scholarly journals The risks behind the widespread use of siliconized syringes in the healthcare practice

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Gustavo Barreto Melo ◽  
Yehuda Shoenfeld ◽  
Eduardo Büchele Rodrigues
Keyword(s):  
Heart Valves ◽  
Silicone Oil ◽  
Breast Implant ◽  
Direct Injection ◽  
Breast Implants ◽  
Immunological Tolerance ◽  
Causal Link ◽  
Drug Preparation ◽  
Healthcare Practice ◽  
The Moment

AbstractInjections are widely performed in the healthcare practice. Silicone has long been thought to be an inert and harmless material. Although used for decades in medical implants, including heart valves, breast implants, and as a tamponade for retinal detachment surgery, silicone oil might have deleterious effects. Agitation of the syringe to expel air at the moment of drug preparation not only leads to silicone oil release but also to therapeutic protein aggregation. Lab studies have shown that silicone oil microdroplets can act as an adjuvant to promote a break in immunological tolerance and induce antibody response. Similarly, recent studies have suggested a causal link between agitation of siliconized syringes and ocular inflammation after intravitreal injection. Systemically, silicone oil has been reported in association with autoimmune diseases and skin granuloma after either direct injection of dermal fillers or secondary leakage from silicone breast implant. However, it has not been established yet a potential link between the silicone oil released by the syringes and such relevant systemic adverse events. Few professionals are aware that agitation of a siliconized syringe might lead to silicone oil release, which, in turn, acts an adjuvant to an increased immunogenicity. We strongly recommend that every healthcare professional be aware of the use of silicone oil in the syringe manufacturing process, the factors that promote its release and the potential complications to the organism. Ultimately, we recommend that safer syringes be widely available.

scholarly journals Granzyme B Is a Biomarker for Suspicion of Malignant Seromas Around Breast Implants

2020 ◽  
Author(s):  
Marshall E Kadin ◽  
John Morgan ◽  
Haiying Xu ◽  
Caroline Glicksman ◽  
David Sieber ◽  
...  
Keyword(s):  
Early Detection ◽  
Tumor Cells ◽  
Breast Implant ◽  
Granzyme B ◽  
Breast Implants ◽  
Large Cell ◽  
Target Cells ◽  
Cytotoxic Lymphocytes ◽  
Tumor Cell Death ◽  
Level Of Evidence

Abstract Background Granzyme B (GrB) is a serine protease secreted, along with pore-forming perforin, by cytotoxic lymphocytes to mediate apoptosis in target cells. GrB has been detected in tumor cells associated with systemic and breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) but its potential use for detection of early BIA-ALCL has not been fully investigated. Objectives Prompted by the increased incidence of BIA-ALCL, the aim of this study was to assess GrB as a new biomarker to detect early disease in malignant seromas and to better understand the nature of the neoplastic cell. Methods A Human XL Cytokine Discovery Magnetic Luminex 45-plex Fixed Panel Performance Assay was used to compare cytokine levels in cell culture supernatants of BIA-ALCL and other T-cell lymphomas, as well as malignant and benign seromas surrounding breast implants. Immunohistochemistry was employed to localize GrB to cells in seromas and capsular infiltrates. Results Differences in GrB concentrations between malignant and benign seromas were significant (P < 0.001). GrB was found in and around apoptotic tumor cells, suggesting that the protease may be involved in tumor cell death. Conclusions GrB is a useful marker for early detection of malignant seromas and to identify tumor cells in seromas and capsular infiltrates. Because there is an overlap between the lowest concentrations of soluble GrB in malignant seromas and the highest concentrations of GrB in benign seromas, it is recommended that GrB be used only as part of a panel of biomarkers for the screening and early detection of BIA-ALCL. Level of Evidence: 5

scholarly journals The A, B and C’s of Silicone Breast Implants: Anaplastic Large Cell Lymphoma, Biofilm and Capsular Contracture

