Search Results (56)

Background: Silicone breast implants have been linked to autoimmune/inflammatory syndrome induced by adjuvants (ASIA). This study evaluates the role of ^99mTc-HYNIC-TOC somatostatin receptor scintigraphy in assessing somatostatin-mediated inflammation and the impact of explantation on inflammatory activity. Methods: Fifty patients with silicone breast implants and symptoms suggestive of ASIA were evaluated. Pre- and postexplantation imaging was performed using ^99mTc-HYNIC-TOC scintigraphy. Matthews correlation coefficients quantified associations between clinical symptoms and imaging findings, and autoantibody profiles were analysed. Results: Scintigraphy identified a significant uptake in organs associated with autoimmune symptoms, particularly joints and salivary glands. Strong correlations were found between imaging findings and symptoms, including knee pain (MCC = 0.81) and sicca syndrome (MCC = 0.96). Explantation resolved abnormal uptake in the surgical bed, though variable uptake persisted in other organs, reflecting systemic inflammatory heterogeneity. Autoantibody analysis revealed positivity in 66% of patients, with antinuclear antibodies being most frequent (30%). Conclusions: ^99mTc-HYNIC-TOC scintigraphy effectively evaluates organ-specific inflammation in ASIA. Explantation reduces localized inflammation but does not consistently address systemic autoimmune responses. Larger prospective studies are needed to validate these findings and improve management strategies for ASIA. Full article

Many kinds of silicones are a wide family of hybrid inorganic–organic polymers which have valuable physical and chemical properties and find plenty of practical applications, not only industrial, but also numerous medical and pharmaceutical ones, mainly due to their good thermal and chemical stability, hydrophobicity, low surface tension, biocompatibility, and bio-durability. The important biomedical applications of silicones include drains, shunts, and catheters, used for medical treatment and short-term implants; inserts and implants to replace various body parts; treatment, assembly, and coating of various medical devices; breast and aesthetic implants; specialty contact lenses; and components of cosmetics, drugs, and drug delivery systems. The most important achievements concerning the biomedical and pharmaceutical applications of silicones, their copolymers and blends, and also silanes and low-molecular-weight siloxanes have been summarized and updated. The main physiological properties of organosilicon compounds and silicones, and the methods of antimicrobial protection of silicone implants, have also been described and discussed. The toxicity of silicones, the negative effects of breast implants, and the environmental effects of silicone-containing personal care and cosmetic products have been reported and analyzed. Important examples of the 3D printing of silicone elastomers for biomedical applications have been presented as well. Full article

Background: Hyaluronic acid (HA) fillers offer a minimally invasive alternative for breast augmentation, appealing to young female patients seeking natural results and minimal recovery time. However, achieving optimal outcomes requires a thorough understanding of breast anatomy, filler properties, and safe injection techniques. This study provides a comprehensive analysis of the anatomical considerations, techniques, and filler properties necessary for optimal breast augmentation using HA filler. It also explores patient selection, long-term safety and efficacy, and the management of complications. A review of key anatomical structures, including glandular tissue, fascial layers, vascular anatomy, and Cooper’s ligaments was conducted. Injection techniques, such as dual-plane and submuscular approaches, were analysed with a focus on pre-procedural imaging. Four cases of young female patients undergoing breast augmentation using HA filler (e.p.t.q. eve X, Jetema Inc., Seoul, Republic of Korea) were analysed. The efficacy of HA fillers in achieving natural breast enhancement was demonstrated in all four cases. Ultrasound played a crucial role in ensuring accurate filler placement, reducing risks like vascular occlusion and filler migration. Patients reported high satisfaction and minimal complications, though periodic treatments were required for maintenance. HA filler-based breast augmentation is a safe and effective option for young female patients, delivering natural results with rapid recovery. Although the results can be temporary and maintenance treatment is required, HA fillers may offer a non-invasive alternative to silicone implants. Optimal outcomes can be achieved through a thorough understanding of anatomy, the use of highly cohesive fillers, and ultrasound-guided injection techniques. Full article

