FDA Issues Update on Rare Breast Implant-Associated Lymphoma FDA Issues Update on Rare Breast Implant-Associated Lymphoma

As of September 30, 2017, the FDA has received a total of 414 medical device reports of anaplastic large cell lymphoma associated with breast implants, most involving implants with textured surfaces.News Alerts
Source: Medscape Medical News Headlines - Category: Consumer Health News Tags: Hematology-Oncology News Alert Source Type: news

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Allergan (NYSE: AGN) has removed its textured breast implants from the market in Europe following a recall request from French regulators. France’s National Agency for the Safety of Medicines and Health Products said that it hasn’t “identified any immediate risk for the health of women carrying the implants,” and that it plans to convene an expert committee to discuss the matter in February next year. The New York Times reported this week that the implants were linked to an uncommon form of lymphoma that can arise years after the implant is placed. Allergan’s CE Mark in the E.U....
Source: Mass Device - Category: Medical Devices Authors: Tags: Implants Recalls Regulatory/Compliance Wall Street Beat Women's Health Allergan Source Type: news
The company ’ s product, in use worldwide, has been under scrutiny since women began developing a type of lymphoma.
Source: NYT Health - Category: Consumer Health News Authors: Tags: Implants Breasts Medical Devices Plastic Surgery Non-Hodgkin's Lymphoma France Allergan Inc Cancer Recalls and Bans of Products Europe Source Type: news
Background: Breast implants have evolved for decades. In 2011, the U.S. Food and Drug Administration identified an association between textured breast implants and breast implant–associated anaplastic large cell lymphoma (BIA-ALCL). The purpose of this study was to identify the trends of textured implant use since that time. Methods: Maintenance of Certification tracer data were queried between 2011 and 2015 for cosmetic breast augmentation cases submitted by American Board of Plastic Surgery diplomates. A nested random effects logistic regression analysis was used to identify associations between variables. Re...
Source: Plastic and Reconstructive Surgery - Category: Cosmetic Surgery Tags: Cosmetic: Original Articles Source Type: research
Learning Objectives: After reading this article, the participant should be able to: 1. Develop a practical method for preoperative implant size selection. 2. List characteristics and examples of fourth- and fifth-generation silicone implants. 3. Recognize the differences in “profile” designations across implant manufacturers. 4. Recall updated statistics on breast implant–associated anaplastic large cell lymphoma and describe current guidelines on disease diagnosis and treatment. 5. Apply atraumatic and aseptic surgical techniques in primary breast augmentation. Summary: Modern primary breast augment...
Source: Plastic and Reconstructive Surgery - Category: Cosmetic Surgery Tags: CME Source Type: research
Conclusions: In situ BIA-ALCLs have an indolent clinical course and remain in complete remission mainly after implant removal. Infiltrative BIA-ALCLs have a more aggressive clinical course. It is therefore critical to perform a rigorous staging using multi-imaging modality including TEP at baseline. Multiple implants could favor the occurrence of BIA-ALCL. New insights into the biology of BIA-ALCL might translate into more targeted and effective therapies in refractory or relapsed patients. The modalities of breast monitoring and reconstruction remain open questions for those patients.DisclosuresLe Bras: Amgen: Consultancy...
Source: Blood - Category: Hematology Authors: Tags: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma-Clinical Studies: Poster I Source Type: research
DISCUSSION:This is the largest and most comprehensive study to date on the epidemiology and prognostic factors of Anaplastic Large Cell Lymphoma. The results of our analysis bring up several interesting trends, the most interesting one being the marked increase in survival rates between 2010- 2015 compared to 2004-2009. This is likely attributed to better treatment modalities. With regards to treatment modalities, patients who underwent chemotherapy followed by adjuvant transplant had better 1, 3, 5 and 10 year survival rates compared to all other treatment modalities. As previously established, younger age at diagnosis is...
Source: Blood - Category: Hematology Authors: Tags: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma-Clinical Studies: Poster II Source Type: research
CONCLUSION: The risk that a woman with breast implants will develop a primary anaplastic large-cell lymphoma is estimated at 0.35 to 1 case per million persons per year. The incidence of implant-associated ALCL is thus very low, yet nevertheless markedly higher than that of other primary lymphomas of the breast. Because of the low case numbers, recommendations for the diagnostic evaluation and treatment of this entity have not been adequately evaluated. Treatment with primary curative intent for BIA-ALCL confers a much better prognosis than when performed for a systemic ALCL. Whenever a patient with a breast implant presen...
Source: Deutsches Arzteblatt International - Category: General Medicine Tags: Dtsch Arztebl Int Source Type: research
By Dr. Binita Ashar, director of the division of surgical devices in the FDA’s Center for Devices and Radiological Health Choosing to obtain a breast implant, whether for augmentation or reconstruction, is a deeply personal choice, from the initial decision to undergo breast implant surgery to the size, material and surface texture. These types of decisions should be discussed between a patient and their provider in a transparent and balanced way with clear information about the benefits and risks of the breast implants and the procedure. As a public health agency, we play an important role in ensuring that patients ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog FDA Voice Source Type: news
AbstractPurpose of ReviewBreast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a recently recognised malignancy of T lymphocytes exclusively associated with textured breast implants. This review aims to evaluate existing theories regarding the epidemiology, pathogenesis, clinical evaluation and management of the disease.Recent FindingsThe true incidence of BIA-ALCL is difficult to define. Prevailing pathogenic theories recognise the interplay between textured implants, Gram-negative bacteria, host genetics (e.g. JAK/STAT, p53) and time. Patients typically present with a delayed seroma and less commonly wit...
Source: Current Hematologic Malignancy Reports - Category: Hematology Source Type: research
The objective of this review is to correlate radiological findings of silicone-induced granuloma of breast implant capsule (SIGBIC) from breast MRI (BMRI) scans and complementary findings of ultrasound (US) and positron emission tomography (PET) scan, and its histology originated from surgical breast implant capsulectomy. To make this correlation possible, we divided SIGBIC into three radiological findings: (1) intracapsular SIGBIC, (2) SIGBIC with extracapsular extension, and (3) mixed SIGBIC associated with seroma. Our experience demonstrates histological-radiological correlation in SIGBIC diagnosis. Knowledge of these f...
Source: Journal of Immunology Research - Category: Allergy & Immunology Tags: J Immunol Res Source Type: research
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