See discussions, stats, and author profiles for this publication at: https://www.researchgate.net/publication/319181298 Cohesive silicone gel implants with smooth, textured or polyurethane-coated surface to restore volume in eviscerated sockets Article  in  Orbit (Amsterdam, Netherlands) · August 2017 DOI: 10.1080/01676830.2017.1353107 CITATIONS 0 READS 61 8 authors, including: Some of the authors of this publication are also working on these related projects: ISTRAD/HCBARRETOS View project Microphthalmia View project Seizo Yamashita 118 PUBLICATIONS   816 CITATIONS    SEE PROFILE Alicia Galindo-Ferreiro Hospital Universitario "Rio Hortega" 86 PUBLICATIONS   89 CITATIONS    SEE PROFILE Marilia Modolo São Paulo State University 12 PUBLICATIONS   74 CITATIONS    SEE PROFILE Claudia Pellizzon São Paulo State University 76 PUBLICATIONS   1,016 CITATIONS    SEE PROFILE All content following this page was uploaded by Claudia Pellizzon on 31 August 2017. 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https://www.researchgate.net/profile/Claudia_Pellizzon?enrichId=rgreq-aee155732acd0374db5f2649c147be78-XXX&enrichSource=Y292ZXJQYWdlOzMxOTE4MTI5ODtBUzo1MzMzOTYxNDYzOTcxODVAMTUwNDE4Mjk1OTUyNA%3D%3D&el=1_x_7&_esc=publicationCoverPdf https://www.researchgate.net/profile/Claudia_Pellizzon?enrichId=rgreq-aee155732acd0374db5f2649c147be78-XXX&enrichSource=Y292ZXJQYWdlOzMxOTE4MTI5ODtBUzo1MzMzOTYxNDYzOTcxODVAMTUwNDE4Mjk1OTUyNA%3D%3D&el=1_x_10&_esc=publicationCoverPdf Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=iorb20 Download by: [200.52.25.211] Date: 18 August 2017, At: 09:32 Orbit The International Journal on Orbital Disorders, Oculoplastic and Lacrimal Surgery ISSN: 0167-6830 (Print) 1744-5108 (Online) Journal homepage: http://www.tandfonline.com/loi/iorb20 Cohesive silicone gel implants with smooth, textured or polyurethane-coated surface to restore volume in eviscerated sockets Cristiano Abreu, Seizo Yamashita, Alicia Galindo-Ferreiro, Marilia Modolo, Claudia H. Pellizzon, Carlos R. Padovani, Mariangela E. A. Marques & Silvana A. Schellini To cite this article: Cristiano Abreu, Seizo Yamashita, Alicia Galindo-Ferreiro, Marilia Modolo, Claudia H. Pellizzon, Carlos R. Padovani, Mariangela E. A. Marques & Silvana A. Schellini (2017): Cohesive silicone gel implants with smooth, textured or polyurethane-coated surface to restore volume in eviscerated sockets, Orbit, DOI: 10.1080/01676830.2017.1353107 To link to this article: http://dx.doi.org/10.1080/01676830.2017.1353107 Published online: 18 Aug 2017. Submit your article to this journal View related articles View Crossmark data http://www.tandfonline.com/action/journalInformation?journalCode=iorb20 http://www.tandfonline.com/loi/iorb20 http://www.tandfonline.com/action/showCitFormats?doi=10.1080/01676830.2017.1353107 http://dx.doi.org/10.1080/01676830.2017.1353107 http://www.tandfonline.com/action/authorSubmission?journalCode=iorb20&show=instructions http://www.tandfonline.com/action/authorSubmission?journalCode=iorb20&show=instructions http://www.tandfonline.com/doi/mlt/10.1080/01676830.2017.1353107 http://www.tandfonline.com/doi/mlt/10.1080/01676830.2017.1353107 http://crossmark.crossref.org/dialog/?doi=10.1080/01676830.2017.1353107&domain=pdf&date_stamp=2017-08-18 http://crossmark.crossref.org/dialog/?doi=10.1080/01676830.2017.1353107&domain=pdf&date_stamp=2017-08-18 Cohesive silicone gel implants with smooth, textured or polyurethane-coated surface to restore volume in eviscerated sockets Cristiano Abreua, Seizo Yamashitaa, Alicia Galindo-Ferreirob,c, Marilia Modoloa, Claudia H. Pellizzond, Carlos R. Padovanid, Mariangela E. A. Marquesa, and Silvana A. Schellinia,c aFaculdade de Medicina de Botucatu, Universidade Estadual Paulista, Botucatu, Sao Paulo, Brazil; bOphthalmology Department, Complejo Asistencial de Palencia, Palencia, Spain; cKing Khaled Eye Specialist Hospital, Riyadh, Saudi Arabia; dInstituto de Biociências de Botucatu, Universidade Estadual Paulista, Botucatu, Sao Paulo, Brazil ABSTRACT The purpose of this article is to evaluate the three different surface coating on cohesive silicone gel implants in eviscerated rabbit eye