Implicações do uso do silicone industrial | Saúde LGBTIA+ - SMS-PMSP

Explica quais as implicações na saúde de quem utilizou silicone industrial em procedimentos estéticos e os cuidados possíveis para melhorar a qualidade de vida dessas pessoas.

Major Clinical Adverse Events of Breast Implant in the Manufacturer and User Facility Device Experience Database.

OBJECTIVE: Search the Manufacturer and User Facility Device Experience database to collect information on adverse events of breast implant. We analyzed the local complications and the breast implant illness (BII) of silicone breast implants, as well as saline breast implants separately, aim to provide a reference for women who want to breast augmentation. MATERIALS AND METHODS: The Manufacturer and User Facility Device Experience database was queried for events reports related to the breast implant between July 1, 2012, and June 30, 2022. Event year and reporting year were summarized. Patient problem was collected and analyzed to distinguish between local complications and BII. RESULTS: A total of 108,728 adverse events in the past 3 years were analyzed, silicone breast implants accounted for 62.1% and saline breast implants accounted for 37.9%. The most common local complication of women receiving silicone breast implants was "Capsular Contracture," accounting for 48.73%. However, the incidence of "capsular contracture" in women who received saline breast implants was only 17.49%. The most common BII was "fatigue/weakness" in both women receiving 2 different breast implants, 17.20% in women receiving silicone breast implants and 24.71% in women receiving saline breast implants. Of note, in all the reports, there was a wide variation in the timing of reporting as compared with the timing of the adverse event. CONCLUSIONS: Although the adverse events of breast implant cannot completely be determined from this study, we provide a reference for women who want to get breast implants, so that they can choose breast implants more carefully. In addition, a better understanding of BII may allow them to think further about whether the benefits of breast implants outweigh the risks.

Altered Foreign Body Response at the Posterior Surface Compared to the Anterior Surface of Human Silicone Breast Implants.

Soft implantable devices are crucial to optimizing form and function for many patients. However, periprosthetic capsule fibrosis is one of the major challenges limiting the use of implants. Currently, little is understood about how spatial and temporal factors influence capsule physiology and how the local capsule environment affects the implant structure. In this work, we analyzed breast implant capsule specimens with staining, immunohistochemistry, and real-time polymerase chain reaction to investigate spatiotemporal differences in inflammation and fibrosis. We demonstrated that in comparison to the anterior capsule against the convex surface of breast implants, the posterior capsule against the flat surface of the breast implant displays several features of a dysregulated foreign body reaction including increased capsule thickness, abnormal extracellular remodeling, and infiltration of macrophages. Furthermore, the expression of pro-inflammatory cytokines increased in the posterior capsule across the lifespan of the device, but not in the anterior capsule. We also analyzed the surface oxidation of breast explant samples with XPS analysis. No significant differences in surface oxidation were identified either spatially or temporally. Collectively, our results support spatiotemporal heterogeneity in inflammation and fibrosis within the breast implant capsule. These findings presented here provide a more detailed picture of the complexity of the foreign body reaction surrounding implants destined for human use and could lead to key research avenues and clinical applications to treat periprosthetic fibrosis and improve device longevity.

Prevalence, clinical characteristics, and management of silicone lymphadenopathy: A systematic review of the literature.

INTRODUCTION: Implant-based breast augmentations and reconstructions are one of the most common surgical procedures performed by plastic surgeons in the United States, which has rapidly increased in popularity since the 2000s. Silicone lymphadenopathy (SL) is a complication of breast implants that involves migration of silicone to nearby soft tissue/lymph nodes. Data on its clinical features and management is scarce. METHODS: SL-related search terms were used to find articles in 3 databases. Of 598 articles, 101 studies met the inclusion criteria. Demographics, clinical presentation, workup, and management data were analyzed. RESULTS: Of 279 cases of SL and 107 with information on initial diagnosis, 35 (33%) were incidental. The most common symptom was painless lymphadenopathy, followed by painful lymphadenopathy. 251 (95%) and 13 (5%) patients had silicone and saline implants, respectively. 149 (68%) patients had implant rupture. Axillary lymphadenopathy was the most affected region (136 cases, 72%), followed by internal mammary (40 cases, 21%), cervical/supraclavicular (36 cases, 19%), and mediastinal (24 cases, 13%) regions. 25% of patients underwent fine-needle aspiration, 12% core needle biopsy, and 59% excisional biopsy. 32% of cases underwent explantation and/or implant exchange. The most common indication for surgery was implant rupture. Histology showed multinucleated giant cells, large histiocytes, and silicone accumulation. CONCLUSIONS: SL is a complication associated with breast implants. The majority of patients are asymptomatic, and most cases are managed conservatively. Minority need a biopsy and surgical interventions due to abnormal imaging, persistent symptoms, and/or implant rupture. Workup and management should be tailored to the patient.

