Symptomatic delayed seromas vs incidental findings on MR, and likelihood of BIA-ALCL in women with textured implants.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e20028-e20028
Author(s):  
Paola Ghione ◽  
Elizabeth J. Sutton ◽  
Qunying Hu ◽  
Natasha Galasso ◽  
Nivetha Ganesan ◽  
...  
Keyword(s):  
Median Time ◽  
Incidental Findings ◽  
Incidental Finding ◽  
Breast Implant ◽  
Breast Implants ◽  
Silicone Implants ◽  
Textured Surface ◽  
Asymptomatic Patients ◽  
Asymptomatic Women

e20028 Background: Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), a subtype of ALCL, arises as a seroma in the space between the implant and the capsule, or as an adjacent mass. BIA-ALCL appears to be related to textured-surface implants, after 7-10 years of exposure. We conducted two large cohort studies. The 1st, a retrospective series (Sutton, 2019) assessed the incidental findings of masses or seromas in 1070 women with breast implants undergoing MR for FDA recommended screening for silent ruptures of silicone implants. Incidental finding of seromas or breast masses on MRI were found in 18/1070 (1.7%) women, of which 1/15 had BIA-ALCL, and was symptomatic at the time of MRI. The 2nd, a prospective study (Cordeiro, 2020) defined the incidence of BIA-ALCL (1/355) in a cohort of 3546 women with textured implants followed long term. Within this cohort, there were 28 clinically relevant delayed seromas (0.79%), 8 of which were BIA-ALCL (28.5%). We hypothesize that combining these databases will inform whether asymptomatic women with textured implants may benefit from MR to r/o BIA-ALCL. Methods: The two IRB approved databases were merged. Patients with incidental findings of seroma on MRI were identified. A majority of the MRIs in this merged cohort were performed to follow the FDA recommended screening for silent ruptures. We identified all clinically relevant late seromas sent to hematopathology to r/o BIA-ALCL by cross checking pathology reports containing the words “lymphoma” or “anaplastic” or “ALCL”. Results: 572 women were included in both studies: followed long term and received an MRI after a median time of 7.4 years after breast reconstruction. 8 of 572 women had an incidental finding of seroma on random MRI, and 2 had capsular masses. None of these 10 asymptomatic women have developed BIA-ALCL to date (median follow-up 9 years). 11 of 572 women had a symptomatic seroma or mass, 4 of which later developed BIA-ALCL, a fifth patient was found to have BIA-ALCL on a PET/CT + lymph node, despite being asymptomatic. Median time from last MR to lymphoma was 5 years (3-8 years). Conclusions: In this merged cohort of patients with textured breast implants, incidence of BIA-ALCL in patients with symptomatic late seromas is around 30%, while seromas found incidentally on MR of asymptomatic patients were negative for BIA-ALCL.

scholarly journals Application of silicone implants in mammoplasty (literature survey)

2018 ◽  
Vol 26 (1) ◽  
pp. 133-149 ◽  
Author(s):  
Dj. A. Khodjamurodova ◽  
M. S. Saidov ◽  
G. М. Khodjamuradov
Keyword(s):  
Mammary Gland ◽  
Surgical Approach ◽  
Breast Implant ◽  
Breast Implants ◽  
Long Term Results ◽  
Silicone Implants ◽  
Augmentation Mammoplasty ◽  
Advantages And Disadvantages

In the article literature data concerning indications to placement of silicone breast implants in plastic surgery are presented. Peculiarities of preoperative preparation of patients aimed at prevention of postoperative complications are considered. The technique of surgical intervention, advantages and disadvantages of different methods are described. Difference in choice of surgical approach and positioning of implant relative to mammary gland are considered. Recommendations are given on selection of the type of implant, on determination of the volume of supposed silicone breast-implant prostheses, and also on the choice of optimal access for their insertion. The early and long-term complications and measures proposed by the authors for their elimination are studied. According to different studies, the commonest complication of the augmentation mammoplasty is contracture of the fibrous capsule surrounding the implant that requires surgical correction. One of main complications of all kinds of augmentation mammoplasty is secondary ptosis of mammary gland. A common complication of the augmentation mammoplasty is incorrect position of implants such as their asymmetry and location on different levels. In case of tubular breast a double inframammary fold may result unless tubularity of areola is corrected. Authors think that a significant number of unsolved problems concerning augmentation mammoplasty, optimal surgical approach, existence of the immediate and long-term complications are reasons for further study of augmentation mammoplasty. Increased dissatisfaction of patients with long-term results of augmentation mammoplasty, necessity to prevent such complication as fibrous contracture, create an urgent need for search of new methods. Thus, application of silicone implants in augmentation mammoplasty requires further study with the aim of optimization of the final aesthetic and clinical result.

