Exploration of Point-of-Care Ultrasonography for Silicone Breast Implant Rupture Detection and Classification.

Background and Objectives: The surge in breast-related surgeries in Korea underscores the critical need for an accurate early diagnosis of silicone breast implant-related issues. Complications such as BIA-ALCL and BIA-SCC add complexity to breast health concerns, necessitating vigilant monitoring. Despite advancements, discrepancies persist between ultrasonographic and pathologic classifications of silicone implant ruptures, highlighting a need for enhanced diagnostic tools. This study explores the reliability of ultrasonography in diagnosing silicone breast implant ruptures and determining the extent of silicone migration, specifically with a focus on guiding potential capsulectomy based on pathology. Materials and Methods: A comprehensive review of medical records encompassing 5557 breast implants across 2790 patients who underwent ultrasound-assisted examinations was conducted. Among the screened implants, 8.9% (249 cases) were diagnosed with silicone breast implant rupture through ultrasonography. Subsequently, 89 women underwent revisional surgery, involving capsulectomy. The pathological analysis of 111 periprosthetic capsules from these cases aimed to assess the extent of silicone migration, and the findings were juxtaposed with the existing ultrasonographic rupture classification. Results: The diagnostic agreement between preoperative sonography and postoperative findings reached 100% for silicone breast implant ruptures. All eighty prosthetic capsules exhibiting a snowstorm sign in ultrasonography demonstrated silicone migration to capsules upon pathologic findings. Conclusions: High-resolution ultrasonography emerged as a valuable and reliable imaging modality for diagnosing silicone breast implant ruptures, with a notable ability to ascertain the extent of free silicone migration to capsules. This diagnostic precision is pivotal in informing decisions about potential capsulectomy during revisional surgery. The study advocates for an update to the current binary ultrasonographic classification, suggesting a more nuanced categorization into three types (subcapsular, intracapsular, and extracapsular) based on pathology.

CD248 Regulates Inflammation and Encapsulation in Silicone-Related Capsule Formation.

BACKGROUND: Capsular contracture is the most common reason for having a secondary breast implant operation. The failure of the implanted device and discomfort are related to foreign body response, which involves a pathologic encapsulation. An up-regulated expression of CD248 was previously demonstrated to modulate inflammation and fibrosis. The authors hypothesized that CD248 contributes to foreign body reaction and contracture during silicone-stimulated capsule formation. METHODS: A murine capsular contracture model was established to correlate CD248 with capsular contracture. The timing and site of CD248 expression were characterized by protein analysis and histologic examination. The capsules between wild-type mice and CD248 knockout mice were compared in this model to verify the possible role of CD248 in silicone-related capsule formation. RESULTS: CD248 was expressed in the peri-silicone implant capsule by stromal fibroblast and perivascular fibroblast. CD248 was overexpressed on day 4 and down to a constant level, but it was still up-regulated through day 21 to day 56 after silicone implantation. The CD248 knockout mice showed a prolonged inflammation period, whereas the wild-type mice developed a thinner but more collagenous capsule. CONCLUSIONS: In conclusion, an effective murine capsular contracture model was established to study the relationship between CD248 and capsular contracture. CD248 may play a role in inflammation and encapsulation during silicone implantation. CD248 deletion in mice contributed to a loose and irregular collagen bundle in a capsule area, implying a decrease in contracture. Therefore, CD248 could be a potential therapeutic target in capsular contracture. CLINICAL RELEVANCE STATEMENT: CD248 may play a role in inflammation and encapsulation during silicone implantation. It could be a potential therapeutic target in clinical capsular contracture.

Evaluating the Irritant Factors of Silicone and Hydrocolloid Skin Contact Adhesives Using Trans-Epidermal Water Loss, Protein Stripping, Erythema, and Ease of Removal.

A composite silicone skin adhesive material was designed to improve its water vapor permeability to offer advantages to wearer comfort compared to existing skin adhesive dressings available (including perforated silicone and hydrocolloid products). The chemical and mechanical properties of this novel dressing were analyzed to show that it has a high creep compliance, offering anisotropic elasticity that is likely to place less stress on the skin. A participant study was carried out in which 31 participants wore a novel silicone skin adhesive (Sil2) and a hydrocolloid competitor and were monitored for physiological response to the dressings. Trans-epidermal water loss (TEWL) was measured pre- and postwear to determine impairment of skin barrier function. Sil2 exhibited a higher vapor permeability than the hydrocolloid dressings during wear. Peel strength measurements and dye counter staining of the removed dressings showed that the hydrocolloid had a higher adhesion to the participants' skin, resulting in a greater removal of proteins from the stratum corneum and a higher pain rating from participants on removal. Once the dressings were removed, TEWL of the participants skin beneath the Sil2 was close to normal in comparison to the hydrocolloid dressings that showed an increase in skin TEWL, indicating that the skin had been highly occluded. Analysis of the skin immediately after removal showed a higher incidence of erythema following application of hydrocolloid dressings (>60%) compared to Sil2, (<30%). In summary, this modified silicone formulation demonstrates superior skin protection properties compared to hydrocolloid dressings and is more suitable for use as a skin adhesive.

