Rupture Of Silicone Breast Implants Research Articles

Photon-counting CT of degenerative changes and rupture of silicone breast implants: a pilot study

BackgroundAccurate assessment of breast implants is important for appropriate clinical management. We evaluated silicone properties and diagnostic accuracy for characterizing silicone implants and detecting degenerative changes including rupture in photon-counting computed tomography (PCCT).MethodsOver 16 months, we prospectively included patients with silicone implants and available breast magnetic resonance imaging (MRI) who received thoracic PCCT performed in prone position. Consensus reading of all available imaging studies including MRI served as reference standard. Two readers evaluated all implants in PCCT reconstructions for degenerative changes. In a subgroup of implants, mean density of silicone, adjacent muscle, and fat were measured on PCCT reconstructions. Contrast-to-noise ratios (CNRs) were calculated for implant-to-muscle and implant-to-fat.ResultsAmong 21 subjects, aged 60 ± 13.1 years (mean ± standard deviation) with 29 implants PCCT showed the following: high accuracy for linguine sign, intraimplant fluid (all > 0.99), peri-implant silicone (0.95), keyhole sign (0.90), and folds of the membrane (0.81); high specificity for linguine sign, intraimplant fluid, keyhole sign, folds of the membrane (all > 0.99), and peri-implant silicone (0.98); and high sensitivity for linguine sign and intraimplant fluid (all > 0.99). In a subgroup of 12 implants, the highest CNR for implant-to-muscle was observed on virtual unenhanced reconstructions (20.9) and iodine maps (22.9), for implant-to-fat on iodine maps (27.7) and monoenergetic reconstructions (31.8).ConclusionsOur findings demonstrate that silicone breast implants exhibit distinct contrast properties at PCCT, which may provide incremental information for detection of degenerative changes and rupture of implants.Relevance statementThoracic photon-counting computed tomography is a promising modality for the diagnostic assessment of silicone breast implants.Key points• Thoracic photon-counting computed tomography demonstrates unique contrast properties of silicone breast implants.• Iodine map reconstructions reveal strong contrast-to-noise ratios for implant-to-muscle and implant-to-fat.• Thoracic photon-counting computed tomography shows high diagnostic accuracy in detecting implant degeneration and rupture.Trial registrationGerman Clinical Trials Register number DRKS00028997, date of registration 2022–08-08, retrospectively registered.Graphical

‘Pasta-Bly’ the best radiologic imaging sign—I saw the linguine sign

The linguine sign is a radiologic sign seen on magnetic resonance imaging (MRI) that indicates intracapsular rupture of silicone breast implants. It refers to multiple curvilinear lines that appear on MRI, representing the outline of the elastomeric shell of the silicone implant floating freely within the silicone gel. The term first appeared in literature in 1992 when optimal imaging techniques and modalities for implant rupture were still unclear, and since then the term “linguine sign” has been widely used to describe evidence of intracapsular rupture.

Systemic sclerosis with anti-RNA polymerase III positivity following silicone breast implant rupture: possible role of B-cell depletion and implant removal in the treatment.

Despite some case reports and small series of women with silicone breast implants (SBI) developing Systemic Sclerosis (SSc), no clear evidence of an association of SBI with SSc is available. However, SSc is characterized by clinical and immunological heterogeneity and autoantibodies are currently the best markers to stratify this heterogeneity of patients. Therefore, we have reviewed the literature for details of autoantibody characterization in reports of SSc associated with SBI. Moreover, the case of an anti-RNA polymerase III-positive SSc with rapid onset and progression, in which SBI rupture was found is described. This case may support a previous observation suggesting a possible role of SBI rupture as a trigger for anti-RNA polymerase III-positive SSc. This possible causal role may be reinforced by the observation that in our patient, despite immunosuppressive treatment, the disease progressed until SBI were removed, and reduction of anti-RNA polymerase III titer was obtained after rituximab treatment. This result may support data suggesting that B-cell depleting therapy may decrease specific autoantibody level in SSc patients, and that these changes are associated with disease improvement.

Gel Bleed and Rupture of Silicone Breast Implants Investigated by Light-, Electron Microscopy and Energy Dispersive X-ray Analysis of Internal Organs and Nervous Tissue

Gel Bleed and Rupture of Silicone Breast Implants Investigated by Light-, Electron Microscopy and Energy Dispersive X-ray Analysis of Internal Organs and Nervous Tissue

Role of US in evaluating breast implant integrity.