Objectives: The term ‘prosthesis’ in reference to breast implants is used to clarify its distinction from the general term ‘breast implant’, which is widely adopted by plastic surgeons. This terminology highlights the role of the implant as a functional tissue substitute, particularly in post-mastectomy reconstruction, rather than solely as a cosmetic enhancement. This distinction is relevant for understanding the long-term implications of implant-based reconstruction and the associated complications. The aim of this systematic review was to compile and analyze the current evidence on the long-term complications associated with breast implants. We explored how these complications vary depending on implant type, surgical techniques, patient-specific factors, and the indication for implantation (cosmetic vs. reconstructive). These indications were analyzed separately to avoid assumptions regarding their correlation with surgical techniques. Methods: A systematic search was conducted across PubMed, Web of Science, and Scopus for studies published up to December 2024, following PRISMA 2020 guidelines and the Cochrane Handbook for Systematic Reviews of Interventions. An initial search identified 1480 studies. After screening and applying inclusion criteria, 11 studies were selected for the final analysis. Studies included in this review reported long-term complications in human subjects, were published in English, and evaluated breast implants. The quality of the included studies was assessed using the ROBINS-E tool. Additionally, subgroup analyses examined differences based on implant type (silicone vs. saline), surgical techniques, and patient characteristics, such as age, comorbidities, and the duration of follow-up. Results: This review study was performed between September 2024 and December 2024. A total of 11 studies were included in the review. The included studies were published between 1997 and 2021, providing a long-term perspective on breast implant complications. The most frequently reported complications were capsular contracture, implant rupture, seroma, and infection, with capsular contracture being the most prevalent. Silicone implants were associated with a higher risk of rupture compared to saline implants. Techniques using textured implants and dual-plane placements were found to reduce the incidence of capsular contracture. Patient-related factors, such as age and smoking status, were identified as significant risk factors for complications, while longer follow-up periods revealed more late-onset complications. Conclusions: This review underscores the importance of understanding the long-term risks of breast implants and highlights the need for personalized surgical planning and thorough follow-up care. Future studies should focus on standardizing outcomes reporting and further evaluating the safety and effectiveness of new implant materials and surgical approaches. Full article

Background/Objectives: Implant-based breast reconstruction (IBBR) is increasingly favored over autologous reconstruction due to its procedural simplicity and recovery benefits. Conducting this reconstruction using either the subpectoral or prepectoral planes has varied aesthetic outcomes. This study utilizes VECTRA XT 3D imaging to objectively assess breast symmetry differences between these surgical techniques. Methods: A retrospective cohort study was conducted analyzing data from patients undergoing unilateral total mastectomy followed by immediate silicone implant reconstruction via subpectoral or prepectoral techniques. The VECTRA XT 3D system provided measurements, including sternal-notch-to-nipple (SN-N), midline-to-nipple (ML-N), and nipple-to-inframammary fold (N-IMF) distances, as well as breast width, volume, and projection, taken more than a year postoperatively, to assess symmetry and aesthetic outcomes. Results: The study included 63 patients—29 in the subpectoral group and 38 in the prepectoral group. The SN-N ratio was 0.91 for the subpectoral group compared to 0.95 for the prepectoral group (p = 0.014). Among patients with a BMI of 25 or higher, the prepectoral group had an SN-N ratio significantly closer to 1 (0.97 ± 0.07) than the subpectoral group (0.89 ± 0.06) (p = 0.027). No statistically significant differences were found in metrics based on the surgical method across age categories divided at 50. Conclusions: The prepectoral IBBR technique shows improved nipple positioning and breast symmetry compared to subpectoral methods, as assessed via precise 3D imaging. This finding suggests potential advantages for surgical planning and patient satisfaction, indicating the need for large cohort studies to further investigate the factors influencing breast symmetry. Full article

Background: Medical devices used for functional or esthetic purposes improve health and quality of life; however, they are not risk-free. Anaplastic large-cell lymphoma (ALCL), associated with breast implants, is a well-known and recognized distinct lymphoma entity. More recently, additional lymphomas have been reported in relation to prosthesis other than breast implants, as these allow the pericyte to develop into a clone that undergoes a maturation process, progressing toward full malignancy. Methods: We performed a systematic review with a descriptive analysis of data extracted from primary studies following PRISMA guidelines, including the search string “(IMPLANT* OR PROSTHES*) AND LYMPHOM*” in the PubMed, Scopus, Embase, and Google-Scholar databases. Data such as patient sex, age, implant site, prosthesis material, and lymphoma type were analyzed. Statistical methods, including Student’s t-test and Fisher’s exact test, were employed to compare lymphoma characteristics, with significance set at a p-value < 0.05. Results: From a total of 5992 studies, we obtained 43 case reports and series on a total of 52 patients diagnosed with prosthesis-associated lymphomas. The majority of implant-related lymphoma cases (85%) were of the B-cell type, mostly fibrin-associated large B-cell lymphoma (LBCL). This lymphoma type was more associated with biological (non-human-derived biological tissue), metallic, and synthetic implants (synthesized from non-organic components) (p-value = 0.007). Patients with ALCL had equal frequencies of metal and silicone prostheses (37.5%, 3 cases each), followed by synthetic prostheses (25%, 2 cases). ALCL cases were most common at skeletal (50%) and muscular-cutaneous sites (25%), whereas B-cell lymphomas were predominantly found in cardiovascular implants (50%), followed by skeletal (27%) and muscular-cutaneous (21%) sites. Death attributed to lymphoma took place in 67% of the cases, mostly LBCL occurring in cardiovascular sites. Conclusions: Because the included studies were limited to case reports and series, a potential non-causal link might have been documented between different implant materials, implant sites and lymphoma types. This underscores the importance of further comprehensive research and monitoring of non-breast implants. Full article

