Ultrasonographic Identification of Shell Surface Types in Commercially Available Silicone Gel-Filled Breast Implants.

BACKGROUND: Breast implant safety issues have resulted in the need for global product recalls and medical device tracing. Conventional methods of breast implant tracing, have to date proven to be unsuccessful. This study aims to evaluate the effectiveness of high-resolution ultrasound (HRUS) screening in identifying implanted breast devices. METHODS: Data from 113 female patients undergoing preoperative ultrasound screening for secondary breast surgery between 2019 and 2022 was prospectively reviewed to evaluate the effectiveness of HRUS imaging with the aid of a sonographic surface catalog to identify the surface and brand type of implanted breast devices. To corroborate the findings and assess the reproducibility of the approach, further evaluations were replicated in New Zealand white rabbits and compared with the results found in humans. RESULTS: In the human recipients, implant surface and brand types were correctly identified by ultrasound imaging in 99% (112 of 113) and 96% (69 of 72) of the cases, either consultation-only or revision, respectively. This constituted an overall success rate of 98% (181 of 185). Furthermore, in a corroborating New Zealand white rabbit model where full-scale commercial implants were introduced and monitored over many months, from the total 28 analyzed, the surface was accurately identified in a total of 27 cases (the one failure being before generation of a sonograph surface catalogue), demonstrating an overall success rate of 96.4%. CONCLUSION: HRUS is, therefore, a valid and first-hand tool for breast implant imaging that can correctly evaluate both surface type and brand type alongside other variables such as implant placement, positioning, flipping, or rupture. CLINICAL RELEVANCE STATEMENT: HRUS is a valid and first-hand tool for the identification and traceability of breast implants that evaluates surface type and brand type. This low-cost, accessible, and reproducible practice provides patients with peace of mind and surgeons with a promising diagnostic tool.

Advances in surface modifications of the silicone breast implant and impact on its biocompatibility and biointegration.

Silicone breast implants are commonly used for cosmetic and oncologic surgical indications owing to their inertness and being nontoxic. However, complications including capsular contracture and anaplastic large cell lymphoma have been associated with certain breast implant surfaces over time. Novel implant surfaces and modifications of existing ones can directly impact cell-surface interactions and enhance biocompatibility and integration. The extent of foreign body response induced by breast implants influence implant success and integration into the body. This review highlights recent advances in breast implant surface technologies including modifications of implant surface topography and chemistry and effects on protein adsorption, and cell adhesion. A comprehensive online literature search was performed for relevant articles using the following keywords silicone breast implants, foreign body response, cell adhesion, protein adsorption, and cell-surface interaction. Properties of silicone breast implants impacting cell-material interactions including surface roughness, wettability, and stiffness, are discussed. Recent studies highlighting both silicone implant surface activation strategies and modifications to enhance biocompatibility in order to prevent capsular contracture formation and development of anaplastic large cell lymphoma are presented. Overall, breast implant surface modifications are being extensively investigated in order to improve implant biocompatibility to cater for increased demand for both cosmetic and oncologic surgeries.

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

Silicone is widely used in chronic implants and is generally perceived to be safe. However, textured breast implants have been associated with immune-related complications, including malignancies. Here, by examining for up to one year the foreign body response and capsular fibrosis triggered by miniaturized or full-scale clinically approved breast implants with different surface topography (average roughness, 0-90 µm) placed in the mammary fat pads of mice or rabbits, respectively, we show that surface topography mediates immune responses to the implants. We also show that the surface surrounding human breast implants collected during revision surgeries also differentially alters the individual's immune responses to the implant. Moreover, miniaturized implants with an average roughness of 4 µm can largely suppress the foreign body response and fibrosis (but not in T-cell-deficient mice), and that tissue surrounding these implants displayed higher levels of immunosuppressive FOXP3+ regulatory T cells. Our findings suggest that, amongst the topographies investigated, implants with an average roughness of 4 µm provoke the least amount of inflammation and foreign body response.

Bulb Cannula Safety for Breast Fat Grafting.

Autologous fat transfer is a common technique to refine the contour of the breast after prosthetic augmentation or reconstruction, correcting remaining asymmetries by injecting previously harvested fat tissue with a cannula. Current procedures are often performed without visualization of the cannula at the delivery site and may require subsequent verification of the implant's integrity. The present paper aims to evaluate the safety of a new bulb tip cannula to be used during breast implant procedures for injecting fat adjacent to a breast implant that reduce the risk of damaging the implant. Two conventional cannulae and 3 bulb cannulae, which have an atraumatic distal tip, were tested in a simulated implant-puncture setting in 3 positions (at 0°, 45°, and 90° of incidence). A Tensile Tester (Instron, High Wycombe, UK) was used to apply force with each cannula device and record the amount of force applied in the attempt to penetrate the implants used, with shell layers having a variable thickness. No implant rupture was observed with the bulb tip cannulae regardless of size or the position in which the cannulae were pressed against the implants. The cannula opening was not impeded and tended to bend instead; 27% of the cases with the conventional lipo-cannulae caused an implant rupture. The bulb tip cannula could enhance the safety of the fat transfer procedure by ensuring no iatrogenic implant disruption and optimal delivery of the fat tissue.

Nanotechnology, nanosurfaces and silicone gel breast implants: current aspects.

Nanotechnology is defined as the design of products that interact with biological systems on the nanoscopic scale. Creating a controlled nanotexture and understanding the ways in which surface properties impact inflammatory response is of the utmost significance in designing implants that can provide satisfactory outcomes.