To assess the diagnostic accuracy and inter-observer variability of ultrasound (US) in recognizing signs of intra or extra-capsular rupture of silicone breast implants by using the magnetic resonance imaging (MRI) findings as the reference standard. 150 patients for a total of 300 implants underwent breast US and subsequently MR examination searching for signs of intra or extra-capsular rupture. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and diagnostic accuracy were calculated for breast US having MRI findings as the reference standard. Cohen's kappa statistics was used in order to assess inter-observer agreement for US. 170/300 (57%) implant ruptures were detected at US (intra-capsular n=110, extra-capsular n=60). By comparing US findings with MR results, overall sensitivity, specificity, accuracy, PPV, and NPV of 79, 63, 70, 65, and 77%, respectively, were found for breast US. In case of intra-capsular rupture, sensitivity, specificity, accuracy, PPV, and NPV of 63, 63, 63, 45, and 77%, respectively, were obtained; 100% values were found for extra-capsular rupture US diagnosis. US can be used as the first examination in patients with breast implants. US intra-capsular rupture detection requires further evaluation by MRI; in case of extra-capsular rupture US diagnosis, surgical implant removal could be proposed without further investigations.

MRI screening for silicone breast implant rupture: accuracy, inter- and intraobserver variability using explantation results as reference standard

The recall of Poly Implant Prothèse (PIP) silicone breast implants in 2010 resulted in large numbers of asymptomatic women with implants who underwent magnetic resonance imaging (MRI) screening. This study's aim was to assess the accuracy and interobserver variability of MRI screening in the detection of rupture and extracapsular silicone leakage. A prospective study included 107 women with 214 PIP implants who underwent explantation preceded by MRI. In 2013, two radiologists blinded for previous MRI findings or outcome at surgery, independently re-evaluated all MRI examinations. A structured protocol described the MRI findings. The ex vivo findings served as reference standard. In 208 of the 214 explanted prostheses, radiologists agreed independently about the condition of the implants. In five of the six cases they disagreed (2.6 %), but subsequently reached consensus. A sensitivity of 93 %, specificity of 93 %, positive predictive value of 77 % and negative predictive value of 98 % was found. The interobserver agreement was excellent (kappa value of 0.92). MRI has a high accuracy in diagnosing rupture in silicone breast implants. Considering the high kappa value of interobserver agreement, MRI appears to be a consistent diagnostic test. A simple, uniform classification, may improve communication between radiologist and plastic surgeon. MRI has a high accuracy in diagnosing rupture in silicone breast implants. MRI appears to be a consistent diagnostic test with excellent interobserver agreement. A simple, uniform classification system, improves communication between radiologist and plastic surgeon. The interobserver agreement on implant rupture is higher than on extracapsular leakage.

Silicone gel breast implant rupture diagnosed by magnetic resonance imaging

CASE REPORT A 50­year­old female was referred to the X­ray department with a complaints of slowly growing mass in the lower outer quadrant of her left breast and a sudden strong pain with change in the breast size and shape. Her past medical history reported an augmentation mammoplasty silicone breast implant 15 years ago. Physical examination showed a localized swelling in the lower outer quadrant of the left breast, with a presence of palpable mass given a high significant of breast implant rupture. Rest of physical examination were normal. A non­contrast magnetic resonance imaging (MRI) revealed a left side breast implant rupture (Figure 1). DISCUSSION Breast implants composed of silicone gel enveloped in a silicone rubber elastomer were introduced in 1963. The frequency of rupture of silicone­gel­filled breast prostheses is unknown, as are the associated health effects [1]. Brown SL et al. reported that on MRI, the prevalence of silicone gel implant rupture in a population­based study of 344 women in Birmingham, Alabama, was 55% and that 22% of ruptured implants showed extracapsular spread of silicon [2]. In 2003, Lisbet et al. reported 33 definite ruptures (10%) and 23 possible ruptures (7%) during a 2­year period. The overall rupture incidence rate for definite ruptures was 5.3 ruptures/100 implants per year [3]. Rupture of silicone breast implants is caused by stress on the implant at the time of surgical placement, trauma, defects in manufacture, long­term repetitive CLINICAL IMAGES OPEN ACCESS