Materials ◽  
2018 ◽  
Vol 11 (12) ◽  
pp. 2393 ◽  
Author(s):  
Maria Mempin ◽  
Honghua Hu ◽  
Durdana Chowdhury ◽  
Anand Deva ◽  
Karen Vickery
Keyword(s):  
Anaplastic Large Cell Lymphoma ◽  
Biofilm Formation ◽  
Cell Lymphoma ◽  
Breast Implant ◽  
Capsular Contracture ◽  
Breast Implants ◽  
Surface Characteristics ◽  
Large Cell ◽  
Breast Implantation ◽  
Large Cell Lymphoma

Breast implantation either for cosmetic or reconstructive e purposes is one of the most common procedures performed in plastic surgery. Biofilm infection is hypothesised to be involved in the development of both capsular contracture and anaplastic large cell lymphoma (ALCL). Capsular contracture is one of the principal reasons for breast revision surgery and is characterised by the tightening and hardening of the capsule surrounding the implant, and ALCL is an indolent lymphoma found only in women with textured implants. We describe the types of breast implants available with regard to their surface characteristics of surface area and roughness and how this might contribute to capsular contracture and/or biofilm formation. The pathogenesis of capsular contracture is thought to be due to biofilm formation on the implant, which results in on-going inflammation. We describe the current research into breast implant associated ALCL and how implant properties may affect its pathogenesis, with ALCL only occurring in women with textured implants.

scholarly journals Breast Implant-Associated Anaplastic Large Cell Lymphoma: A Case Report

2021 ◽  
Vol 4 (1) ◽  
pp. 28-34
Author(s):  
Kumkum Vadehra ◽  
Jennifer Cai ◽  
Rashmi Rekha Bhuyan ◽  
Ping Ji ◽  
Rose Venegas ◽  
...  
Keyword(s):  
Tumor Cells ◽  
Anaplastic Large Cell Lymphoma ◽  
Cell Lymphoma ◽  
Breast Implant ◽  
Fluid Collection ◽  
Breast Implants ◽  
Large Cell ◽  
Silicone Implants ◽  
Axillary Lymph ◽  
Large Cell Lymphoma

Breast implant-associated anaplastic large cell lymphoma (ALCL) is a recently recognized type of T-cell lymphoma that can develop following breast implants, with morphologic and immunophenotypic features indistinguishable from those of ALK-negative ALCL. Here we report a case of a 58-year-old woman with a history of subglandular silicone implants placed for bilateral breast augmentation 25 years ago, who presented with bilateral breast pain and was found to have bilateral Baker Grade III capsular contracture, and heterogenous fluid collection centered near the left third costochondral articulation, a suspicious left chest wall lesion, and left axillary lymphadenopathy on imaging. A left axillary lymph node core biopsy and an aspiration of the fluid were performed, and no malignant cells were identified. The patient underwent bilateral removal of breast implants and total capsulectomies. Microscopic examination of the capsule surrounding the left breast implant revealed large pleomorphic tumor cells in a fibrinous exudate. By immunohistochemistry, the tumor cells were found to be positive for CD3 (subset), CD4, CD7, CD30 (strong and uniform), and CD43, and negative for CD2, CD5, CD8, and ALK1, supporting the diagnosis of breast implant-associated ALCL. No lymphoma cells were identified in the right breast capsule, confirmed by CD30 stain. Breast implant-associated ALCL is a very rare disease that can develop many years after breast implant placement. Proper evaluation with breast imaging and pathologic workup is essential to confirm the diagnosis in suspected cases. Our case highlights that adequate sampling is important in the investigation of patients with suspected breast implant-associated ALCL.

