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Multiplex CD30/Carbonic Anhydrase IX Lateral Flow Assay for Rapid Triage of Suspected BIA-ALCL in Peri-implant Seroma Fluid.
[BACKGROUND] Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare lymphoma associated with textured implants. Earlier detection and timely implant/capsulectomy reduce morbidity and improve outcomes. CD30 is a sensit…
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The Study of the Safety and Effectiveness of Motiva SmoothSilk Silicone Gel-filled Breast Implants in Patients Undergoing Primary and Revisional Breast Augmentation: 5-Year Clinical Data.
[BACKGROUND] The FDA requires implant manufacturers to continue collecting safety and efficacy data annually through Year 10. Investigators are encouraged to follow their enrolled patients in person to obtain the most accurate and complete …
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Non-Breast Implantable Medical Devices and Associated Malignancies: A Systematic Review.
Innovation in healthcare has led to the development of numerous implantable medical devices (IMDs). However, advances in our knowledge of breast implant-associated malignancies have raised questions about the prevalence, etiology, and manag…
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The Diagnosis and Management of Patients With Findings Consistent With a Breast Implant Associated-Somatic Symptom Disorder (BIA-SSD).
[BACKGROUND] Psychological factors seem to play a significant role in the perception and magnification of somatic symptoms in patients with breast implant illness (BII). Further, recent studies have shown that some patients with self-report…
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Multiplex Lateral Flow Assay Combining CD30 and IL-10 for the Detection of BIA-ALCL.
[BACKGROUND] Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) has affected more than 1700 women. Treatment morbidity is reduced and survival improved by early detection and removal of implant and capsule. [OBJECTIVE] To …
- Discussion: Subfascial Transaxillary Breast Augmentation: Critical Evaluation of a 25-Year Review of 1015 Consecutive Cases.
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Systemic Symptoms Associated With Breast Implants: A Psychological Study of Beliefs and Emotions.
[BACKGROUND] Systemic symptoms associated with breast implants (SSBI) is a term used to describe a variety of symptoms self-reported by some patients with breast implants. [OBJECTIVES] Authors of recent literature demonstrate a lack of bio…
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IL-9 Is a Biomarker of BIA-ALCL Detected Rapidly by Lateral Flow Assay.
[BACKGROUND] A delayed seroma around breast implants is the most common clinical presentation of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Interleukin-9 (IL-9), IL-10, and IL-13 concentrations are significantly hi…
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The Study of the Safety and Effectiveness of Motiva SmoothSilk Silicone Gel-Filled Breast Implants in Patients Undergoing Primary and Revisional Breast Augmentation: Three-Year Clinical Data.
[BACKGROUND] Silicone breast implant design has evolved over the last 50 years. Regulatory bodies including the FDA require data to support the modifications designed to improve the safety, efficacy, longevity, and biocompatibility of breas…
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CD30 Lateral Flow and Enzyme-Linked Immunosorbent Assays for Detection of BIA-ALCL: A Pilot Study.
[INTRODUCTION] Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) commonly presents as a peri-implant effusion (seroma). CD30 (TNFRSF8) is a consistent marker of tumor cells but also can be expressed by activated lymphocyte…
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Microbes, Histology, Blood Analysis, Enterotoxins, and Cytokines: Findings From the ASERF Systemic Symptoms in Women-Biospecimen Analysis Study: Part 3.
[BACKGROUND] There has been an increasing need to acquire rigorous scientific data to answer the concerns of physicians, patients, and the FDA regarding the self-reported illness identified as breast implant illness (BII). There are no diag…
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Longevity of Post-Explantation Systemic Symptom Improvement and Potential Etiologies: Findings From the ASERF Systemic Symptoms in Women-Biospecimen Analysis Study: Part 4.
[BACKGROUND] Breast Implant Illness (BII) describes a variety of symptoms reported by patients with breast implants. Biospecimens data revealed minimal statistical differences between BII and non-BII cohorts. Baseline analysis of PROMIS dat…
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Defining Internal Tissue Closure: High-Resolution Ultrasound Evaluation of Interi-A Novel Internal Tissue Closure System.
[BACKGROUND] Seroma remains a leading postsurgical complication in plastic surgery. Conventional drains are ineffective in clearing blood and fluid and closing down surgical spaces. The Interi (Internal Closure System, IC Surgical, Grand Ra…
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Impact of Capsulectomy Type on Post-Explantation Systemic Symptom Improvement: Findings From the ASERF Systemic Symptoms in Women-Biospecimen Analysis Study: Part 1.
[BACKGROUND] Breast Implant Illness (BII) is a term used to describe a variety of symptoms by patients with breast implants for which there are no abnormal physical or laboratory findings to explain their symptoms. There currently exists a …
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Heavy Metals in Breast Implant Capsules and Breast Tissue: Findings from the Systemic Symptoms in Women-Biospecimen Analysis Study: Part 2.
[BACKGROUND] Breast Implant Illness (BII), as described in recent medical literature and by social media, describes a range of symptoms in patients with breast implants for which there are no physical findings or laboratory results that exp…
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Granzyme B Is a Biomarker for Suspicion of Malignant Seromas Around Breast Implants.
[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-a…
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Comparative Analysis of Cytokines of Tumor Cell Lines, Malignant and Benign Effusions Around Breast Implants.
[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 accumulat…
- Reply: Risk Factor Analysis for Capsular Contracture, Malposition, and Late Seroma in Subjects Receiving Natrelle 410 Form-Stable Silicone Breast Implants.
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Risk Factor Analysis for Capsular Contracture, Malposition, and Late Seroma in Subjects Receiving Natrelle 410 Form-Stable Silicone Breast Implants.
[BACKGROUND] Natrelle 410 silicone breast implants are approved in the United States for breast augmentation, reconstruction, and revision. [METHODS] In two ongoing, prospective, multicenter 10-year studies, 17,656 subjects received Natrel…
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Natrelle 410 Extra-Full Projection Silicone Breast Implants: 2-Year Results from Two Prospective Studies.
[BACKGROUND] The safety and effectiveness of the Natrelle Style 410 highly cohesive silicone gel breast implant (Allergan, Inc., Irvine, Calif.) in full or moderate height and projection have been shown in a 10-year study. Extra-full projec…