Allergic manifestations in women with silicone breast implants.

INTRODUCTION: Silicone breast implants (SBI) result in immune dysregulation and are associated with autoimmune diseases. Recently, we reported dysregulated levels of IgG autoantibodies directed against G protein-coupled receptors (GPCRs) of the autonomic nervous system which were linked to the autoimmune dysautonomia in silicone breast implant illness (SBII). AIMS: We aimed to explore the possible association between allergy with dysregulated IgE autoantibodies directed against GPCRs of the autonomic nervous system in women with SBI. METHODS: Circulating levels of IgE autoantibodies against GPCRs of the autonomic nervous system (adrenergic, muscarinic, endothelin and angiotensin receptors) have been evaluated in women with SBIs who complained of allergic symptoms, and compared to subjects with SBI without allergic manifestations and to age-matched healthy women without SBI. RESULTS: We report a significant dysregulation in three circulating autoantibodies: IgE-beta1 adrenergic receptor (B1AR), IgE-alpha 1 adrenergic receptor (A1AR) and IgE-muscarinic acetylcholine receptor type 1 (M1R) autoantibodies in women with SBI who complained of allergic symptoms. CONCLUSIONS: Allergic reactions associated with SBI are not uncommon. Imbalance of circulating levels of IgE autoantibodies against GPCRs of the autonomic nervous system might play a role not only in allergic reactions, but also in other enigmatic aspects of SBII such as autoimmune dysautonomia.

Pulmonary adverse events of breast silicone implants and silicone injection.

The incidence of breast implants and silicone injections has continuously increased since their FDA approval for use in the 1960's. The prevalence of overall adverse events is approximately 20%. The actual incidence of pulmonary adverse events is unknown. This review focuses on the pulmonary adverse events of breast implants and silicone injections. Vascular complications are represented by acute and chronic embolisation syndromes with a clinico-radiological presentation of alveolar hemorrhage. Inflammatory complications are numerous, including siliconoma, which is a granulomatous reaction mimicking a mesothelioma. On the other hand, there are some reports arguing a link between the development of auto-immune diseases and breast implants, such as scleroderma, rheumatoid arthritis, Sjögren's syndrome, and dermatomyositis. Finally, for patients with asthma, breast implants may contribute to poor disease control. Cases of eosinophilic granulomatosis with polyangeitis have been described. Thus, it is of interest to decipherate mechanisms and incidence of these effects in prospective studies to better manage pulmonary diseases in patients wearing breast implants in order to understand their role as culprits or bystanders. In addition, characterization of subpopulations with increased risk of adverse events is needed as we highlighted that some subpopulations seem to be at greater risk of developing them, notably asthmatics.

Accidental rupture of membranes and neonatal infection after labor induction with silicone or latex balloon catheters: A retrospective cohort study.

OBJECTIVE(S): Accidental rupture of membranes (acROM), an insertion-related complication of the balloon catheter for labor induction, may prolong the duration of ruptured membranes. Prolonged rupture of membranes is associated with an increased risk of intra-uterine infection with possibly neonatal infection as result. Little is known about safety profiles of different catheters regarding the occurrence of these complications. This study compares the incidence of neonatal early-onset sepsis (EOS) and acROM in women receiving either silicone or latex balloon catheters. STUDY DESIGN: A retrospective cohort study was performed including 2200 women (silicone balloon catheter, n = 1100 vs. latex balloon catheter, n = 1100). The primary outcomes were the incidence of acROM, and suspected and proven neonatal EOS. Secondary outcomes were: prolonged rupture of membranes, intrapartum fever, pre- or postnatal neonatal exposure to antibiotics, and perinatal outcomes. A subgroup analysis was performed between women with and without acROM. RESULTS: No statistically significant difference with regard to suspected or proven EOS was seen between the silicone and latex groups. The acROM rate was significantly higher in the silicone group compared to the latex group (2.9 % and 0.3 %, p < 0.01). Prolonged rupture of membranes was significantly more common in the silicone group compared to the latex group (5.0 % and 2.4 %, p < 0.01), as was the use of intrapartum antibiotics (12.7 % and 9.6 %, p = 0.02). Neonates were significantly more often exposed to pre- or postnatal antibiotics in the silicone group compared to the latex group (17.6 % and 13.6 %, p = 0.01). Subgroup analysis showed significantly more suspected and proven neonatal EOS when catheter-insertion was complicated with acROM (11.4 % and 20.0 %), compared to cases without acROM (3.8 % and 2.5 %), irrespective of the type of catheter used. CONCLUSION(S): The use of silicone balloon catheters for labor induction results in higher rates of acROM, prolonged rupture of membranes and use of intrapartum antibiotics, compared to latex balloon catheters. No statistically significant differences were found in the occurrence of suspected or proven neonatal EOS, however neonates from the silicone group were more often exposed to pre- or postnatal antibiotics. When acROM occurs, irrespective of type of catheter used, suspected and proven neonatal EOS was seen more often.

