J.E., Dos Santos, L.M., Fischer, F., Gotz, C., El Fray, M.,Altstadt, V, Tomkin, M., 2009b. Fatigue testing of implantablespecimens; effect of sample size and branching on thedynamic fatigue properties of polyisobutylene-basedbiomaterials. Polymer 50 (2), 591–597.
Puskas, J.E., El Fray, M., Tomkins, M., Dos Santos, L.M., Fischer, F.,
Altstadt, V., 2009c. Dynamic stress relaxation of thermoplastic