Silicone Particles in Capsules Around Breast Implants: An Investigation Into Currently Available Implants in North America.

BACKGROUND: Breast implants have always been composed of a silicone elastomer envelope filled with either silicone gel or saline. Breast implant illness (BII) is a set of symptoms that has previously been linked to the leakage of silicone particles from the implants into the body. OBJECTIVES: Our research aimed to quantify the number of silicone particles present in the capsules of breast implants available in North America. METHODS: Thirty-five periprosthetic capsules were sampled and analyzed, and silicone particles were counted and measured. The capsule surface area was then measured and utilized to calculate particle density and total number of silicone particles. RESULTS: Eighty-five percent of capsules analyzed from silicone gel implants contained silicone, with an average of 62 particles per mm3 of capsular tissue. These implants had approximately 1 million silicone particles per capsule. In contrast, none of the saline implant capsules contained silicone. Capsules from macrotextured tissue expanders contained fewer and larger silicone particles. CONCLUSIONS: Silicone gel implants presented silicone particle bleeding into the periprosthetic capsule, totaling on average 1 million silicone particles per capsule. On the other hand, no silicone particle bleeding was observed from saline breast implants. These data suggest that particle bleeding comes from the inner silicone gel, and not from the smooth outer silicone shell. Previous studies have reported the presence of breast implant illness in patients with both silicone- and saline-filled implants. Therefore, our data suggest that silicone migration is not the sole cause of BII.

Submuscular Buttock Augmentation With Silicone Implants in 80 Female Patients.

BACKGROUND: Over the past 4 decades, gluteal augmentation has increased enormously in popularity, and numerous techniques have been developed to provide patients with the best possible outcomes. The submuscular technique has been shown to be a reliable option for a broad cohort of patients. OBJECTIVES: The main objective of this retrospective study was to describe the characteristics and clinical outcomes of a group of patients who underwent gluteal augmentation by the submuscular technique. METHODS: A retrospective analysis was conducted on 80 female patients who underwent submuscular gluteal augmentation with silicone implants between August 2019 and May 2022. All of the patients were operated on by the authors of the present study. RESULTS: Information about patient demographics, implants, complications, and treatments was analyzed. Moreover, the satisfaction of the patients was assessed by means of a short survey. The most frequent complication was wound dehiscence. Only 7 patients required surgical revisions, and 2 required isolated antibiotic therapy. All complications were effectively addressed and no implants had to be removed. Furthermore, the retrospective analysis revealed a noteworthy association between the size of the implant and the occurrence of complications. CONCLUSIONS: The submuscular method provides the best aesthetic results and adequate safety for patients. It significantly minimizes the possibility of complications, such as fluid collection due to muscle fiber dissection or implant exposure/extrusion.

Rupture of 40-year-old silicone gel breast implants: a case report.

BACKGROUND: Implant rupture is one of the complications of breast augmentation surgery. The rupture of silicone implants is often insidious, potentially causing problems at any time. This is a case report of the rupture of 145-cc breast implants manufactured by Dow Corning Corporation and their removal at 40 years after augmentation. CASE PRESENTATION: A 70-year-old female patient was admitted for the removal of a lump in the upper and inner quadrants of the right breast. After a detailed examination, a rupture of the bilateral breast implants was diagnosed. Explantation without replacement was performed; the entire procedure proceeded smoothly. Immunohistochemical staining revealed siliconoma with lymphoid hyperplasia and calcification in the bilateral breasts with no signs of malignancy. CONCLUSIONS: Silicone breast augmentation is one of the most popular aesthetic surgical procedures worldwide. Therefore, it is important to educate patients on the need for close monitoring of their implants after augmentation through magnetic resonance imaging or ultrasound to facilitate early detection of any changes before a rupture occurs. Early detection of the implant rupture, in turn, will facilitate early and effective management.