Morphea after Silicone Implants.

Dear Editor, Silicone is a hydrophobic polymer containing silicon. Silicon is an essential compound of soft tissue proteoglycans. Reports about morphea and other autoimmune connective tissue disorders in association with silicone implants have stimulated the discussion of a possible link between the two, such as immunological cross-reactivity of silicone and connective tissue components (1). A number of case reports suggested a possible link to adjuvant autoimmune syndrome (2), morphea of the breast (3-5), and systemic scleroderma (6-8), among others. One study measured tissue silicon levels in women with silicone breast implants with and without symptoms or signs and compared these data with women who had either a saline breast implant or no augmentation at all. The authors detected higher levels of silicon in capsular tissue of patients with silicone implants, independent of the presence of any symptoms or signs (9,10). The conclusion was that there is no evidence of an association between silicone implants and autoimmune connective tissue disorders. Three other clinical trials investigating the role of silicone implants and induction of autoimmune connective tissue disorders also failed to find an association between the two (11-13). We report the case of a 32-year-old female patient who developed morphea of the breasts after silicone implants for augmentation after risk-reducing mastectomy for Cowden syndrome. She presented with pronounced capsule fibrosis of the implants. With a delay of several years, an ill-defined slightly hyperpigmented area developed on the breasts and ventral chest (Figure 1). The lesion was analyzed by dermoscopy (Figure 2), which found mild erythema, reduced vessels, and white areas (ill-defined dull white globules, fibrotic beams). A skin biopsy was taken. Histopathological analysis showed a normal epidermal layer, minor papillary edema, and some vascular ectasias in the papillary dermis and upper corium (Figure 3). There was mild perivascular inflammatory infiltrate of the deep dermal vascular plexus, composed of lymphocytes and monocytes with some plasma cells (Figure 4). Elastic fibers seemed unaffected (Figure 5). The diagnosis of an early morphea of the edematous-inflammatory stage was established. Treatment with topical corticosteroids and UVB-311 nm irradiation was recommended. Morphea of the breasts is an uncommon disorder. It may occur after radiotherapy of breast cancer, after silicone augmentation, or without any known cause (14-16). A meta-analysis found an increased risk for morphea/scleroderma, with a relative risk between 1.30 to 2.13 and an odds ratio for case control studies of 1.68 (17). The US FDA Breast Implant Approval Study evaluated almost 100,000 female patients with breast implants. An increased risk of Sjögren's syndrome, scleroderma, and rheumatoid arthritis was reported (18). We could not find any reference of an association between capsular fibrosis and morphea of the breast, although both represent fibrotic disorders. In conclusion, it seems possible that there is a link between morphea of the breast and chest as described herein and silicone breast implants, which is supported by epidemiological studies. However, a direct causal relationship is hard to demonstrate with a single case.

Complication of Ear Impression: Foreign Body in the Eustachian Tube Eroding the Carotid Canal.

The realization of customized earing plugs and earmolds for hearing aids requires an impression of the external auditory canal to obtain a siliconized mold. Silicone used for ear impressions is known to be safe and inert but deposition of silicone in the middle ear can middle and inner ear damages. We present a case of accidental injection of silicone in the middle ear and the Eustachian tube resulting in an erosion of the carotid canal. Laryngoscope, 133:3358-3360, 2023.

Pectoralis Major Muscle Morbidity After Submuscular Silicone-based Breast Reconstruction: A Systematic Review.

