Tim Y. Li, Sophia Salingaros, Hector F. Salazar, Riley D. Mayne, Jini Jeon, Carlos Urrea de la Puerta, Matthew W. Liao, Samuel J. Medina, Xue Dong, Lawrence J. Bonassar and Jason A. Spector*,
{"title":"Designing Positionally Stable Smooth Breast Implants","authors":"Tim Y. Li, Sophia Salingaros, Hector F. Salazar, Riley D. Mayne, Jini Jeon, Carlos Urrea de la Puerta, Matthew W. Liao, Samuel J. Medina, Xue Dong, Lawrence J. Bonassar and Jason A. Spector*, ","doi":"10.1021/acsbiomaterials.4c0222210.1021/acsbiomaterials.4c02222","DOIUrl":null,"url":null,"abstract":"<p ><i>Background</i>: The voluntary recall and ban of several textured breast implant models worldwide, secondary to their association with Breast Implant-Associated Anaplastic Large Cell Lymphoma, has limited the key benefit of a textured surface─positional stability. We have engineered a Positionally Stable Smooth Implant (PSSI) containing millimeter-scaled cylindrical wells on the implant surface for capsule ingrowth and device stabilization. <i>Objectives</i>: To evaluate the long-term positional stability of PSSI designs <i>in vivo</i> and characterize capsule formation. <i>Methods</i>: Miniature breast implants were manufactured using poly(dimethylsiloxane). PSSI were designed with various dimensions of well width, depth, and number. Comparison groups consisted of smooth and textured implants. Six sterilized implants per group were implanted subcutaneously into the bilateral dorsa of Sprague–Dawley rats. Implant rotation was measured with MicroCT every 2 weeks. Implant-capsule units were explanted at 3 months for histological analysis. <i>Results</i>: All PSSI groups exhibited significantly less cumulative positional rotation than smooth implants (<i>p</i> < 0.05), with stability comparable to that of textured implants. Upon explantation, microCT and gross examination revealed notable capsule ingrowth within the PSSI wells. Histological evaluation of foreign body response showed significantly fewer pro-inflammatory M1 macrophages in the PSSI capsules compared to the textured control. Additionally, myofibroblast expression, which is implicated in capsular contracture, was significantly lower in both the PSSI and textured groups compared to smooth implants. <i>Conclusions</i>: This novel smooth-surface breast implant design provided equivalent positional stability and reduced pro-inflammatory M1 macrophage expression compared to textured implants. These results suggest a promising, safer alternative to textured implants for inducing positional stability.</p>","PeriodicalId":8,"journal":{"name":"ACS Biomaterials Science & Engineering","volume":"11 3","pages":"1765–1775 1765–1775"},"PeriodicalIF":5.4000,"publicationDate":"2025-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"ACS Biomaterials Science & Engineering","FirstCategoryId":"5","ListUrlMain":"https://pubs.acs.org/doi/10.1021/acsbiomaterials.4c02222","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MATERIALS SCIENCE, BIOMATERIALS","Score":null,"Total":0}
Designing Positionally Stable Smooth Breast Implants
Background: The voluntary recall and ban of several textured breast implant models worldwide, secondary to their association with Breast Implant-Associated Anaplastic Large Cell Lymphoma, has limited the key benefit of a textured surface─positional stability. We have engineered a Positionally Stable Smooth Implant (PSSI) containing millimeter-scaled cylindrical wells on the implant surface for capsule ingrowth and device stabilization. Objectives: To evaluate the long-term positional stability of PSSI designs in vivo and characterize capsule formation. Methods: Miniature breast implants were manufactured using poly(dimethylsiloxane). PSSI were designed with various dimensions of well width, depth, and number. Comparison groups consisted of smooth and textured implants. Six sterilized implants per group were implanted subcutaneously into the bilateral dorsa of Sprague–Dawley rats. Implant rotation was measured with MicroCT every 2 weeks. Implant-capsule units were explanted at 3 months for histological analysis. Results: All PSSI groups exhibited significantly less cumulative positional rotation than smooth implants (p < 0.05), with stability comparable to that of textured implants. Upon explantation, microCT and gross examination revealed notable capsule ingrowth within the PSSI wells. Histological evaluation of foreign body response showed significantly fewer pro-inflammatory M1 macrophages in the PSSI capsules compared to the textured control. Additionally, myofibroblast expression, which is implicated in capsular contracture, was significantly lower in both the PSSI and textured groups compared to smooth implants. Conclusions: This novel smooth-surface breast implant design provided equivalent positional stability and reduced pro-inflammatory M1 macrophage expression compared to textured implants. These results suggest a promising, safer alternative to textured implants for inducing positional stability.
期刊介绍:
ACS Biomaterials Science & Engineering is the leading journal in the field of biomaterials, serving as an international forum for publishing cutting-edge research and innovative ideas on a broad range of topics:
Applications and Health – implantable tissues and devices, prosthesis, health risks, toxicology
Bio-interactions and Bio-compatibility – material-biology interactions, chemical/morphological/structural communication, mechanobiology, signaling and biological responses, immuno-engineering, calcification, coatings, corrosion and degradation of biomaterials and devices, biophysical regulation of cell functions
Characterization, Synthesis, and Modification – new biomaterials, bioinspired and biomimetic approaches to biomaterials, exploiting structural hierarchy and architectural control, combinatorial strategies for biomaterials discovery, genetic biomaterials design, synthetic biology, new composite systems, bionics, polymer synthesis
Controlled Release and Delivery Systems – biomaterial-based drug and gene delivery, bio-responsive delivery of regulatory molecules, pharmaceutical engineering
Healthcare Advances – clinical translation, regulatory issues, patient safety, emerging trends
Imaging and Diagnostics – imaging agents and probes, theranostics, biosensors, monitoring
Manufacturing and Technology – 3D printing, inks, organ-on-a-chip, bioreactor/perfusion systems, microdevices, BioMEMS, optics and electronics interfaces with biomaterials, systems integration
Modeling and Informatics Tools – scaling methods to guide biomaterial design, predictive algorithms for structure-function, biomechanics, integrating bioinformatics with biomaterials discovery, metabolomics in the context of biomaterials
Tissue Engineering and Regenerative Medicine – basic and applied studies, cell therapies, scaffolds, vascularization, bioartificial organs, transplantation and functionality, cellular agriculture