Resultados preliminares de tres años de eventos adversos con implantes mamarios de poliuretano Silimed® / Three-year preliminary results of adverse events with Silimed® polyurethane breast implant

Antecedentes. Se solicita a los fabricantes que garanticen los estándares de calidad actuales, actualicen el plan de investigación del dispositivo y actualicen los informes de eficacia/seguridad. El objetivo de este estudio es estimar la seguridad y eficacia de los implantes mamarios de Silimed disponibles para la venta. Métodos. Este es un ensayo de fase IV, abierto, no aleatorizado, realizado en Río de Janeiro/Brasil. Los participantes se seleccionaron consecutivamente. Los principales criterios de elegibilidad son: recibir los implantes mamarios de Silimed para el aumento estético hasta 21 días antes de la visita de inclusión; no tener condiciones que aumenten el riesgo de eventos adversos a corto plazo. Las intervenciones son los implantes mamarios de poliuretano de Silimed. Los resultados de seguridad se consideran eventos adversos y el plan de análisis es estimar la incidencia de eventos adversos de Kaplan-Meier. Resultados. Se analizaron un total de 213 con seguimiento hasta 36 meses. La edad media era de 33,04 años. El riesgo de extracción del implante fue del 0,0% a los 36 meses. La estimación del riesgo de Kaplan-Meier para el seroma fue del 1,3%, no hubo casos de contractura capsular clínicamente relevante (Backer III/ IV), reintervención, infección y ruptura del implante. Conclusiones. Las tasas de eventos se consideraron prometedoras. Los informes futuros del estudio en curso mejorarán la interpretación de los datos actuales. Identificador de ClinicalTrials.gov: NCT03356132.

Background. Manufacturers are requested to ensure the current quality standards, update the device's investigation plan and update efficacy/safety reports. The aim of this study is to estimate the safety and efficacy of Silimed's breast implants available for sale. Methods: This is a phase IV, open label, non-randomized trial, performed at Rio de Janeiro/Brazil. Participants were selected consecutively. Main eligibility criteria are: received Silimed's breast implant(s) for aesthetic augmentation up to 21 days before the inclusion visit; not having conditions that increases adverse event short term risk. Interventions are Silimed's polyurethanebreast implants. Safety outcomes are considered adverse events and the analysis plan is to estimate Kaplan-Meier incidence of adverse events. Results. A total of 213 were analyzed with follow-up up to 36 months. The average age was 33.04 years. The risk for implant removal was 0.0% at 36 months. The Kaplan-Meier risk estimate for seroma was 1.3%, there were no cases of clinically relevant capsular contracture (Backer III/IV), reoperation, infection and implant rupture. Conclusions. Rates of events were considered promising. Future reports from the ongoing study will improve the interpretation of current data. Clinical Trials. gov Identifier: NCT03356132.

Separating Myth from Reality in Breast Implants: An Overview of 30 Years of Experience.

SUMMARY: The purpose of this article is to review the pivotal events in the history of breast implants in the United States, including the events leading to the U.S. Food and Drug Administration moratorium on the use of silicone gel implants and subsequent approval; the emergence of breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL); and persistent concerns about an association between breast implants, autoimmune disease, and systemic symptoms. This article reviews the medical literature to outline our current knowledge on BIA-ALCL; offers recommendations for diagnosis and management of symptomatic and asymptomatic patients with textured implants; and reviews the science of potential associations of implants with autoimmune and systemic symptoms. The authors hope to help patients separate myths from reality and make educated decisions on having breast implants placed or removed.

Silicone breast implant rupture is more prevalent in the dominant limb side: A retrospective cohort study.

BACKGROUND: Breast implant rupture is associated with multiple risk factors such as implant age, manufacturer, and a history of trauma to the breast. However, the exact mechanism of breast implant rupture remains unclear. We hypothesize that repetitive minor mechanical forces on the implant collectively play a significant role in the cascade that eventually leads to its rupture. Therefore, we expect a more significant cumulative effect on the breast implant in the dominant upper limb side. Thus, we aim to ascertain whether laterality in silicone breast implant rupture is associated with the dominant upper limb. METHODS: A retrospective cohort study was performed on patients with silicone breast implants who underwent an elective breast implant removal or exchange. All patients had breast augmentations for cosmetic reasons. We collected data on implant rupture laterality and limb dominance together with known risk factors like patient age, implant age, implant pocket, and implant volume. RESULTS: A total of 154 patients with unilateral implant rupture were included in the study. Among patients with a dominant right limb (n = 133), an ipsilateral rupture was found in 77 patients (58%) (p = 0.036), while in patients with a left dominant limb (n = 21), an ipsilateral rupture was found in 14 patients (67%), (p = 0.036). CONCLUSIONS: The dominant limb was a significant risk factor for ipsilateral breast implant rupture. The prevailing theory that cyclic envelope movement carries an increased rupture risk is reinforced in this study. Extensive prospective studies are needed to clarify risk factors for implant rupture further.