Breast implant surgery has evolved significantly, yet challenges such as capsular contracture remain a persistent concern. This review presents an in-depth analysis of recent advancements in understanding the immune mechanisms and clinical implications associated with silicone mammary implants (SMIs). The article systematically examines the complex interplay between immune responses and capsular fibrosis, emphasizing the pathophysiological mechanisms of inflammation in the etiology of this fibrotic response. It discusses innovations in biomaterial science, including the development of novel anti-biofilm coatings and immunomodulatory surfaces designed to enhance implant integration and minimize complications. Emphasis is placed on personalized risk assessment strategies, leveraging molecular insights to tailor interventions and improve patient outcomes. Emerging therapeutic targets, advancements in surgical techniques, and the refinement of post-operative care are also explored. Despite notable progress, challenges such as the variability in immune responses, the long-term efficacy of new interventions, and ethical considerations remain. Future research directions are identified, focusing on personalized medicine, advanced biomaterials, and bridging preclinical findings with clinical applications. As we advance from bench to bedside, this review illuminates the path forward, where interdisciplinary collaboration and continued inquiry weave together to enhance the art and science of breast implant surgery, transforming patient care into a realm of precision and excellence. Full article

Since breast cancer is one of the most common forms of cancer in women, silicone mammary implants have been extensively employed in numerous breast reconstruction procedures. However, despite the crucial role they play, their interaction with the host’s immune system and microbiome is poorly understood. Considering this, the present work investigates the immunomodulatory and bacterial mitigation potential of six textured surfaces, based on linear step-like features with various regular and irregular multiscaled arrangements, in comparison to a flat PDMS surface. We hypothesise that the chosen surface geometries are capable of modulating the cellular response through mechanical interdigitation within the multiscaled surface morphology, independent of the surface chemical properties. Each type of sample was characterised from a physico-chemical and biological points of view and by comparison to the flat PDMS surface. The overall results proved that the presence of linear multiscaled step-like features on the PDMS surface influenced both the surface’s characteristics (e.g., surface energy, wettability, and roughness parameters), as well as the cellular response. Thus, the biological evaluation revealed that, to different degrees, biomaterial-induced macrophage activation can be mitigated by the newly designed microtextured surfaces. Moreover, the reduction in bacteria adherence up to 90%, suggested that the topographical altered surfaces are capable of suppressing bacterial colonisation, therefore demonstrating that in a surgical environment at risk of bacterial contamination, they can be better tolerated. Full article

This study aimed to evaluate the impact of three two-dimensional (2D) mammographic acquisition techniques on image quality and radiation dose in the presence of silicone breast implants (BIs). Then, we propose and validate a new International Atomic Energy Agency (IAEA) phantom to reproduce these techniques. Images were acquired on a single Hologic Selenia Dimensions^® unit. The mammography of the left breast of a single clinical case was included. Three methods of image acquisition were identified. They were based on misused, recommended, and reference settings. In the clinical case, image criteria scoring and the signal-to-noise ratio on breast tissue (SNR_BT) were determined for two 2D projections and compared between the three techniques. The phantom study first compared the reference and misused settings by varying the AEC sensor position and, second, the recommended settings with a reduced current-time product (mAs) setting that was 13% lower. The signal-difference-to-noise ratio (SDNR) and detectability indexes at 0.1 mm (d’ 0.1 mm) and 0.25 mm (d’ 0.25 mm) were automatically quantified using ATIA software. Average glandular dose (AGD) values were collected for each acquisition. A statistical analysis was performed using Kruskal–Wallis and corrected Dunn tests (p < 0.05). The SNR_BT was 2.6 times lower and the AGD was −18% lower with the reference settings compared to the recommended settings. The SNR_BT values increased by +98% with the misused compared to the recommended settings. The AGD increased by +79% with the misused settings versus the recommended settings. The median values of the reference settings were 5.8 (IQR 5.7–5.9), 1.2 (IQR 0.0), 7.0 (IQR 6.8–7.2) and 1.2 (IQR 0.0) mGy and were significantly lower than those of the misused settings (p < 0.03): 7.9 (IQR 6.1–9.7), 1.6 (IQR 1.3–1.9), 9.2 (IQR 7.5–10.9) and 2.2 (IQR 1.4–3.0) mGy for the SDNR, d’ 0.1 mm, d’ 0.25 mm and the AGD, respectively. A comparison of the recommended and reduced settings showed a reduction of −6.1 ± 0.6% (p = 0.83), −7.7 ± 0.0% (p = 0.18), −6.4 ± 0.6% (p = 0.19) and −13.3 ± 1.1% (p = 0.53) for the SDNR, d’ 0.1 mm, d’ 0.25 mm and the AGD, respectively. This study showed that the IAEA phantom could be used to reproduce the three techniques for acquiring 2D mammography images in the presence of breast implants for raising awareness and for educational purposes. It could also be used to evaluate and optimize the manufacturer’s recommended settings. Full article

