Gel Bleeding Research Articles

Why Is the Baker Classification Inadequate for Classifying Silicone Implant Fibrous Capsules?

Baker's clinical classification is adopted as the gold standard for grading complications related to silicone implants. Despite being widely used for this purpose, the classification has several limitations, highlighting subjectivity, reproducibility, and interobserver agreement. In this technical report, we aim to present the reasons for the inadequacy of the Baker classification for breast implants and the main factors contributing to false-negative results using recent theories of surface tension of fluids and gel bleeding. We also present an alternative classification proposal using magnetic resonance imaging of the breasts.

Axillary silicone lymphadenopathy caused by gel bleeding with intact silicone breast implants: a case report

Gel bleeding following breast augmentation using silicone breast implants (SBIs) occurs when microscopic silicone droplets diffuse through the implant surface, potentially resulting in complications such as capsular contracture and immune responses related to breast implant illness. Prompt and reliable diagnostic measures are crucial, as the presentation of gel bleeding can resemble cancer, making an accurate diagnosis challenging. This report discusses a rare case of axillary silicone lymphadenopathy caused by gel bleeding in a 48-year-old woman with intact SBIs. Silicone lymphadenopathy can be suspected based on mammography, ultrasonography, and magnetic resonance imaging in patients with a history of SBI insertion, and confirmation can be obtained through a pathological examination. Excisional biopsy is generally recommended for symptomatic patients, while treatment may not be necessary for asymptomatic patients; However, removal can be considered if the patient indicates a preference for it. Patients with silicone lymphadenopathy require replacement of SBIs to examine the breast capsule and verify the integrity of the implant. This case highlights the importance of considering gel bleeding as a potential cause of silicone lymphadenopathy, even in patients with intact SBIs.

Breast silicone implants' pericapsular impairment: current underdiagnosed status.

Many complications related to silicone implants have been reported recently, from clinical symptoms manifestations to association with some specific types of cancer. During the early 2010s, it was believed that implants were biocompatible and inert to the human body and that gel bleeding/leakage events were rare and without repercussions for the human body. However, at the end of 2010s, several studies pointed out that gel bleeding was more frequent than previously believed, and the pathogenic potential of free silicone should not be ignored. The Food and Drug Administration recommends performing magnetic resonance imaging in asymptomatic patients 5-6 years after implant placement. The descriptors in the Breast Imaging and Reporting Data System lexicon seem outdated for classifying the new generations of implants with cohesive gel, which hinders the diagnosis of device complications. In this review, supported by our research data publications related to silicone implants for 6 years on a prospective study protocol, most of them being original articles, we summarized the main complications observed in clinical practice and discuss the impact of these changes on patients' outcomes focusing on the pericapsular space.

Internal mammary lymph node siliconoma in absence of prosthesis rupture: a case series that raises concern for potential risk of overdiagnosis.

Silicon migration after rupture is an adverse event of breast implant, whose risk increases with the aging of prosthesis. The exact prevalence of this complication remains unclear and reported data are inconsistent. In addition, microscopic diffusion of silicone gel through intact implant, known as gel bleeding, might verify thus complicating diagnosis. Although high cohesive gel has reduced the occurrence of gel bleeding, this phenomenon is still possible and its occurrence rate remains underestimated. If silicon droplets migrate in locoregional lymph node, a swelling that mimics recurrence can arise. Therefore, a risk of overdiagnosis is possible when clinicians rely only on imaging techniques. The aim of this study is to evaluate the actual prevalence of metastasis in internal mammary lymph node (IMLN) in presence of PET positive uptake and no prosthesis rupture. We retrospectively evaluated our patient's records and selected those with intact breast implants and suspected relapse in IMLN that underwent biopsy, either surgical or imaging guided. All patients performed PET/CT scan showing pathological uptake in IMLNs. A breast magnetic resonance (MRI) or ultrasound (US) imaging confirmed a suspicious adenopathy and excluded prosthesis rupture. From 2015 to 2019 a total of nine patients underwent biopsy of the IMLN and only six of them met inclusion criteria. Four biopsies were CT-guided, two were surgical. Three patients (50%) were diagnosed with breast cancer relapse while two (33.3%) were found with siliconoma and one (16.7%) was inflammatory. Siliconoma can occur even without evidence of capsule rupture, challenging the clinicians and leading to a risk of relapse over diagnosis. Echographic, MRI and nuclear medicine imaging criteria may be not sufficient in differential diagnosis. To overcome the issue, we suggest introducing into the clinical practice the biopsy of suspicious enlarged IMLN with minimally invasive technique.