Silicone implants or tissue expanders placed under the pectoralis major (PM) muscle are often used for breast reconstruction. However, the disruption of PM insertions, which is often an inevitable part of the surgical procedure, is known to cause PM morbidity and, subsequently, problems with the use of the ipsilateral arm. In this systematic review, we present current knowledge regarding the effect of submuscular silicone-based breast reconstruction on the function of PM and the ipsilateral arm. A search of the relevant English literature was performed through PubMed and ten eligible studies were identified. Articles reporting breast augmentation were accepted as the techniques of implant insertion are similar to reconstruction. Questionnaires reporting the status of the arm, analysis of the range of motion of the shoulder with 3-D video, isometric or isokinetic dynamometry, ultrasound shear-wave elastography, volumetric MRI, electromyography and light and electron microscopy of the PM fibers were used for the assessment of PM and arm status. The insertion of implants under the PM, especially when combined with dissection of some of its insertions, seems to be associated with measurable abnormal microscopic, imaging, and dynamometric findings. However, the intact part of the muscle and possibly other nearby muscular structures are able to compensate for the lost part of PM. Thus, the insertion of implants fully or partially under the PM seems to have no or little effect on the function of the ipsilateral upper limb in daily life.

Silicone prosthetics and anti-thyroid autoimmunity.

INTRODUCTION: In esthetic surgery, the use of silicone implants is a topic of hot discussion. MATERIAL AND METHODS: An analysis of 119 esthetic surgical interventions on the mammary gland was performed. A study of the immune and endocrine parameters after mammoplasty was carried out. RESULTS: The phenomenon of an increase in the levels of autoantibodies to the TSH receptor was revealed. The phenomenon of pre-operative growth of prolactin and TSH levels has been confirmed. An increase in thyroid autoimmunity after silicone mammoplasty is interpreted as a result of a silicone adjuvant action. An increase in the incidence of ASIA syndrome in patients who underwent breast surgery was registered. However, it was observed in both patients with silicone and non-silicone breast surgeries and therefore could not be solely explained by the use of silicone. Within 12 months following silicone mammoplasty, the patients with an increase of anti-TSH receptor autoimmunity nevertheless did not show any clinical and laboratory signs of overt thyroid disease, thus staying in a pre-nosological state. PRACTICAL RECOMMENDATIONS: Based on these results, we recommend the following for esthetic surgery: (a) all patients planned for silicone implant surgery should be examined for autoantibodies to the TSH receptor and (b) patients who have undergone breast endoprosthesis, starting 6 months after the operation, need long-term follow-up for thyroid status with mandatory testing for the level of these autoantibodies.

Complications of severe breast deformities after a silicone injection over 20-year and a successful surgical treatment.

Breast deformities caused by silicone injections affect aesthetic results and cause irreversible complications in patients. In the treatment, it is necessary to entirely remove silicone particles and infiltrated and fibrous breast tissues. The maximal preservation of healthy breast tissues is also critical. This report presents a case of severe breast deformities as complications 20 years after silicone injections at an unreputable aesthetic center. During the surgery, the authors separately removed fluid (silicone) masses and reconstructed mammary glandular tissues. Breast reconstruction was performed by the anchor breast lift along with the functional preservation of the nipple-areola complex and the superomedial pedicle. The surgery entirely addressed complications after injecting a large amount of silicone. 6 months postoperatively, the surgical outcomes were satisfactory. The surgical excision should be done to remove silicone-infiltrated tissues as much as possible before the reconstructive surgery. The combination of radical surgical excision and reconstructive surgery using the anchor breast lift as a single-stage procedure brought good aesthetic results.

Autoimmune/inflammatory syndrome induced by adjuvants (ASIA), medical treatment of severe systemic compromise: case report.

Case description: A 42-year-old woman with severe pulmonary and mediastinal inflammatory involvement, secondary to infiltration of a silicone-related allogenic material with systemic migration. Clinical findings: The patient developed esophageal and bronchial stenosis, recurrent infections, malnutrition, and respiratory deterioration, making surgical removal of the allogenic material impossible. Treatment and outcome: Clinical and radiological improvement was achieved after treatment with multiple intravenous and oral immunomodulators. Clinical relevance: Autoimmune/inflammatory syndrome induced by adjuvants (ASIA) is a heterogeneous disease resulting from exposure to allogenic substances in a susceptible subject. These substances cause autoimmune or autoinflammatory phenomena. Since ASIA was described ten years ago, its diagnostic criteria are still under discussion, with an uncertain prognosis. The ideal therapy is based on eliminating the causative substance, but this is not always possible. Therefore, it is necessary to start an immunomodulatory treatment, using it in this patient, a scheme that had not been previously reported in the literature.