Background: This study aims to describe a prospective clinical cohort of patients with silicone breast implants and suspected Breast Implant Illness (BII). Methods: Women were included in a specialized silicone outpatient clinic at Amsterdam UMC, the Netherlands. Baseline characteristics were collected including medical history, implant details, and symptoms. Experienced physicians categorized BII suspicion as high, moderate, or low, based on symptoms and after exclusion of other probable causes. Additionally, participants completed questionnaires assessing symptoms and daily life impact at baseline, 6 months, 1, 2, and 5 years. For this initial analysis, the results from the first three years of inclusions were collected. Results: Data from 353 women were collected from December 2020–December 2023. At baseline, the most reported symptoms were fatigue, arthralgia, myalgia, and morning stiffness, accompanied by local symptoms in 83.3% of patients. At the clinic, 112 women were categorized as having high suspicion of BII, 147 women as moderate, and 94 women as low. At follow-up, 182 women (51.6%) opted for explantation. Following explantation, women with a high or moderate suspicion of BII experienced more significant symptom improvement, accompanied by a decrease in anxiety and a greater sense of control over their illness, compared to women with a low suspicion of BII. Conclusions: Our study highlights a distinct interplay of systemic and local symptoms among women with suspicion of BII. Women with a high or moderate BII suspicion benefit significantly more from explantation than women with low suspicion. Experienced physicians are pivotal in effectively assessing and guiding this patient group, highlighting the need for tailored clinical approaches. Full article

Background and Objectives: Mammary gland surgery has become very common, but there are complications of these operations, including the concept of breast implant illness (BII) in women with silicone gel breast implants (SBI), who suffer from various symptoms such as myalgia, arthralgia, fatigue, fever, dry eyes, or dry mouth. Silicone biomaterials are synthetic polymers that have their own physical and chemical properties and can exert their effect at the site of use and possibly on the general status of the body, causing inflammation and oxidative stress signs. The aim of the study was to examine components of the blood antioxidant system (AOS) of the mastopexy and breast augmentation patients before the operation, on the first post-op day, and 6 months after surgery. Materials and Methods: Healthy breast surgery patients (women aged 31 to 60 years without visible pathologies) were selected for the study and formed 2 groups: breast lift—mastopexy without silicone biomaterials (I group, 30 patients) and breast augmentation using silicone biomaterials (II group, 28 patients). All patients underwent standard preoperative tests. Glutathione peroxidase (GPxSe) and gamma-glutamyl transferase (GGT) in blood, selenium (Se), selenium protein P (SelPP), and total antioxidant status (TAS) in plasma were measured as AOS parameters. The concentration of vitamin D was also determined. A total of 174 blood tests were performed. Results: Overall, there were no differences in both groups in measured antioxidant system indicators over time; neither changes in objective nor subjective status were observed. However, baseline activity of GPxSe was relatively high but restored to normal values 6 months after surgery. In the mastopexy group, GPxSe decreased from 12,961.7 U/L by 18.9% to 10,513.4 U/L, and in the breast augmentation group, from 15,505.0 U/L by 25.1% to 11,265.5 U/L, which is a decrease of 18.9% and 25.1%, respectively. The patients did not note any complaints; other indicators of standard biochemical tests were within normal limits. Conclusions: The two types of surgical interventions, breast mastopexy and augmentation of the mammary glands, do not significantly impact blood AOS and are physiological in nature. Full article

