The surface topography of silicone breast implants mediates the foreign body response in mice, rabbits and humans

Doloff, Joshua C.; Veiseh, Omid; Mezerville, Roberto de; Sforza, Marcos; Perry, Tracy Ann; Haupt, Jennifer L.; Jamiel, Morgan; Chambers, Courtney; Nash, Amanda; Aghlara-Fotovat, Samira; Stelzel, Jessica L.; Bauer, Stuart J.; Neshat, Sarah Y.; Hancock, John; Romero, Natalia Araujo; Hidalgo, Yessica Elizondo; Leiva, Isaac Mora; Munhoz, Alexandre Mendonça; Bayat, Ardeshir; Kinney, Brian M.; Hodges, H. Courtney; Miranda, Roberto N.; Clemens, Mark W.; Langer, Robert

doi:10.1038/s41551-021-00739-4

Cited by 134 publications

(102 citation statements)

References 56 publications

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“…Furthermore, resin devices developed thin, yet dense and almost avascular brotic capsules, while PA brotic layers were about 2-fold thicker yet tended to be lax and vascularized. This was in line with previous reports showing material a roughness < 1 µm, such as that of resin, promoted broblast spreading and dense brotic layers, whereas a a roughness of 1 -4 µm, observed with PA, had the opposite effect 34 . Thus, the density and composition, rather than the thickness, of the brotic layer may be better indicators of potential implant integration in the subQ space.…”

Section: Discussionsupporting

confidence: 93%

Implantable niche with local immunosuppression for islet allotransplantation achieves type 1 diabetes reversal.

Paez‐Mayorga

Campa-Carranza

Capuani

et al. 2022

Preprint

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Pancreatic islet transplantation efficacy for type 1 diabetes (T1D) management is limited by hypoxia-related graft attrition and need for systemic immunosuppression. To overcome these challenges, we developed the Neovascularized Implantable Cell Homing and Encapsulation (NICHE) device, which integrates direct vascularization for facile mass transfer and localized immunosuppressant delivery for islet rejection prophylaxis. Here, we investigated NICHE efficacy for allogeneic islet transplantation and long-term diabetes reversal in an immunocompetent rat model. We demonstrated that polyamide is superior to resin for NICHE subQ integration and vascularization. We demonstrated allogeneic islets transplanted within pre-vascularized NICHE were engrafted, revascularized, and reverted diabetes in rats for over 150 days. Notably, we confirmed that localized immunosuppression prevented islet rejection without inducing toxicity or systemic immunosuppression. Moreover, for translatability efforts, we showed NICHE biocompatibility and feasibility of deployment, as well as short-term allogeneic islet engraftment in an MHC-mismatched nonhuman primate model. In sum, the NICHE is a safe and effective platform for islet transplantation and long-term T1D management.

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Section: Discussionsupporting

confidence: 93%

Implantable niche with local immunosuppression for islet allotransplantation achieves type 1 diabetes reversal.

Paez‐Mayorga

Campa-Carranza

Capuani

et al. 2022

Preprint

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“…It is based on the surface roughness (Ra) on scanning electron microscopy [25]. Therefore, the surface topography of a device is classified into smooth (Ra < 10 µm), microtextured (10 µm ≤ Ra ≤ 50 µm) or macrotextured (Ra > 50 µm) [26].…”

Section: Discussionmentioning

confidence: 99%

A Preliminary Retrospective Study to Assess the Short-Term Safety of Traditional Smooth or Microtextured Silicone Gel-Filled Breast Implants in Korea

Han

Kim

et al. 2021

Medicina

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Background and objectives: We conducted this preliminary retrospective study to assess the short-term safety of silicone gel-filled breast implants (SGBIs) that are commercially available in Korean women. Materials and methods :The current retrospective, observational study was conducted in a total of 2612 patients (n = 2612) who underwent augmentation mammaplasty using breast implants at our hospitals between 1 January, 2017 and 31 August 2021. Results: Overall, there were a total of 248 cases (9.49%) of postoperative complications; these include 112 cases of early seroma, 52 cases of shape deformation, 32 cases of CC, 12 cases of early hematoma, 12 cases of rupture, 12 cases of infection, 12 cases of stretch deformities with skin excess and 4 cases of rippling. Overall complication-free survival of the breast implant was estimated at 1564.32 ± 75.52 days (95% CI 1416.39–1712.32). Then, the Motiva Ergonomix™SilkSurface showed the longest survival (1528.00 ± 157.92 days [95% CI 1218.48–1837.56]), followed by the BellaGel®SmoothFine (1458.4 ± 65.76 days [95% CI 1329.56–1587.28]), the Sebbin® Sublimity (1322.00 ± 51.20 days [95% CI 1221.64–1422.32]), the BellaGel® Smooth (1138.72 ± 161.28 days [95% CI 822.6–1454.84), the Mentor® MemoryGel™ Xtra (698.4 ± 52.64 days [95% CI 595.28–801.52]) and the Natrelle® INSPIRA™ (380.00 ± 170.88 days [95% CI 45.04–714.96]) in the decreasing order. On subgroup analysis, both the Motiva ErgonomixTM and Mentor® MemoryGel™ Xtra showed no postoperative complications. However, the BellaGel®SmoothFine, Sebbin® Sublimity and BellaGel® Smooth showed incidences of 8.87%, 4.84% and 1.61%, respectively. A subgroup analysis also showed differences in incidences of postoperative complications between microtextured and smooth breast implants (15.18% vs. 16.67%). Conclusions: In conclusion, our results indicate that diverse types of an SGBI are commercially available and their safety profile varies according to the manufacturer. Plastic surgeons should consider the safety profile of each device in selecting the optimal types of the device for Korean women who are in need of an implant-based augmentation mammaplasty. However, this warrants a single-surgeon, single-center studywith long periods of follow-up.