sockets. Forty-five albino rabbits underwent right eye evisceration and received hemisphere-shaped cohesive silicone gel implantswith smooth (Group 1), textured (Group 2), or polyurethane-coated surface (Group 3) in the socket. The animals were euthanized at 7, 30, and 90 days postoperatively. Computed tomography of the orbits was performed prior to euthanasia. Subsequently, the orbital contents were removed and underwent histologic and morphometric exam- ination. Data were statistically analyzed. There were no adverse effects throughout the study. The majority of implants in the Group 1 exhibited 180° rotation. The Group 3 experienced an intense inflammatory reaction around the implant and implant deformation probably due to pseudocapsule contraction. Cohesive silicone gel implants had good integration into the scleral socket. Optimal results were obtained with cohesive silicone gel textured implants (Group 2). Smooth implants (Group 1) rotated significantly, whereas polyurethane (Group 3) coated implants precipitated an intense inflam- matory reaction and were deformed postoperatively. KEYWORDS Anophthalmic socket; cohesive silicone gel implant; experimental study; orbital implants; superficial texture Introduction Studies on silicone implants to restore volume in an anophthalmic socket are rare.1,2 However, cohesive silicone implants are widely used for cosmetic breast augmentation surgery.3 Controversy remains on whether to use textured or polyurethane-coated silicone implants. Although poly- urethane precipitates amore robust inflammatory reaction, it appears to results in less capsular contracture postoperatively.4 However, textured silicone implants are widely used resulting in very similar outcomes to polyur- ethane-coated silicone implants.3,5 A rough external texture of implants placed in anophthalmic sockets can result in conjunctival erosion causing dehiscence with implant exposure and/or extrusion,6 suggesting that implants with a textured surface should be used with discretion for this purpose. There is only one experimental study about cohesive silicone implant in anophthalmic socket reporting good results and encouraging the use of this type of implants.7 To our knowledge, there are no studies comparing dif- ferent surface coatings on cohesive silicone gel implants placed in the orbital cavity. The present study evaluates cohesive silicone gel implants covered with a smooth, textured, or polyur- ethane-coated silicone surface to determine the best alternative for use as an implant in eviscerated anophthalmic sockets. Materials and methods This single-blinded, randomized, experimental study eval- uated 45 male albino Norfolk rabbits (Oryctolagus cunicu- lus) that underwent evisceration and cohesive silicone gel implants with one of three different surface coatings. This study was performed in accordance with the ethical prin- ciples for animal studies and approved by Institutional Research Ethics Committee. All the rabbits were between 3 and 6 months of age and weighed between 1,690 and 2,884 g. The rabbits were provided by the Central Animal House of the Universidade Estadual Paulista (UNESP), Campus of Botucatu, Sao Paulo State, Brazil. All rabbits were anesthetized with an intravenous injec- tion of tiletamine and zolazepam 15mg/kg (Zoletil, Virbac, São Paulo, Brazil) and 2 drops of 0.4% oxibuprocaine (Oxinest, Latinofarma, São Paulo, Brazil) in the right eye. CONTACT Silvana Artioli Schellini sartioli@fmb.unesp.br Faculdade de Medicina de Botucatu, UNESP, CEP: 18618-970, Botucatu, São Paulo State, Brazil. Color versions of one or more of the figures in the article can be found online at www.tandfonline.com/iorb. ORBIT https://doi.org/10.1080/01676830.2017.1353107 © 2017 Taylor & Francis D ow nl oa de d by [ 20 0. 52 .2 5. 