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| Sebbin's Statement on Anaplastic Large Cell Lymphoma (ALCL) & Breast Implants | ||
| By: PR Newswire Association LLC. - 20 Sep 2017 | Back to overview list |
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BOISSY L’AILLERIE, France, September 20, 2017 /PRNewswire/ -- Anaplastic Large Cell Lymphoma (ALCL) is a malignant disease affecting the lymphatic system. Although it is a very rare condition, experts now agree that the risk of developing ALCL in the breast is higher in the presence of a breast implant. This variant of the disease is called Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with a textured surface. (Logo: http://mma.prnewswire.com/media/558818/Sebbin_Logo.jpg ) As of February 1, 2017, the FDA had received 359 reports on BIA-ALCL. Based on several sources of evidence, the FDA, as well as many other health authorities globally confirmed the rarity of the disease. The FDA thus stated that there is no need for patients to change their routine medical care and follow-up. Patient safety is our first priority. Diederik Van Goor, CEO of Groupe Sebbin states: "Patient safety has always been and will remain a priority for Groupe SEBBIN. Although no case of BIA-ALCL worldwide has been reported with SEBBIN implants to date, our company closely collaborates with all health authorities to better understand the disease. Over the past 15 years, several thousand patients have been included in long term clinical studies involving SEBBIN implants. These studies, performed in collaboration with plastic surgeons all over the world, are aimed at gathering and communicating data about the safety of our products. As early as 2014, Groupe SEBBIN established a large-scale study with two major Universities and several clinicians to improve the understanding of the biocompatibility of different implant surface textures. All findings of this research are published and available to the scientific community." BIA-ALCL is rare but requires close vigilance. Even though BIA-ALCL is a very rare complication, Groupe SEBBIN takes it very seriously. We are convinced that a close collaboration between manufacturers, clinicians and health authorities is key to greater understanding of BIA- ALCL, and will ultimately benefit patient safety. About Sebbin Group Sebbin is a global medical device company headquartered in France established for more than 30 years. It creates, develops, manufactures and markets high quality medical devices for aesthetic and reconstructive surgery. All products are manufactured with the upmost care and attention at its cutting-edge facility close to Paris. Strict quality control over 100% of their silicone implants ensures optimum safety for the patient. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm (Accessed on 07.09.2017) Contact : SOURCE Sebbin 
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