The PIP mammary prosthesis: A product recall study

Concerns about the durability of silicone breast implants manufactured by Poly Implant Prothèse (PIP) have been expressed for several years prior to their formal withdrawal from the market in March 2010. Although precise details of what elements were at fault remain unclear, concerns have been raised about both the elastomer and the filler gel. Media speculation has focussed on device safety, longevity and, recently, a possible association with lymphoma, specifically anaplastic large cell lymphoma (ALCL). There is however, no actual data concerning these implants with which to guide and inform when concerned patients seek advice. PIP mammary prostheses were used by the senior author for both primary and revision breast augmentation (BA) during the period January 2000-August 2005. A database of patients was constructed and attempts made to contact each patient offering a free consultation and referral for ultrasound scan (USS). Chief outcome measures included secondary surgery, the implant rupture rate and time to rupture. 453 consecutive patients with PIP devices were identified. Of this number 30 had already undergone implant exchange for a variety of reasons. 180 (39.7%) could not be contacted and 19 had undergone explantation elsewhere, including the NHS. Of those who could be contacted, 47 declined consultation as they had no concerns. 97 had neither clinical signs nor radiographic evidence of implant rupture and elected to remain under regular review. At the time of writing, 38 have undergone implant exchange after ultrasonographic indication of rupture and the overall patient rupture rate for the PIP implant is 15.9-33.8%. This cohort correlates reduced implant longevity with each successive year from 2000 and no cases of ALCL have been diagnosed. Long-term studies such as this are difficult to undertake for a number of reasons as they place a significant additional burden of resources on a practice. They are, however, essential from an industry perspective both for the provision of information and supporting audit and professional standing. Being only a single-handed practice, this initial study is the tip of an iceberg that may affect 40,000 women in the UK with PIP implants, but it does provide some hard data with which to guide our patients. It is also believed to be the first independent product recall study in aesthetic breast surgery.

Still’s disease, lupus-like syndrome, and silicone breast implants. A case of ‘ASIA’ (Shoenfeld’s syndrome)

In recent years, four conditions, siliconosis, Gulf War syndrome (GWS), macrophagic myofasciitis syndrome (MMF) and post-vaccination phenomena, were linked to a previous exposure to an adjuvant, suggesting a common denominator, and it has been proposed to incorporate comparable conditions under a common syndrome entitled Autoimmune/inflammatory Syndrome Induced by Adjuvants (ASIA). We report a case of a female who at the age of 11 years was diagnosed with Still's disease. At the age of 22 she underwent silicone breast implants and presented with a transient lupus-like syndrome. Then, at 25 years old she had a severe activation of Still's disease in association with rupture of silicone breast implants. When the prostheses were removed, the clinical picture improved. This case fulfills the criteria for ASIA and complements seven previous reports of Still's disease in association with silicone breast implants.

The Effect of Study Design Biases on the Diagnostic Accuracy of Magnetic Resonance Imaging for Detecting Silicone Breast Implant Ruptures: A Meta-Analysis

The U.S. Food and Drug Administration has recommended that all silicone breast implant recipients undergo serial screening to detect implant rupture with magnetic resonance imaging. The authors performed a systematic review and meta-analysis to examine the effect of study design biases on the estimation of magnetic resonance imaging diagnostic accuracy measures. Studies were identified using the MEDLINE, EMBASE, ISI Web of Science, and Cochrane library databases. Two reviewers independently screened potential studies for inclusion and extracted data. Study design biases were assessed using the Quality of Diagnostic Accuracy Studies tool and the Standards for Reporting of Diagnostic Accuracy Studies checklist. Meta-analyses estimated the influence of biases on diagnostic odds ratios. Among 1175 identified articles, 21 met the inclusion criteria. Most studies using magnetic resonance imaging (10 of 16) and ultrasound (10 of 13) examined symptomatic subjects. Magnetic resonance imaging studies evaluating symptomatic subjects had 14-fold higher diagnostic accuracy estimates compared with studies using an asymptomatic sample (relative diagnostic odds ratio, 13.8; 95 percent confidence interval, 1.83 to 104.6) and 2-fold higher diagnostic accuracy estimates compared with studies using a screening sample (relative diagnostic odds ratio, 1.89; 95 percent confidence interval, 0.05 to 75.7). Many of the published studies using magnetic resonance imaging or ultrasound to detect silicone breast implant rupture are flawed with methodologic biases. These methodologic shortcomings may result in overestimated magnetic resonance imaging diagnostic accuracy measures and should be interpreted with caution when applying the data to a screening population.

Ultrasound diagnosis of breast implant rupture: beware the atypical presentation and interpret with care

Rupture of silicone breast implants is a recognised complication. We report a 36-year-old lady that 16 years post-augmentation presented with a unilateral gradually swollen breast with no associated lymphadenopathy. Ultrasound examination reported implant rupture, and exchange of implants was subsequently performed, only to reveal serous fluid (negative to culture, cytology and microscopy) and a macroscopically intact implant. A review of the literature has revealed that other imaging modalities are, either in isolation or in combination, more sensitive and specific for implant rupture. We therefore aim to raise awareness of this in the hope that we can potentially prevent further unnecessary operations.