Background and Objectives: The correction of breast hypertrophy and ptosis with implant placement has always posed a challenge for plastic surgeons. Various methods have been devised, yielding conflicting results. The purpose of this study is to describe our surgical technique of breast reduction with silicone implants, present the safety profile of the procedure, and report patient-reported outcomes. Materials and Methods: A retrospective review was performed on our case series of cosmetic breast surgery performed by the senior author between October 2020 and November 2023. Only patients who had over 300 g of breast tissue removed were included. The surgery and demographic characteristics were recorded. Patients were asked to complete a questionnaire about satisfaction with their breasts pre-operatively and after the surgery. Results: Over 745 cases were performed, and 25 were included in the analysis. In total, 78.3% of the patients presented with a Grade 3 ptosis. The mean implant size was 352.39 cc (range 300–455 cc). The breast tissue removed ranged from 312 to 657 g. The mean follow-up was 14.17 months. Only one case required revision surgery after developing capsular contracture and a waterfall deformity. Patients reported a statistically significant improvement across all domains of the questionnaire (p < 0.001). Conclusions: Breast reduction plus implants is a safe and effective alternative for patients with large ptotic breasts who wish to attain a full upper pole. It carries a similar risk profile to augmentation mastopexy and maintains its functional benefits in alleviating back, neck, and shoulder pain. Full article

Breast cancer ranks among the most commonly diagnosed cancers worldwide and bears the highest mortality rate. As an integral component of cancer treatment, mastectomy entails the complete removal of the affected breast. Typically, breast reconstruction, involving the use of silicone implants (augmentation mammaplasty), is employed to address the aftermath of mastectomy. To mitigate postoperative risks associated with mammaplasty, such as capsular contracture or bacterial infections, the functionalization of breast implants with coatings of cyclodextrin polymers as drug delivery systems represents an excellent alternative. In this context, our work focuses on the application of a mathematical model for simulating drug release from breast implants coated with cyclodextrin polymers. The proposed model considers a unidirectional diffusion process following Fick’s second law, which was solved using the orthogonal collocation method, a numerical technique employed to approximate solutions for ordinary and partial differential equations. We conducted simulations to obtain release profiles for three therapeutic molecules: pirfenidone, used for preventing capsular contracture; rose Bengal, an anticancer agent; and the antimicrobial peptide KR-12. Furthermore, we calculated the diffusion profiles of these drugs through the cyclodextrin polymers, determining parameters related to diffusivity, solute solid–liquid partition coefficients, and the Sherwood number. Finally, integrating these parameters in COMSOL multiphysics simulations, the unidirectional diffusion mathematical model was validated. Full article

Background: Capsular contracture remains a common complication in silicone breast implantation. The etiology, formation mechanisms, predisposing and favoring factors are still subjects of research. This study aims to demonstrate the effectiveness of using autologous fat introduced periprosthetically in preventing capsular contracture compared to other known methods: antibiotics and corticosteroids. Methods: A cohort of 80 Wistar rats was included in the study, divided into four subgroups. All subjects received a silicone implant, implanted in a pocket created along the abdominal midline. The first subgroup served as the control group, with subjects having the implant placed without any treatment. For the second and third subgroups, the implants were treated with an antibiotic solution and intramuscular injections of dexamethasone, respectively. The subjects in the last subgroup received centrifuged autologous fat introduced periprosthetically. Results: The subgroup with autologous fat exhibited a significantly smaller capsule thickness, which was poorly represented, with a smooth surface. The use of autologous fat for treating silicone prosthesis was linked with the lack of acute inflammation around the prosthetic site. Conclusions: Autologous fat helps to minimize the “non-self” reaction, which results in the development of a periprosthetic capsule consisting of mature collagen fibers interspersed with adipocytes. Full article

Breast cancer is the most common cancer in women globally, often necessitating mastectomy and subsequent breast reconstruction. Silicone mammary implants (SMIs) play a pivotal role in breast reconstruction, yet their interaction with the host immune system and microbiome remains poorly understood. This study investigates the impact of SMI surface topography on host antimicrobial responses, wound proteome dynamics, and microbial colonization. Biological samples were collected from ten human patients undergoing breast reconstruction with SMIs. Mass spectrometry profiles were analyzed for acute and chronic wound proteomes, revealing a nuanced interplay between topography and antimicrobial response proteins. 16S rRNA sequencing assessed microbiome dynamics, unveiling topography-specific variations in microbial composition. Surface topography alterations influenced wound proteome composition. Microbiome analysis revealed heightened diversity around rougher SMIs, emphasizing topography-dependent microbial invasion. In vitro experiments confirmed staphylococcal adhesion, growth, and biofilm formation on SMI surfaces, with increased texture correlating positively with bacterial colonization. This comprehensive investigation highlights the intricate interplay between SMI topography, wound proteome dynamics, and microbial transmission. The findings contribute to understanding host–microbe interactions on SMI surfaces, essential for optimizing clinical applications and minimizing complications in breast reconstruction. Full article