21 1] a t 0 9: 32 1 8 A ug us t 2 01 7 http://www.tandfonline.com/iorb https://crossmark.crossref.org/dialog/?doi=10.1080/01676830.2017.1353107&domain=pdf&date_stamp=2017-08-15 The right eye was eviscerated in all cases under aseptic and antiseptic conditions. Subsequently, hemisphere-shaped cohesive silicone gel implant with similar content to the breast implants were placed in the socket. The implants had either a smooth (Group 1) surface coating, a textured (Group 2) surface or a polyurethane-coated surface (Group 3) (Silimed Ltda, Rio de Janeiro, Brazil). The implants were placed within the scleral cavity with the convex side facing outward (Figure 1). The sclera was sutured with continu- ous stitches using a 6–0 nonabsorbable braided thread (Mersilene, Ethicon, Johnson & Johnson do Brasil Indústria e Comércio Ltda, São Paulo, Brazil) followed by a continuous running conjunctival suture using the same thread. There were 15 rabbits in each group, of which 5 rabbits per group were euthanized at 7, 30, or 90 days after implantation placement. All of the animals were evaluated daily, for local or systemic changes. Immediately prior to euthanasia, computed tomography (CT) scans of the orbits (Shimadzu SCT 7800-TC, Japan) were performed with default positioning in the ventral decubitus. CT scans were composed of a total of 30 axial cuts of 1 mm thickness at 1 mm intervals (parameters 130 mA and 120 Kv) with three-dimensional reconstruction to evaluate implant position (rotation and/or migration) and possible changes surrounding the implant. The animals were then euthanized by anesthetic overdose. The orbital contents were removed, fixed in 10% formaldehyde, embedded in paraffin and stained with hematoxylin-eosin. Morphometric exam- ination was performed to evaluate pseudocapsule thickness in the anterior and posterior aspects of the implant using a Leica DMLS microscope (Germany) coupled to a video camera (Leica Qwin Software, Germany). Statistical analysis of the quantitative variables was performed with two-way analysis of variance (Group X Stage) followed by Tukey’s multiple comparisons test for continuous variables and a nonparametric method for discrete variables. For qualitative variables, the Goodman association test was performed for contrasts between and within binominal populations. A P value less than 0.05 was considered statistically significant. Results Clinical evaluation All the animals exhibited good clinical course with no cases of extrusion or infection of the orbit or surrounding tissues. CT scan evaluation There was one case with peri-implant edema in Group 3 at 7 days postoperatively. A change of implant position occurred in 10 cases and was more frequent and intense in the Group 1, with 3 out of 5 animals exhibiting a 180° rotation by 90 days postoperatively. Groups 2 and 3 experi- enced rotation below 90° or no change in implant position (Figure 2). At 90 days postoperatively, there were discrete deformities in 3 implants in the Group 3 only. Histological evaluation On macroscopic evaluation, there were cases of the implant adherence to the sclera, especially in the Groups 2 and 3. There were no cases of inflammation within the implants and the scleral socket was preserved in all groups throughout the study. At 7 days postoperatively, tissue reaction was observed in the scleral-implant interface that was similar between groups, with characteristics of heal- ing repair showing edema, numerous red blood cells (RBCs), fibrin network and a small number of inflamma- tory cells which were predominantly neutrophils. There were clinically significant differences in the pseudocap- sule between groups. At 30 days postoperatively, groups 1 and 2 showed inflammatory processes around the implant. The pseudocapsule was composed of fibroblasts, a few histiocytes, new vessels containing RBCs, and hemosiderin deposits with no edema. At 90 days post- operatively, the pseudocapsules in Groups 1 and 2 were Figure 1. Implants used in this study in hemisphere-shaped, composed by cohesive silicone gel with a smooth (Group 1, A), textured (Group 2, B) or polyurethane-coated surface (Group 3, C). 2 C. ABREU ET AL. D ow nl oa de d by [ 20 0. 52 .2 5. 