scholarly journals Application of silicone implants in mammoplasty (literature survey)

2018 ◽  
Vol 26 (1) ◽  
pp. 113-149
Author(s):  
Dj. A. Khodjamurodova ◽  
M. S. Saidov ◽  
G. М. Khodjamuradov
Keyword(s):  
Mammary Gland ◽  
Surgical Approach ◽  
Breast Implant ◽  
Breast Implants ◽  
Long Term Results ◽  
Silicone Implants ◽  
Augmentation Mammoplasty ◽  
Advantages And Disadvantages

In the article literature data concerning indications to placement of silicone breast implants in plastic surgery are presented. Peculiarities of preoperative preparation of patients aimed at prevention of postoperative complications are considered. The technique of surgical intervention, advantages and disadvantages of different methods are described. Difference in choice of surgical approach and positioning of implant relative to mammary gland are considered. Recommendations are given on selection of the type of implant, on determination of the volume of supposed silicone breast-implant prostheses, and also on the choice of optimal access for their insertion. The early and long-term complications and measures proposed by the authors for their elimination are studied. According to different studies, the commonest complication of the augmentation mammoplasty is contracture of the fibrous capsule surrounding the implant that requires surgical correction. One of main complications of all kinds of augmentation mammoplasty is secondary ptosis of mammary gland. A common complication of the augmentation mammoplasty is incorrect position of implants such as their asymmetry and location on different levels. In case of tubular breast a double inframammary fold may result unless tubularity of areola is corrected. Authors think that a significant number of unsolved problems concerning augmentation mammoplasty, optimal surgical approach, existence of the immediate and long-term complications are reasons for further study of augmentation mammoplasty. Increased dissatisfaction of patients with long-term results of augmentation mammoplasty, necessity to prevent such complication as fibrous contracture, create an urgent need for search of new methods. Thus, application of silicone implants in augmentation mammoplasty requires further study with the aim of optimization of the final aesthetic and clinical result.

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.

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.

scholarly journals Life-Saving Silicone Breast Implant After Firearm Injury: Case Report and Treatment Recommendations

2020 ◽  
Vol 6 ◽  
pp. 2513826X1989882
Author(s):  
Giancarlo McEvenue ◽  
Anastasia Oikonomou ◽  
Noah Ditkofsky ◽  
Joan Lipa
Keyword(s):  
Breast Implant ◽  
Breast Implants ◽  
Operative Management ◽  
Implant Removal ◽  
Silicone Implants ◽  
High Resolution Computed Tomography ◽  
Firearm Injury ◽  
Firearm Injuries ◽  
Life Saving ◽  
Ballistic Injury

Breast augmentation with silicone implants is one of the most commonly performed operations by plastic surgeons. Here, we report a case of a 30-year-old female patient with a ballistic injury to bilateral breast implants, where the silicone implant was likely responsible for deflecting the bullets trajectory and saving the women’s life. Ballistics analysis of bullet trajectory was performed with high-resolution computed tomography scan analysis. Operative management was implant removal, pocket irrigation, and a short course of antibiotics. A literature review was performed on all previously published breast implant–related firearm injuries. The authors advise operative management with implant removal and delay of replantation for minimum 6 months’ time.

scholarly journals Device-Specific Findings of Imprinted-Texture Breast Implants: Characteristics, Risks, and Benefits

2019 ◽  
Author(s):  
Roger N Wixtrom ◽  
Vikram Garadi ◽  
John Leopold ◽  
John W Canady
Keyword(s):  
Risk Reduction ◽  
Breast Implant ◽  
Capsular Contracture ◽  
Breast Implants ◽  
Surface Metrology ◽  
Textured Surface ◽  
Primary Reconstruction ◽  
Implant Surface ◽  
Risks And Benefits ◽  
Core Study