Baker Grade IV Capsular Contracture Is Correlated with an Increased Amount of Silicone Material: An Intrapatient Study.

BACKGROUND: Breast implant surgery is one of the most frequently performed procedures by plastic surgeons worldwide. However, the relationship between silicone leakage and the most common complication, capsular contracture, is far from understood. This study aimed to compare Baker grade I with Baker grade IV capsules regarding their silicone content in an intradonor setting, using two previously validated imaging techniques. METHODS: Twenty-two donor-matched capsules from 11 patients experiencing unilateral complaints were included after bilateral explantation surgery. All capsules were examined using both stimulated Raman scattering (SRS) imaging and staining with modified oil red O (MORO). Evaluation was done visually for qualitative and semiquantitative assessment and automated for quantitative analysis. RESULTS: Using both SRS and MORO techniques, silicone was found in more Baker grade IV capsules (eight of 11 and 11 of 11, respectively) than in Baker grade I capsules (three of 11 and five of 11, respectively). Baker grade IV capsules also showed significantly more silicone content compared with the Baker grade I capsules. This was true for semiquantitative assessment for both SRS and MORO techniques ( P = 0.019 and P = 0.006, respectively), whereas quantitative analysis proved to be significant for MORO alone ( P = 0.026 versus P = 0.248 for SRS, respectively). CONCLUSIONS: In this study, a significant correlation between capsule silicone content and capsular contracture is shown. An extensive and continued foreign body response to silicone particles is likely to be responsible. Considering the widespread use of silicone breast implants, these results affect many women worldwide and warrant a more focused research effort. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, III.

Silicone Migration From Breast Implants: A Case of Ocular Siliconoma and Literature Review.

BACKGROUND: Breast augmentation with implants is one of the most popular cosmetic surgery operations performed worldwide. Complications of breast implants are well recognized, and include capsular contracture, implant rupture, and infrequently distant migration of silicone, resulting in siliconoma. Distant migration of silicone can present many years after implantation with a wide variety of signs and symptoms. OBJECTIVES: The aim of this study was to describe the authors' experience of orbital silicone migration and to review the literature describing documented cases of distant silicon migration from breast implants, both ocular and nonocular. METHODS: In January 2022, a case of breast implant augmentation presented with silicone migration into the right orbit. This rare case was monitored and diagnosed with ocular muscle palsy and diplopia. Here, the authors present the patient's presenting complaint, symptomatology, working investigations, and outcomes. A comprehensive report of all available cases of distant silicone migration is presented along with their associated complications and more specifically ocular silicone migration. RESULTS: Systemic migration of silicone from breast implants to the orbital region is extremely rare: a total of 4 previous cases of ocular silicone migration from breast implants have been described previously; the authors describe the fifth case herein. CONCLUSIONS: Silicone implant rupture can present with a wide variety of clinical symptoms that may mimic different clinical pathologies. In every patient with a history of breast augmentation with silicone implants, the possibility of silicone migration should be always taken into consideration during the differential diagnosis process.

[Siliconosis with rheumatoid polyarthritis following a breast implant rupture: Case report and literature review]. / Siliconose avec polyarthrite rhumatoïde dans les suites d'une rupture d'implant mammaire : cas clinique et revue de la littérature.

Breast implant rupture is a common complication in plastic surgery, with various clinical presentations, due to silicone migration. In this article, we present the case of a patient with ruptured silicone implants, who developed siliconosis with rheumatoid polyarthritis, and evolved favourably after explantation surgery. The physiopathology of this disease, and the implication of silicone migration are still controversial, and yet to be confirmed.

[Five Cases of Breast Cancer Developed after Silicone Breast Implant].

We report 5 cases of breast cancer that developed after cosmetic augmentation using silicone breast implants. The chief complaints were breast tumor in 3 cases, skin change in 1 case, and nipple bleeding in 1 case. Intervals between silicone breast implants and breast cancer surgeries ranged from 10 to 31 years. The pTNM stages included were Stage 0, Ⅰ, ⅡA, ⅢB, and Ⅳ, respectively, and the subtypes included were 3 Luminal types and 2 Luminal-HER2 types. Silicone bag rupture was noted in 1 case, and all bags were removed during surgery. The breast cancer surgeries performed were four breast- conserving surgeries and one mastectomy. The follow-up period ranged between 1.8 and 14 years(mean 5.1 years). All cases survived, but 2 cases had recurrences; the Stage ⅢB case experienced lung metastasis 2 years postoperatively and Stage Ⅳ case had induced pCR by chemotherapy postoperatively, but therapeutic self-interruption led to recurrences at the contralateral axillary nodes and contralateral breast and lung metastases 3 years postoperatively. Judging from limited reports of breast cancer after silicone breast implant in Japan, their incidence seems to be extremely low, and the incidence in our clinic during these 15 years(5 out of 1,851 primary breast cancers)is 0.27%.

