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Artículos

Prohiben venta de protesis de silicona texturizada en Francia

GC Aesthetics communication to professional customers ANSM decision dated February 4 th, 2019 on Macro textured breast implants

It is our mission at GC Aesthetics – first and foremost - to be a true partner with our patients and customers with respect to product design and performance, product quality and of course product safety. It is also a top priority for us that we are transparent in our communications and our actions. As your partner, we are always monitoring the developments in our industry, including the recent concerns around Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).

Today the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), which is the French National Security Agency of Medicines and Health Products, has taken the isolated action to stop the continued sale of what they consider as macro-texture breast implants in France for several manufacturers. This decision requires that GC Aesthetics remove our textured Impleo, GFX, Cogel and Matrix products from the French market ONLY from 5 th of April 2019.

Due to the low risk of occurrence associated with the BIA-ALCL, ANSM is not recommending explantation from patients.

ANSM decision link:

https://www.ansm.sante.fr/S-informer/Communiques-Communiques-Points-presse/L-ANSM-decide-par-mesure-de-precaution-de-retirer-du-marche-des-implantsmammaires-macrotextures-et-des-implants-mammaires-a-surface-recouverte-de-polyurethane-L-ANSM-ne-recommande-pas-d-explantation-preventive-pour-lesfemmes-porteuses-de-ces-implants-Communique

With patient safety at the heart of what we do, we recognize the significant interest from public, surgeons and regulators in the very rare complication of BIA-ALCL observed in a small population of women who have had breast implant surgery.

GC Aesthetics has the longest combined history of quality in the industry and a reputation for making patient safety and product quality our number 1 priority. GC Aesthetics’ implant safety has been proven through a number of large scale, long term prospective clinical studies involving our textured and smooth surface implants in over 1000 patients, including the only two large scale prospective European study of breast implants with 10-year patient follow up.

With over 3 million implants sold over the last 10 years across 70 countries, we have experienced very low complication rates and are proud of our safety record. We would like to update you on the continued reliability and quality of our products and transparently share with you specific data related to our products and BIA-ALCL in particular:

The global data from our own audited systems demonstrate very low rates of BIA-ALCL associated with our products.

  • In over 2 Million GC Aesthetics Eurosilicone textured implants sold globally since 2006, there have been 7 associated cases of BIA-ALCL, equating to a rate of less than 1 in 291,000 implants (<0.00035%)
  • In over 800,000 GC Aesthetics Nagor textured implants sold globally since 2003, there have been 11 associated cases of BIA-ALCL, equating to a rate of less than 1 in 73,000 implants (<0.0014%).

Furthermore, globally the rate of BIA-ALCL associated with GCA textured implants in the last 10 years is less than 0.0007% and 0% for GCA smooth implants.

Additionally, in the last few months we have successfully renewed our European CE Marks for all textured and smooth Eurosilicone and Nagor breast implants enabling our products to continue serving customers in France and outside France. We remain committed to meet all stringent global standards and regulations.

Specifically in France, our Nagor breast implant has had no reported cases of BIA-ALCL and our current Eurosilicone textured breast implants have had only 2 cases of BIA-ALCL versus the 59 cases reported by ANSM. Our Eurosilicone Round textured breast implant remains approved for use in France is unaffected by the ANSM decision and has had no cases of BIA-ALCL reported in France.

Further study of BIA-ALCL is ongoing. As a responsible company we will continue to closely monitor the incidence of BIA-ALCL and participate in collaborative global research. GCA is committed to continue to be well positioned at the forefront of the industry with a permanent focus on patient safety.

Based on the above transparent information we are more committed than ever to continue to support the market needs with safe and effective solutions to underpin our established "We Care” philosophy.

Best


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