21 1] a t 0 9: 32 1 8 A ug us t 2 01 7 similar and were easily identified from their intense pink color, composed of mature fibroblasts, and a hyalinized collagen on the entire implant. The Group 3 had a more robust inflammatory reaction throughout the study, forming a thicker pseudocapsule at 30 days postopera- tively, that was composed by neutrophils and monocytes, irregular focal thickening with localized accumulation of inflammatory cells, active neovascularization and empty spaces in the pseudocapsule. At 90 days postoperatively, the pseudocapsules in the Group 3 were composed of mature fusiform fibroblasts, with a granulomatous reac- tion composed by multinucleated giant cells and a lym- phoplasmocytic infiltrate. The spaces within the pseudocapsule increased in size. A pink, amorphous, birefringent phagocytized material was identified in the peri-implant reaction (Figure 3). Quantitative evaluation of the pseudocapsule The pseudocapsule was generally thicker after 7 days post- operatively and decreased by the last postoperative obser- vation. At 30 days postoperatively, the anterior and posterior aspect of the pseudocapsule were thicker in the Group 3 compared to the other groups. At 90 days post- operatively, the thickness of the anterior aspect of the pseudocapsule did not differ between groups. The posterior aspect of the pseudocapsule was thinner in the Group 2 compared to the other groups at 90 days postoperatively. The area of inflammation was statistically significantly higher in the Group 3 compared to the other groups at 90 days postoperatively (P < 0.05; Table 1). Discussion The primary impetus for this study was to evaluate the use of cohesive silicone gel implants to replace volume in anophthalmic sockets because, theoretically, conven- tional implants have a rigid surface as well the external prosthesis, which can cause contact-induced damage during extraocular muscle movement. This damage can increase the risk of conjunctival or scleral dehis- cence and extrusion. We believe that a soft implant in the socket can reduce traumatic contact with the exter- nal prosthesis, reducing complications. We elected to use hemispheric shaped implants due to the shallow format of the rabbits orbit. This comparison of three different surface coatings on the cohesive silicone implants was performed in order to observe which one can have better results to be applied in an anophthalmic cavity. The lack of infection and/or implant extrusion indicated a clinically favorable result for the smooth, textured, or polyur- ethane-coated cohesive silicone implants in the current animal-model study. Only the implants in Group 1 rotated by 180°. The remaining groups had only incomplete or no rotation of the implants. The smooth surface of the implants in Group 1 allow it to move freely, leading to changes in the position of the implant that may result in poor cosm- esis. This finding confirmed the macroscopic findings of adherence between the implant and host tissues in Groups 2 and 3 but no adherence in Group 1. The adherence to the scleral tissue at 30 days and, more so, at 90 days after implant insertion in Groups 2 and 3 was indicative of implant integration to the host tissue. The cohesive silicone gel implant is surrounded by impermeable membranes and integration only occurs with the coating, whereas the inner aspect remains inert, which was confirmed by the histological findings in the current study. Hence, as reaction with the host is limited to the coating, the texturized and polyurethane-coated silicone implants are considered semi-integrated or par- tially integrated implants. In breast implants, the host tissue surrounds the implant composed of cohesive silicone gel with a pseudocapsule formed by fibroblasts, inflammatory cells, and collagen.8 The role of the pseudocapsule in stiffening and contraction of breast implants has been extensively studied3 and is Figure 2. Tomographic images of rabbit skulls showing the right anophthalmic socket filled with a hemisphere-shaped silicone implant. (A) position of the implant in G2 animal with the external convexity, the same as when the hemisphere was inserted, i.e., outward convexity. (B) implant in G1 animal with a partial rotation in the lower sector (arrow). (C) implant in G1 animal had rotated by 180° of the original the position and the convexity of the implant being turned towards the posterior part of the orbital cavity (arrow). (D) implant in G3 animal in position but distorted in the medial portion (arrow). ORBIT 3 D ow nl oa de d by [ 20 0. 