Breast Implant-Associated Anaplastic Large Cell Lymphoma in Australia: A Longitudinal Study of Implant and Other Related Risk Factors

2019 ◽  
Vol 40 (8) ◽  
pp. 838-846 ◽  
Author(s):  
Anna Loch-Wilkinson ◽  
Kenneth J Beath ◽  
Mark R Magnusson ◽  
Rodney Cooter ◽  
Karen Shaw ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Anaplastic Large Cell Lymphoma ◽  
Cell Lymphoma ◽  
Early Stage ◽  
Breast Implant ◽  
Breast Implants ◽  
Large Cell ◽  
Regulatory Action ◽  
Level Of Evidence ◽  
Large Cell Lymphoma

Abstract Background Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an emerging cancer that has been linked to the use of textured devices. The recent increase in number and frequency of cases has led to worldwide regulatory action. Objectives The authors aimed to longitudinally study BIA-ALCL in Australia since the index case was first reported in 2007. Methods Confirmed historical cases were collected and then prospectively analyzed from October 2015 to May 2019. Clinical and implant exposure data were determined and compared with company sales data for 4 devices to generate implant-specific risk. Results A total 104 cases of BIA-ALCL were diagnosed in Australia with exposure to 149 unique breast implants. The mean age of patients was 48.2 years (range, 22.4-78.5 years). They had an average time from implantation to diagnosis of 6.8 years. A total 51.7% of implants utilized in this cohort were Allergan Biocell devices. The indication for implant usage was for primary cosmetic augmentation in 70%, post-breast cancer reconstruction in 23%, and following weight loss/pregnancy in 7%. The majority of women presented with early (stage 1) disease (87.5%). The risk for developing BIA-ALCL ranged from 1 in 1947 sales (95% confidence interval = 1199-3406) for Silimed Polyurethane devices to 1 in 36,730 (95% confidence interval = 12,568-178,107) for Siltex imprinted textured devices. Conclusions Implants with higher surface area/texture seem to be more associated with BIA-ALCL in Australia. Recent regulatory action to suspend, cancel, or recall some of these higher risk devices is supported by these findings. Level of Evidence: 2

The Silicone Gel Breast Implant Controversy—A Chronology of Recent Regulations and Decisions

1993 ◽  
Vol 10 (2) ◽  
pp. 89-93
Author(s):  
Howard A. Tobin
Keyword(s):  
Drug Administration ◽  
Breast Implant ◽  
Breast Implants ◽  
Press Coverage ◽  
Silicone Breast Implants ◽  
Consumer Activism ◽  
Silicone Gel ◽  
Congressional Investigations ◽  
Regulatory Actions

This article summarizes the regulatory actions of the Food & Drug Administration as related to gel-filled silicone breast implants. It also relates the actions to the influences of outside forces such as press coverage, congressional investigations, and consumer activism.

Breast Implant Related Anaplastic Large Cell Lymphoma ALK- (ALCL ALK-) – Case Report

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 5086-5086 ◽  
Author(s):  
Alejandro Arbelaez ◽  
Laurence Catley ◽  
Louis Pool
Keyword(s):  
Conflicts Of Interest ◽  
Case Reports ◽  
Breast Implant ◽  
Treatment Options ◽  
Fluid Collection ◽  
Case Series ◽  
Breast Implants ◽  
Large Cell ◽  
Lymphoid Cells ◽  
Malignant Cells

Abstract Case presentation A 29 underwent bilateral cosmetic breast augmentation 10 years previously (McGhan Textured Round 400 mL implants). Six months before, she developed slowly progressive right breast pain and inflammatory signs associated with fluid collection around the right breast that was drained. A yellow cloudy fluid was examined and showed atypical large lymphoid cells. The cell block prepared in another institution showed numerous lymphoid cells including large atypical cells with lobated nuclei. PET CT scan was negative, same as bone marrow aspirate and trephine for lymphoma infiltration. Following bilateral removal of the breast implants, further histopathology studies showed no infiltration by lymphoma of the breast capsules or scar tissue. However, right breast peri prosthetic fluid microscopy showed a population of single malignant cells with scanty cytoplasm, numerous mitosis, and nuclei showing single and multiple nucleoli. Some cells showing horseshoe nuclei. The malignant cells were positive for CD30 and LCA and negative for CD20, CD68, AE1-3, and ALK 1. FISH for ALK was not possible (Fig 1) Discussion Primary breast lymphomas are very rare conditions; they represent less than 1% of all NHL and less than 0.7% of all breast malignancies. There have been some cases reported in the medical literature of ALCL ALK- associated with breast implants. All the cases have been described in patients with textured implants, such as in this case and the reason is unknown. There are two main types of ALCL of the breast based on published case reports: a mass and an effusion. Primary breast effusion associated ALCL portends a good prognosis despite the fact that they are ALK-. The development of ALCL proximal to breast implants suggests that they are the result of an immune reaction to the silicone. Whether they represent true malignancy or a localised reactive phenomenon is not entirely clear yet. In previous case series, the condition has been described as indolent. However, given the low incidence of this condition and the limited literature available; it is difficult to know what the best treatment approach is. Following confirmation of the diagnosis, treatment options were discussed with the patient and the preferred option was active treatment with local radiation after removal of breast implants. Disclosures: No relevant conflicts of interest to declare.