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“…Therefore, modulating implant surface properties is a common strategy to enhance tissue integration while simultaneously reducing the incidence and severity of implant FBR and fibrosis. In addition to or combined with altering implant surface chemistry [ 65 ], treatments include modulation of physical parameters such as surface hydrophilicity or wettability [ 66 ], porosity [ 67 , 68 ], stiffness (elastic modulus) [ 69 , 70 ], anisotropic ‘roughness’ [ 71 , 72 ], and regular topographies [ 73 , 74 ] ( Figure 2 ).…”

Section: What Is Different Between Normal Wound Healing and The Fbr? The Implantmentioning

confidence: 99%

“…Despite their fibrosis-suppressing effect, the safety of textured breast implants has been reviewed by the FDA, as there are studies suggesting that patients with textured breast implants and surface roughness of 300 µm are at a higher risk of developing breast implant-associated anaplastic large-cells lymphoma compared to patients with smooth implants [ 99 , 100 ]. To mitigate such reactions, micro- and nanotextured implant surfaces have been developed with combined smooth and textured surfaces and a surface roughness of 1–100 µm [ 74 , 101 ]. In the range of these dimensions, surface roughness features around 4 µm were recently shown to cause minimal inflammation and FBR in different animal models and humans [ 74 ].…”

Section: What Is Different Between Normal Wound Healing and The Fbr? The Implantmentioning

confidence: 99%

“…To mitigate such reactions, micro- and nanotextured implant surfaces have been developed with combined smooth and textured surfaces and a surface roughness of 1–100 µm [ 74 , 101 ]. In the range of these dimensions, surface roughness features around 4 µm were recently shown to cause minimal inflammation and FBR in different animal models and humans [ 74 ]. Another interesting approach to counteract host reactions is to provide the implant material with a stealth coat of ‘body-own’ ECM [ 102 , 103 ].…”

Section: What Is Different Between Normal Wound Healing and The Fbr? The Implantmentioning

confidence: 99%

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Implant Fibrosis and the Underappreciated Role of Myofibroblasts in the Foreign Body Reaction

Noskovičová

Hinz

Pakshir

2021

Cells

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Body implants and implantable medical devices have dramatically improved and prolonged the life of countless patients. However, our body repair mechanisms have evolved to isolate, reject, or destroy any object that is recognized as foreign to the organism and inevitably mounts a foreign body reaction (FBR). Depending on its severity and chronicity, the FBR can impair implant performance or create severe clinical complications that will require surgical removal and/or replacement of the faulty device. The number of review articles discussing the FBR seems to be proportional to the number of different implant materials and clinical applications and one wonders, what else is there to tell? We will here take the position of a fibrosis researcher (which, coincidentally, we are) to elaborate similarities and differences between the FBR, normal wound healing, and chronic healing conditions that result in the development of peri-implant fibrosis. After giving credit to macrophages in the inflammatory phase of the FBR, we will mainly focus on the activation of fibroblastic cells into matrix-producing and highly contractile myofibroblasts. While fibrosis has been discussed to be a consequence of the disturbed and chronic inflammatory milieu in the FBR, direct activation of myofibroblasts at the implant surface is less commonly considered. Thus, we will provide a perspective how physical properties of the implant surface control myofibroblast actions and accumulation of stiff scar tissue. Because formation of scar tissue at the surface and around implant materials is a major reason for device failure and extraction surgeries, providing implant surfaces with myofibroblast-suppressing features is a first step to enhance implant acceptance and functional lifetime. Alternative therapeutic targets are elements of the myofibroblast mechanotransduction and contractile machinery and we will end with a brief overview on such targets that are considered for the treatment of other organ fibroses.

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The surface topography of silicone breast implants mediates the foreign body response in mice, rabbits and humans

Cited by 134 publications

References 56 publications

Implantable niche with local immunosuppression for islet allotransplantation achieves type 1 diabetes reversal.

Implantable niche with local immunosuppression for islet allotransplantation achieves type 1 diabetes reversal.

A Preliminary Retrospective Study to Assess the Short-Term Safety of Traditional Smooth or Microtextured Silicone Gel-Filled Breast Implants in Korea

Implant Fibrosis and the Underappreciated Role of Myofibroblasts in the Foreign Body Reaction

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