52 .2 5. 21 1] a t 0 9: 32 1 8 A ug us t 2 01 7 Figure 3. G1 - (A) Tissue reaction at 7 days after surgery showing a large number of red blood cells, edema and inflammatory reaction around the implant and over the sclera, composing the pseudocapsule (arrow); sclera (s); (B) after 30 days there are less cellular reaction and the fibrin is well organized; (C) 90 days after surgery the pseudocapsule (arrow) is well defined as composed of mature fibroblasts and a hyalinized collagen membrane; sclera (s). G2 – (D) Similar tissue reaction than observed in GI 7 days after surgery; (E) after 30 days, pseudocapsule (arrow) composed of fibroblasts and a small number of inflammatory cells was observed, similar than in GI; (F) pseudocapsule (arrow) composed by fibroblasts and a small amount of inflammatory cells; sclera (s). G3 – (G) The polyurethane-coated surface is well defined after 7 days of the surgery, with edema, inflammatory reaction and pieces of a pink and amorphous material (star) surrounded by tissue reaction, forming a pseudocapsule (arrow) around the implant; sclera (s); (H) 30 days after surgery the inflammatory reaction persists; (I) also 90 days after surgery is possible to observe neovessels and inflammatory reaction around the pink pieces (star) of the polyurethane-coating. Table 1. Media and standard deviation of pseudocapsule according to the type if implant and postoperative day of euthanasia. Postoperative day of euthanasia Pseudocapsule Group 7 days 30 days 90 days G1 533,39 (63,10) aA 368,86 (82,89) abA 501,17 (144,91) aAB Thickness G2 532,02 (112,93) aB 345,72 (95,65) aA 462,31 (161,5) aAB Anterior G3 509,83 (90,28) aA 524,89 (136,3) bA 458,39 (112,69) aA G1 475,87 (89,40) aB 300,64 (79,05) aA 395,53 (151,86) bAB Thickness G2 444,47 (63,78) aB 267,36 (52,17) aA 197,24 (33,77) aA Posterior G3 412,11 (92,93) aAB 467,15 (94,55) bB 337,35 (64,56) bA G1 0,51 (0,03) aB 0,50 (0,02) aB 0,44 (0,05) aA Area G2 0,55 0,05) aB 0,50 (0,03) aA 0,49 (0,04) bA G3 0,54 (0,02) aA 0,54 (0,03) aA 0,56 (0,03) cA Lower case letters: comparison of groups (G1, G2, G3) fixed sacrifice moments. Capital letters: comparison of moments (7,30,90 days) fixed groups. Same letters mean no significant difference between data. 4 C. ABREU ET AL. D ow nl oa de d by [ 20 0. 52 .2 5. 21 1] a t 0 9: 32 1 8 A ug us t 2 01 7 considered a major complication of cosmetic breast reconstruction.9 There were 3 cases of implant deformity in Group 3 at 90 days postsurgery. This finding might be suggestive of pseudocapsule contracture. The thickness of the anterior and posterior aspects of the implants did not significantly differ between groups and tended to be higher in the initial postoperative period in all groups when edema is higher and collagen is not organized. However, by 30 and 90 days the pseudocapsule around the implants is easily recognized. Pseudocapsule thickness and fibrosis can cause hardening and deforma- tion of the implant.3,10 The histological peri-implant reac- tion, observed mainly in Group 3 at 90 days postoperatively was characterized by an extended inflam- matory reaction, including active neovascularization and edema resulting from the nonselective permeability of the numerous newly formed vessels. These signs may indicate an unstable scarring process in Group 3, even at 90 days postoperatively, suggesting that the tissue repair process was still active.11 Texturizing the surface of breast implants is con- sidered an advancement because the pseudocapsular thickness and indices of capsular contracture are lower than in smooth implants over the long term.3,5 However, the implant surface alone does not appear to influence the pseudocapsular thickness or contrac- ture. Peri-implant fluid collects for a variety of rea- sons, including the degree of surgical trauma and increased bleeding due to systemic complications may also lead to a higher tendency for capsular con- traction, favoring a prolonged inflammatory process.3,5 In the current study, histologic evaluation indicated a more intense