Side effects in breast implants related to radiotherapy in breast cancer reconstructive surgery.

Breast reconstructive surgery with silicone implants is routinely one of the techniques performed immediately after a mastectomy and before adjuvant radiotherapy. Implant shell degradation may result in gel bleeding that can trigger capsular disease. The silicone corpuscle in contact with the implant fibrous capsule can promote an inflammatory reaction, identified as silicone-induced granuloma which is, related to clinical complaints referred to as breast implant illness. This short communication aims to demonstrate and discuss the impact of radiotherapy's side effects on patients with post-mastectomy reconstructive breast surgery with silicone implants followed by adjuvant radiation therapy.

The Breast Tumor Microenvironment: Could Silicone Breast Implant Elicit Breast Carcinoma?

Complications related to breast implants have received much attention recently. Breast implant-associated anaplastic large cell lymphoma, silicone-induced granuloma of breast implant capsule, and breast implant illness are the main complications reported in the medical literature. However, the literature contains limited evidence regarding the possibility of silicone implants eliciting breast carcinoma. In this manuscript, we propose a theory in which the immune response to silicone breast implant gel bleeding acts as a triggering point for tumor oncogenesis in breast tissue. This hypothesis is derived from our findings of a case of invasive and undifferentiated medullary carcinoma in a patient with a silicone breast implant. The following concepts have been used to support this theory: 1) silicone bleeding from intact breast implants; 2) metaplasia: an adaptation to injury and precursor to dysplasia and cancer; 3) T-cell dysfunction in cancer immunity; 4) inhibitory cells in the tumor microenvironment (TME); 5) morphogenesis and bauplan; and 6) concepts underlying medullary carcinoma. We propose that the inflammatory process in response to silicone particles in the pericapsular glandular tissue favors the development of cellular mutations in specialized epithelial cells. This reverse morphogenesis could have resulted in breast carcinoma of the medullary type in the present case.

Silicone Induced Granuloma of Breast Implant Capsule (SIGBIC) diagnosis: Breast Magnetic Resonance (BMR) sensitivity to detect silicone bleeding.

To evaluate the sensitivity (S) of BMRI to detect silicone gel bleeding in a prospective observational study, including consecutive patients referred for BMRI scan. From January 2017 to March 2018, we evaluated patients with breast implants referred for BMRI in a prospective observational study. For SIGBIC diagnosis, we adopted three new original imaging features: black drop signal; T2* hyper signal mass; and delayed contrast enhancement, considered as irrevocable signs to detect gel bleeding (GB). Histology confirmed the presence of a silicone corpuscle in breast implant capsular specimens. The accuracy of BMRI SIGBIC findings to predict GB was determined. We also compared SIGBIC diagnosis criteria to those features proposed by the BI-RADS léxicon, considered as equivocal findings. 208 patients had SIGBIC diagnosis at BMRI, and the histology confirmed GB in all cases. There were no false-positive results. Compared to the BI-RADS equivocal findings (S = 0.74), SIGBIC criteria had better sensitivity for GB diagnosis. SIGBIC diagnosis has high sensitivity to predict GB by the three irrevocable BMRI features described by the authors. We suppose GB is underdiagnosed in clinical practice by BI-RADS features. Study protocol: Plataforma Brasil CAAE: 77215317.0.0000.0072.

Poly Implant Proth\xe8se silicone breast implants: implant dynamics and capsular contracture

BackgroundThe Poly Implant Prothèse (PIP) implants were withdrawn from the market in 2010 due to the use of low-grade silicone, causing a high risk for implant rupture. The aim of this study was to investigate the implant dynamics of PIP breast implants, as well as to determine the rate and predictors of implant gel bleeding, rupture, and capsular contracture in PIP implants.MethodsEighty women with a total of 152 PIP implants who underwent a reoperation in 2012 were enrolled in this study. Physical investigation included assessing the Baker score and demographics were retrospectively traced in medical records. The pre- and post-operative volumes of the implants were calculated and their state was determined intraoperatively by the surgeon.ResultsThe implants were removed after a mean implant duration of 11 ± 2.1 years. Gel bleed and implant rupture occurred in respectively 42 and 25% of the implants. Intact implants had post-operative volume increase as well as decrease. There was a correlation between gel bleeding and more post-operative implant volume increase (P ≤ 0.05). Capsular contracture had a protective effect against post-operative implant volume increase (P ≤ 0.05), while a post-operative implant volume increase provided a protective influence in developing capsular contracture (P ≤ 0.05). Additionally, implant rupture led to a higher risk of capsular contracture (P ≤ 0.05).ConclusionsWe managed to illustrate that PIP implant shells were too permeable and that there is a correlation between gel bleeding and the increase of the post-operative implant volume. Implant rupture led to a higher risk for developing capsular contracture.Level of evidence: Level III, risk / prognostic study.