Intrapulmonary and Cutaneous Siliconomas after Silent Silicone Breast Implant Failure

Since the implementation and use of silicone implants in breast surgery the risks are published and discussed. Especially, the incidence of late silicone implant rupture and its potential risk to induce local siliconomas are still under discussion and not sufficiently evaluated. So far literature data offer no information of intrapulmonal or peripheral located cutaneous siliconomas because of systemic migration of silicone after breast augmentation. In light of silicones checkered history, and given the large and growing number of women who choose to undergo breast augmentation surgery each year, the presented clinical findings in our study are likely to be of interest to medical professionals, producers, and consumers alike. We present six female patients with an average age of 55 (+/-5) years with bilateral rupture of silicone implants after breast augmentation for aesthetic reasons. The average time after operation was 18 (+/-6) years. In five patients, we identified peripheral located cutaneous siliconomas and one patient suffered from an intrapulmonal siliconoma. The diagnosis of bilateral rupture of the silicone implants was performed preoperatively by MRI-scans. All five peripheral cutaneous siliconomas and the intrapulmonal siliconoma were validated by histopathologic analysis. Six female patients suffered from bilateral rupture of silicone implants after breast augmentation. In five patients, we identified peripheral located cutaneous siliconomas which were surgically excised. One patient suffered from an intrapulmonal siliconoma. In this unique case a lobectomy with resection of the pulmonal segment 10 had to be performed. Clinical findings of peripheral cutaneous and even intrapulmonary siliconomas after bilateral rupture of silicone breast implants indicate a systemic hematogen or lymphatic pathway of silicone. These findings suggest that it is mandatory to inform the patient about the potential risk of local siliconomas, but also about the potential risk of peripheral cutaneous or even intrapulmonary siliconomas caused by systemic hematogen or lymphatic pathways of silicone after silent implant failure.

The Diagnosis of Silicone Breast-Implant Rupture: Clinical Findings Compared With Findings at Magnetic Resonance Imaging

The Diagnosis of Silicone Breast-Implant Rupture: Clinical Findings Compared With Findings at Magnetic Resonance Imaging

The Diagnosis of Silicone Breast-Implant Rupture: Clinical Findings Compared With Findings at Magnetic Resonance Imaging

The Diagnosis of Silicone Breast-Implant Rupture: Clinical Findings Compared With Findings at Magnetic Resonance Imaging

The diagnosis of breast implant rupture: MRI findings compared with findings at explantation

Study objective: The aim of this study was to evaluate the accuracy of Magnetic Resonance Imaging (MRI) as performed according to a strict study protocol in diagnosing rupture of silicone breast implants. Material and methods: The study population consisted of 64 women with 118 implants, who had participated in either one or two study MRI examinations, aiming at determining the prevalence and incidence of silent implant rupture, respectively, and who subsequently underwent explantation. Implant rupture status was determined by four independent readers and a consensus diagnosis of either rupture (intracapsular or extracapsular), possible rupture or intact implant was then obtained. Strict predetermined rupture criteria were applied as described in this report and findings at surgery were abstracted in a standardised manner and results compared. Results: At MRI, 66 implants were diagnosed as ruptured, nine as possibly ruptured and 43 as intact. Among the ruptured implants, 27 were categorized as extracapsular. At surgery, on average 297 days after the MRI, 65 of the 66 rupture diagnoses were confirmed, as were 20 of the cases with extracapsular silicone. Eight of the nine possibly ruptured implants were in fact ruptured at surgery. Thirty-four of the 43 intact implants were described as intact at surgery. When categorising possible ruptures as ruptures, there were one false positive and nine false negative rupture diagnoses at MRI yielding an accuracy of 92%, a sensitivity of 89%, and a specificity of 97%. Correspondingly, the predictive value of a positive MRI examination was 99% and the predictive value of a negative MRI examination was 79%. Conclusions: We conclude that MRI is highly accurate for identification of silicone breast implant rupture, with a high sensitivity and specificity when evaluation of images are based on presence of well-defined rupture criteria.