Breastfeeding After Breast Implant Surgery

2020 ◽  
Vol 11 (4) ◽  
pp. 202-206
Author(s):  
Catherine Watson Genna
Keyword(s):  
Milk Production ◽  
Breast Augmentation ◽  
Breast Surgery ◽  
Breast Implant ◽  
Significant Risk ◽  
Breast Implants ◽  
Augmentation Mammaplasty ◽  
Implant Surgery ◽  
History Of ◽  
Type Of Surgery

Breast surgery increases the risk for difficulties with milk production and breastfeeding. Research on lactation outcomes of breast augmentation with implants is reassuring, but reveals a significant risk of low milk production that varies with the type of surgery and position of the implants. Understanding the potential effects of breast implants on breastfeeding can help lactation professionals optimize outcomes for families with a history of augmentation mammaplasty.

scholarly journals Experimental model of capsular contracture in silicone implants

2003 ◽  
Vol 18 (spe) ◽  
pp. 22-28 ◽  
Author(s):  
Érika Malheiros Bastos ◽  
Miguel Sabino Neto ◽  
Lydia Masako Ferreira ◽  
Élvio Bueno Garcia ◽  
Richard Eloin Liebano ◽  
...  
Keyword(s):  
Plastic Surgery ◽  
Experimental Model ◽  
Breast Implant ◽  
Capsular Contracture ◽  
Breast Implants ◽  
Silicone Implants ◽  
Frequent Complication

The breast implant procedure is one of the most performed into Plastic Surgery and the contracture that occurs the capsule formed around the breast implants one of most frequent complication. We describe here one experimental model of capsule contracture in rats.

IgA Myeloma and Still’s Disease in a patient with bilateral silicone breast implants

Open Medicine ◽  
2008 ◽  
Vol 3 (2) ◽  
pp. 229-231
Author(s):  
Punit Yadav ◽  
Iwona Ordyniec ◽  
Salem Madi
Keyword(s):  
Bone Marrow ◽  
Breast Implant ◽  
Breast Implants ◽  
Bone Marrow Examination ◽  
Adult Onset Still’S Disease ◽  
Adult Onset ◽  
Still’S Disease ◽  
Silicone Breast Implants ◽  
Still's Disease ◽  
Adult Onset Still's Disease

AbstractWe report a case of a woman with bilateral silicone breast implants who presented with recurrent high grade fever, joint and muscle aches. An extensive workup failed to indicate an infectious source of her illness, so based on her symptoms a clinical diagnosis of Adult Onset Still’s disease was made. However, subsequent investigations revealed raised IgA paraprotein levels in her serum which led to a bone marrow examination. Bone marrow examination was consistent with IgA Myeloma. Chemotherapy was commenced which led to a decrease in the paraprotein level. In addition, she was treated with non steroidal anti-inflammatory drugs and intraarticular steroid injections which provided marked symptomatic relief. The case indicates a possible association of Myeloma and Adult Onset Still’s Disease in a patient with bilateral silicone breast implant.

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