Abstract Background The relative risks and benefits of various textured breast implants are the focus of considerable discussion. Studies have suggested different risk-benefit profiles for different implant surface topographies. Objectives The study aim was to provide device-specific, quantitative information on Mentor’s imprinted Siltex Textured breast implants with respect to textured surface characteristics and ISO 14607 classification, risk of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL), and risk-reduction benefits relative to smooth implants. Methods Surface metrology was performed. Data for smooth and Siltex implants from the prospective MemoryGel Core Study were evaluated by Kaplan-Meier analysis for the most frequently occurring postoperative complications in augmentation and reconstruction leading to subsequent reoperation. Results The overall average surface roughness for Siltex MemoryGel and MemoryShape implants was 29.5 and 36.1 µm, respectively. A statistically significantly lower rate of reoperation in patients with Siltex compared with smooth devices over 10 years was observed for both capsular contracture in subglandular primary augmentation patients (2.02% vs 19.84%) and for asymmetry in primary reconstruction patients (3.88% vs 11.1%). Conclusions Surface analysis demonstrated that Siltex implants fall within the ISO 14607 category of “microtexture” breast implants. These devices exhibited a rare risk of BIA-ALCL (0.0012%) based on the most extensive data available. Relative to smooth implants, these Siltex devices provided risk-reduction benefits for the most common reason of reoperation in patients who underwent primary augmentation (capsular contracture) or primary reconstruction (asymmetry) in the Core Study. These findings provide valuable risk-benefit information for surgeons and their patients. Level of Evidence: 2

scholarly journals Protecting Scientific Integrity: The Commercial Speech Doctrine Applied to Industry Publications

2011 ◽  
Vol 37 (2-3) ◽  
pp. 203-224
Author(s):  
Joanna K. Sax
Keyword(s):  
Breast Implant ◽  
Breast Implants ◽  
New Drugs ◽  
Scientific Integrity ◽  
Full Disclosure ◽  
Commercial Speech ◽  
Economic Reality ◽  
New Treatments ◽  
Long Term Studies

The pharmaceutical industry is a competitive business. Companies spend billions of dollars researching and developing new drugs. Many drugs never make it to market. For the limited drugs that make it through the experimental, regulatory, and clinical rigors of drug development, companies recoup their lost expenditures for the drugs that previously failed.Pharmaceutical companies face increasing pressure to bring new treatments to market in order to survive. The economic reality of survival and profits may distort a company's decision-making process regarding full disclosure on a particular new drug. An example of this type of conflict was seen in the silicone breast implant fiasco in the 1970s, 1980s, and 1990s. Dow Corning, the manufacturer of the implants, withheld important data from long-term animal models that demonstrated adverse effects from the breast implants. Further, Dow failed to conduct long-term studies on breast implants, even when armed with data indicating that such studies were necessary to ensure the continued health of the patients.

Comparative Analysis of Cytokines of Tumor Cell Lines, Malignant and Benign Effusions Around Breast Implants

2019 ◽  
Vol 40 (6) ◽  
pp. 630-637 ◽  
Author(s):  
Marshall E Kadin ◽  
John Morgan ◽  
Nick Kouttab ◽  
Haiying Xu ◽  
William P Adams ◽  
...  
Keyword(s):  
Breast Implant ◽  
Breast Implants ◽  
Interferon Γ ◽  
Textured Surface ◽  
Malignant Cells ◽  
Level Of Evidence ◽  
Scar Contracture ◽  
Ancillary Test ◽  
Soluble Cd30 ◽  
Insight Into

Abstract Background More than 700 women have developed an anaplastic large T cell lymphoma (ALCL) surrounding textured surface breast implants, termed breast implant–associated ALCL (BIA-ALCL). Most patients with BIA-ALCL present with an accumulation of fluid (delayed seroma) around the implant. However, benign seromas without malignant cells complicating scar contracture, implant rupture, trauma, infection, and other causes are more common. For proper patient management and to avoid unnecessary surgery, a simple diagnostic test to identify malignant seromas is desirable. Objectives The aim of this study was to develop an ancillary test for the diagnosis of malignant seromas and to gain insight into the nature of the malignant cells and their microenvironment. Methods We employed an immunologic assay on only 50 µL of aspirated seroma fluid. The assay measures 13 cytokines simultaneously by flow cytometry. To establish a baseline for clinical studies we measured cytokines secreted by BIA-ALCL and cutaneous ALCL lines. Results Our study of cell line culture supernatants, and 8 malignant compared with 9 benign seromas indicates that interleukin 9 (IL-9), IL-10, IL-13, IL-22, and/or interferon γ concentrations >1000 pg/mL distinguish malignant seromas from benign seromas. IL-6, known to be a driver of malignant cells, is also elevated in benign seromas and does not distinguish them from malignant seromas. Conclusions The cytokine assay introduced in this study can be used together with levels of soluble CD30 to identify malignant seromas. Validation of these findings in a larger prospective patient cohort is warranted. The unique pattern of cytokine expression in malignant effusions surrounding breast implants gives further insight into the pathogenesis and cells of origin of BIA-ALCL. Level of Evidence: 5

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