Descripción del caso: Mujer de 42 años con compromiso inflamatorio pulmonar y mediastinal severo, secundario a infiltración de un material alogénico relacionado con la silicona con migración sistémica. Hallazgos clínicos: La paciente desarrolló estenosis esofágica y bronquial, infecciones recurrentes, desnutrición y deterioro respiratorio, imposibilitando la extracción quirúrgica del material alogénico. Tratamiento y resultado: Mejoría clínica y radiológica lograda tras un tratamiento con múltiples inmunomoduladores intravenosos y orales. Relevancia clínica: El síndrome autoinmune / inflamatorio inducido por adyuvantes (ASIA) es una enfermedad heterogénea que resulta de la exposición a sustancias alógenas en un sujeto con susceptibilidad genética. Estas sustancias inducen fenómenos autoinmunitarios o autoinflamatorios. Desde que ASIA fue descrito hace 10 años, sus criterios diagnósticos continúan en discusión, con un pronóstico incierto. El tratamiento idóneo se basa en eliminar la sustancia causante, pero no siempre es posible, por lo cual se hace necesario iniciar un tratamiento inmunomodulador, empleándose en esta paciente un esquema que no había sido reportado previamente en la literatura.

Host-Reaction Following Silicone Tube Implantation For Lower Limb Lymphoedema Mimicking Implant Infection.

INTRODUCTION: Silicone tube implantation in lymphoedema reduces symptoms by improving fluid drainage. Although there are descriptions of implant host reaction that can be misdiagnosed as graft infections these are scarce. REPORT: A 34 year old female with lymphoedema of the lower limb, underwent silicone tube implantation. Ten months after surgery, the patient presented with fever and dermatolymphangioadenitis of the limb. Ultrasound suggested an abscess surrounding the tubes. Clinical improvement was achieved after a 6-day cycle of meropenem. She was discharged under oral cefuroxime and clindamycin for one week. After 1 month, CT-angiography was performed showing only residual inflammation surrounding the tubes, the patient was asymptomatic and limb diameter was normal. CONCLUSION: Sudden onset and improvement of the patient's condition after a short cycle of antibiotics without the need of tube removal supports a host-like reaction rather than an actual infection. Doctors should be aware of such complications avoiding unnecessary procedures.

[Autoimmune/inflammatory syndrome induced by adjuvants. Case report]. / Síndrome autoinmunitario/inflamatorio inducido por adyuvantes. Reporte de caso.

Background: The indiscriminate application of substances for aesthetic purposes, such as silicone in breast implants, leads to the production of common local signs such as inflammation, skin irregularities, edema, erythema, vascular neoformations, and ulcers, which can evolve into general symptoms such as fever, asthenia, weakness, arthralgia or activate the immune system abnormally, causing the appearance of autoimmune diseases. This set of signs and symptoms is called adjuvant-induced autoimmune/inflammatory syndrome. Clinical case: We present the case of a 50-year-old woman with a history of silicone-based breast implants who spontaneously developed a hemorrhagic coagulopathy, type A acquired hemophilia was documented, that is, autoantibodies against coagulation factor VIII. Thanks to the work of a multidisciplinary team, it is possible to successfully diagnose and treat the patient with bridging agents, implant removal and management of associated symptoms. Conclusion: the importance of knowing the pathology is recognized, which, although it is rare, when it occurs has a high mortality rate if it is not diagnosed and treated on time.

Introducción: la aplicación de sustancias con fines estéticos de forma indiscriminada, como es el caso de la silicona en los implantes mamarios, llevan a la producción de signos locales comunes como: inflamación, irregularidad en la piel, edema, eritema, neoformaciones vasculares y úlceras, que pueden evolucionar a síntomas generales como la fiebre, astenia, adinamia, artralgias o a activar, de manera anómala, el sistema inmunitario, causando la aparición de enfermedades autoinmunitarias. A este conjunto de signos y síntomas se le denomina síndrome autoinmunitario/inflamatorio inducido por adyuvantes. Caso clínico: presentamos el caso de una mujer de 50 años con antecedente de implantes mamarios a base de silicona que desarrolla, de manera espontánea, una coagulopatía hemorrágica, se documenta hemofilia tipo A adquirida, es decir, autoanticuerpos contra el factor VIII de la coagulación. Gracias al trabajo de un equipo multidisciplinario se consigue diagnosticar y tratar de manera exitosa a la paciente con agentes de puente, remoción de los implantes y manejo de los síntomas asociados. Conclusión: se reconoce la importancia de conocer la patología que, si bien es rara, cuando se presenta tiene alta tasa de mortalidad si no se diagnostica y trata a tiempo.