Migration of a Ruptured, Silicone Gel-Filled Breast Implant into Sternal and Abdominal Areas

Breast implants have been used for breast reconstruction and augmentation for the last 50 years. There are about 100,000 women in the United Kingdom with silicone implants, of which approximately 60% are for breast reconstruction following mastectomy [1]. Approximately one to two million women have undergone breast implantation in the United States [2]. The silicone Poly Implant Prothese breast implant (also marketed as M-Implants and Rofil-implants) were made in France from 2001 until March 2010 [3]. Capsular contracture is a common complication following breast augmentation surgery [4]. In a 25-year prospective, population-based study, capsular contracture and malposition were reported as the first and third most common reasons for secondary surgery, respectively. Rupture has also long been considered one of the key complications of silicone-gel breast implants [5]. Rupture of silicone implants has received increased scrutiny over the years. Implant ruptures can be overt or silent. Sensitivity of plastic surgeons to a diagnosis of rupture is estimated to be approximately 30%. However, the gross migration of the gel from ruptured breast implants – associated with gel bleeding into either the breast parenchyma or surrounding areas – is rare [6]. The migration of silicone gels as subcutaneous nodules can cause local reactions such as siliconoma. Here we report a case of a woman with the distant migration of silicone gel from a ruptured breast implant into the sternal and abdominal areas.

Silicon chemistry and silicone breast implants

Breast implants are applied to correct the size, form, and feel of a woman’s breasts in post-mastectomy breast reconstruction, for correcting congenital defects and deformities of the chest wall, for aesthetic breast augmentation, and for creating breasts in the male-to-female transsexual patient. The most widely applied silicone implants have an elastomer silicone shell filled with viscous silicone gel. It has become increasingly clear that it is important for plastic surgeons to know and to provide patients with the latest information on silicone breast implants. This article was therefore written to provide more insight into the composition of silicone breast implants and their characteristics. After describing the chemical properties of silicones and silicone implants, gel bleeding and the consequences of aging of silicone implants will be discussed. The information provided can also give a hint as to why silicone implants have been consistently implicated in health issues ever since the late 1960s.

An Experimental Analysis of Silicone Leakage

We analyzed whether gel bleed, the leakage of silicone gel from breast implants, occurs in the human body. We simulated the phenomenon with olive oil. Silicone breast implants were submerged in olive oil, and the concentration of silicone polymers in the olive oil was measured periodically with nuclear magnetic resonance spectroscopy. We found no increase in the silicone concentration. However, clinical conditions might not be adequately simulated because of the shortness of the experimental period and the lack of external stress. However, when clinical experiences and our data are considered, we think that silicone implant durability is an important factor to prevent leakage or gel bleeding.

Augmentation Mammaplasty: Retrospective Analysis of 210 cases

Since its introduction in 1895, augmentation mammaplasty has gained widespread acceptance. The choice of breast augmentation procedure is determined almost entirely by three variables: the selection of incision location, the pocket plane for implant placement (either subpectoral or completely subglandular), and the appropriate implant. The current study evaluated 210 cases of augmentation mammaplasty retrospectively. A capsular contracture rate of 8% was found. Rupture and gel bleeding were observed in eight cases (4%). For various reasons, such as capsular contracture or implant rupture, the prostheses were renewed once in 16 patients (8%) and twice in 5 patients (2%). Submammary incision was used in 42 cases (20%). The patients in 23 cases responded that they had implant folds or edges they could feel (11%). Only 4 of these 23 patients stated that feeling the edge of the implant was a concern for them. Of the 210 augmented breasts, 5 had diminished sensation postoperatively (2%), as interpreted by the patient.