inflammatory reaction in Group 3. However, there were very few statistically significant differences in the quantitative evaluation of the peri-implant reaction. Notably, the cell number measurements were highly vari- able necessitating nonparametric analysis. The histologic evaluation indicated that the pseudocap- sule in Group 3 was very different from the other groups mainly in the robust granulomatous reaction and the frag- ments of polyurethane foam that had been phagocytized by multinucleated giant cells. This aggressive reaction could have been a result of the polyurethane itself or due to any of the other substance adsorbed onto its surface, such as talc, inciting inflammatory cell phagocytosis, and a tendency for a chronic inflammatory reaction,8,12,13 maintained for a longer time in Group 3. Polyurethane-coated implants promote a disorga- nized collagen fiber architecture with a mutually neu- tralizing three-dimensional distribution of the contractile forces, thus hampering the formation of deforming contractures.13 However, in the present study, some of the polyurethane-coated implants exhib- ited possible contracture on CT examination, a finding that warrants further investigation. The scleral socket was preserved in all cases in all groups, highlighting the positive role of the cohesive sili- cone gel implants in volume replacement after evisceration. Conclusion Cohesive silicone gel implants resulted in a good tissue response, inducing a weak inflammatory reaction with no significant complications out to 90 days postoperatively. The outcome of this study indicates that textured implants (Group 2) resulted in the best outcomes includ- ing maintaining position and lower inflammation of the pseudocapsule. Further studies should investigate texture cohesive silicone gel implants to replace volume in the human anophthalmic cavity. Greater understanding of the interaction between the textured cohesive silicone gel implant and the external prosthesis is required. Acknowledgments This paper was presented as a poster at 2015 American Academy, Las Vegas, USA. This study was conducted at Faculdade de Medicina de Botucatu/King Khaled Eye Specialist Hospital. Disclosure statement The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the article. References 1. Rycroft PV. The use of silicone rubber as an implant following enucleation. Proc R Soc Med. 1965;13:736–738. 2. Son JH, Kim C-S, Yang JW. Comparison of experi- mental porous silicone implants and porous polyethy- lene implants. Graef Arch Clin Exp Ophthalmol. 2012;250:879–885. 10.1007/s00417-011-1902-7. 3. Collis N, Coleman D, Foo ITH, Sharpe DT. Ten-year review of a prospective randomized controlled trial of textured versus smooth subglandular silicone gel breast implants. Plast Reconstr Surg. 2000;106:786–791. doi:10.1097/00006534-200009020-00005. 4. Pompei S, Arelli F, Labardi L, et al. Breast reconstruction with polyurethane implants: preliminary report. Eur J Plast Surg. 2012;35:441–447. doi:10.1007/s00238-011-0612-z. 5. Wong CH, Samuel M, Tan BK, Song C. Capsular contracture in subglandular breast augmentation with textured versus smooth breast implants: a systematic review. Plast Reconstr Surg. 2006;118:1224–1236. doi:10.1097/01.prs.0000237013.50283.d2. 6. Schellini SA, Hoyama E, Padovani CR, Ferreira VLR, Roca R. 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D ow nl oa de d by [ 20 0. 52 .2 5. 21 1] a t 0 9: 32 1 8 A ug us t 2 01 7 View publication statsView publication stats https://doi.org/10.1590/S0004-27492000000300002 https://doi.org/10.1590/S0004-27492012000300010 https://doi.org/10.1590/S0004-27492012000300010 https://doi.org/10.1097/00006534-199711000-00029 https://doi.org/10.1097/00006534-199711000-00029 https://doi.org/10.1007/BF00190074 https://doi.org/10.1590/S0102-86502008000100015 https://doi.org/10.1016/0007-1226(86)90133-5 https://www.researchgate.net/publication/319181298 Abstract Introduction Materials and methods Results Clinical evaluation CT scan evaluation Histological evaluation Quantitative evaluation of the pseudocapsule Discussion Conclusion Acknowledgments Disclosure statement References