The diagnosis of breast implant rupture: MRI findings compared with findings at explantation

Study objective: The aim of this study was to evaluate the accuracy of Magnetic Resonance Imaging (MRI) as performed according to a strict study protocol in diagnosing rupture of silicone breast implants. Material and methods: The study population consisted of 64 women with 118 implants, who had participated in either one or two study MRI examinations, aiming at determining the prevalence and incidence of silent implant rupture, respectively, and who subsequently underwent explantation. Implant rupture status was determined by four independent readers and a consensus diagnosis of either rupture (intracapsular or extracapsular), possible rupture or intact implant was then obtained. Strict predetermined rupture criteria were applied as described in this report and findings at surgery were abstracted in a standardised manner and results compared. Results: At MRI, 66 implants were diagnosed as ruptured, nine as possibly ruptured and 43 as intact. Among the ruptured implants, 27 were categorized as extracapsular. At surgery, on average 297 days after the MRI, 65 of the 66 rupture diagnoses were confirmed, as were 20 of the cases with extracapsular silicone. Eight of the nine possibly ruptured implants were in fact ruptured at surgery. Thirty-four of the 43 intact implants were described as intact at surgery. When categorising possible ruptures as ruptures, there were one false positive and nine false negative rupture diagnoses at MRI yielding an accuracy of 92%, a sensitivity of 89%, and a specificity of 97%. Correspondingly, the predictive value of a positive MRI examination was 99% and the predictive value of a negative MRI examination was 79%. Conclusions: We conclude that MRI is highly accurate for identification of silicone breast implant rupture, with a high sensitivity and specificity when evaluation of images are based on presence of well-defined rupture criteria.

Evaluation of the rupture of silicone breast implants by mammography, ultrasonography and magnetic resonance imaging in asymptomatic patients: correlation with surgical findings.

Different imaging methods can identify the integrity of breast implants and also the extent of possible silicone leakage. Mammography, ultrasonography and magnetic resonance imaging are often used to evaluate the integrity of breast implants, usually in patients that are symptomatic for rupture. A group of clinically asymptomatic patients was taken as a sample. These patients wanted to remove or change their breast implants for psychological or cosmetic reasons. The purpose of this study was to compare the efficacy of mammography, sonography and magnetic resonance imaging in the detection of breast implant rupture in an asymptomatic population. Prospective study. Department of Diagnostic Imaging, Universidade de São Paulo, São Paulo, Brazil. The participants were 44 asymptomatic patients who subsequently had implants surgically removed. Eighty-three implants were evaluated by both film-screen mammography and high-resolution sonography and 77 implants were evaluated by magnetic resonance imaging. The sensitivity and specificity of mammography, ultrasonography and magnetic resonance imaging were assessed using predetermined diagnostic criteria for implant rupture. All radiological signs were discussed and false positives and false negatives were retrospectively evaluated to identify the pitfalls in the investigations. The respective sensitivity and specificity of mammography were 20% and 89%; sonography, 30% and 81%; and magnetic resonance imaging, 64% and 77%. The differences between patients with breast implants for cosmetic and oncological reasons were discussed. Our experience suggests that magnetic resonance imaging seems to be the best imaging method on its own for the evaluation of rupturing among asymptomatic patients.

Silicone gel breast implant rupture rates: research issues.

Documenting the rate of rupture of silicone breast implants appears to be deceptively easy. Largely because of the phenomenon of "silent rupture," it isn't. The authors explore the various technical biases (selection, misclassification, and confounding) and methodological problems that have plagued much of the research conducted to date. By means of a series of illustrations, they argue that explantation has limited utility. Noninvasive techniques have to be used to gather the proper type of data on the timing and frequency of these events. Only with the proper incidence data will researchers be able to identify better the different mechanisms underlying implant rupture and the relative importance of each. The authors recommend that better and standardized definitions of implant rupture be developed, that greater recognition be given to the technical biases and a greater effort be made to eliminate them from investigations of implant rupture, and that more research be conducted by multidisciplinary teams. Because of the growing awareness of the complexity of this issue, the authors also recommend that properly constituted advisory teams be used to provide comprehensive oversight of future research projects from beginning to end.

Silicone thorax: a complication of tube thoracostomy in the presence of mammary implants

Rupture of silicone breast implants is usually either iatrogenic or due to trauma. We present a case of blunt chest wall trauma in a patient with bilateral breast implants. Emergency chest tube thoracostomy resulted in rupture of one of the prostheses and caused subsequent migration of silicone into the chest cavity, where it led to empyema. The patient ultimately required a thoracotomy to evacuate the silicone and decorticate the lung. Review of the literature and methods to avoid this complication are described.