A study of the aging of silicone breast implants using 29Si, 1H relaxation and DSC measurements

In this study 26 previously implanted silicone breast implants from the same manufacturer (Dow Corning) were investigated with two different analytical methods to characterize potential aging processes such as migration of monomer material from the gel and shell to local and distant sites, chemical alterations of the polymer, and infiltration of body compounds such as lipids. 1H and 29Si NMR relaxation measurements (spin–lattice, T 1, and spin–spin, T 2, relaxation times) were used to study the molecular dynamics of polysiloxane chains, both in gels and in shells. In addition, changes in physical properties were monitored by differential scanning calorimetry (DSC). The results of these measurements indicate that NMR relaxation times are influenced by implant generation, implantation time, shell texture and implant status. 1H T 2 values of shells and gels show a tendency to increase with increasing implantation time, indicating higher mobility and possible disintegration of the polymer network of older implants. Furthermore, the data suggest that aging also involves the migration of low cyclic molecular weight (LMW) silicone and linear chain polymer material from the gels into the shells. The high “bleeding” rate of second-generation (G2) implants (implantation period around 1973–1985), exhibiting thin shells is reflected in reduced relaxation times of these devices, most likely due to a loss of low molecular weight fractions from the gels. Moreover, “gel bleeding” also influences the melting behavior observed in DSC studies. Increased shell rigidity (high T m and T g) tends to be correlated with longer 29Si relaxation times of the corresponding gels, suggesting a reduced transfer of LMW silicones and linear chain polymer from the gel to the shell and to the outside. Remarkably, textured implants seem to be less susceptible to degradation processes than implants with thin shells.

Silicone breast implants: correlation between implant ruptures, magnetic resonance spectroscopically estimated silicone presence in the liver, antibody status and clinical symptoms.

To determine the impact of implant integrity on clinical symptoms and antibody status in women with silicone breast implants (SBIs). Ninety consecutive women were examined by means of magnetic resonance imaging (MRI) to assess the integrity of their silicone breast implants. The presence of silicone in the liver was estimated by (1)H localized stimulated echo acquisition mode (STEAM) magnetic resonance spectroscopy (MRS). Results were correlated with patients' complaints, as evaluated by a standardized questionnaire, physical examination by a rheumatologist and antibody screening. Breast MRI revealed defects in 24 patients (26.6%); in 13 (54.2%) of these women, silicone was detected in the liver by MRS. Of the 66 patients with MRI-estimated intact implants, 15 (22.7%) had apparent silicone in their liver, arguing for gel bleeding. Clinically, two patients had had rheumatoid arthritis before SBIs, whereas the other patients revealed no typical symptoms of arthritis or connective tissue disease (CTD). The patients with MRS evidence of silicone in the liver had no statistically significant differences in their complaints with the exception of the most frequent symptom, tingling/numbness of the fingers (82.1 vs 51.6%, P=0.006). A positive pattern of antinuclear antibodies (ANA) was obtained in 13 of the 28 MRS-positive patients (46.4%) and in 15 of the 62 MRS-negative patients (24.2%, P=0.033). However, in only one of these 28 ANA-positive patients was a specific weak antibody titre against SS-A detected by ELISA. Implant integrity has no major impact on rheumatic symptoms of women with SBIs. This finding supports the standpoint that silicone does not cause either a specific CTD or any other distinct disease entity. However, the moderately increased incidences of ANA-positivity and neuropathy-associated symptoms require explanation.

The value of sonography for the discovery of complications after the implantation of silicone gel prostheses for breast augmentation or reconstruction

To determine sensitivity and specificity of real-time ultrasonography in detecting breast implant complications. The results of preoperative ultrasonography of 121 silicone implants in 65 patients were compared with the results after operative implant removal. With a sensitivity of 89.25% and a specificity of 92.1%, complications such as gel bleeding (n = 43), rupture with leakage (n = 63), and implant dissolution (n = 4) become manifest. Capsule formation, fibrosis, siliconoma and calcifications were often underestimated in their extent. Negative ultrasonography findings were found in 10.7% (n = 13) with positive clinical findings. The combination of clinical and ultrasonography findings leads to the detection of implant complications.

Calf augmentation with new solid silicone implants.

Calf augmentation has been standardized by the use of banana-shaped silicone gel implants for almost 20 years. Capsule formation and resulting distignement, dislocation, gel bleeding, and implant rupture are rare but unpleasant complications. A new implant of solid silicone (McGhan, Santa Barbara, CA, USA) in the anatomical shape of one belly of the M. gastrocnemius placed subfascially appears to overcome these problems.