Ideal Implant Structured Breast Implants: Core Study Results through 10 Years.

BACKGROUND: The Ideal Implant structured breast implant uses different technology than unstructured saline or silicone gel implants, making it a third type of implant. U.S. Food and Drug Administration (FDA) and Health Canada granted approval in November of 2014. This saline-filled implant has an internal structure consisting of a series of nested shells that support the upper pole when upright and control movement of the saline to provide a natural feel. Because women can look in the mirror to know their implants are intact, they have peace of mind. In contrast, most women are concerned about silicone gel implant ruptures, which are silent and require FDA-recommended magnetic resonance imaging or ultrasound scans for detection. METHODS: This U.S. trial enrolled 502 women: 399 for primary and 103 for revision augmentation. Investigators were 45 American Board of Plastic Surgery-certified plastic surgeons at 35 sites. Of the 502 women enrolled, 426 (84.9%) completed 10-year follow-up visits, a higher percentage than all other FDA breast implant trials. RESULTS: Through 10 years of follow-up, surgeon satisfaction was 94.8% for primary and 87.4% for revision augmentation; and patient satisfaction was 92.7% for primary and 82.3% for revision augmentation. Cumulative Kaplan-Meier risk rates for two major adverse events were lower than in the silicone gel implant trials: Baker class III and IV capsular contracture was 6.6% for primary and 11.5% for revision augmentation; and rupture/deflation was 3.7% for primary and 4.7% for revision augmentation. CONCLUSION: Ten-year results from 426 women show the Ideal Implant has high patient and surgeon satisfaction, a low rate of capsular contracture, and a low rate of rupture/deflation. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Xanthogranulomatous inflammation and spindle cell proliferation in response to silicone breast implant leakage.

This case study highlights the rare complications of silicone breast implants, as well as the diagnostic limitations of imaging. The patient initially presented with leakage of bilateral breast implants as discovered by a positron emission tomography (PET)-computerized tomography (CT) scan performed as part of a workup for small bowel Langerhans cell sarcoma metastases. The imaging results of the PET-CT scan revealed increased activity bilaterally with an enhancing, irregular, heterogeneously enhancing mass in the right breast. Given the clinical suspicion for breast implant-associated anaplastic large cell lymphoma, further investigation including surgical excision was undertaken. What initially was a concern for a serious complication of long-standing breast implants, fortuitously turned out to be a benign but exuberant xanthogranulomatous inflammatory reactive process. We hope that our report will add to the literature of this rare phenomenon and highlight it as a differential diagnosis of a mass in association with breast implants.

Prospective Study of Clinical Outcomes From a Breast Implant Assessment Service.

BACKGROUND: Breast augmentation remains the commonest cosmetic surgical procedure worldwide, in spite of recent regulatory action. OBJECTIVES: The aim of this study was to evaluate women with breast implants attending a breast implant assessment clinic and to capture clinical and implant data in women presenting to the service. METHODS: Patients were enrolled prospectively between January 2018 and December 2021. Clinical, implant, and practitioner data were recorded. Patients reported satisfaction on size, shape, and overall outcome as well as the presence or pain. Radiological evaluation, where indicated, was performed and data were included on these findings. RESULTS: A total of 603 patients were assessed. Their mean age was 42.7 years and mean age at implantation was 29.1 years. The most common complications were capsular contracture followed by pain, waterfall deformity, and double bubble, with rupture/contracture rates increasing after the 10-year mark. The risk of double bubble was significantly lower if patients were operated on by certified practitioners (odds ratio = 0.49, P = 0.011). There was almost universally poor awareness of the risks of breast implants in patients presenting for evaluation. CONCLUSIONS: This study has shown benefit in a breast implant assessment clinic to gather information on adverse events and patient-reported outcomes following breast implant surgery. Having appropriately trained and certified practitioners perform cosmetic augmentation significantly lowers the risk of implant malposition and deformity. Any adverse event occurring within 5 years of initial surgery should be flagged as a mandatory reportable clinical indicator and trigger further investigation.